mycophenolate (Rx)

Brand and Other Names:CellCept, Myfortic, more...MMF
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 250mg

tablet

  • 500mg

oral suspension

  • 200mg/mL

powder for injection

  • 500mg/vial

tablet, delayed release

  • 180mg
  • 360mg

Kidney Transplant

Prophylaxis of organ rejection in patients receiving allogeneic renal transplants; use concomitantly with cyclosporine and corticosteroids

Mycophenolate mofetil (MMF): 1 g PO/IV q12hr, infused over ≥2 hours

Mycophenolic acid (MPA): 720 mg PO q12hr

Heart Transplant

Prophylaxis of organ rejection in patients receiving allogeneic cardiac transplants; use concomitantly with cyclosporine and corticosteroids

MMF: 1.5 g PO/IV q12hr, infused over ≥2 hours

Liver Transplant

Prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants; use concomitantly with cyclosporine and corticosteroids

MMF (IV): 1 g q12hr; infused over ≥2 hours

MMF (PO): 1.5 g q12hr

Dosing Modifications

Renal impairment

  • MMF: In severe renal impairment (glomerular filtration rate [GFR] <25 mL/min/1.73 m²), not to exceed 1 g q12hr
  • No dosage adjustment needed in renal transplant patients experiencing delayed graft function postoperatively

Lupus Nephritis (Off-label)

Induction therapy for lupus nephritis (MMF)

Induction: 1 g PO q12hr with a glucocorticoid or 2-3 g for 6 months with glucocorticoids

Maintenance: 0.5-3 g/day or 1 g PO q12hr or 1-2 g daily

Administer with initial IV corticosteroid pulse for 3 days, then prednisone 0.5-1 mg/kg/day PO; not to exceed 10 mg/day; after a few weeks, prednisone may be tapered to lowest effective dose

Dosage Forms & Strengths

capsule

  • 250mg

tablet

  • 500mg

oral suspension

  • 200mg/mL

tablet, extended release

  • 180mg
  • 360mg

Kidney Transplant

<3 months

  • Safety and efficacy not established

>3 months

  • Prophylaxis of organ rejection in patients receiving allogeneic renal transplants
  • MMF (suspension): 600 mg/m² PO q12hr; not to exceed 2 g/day  
  • MMF: BSA 1.25-1.5 m²: 750 mg capsule PO q12hr
  • MMF: BSA >1.5 m²: 1 g capsule/tablet PO q12hr
  • Extended-release MPA: 400 mg/m² PO q12hr; not to exceed 720 mg q12hr
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Interactions

Interaction Checker

and mycophenolate

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            Contraindicated (2)

            • cholestyramine

              cholestyramine decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Cholestyramine binds bile acids and reduces mycophenolic acid exposure.

            • colestipol

              colestipol will decrease the level or effect of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Contraindicated. Colestipol binds bile acids and reduces mycophenolic acid exposure

            Serious - Use Alternative (79)

            • adalimumab

              adalimumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • adenovirus types 4 and 7 live, oral

              mycophenolate decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

            • alefacept

              alefacept and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • amoxicillin

              amoxicillin will decrease the level or effect of mycophenolate by Other (see comment). Avoid or Use Alternate Drug. Effect may be due to impairment of enterohepatic recirculation

            • ampicillin

              ampicillin, mycophenolate. Either increases levels of the other by decreasing renal clearance. Avoid or Use Alternate Drug.

            • anakinra

              anakinra and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • anthrax vaccine

              mycophenolate decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin equine

              antithymocyte globulin equine and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • azathioprine

              azathioprine and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • basiliximab

              basiliximab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • BCG vaccine live

              mycophenolate decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • canakinumab

              canakinumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • carbonyl iron

              carbonyl iron decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • diphtheria & tetanus toxoids

              mycophenolate decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • diphtheria & tetanus toxoids/ acellular pertussis vaccine

              mycophenolate decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

              mycophenolate decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • etanercept

              etanercept and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • ethinylestradiol

              mycophenolate decreases effects of ethinylestradiol by unknown mechanism. Avoid or Use Alternate Drug. Patients should consider using an alternative or additional form of contraception.

            • everolimus

              everolimus and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • ferric maltol

              ferric maltol decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • ferrous fumarate

              ferrous fumarate decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • ferrous gluconate

              ferrous gluconate decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • ferrous sulfate

              ferrous sulfate decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • glatiramer

              glatiramer and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • golimumab

              golimumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • hepatitis A vaccine inactivated

              mycophenolate decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis a/b vaccine

              mycophenolate decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis a/typhoid vaccine

              mycophenolate decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hepatitis b vaccine

              mycophenolate decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • human papillomavirus vaccine, nonavalent

              mycophenolate decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • human papillomavirus vaccine, quadrivalent

              mycophenolate decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • infliximab

              infliximab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • influenza virus vaccine quadrivalent

              mycophenolate decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, adjuvanted

              mycophenolate decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • influenza virus vaccine quadrivalent, cell-cultured

              mycophenolate decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine quadrivalent, intranasal

              mycophenolate decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine trivalent

              mycophenolate decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • influenza virus vaccine trivalent, adjuvanted

              mycophenolate decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • iron dextran complex

              iron dextran complex decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • iron sucrose

              iron sucrose decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • Japanese encephalitis virus vaccine

              mycophenolate decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • leflunomide

              leflunomide and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • measles (rubeola) vaccine

              mycophenolate decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • measles mumps and rubella vaccine, live

              mycophenolate decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • measles, mumps, rubella and varicella vaccine, live

              mycophenolate decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • meningococcal A C Y and W-135 polysaccharide vaccine combined

              mycophenolate decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • muromonab CD3

              muromonab CD3 and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • nafcillin

              nafcillin, mycophenolate. Either increases levels of the other by decreasing renal clearance. Avoid or Use Alternate Drug.

            • pivmecillinam

              pivmecillinam, mycophenolate. Either increases levels of the other by decreasing renal clearance. Avoid or Use Alternate Drug.

            • pneumococcal vaccine 13-valent

              mycophenolate decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine heptavalent

              mycophenolate decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • pneumococcal vaccine polyvalent

              mycophenolate decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • polysaccharide iron

              polysaccharide iron decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • rabies vaccine

              mycophenolate decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.

            • rabies vaccine chick embryo cell derived

              mycophenolate decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • rilonacept

              mycophenolate and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • rose hips

              rose hips decreases levels of mycophenolate by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Interaction only with oral iron administration.

            • rotavirus oral vaccine, live

              mycophenolate decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • rubella vaccine

              mycophenolate decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • sirolimus

              mycophenolate and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • smallpox (vaccinia) vaccine, live

              mycophenolate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tacrolimus

              mycophenolate and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • temocillin

              temocillin, mycophenolate. Either increases levels of the other by decreasing renal clearance. Avoid or Use Alternate Drug.

            • temsirolimus

              mycophenolate and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tetanus toxoid adsorbed or fluid

              mycophenolate decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ticarcillin

              ticarcillin, mycophenolate. Either increases levels of the other by decreasing renal clearance. Avoid or Use Alternate Drug.

            • tick-borne encephalitis vaccine

              mycophenolate decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tocilizumab

              tocilizumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tofacitinib

              mycophenolate, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tongkat ali

              mycophenolate and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • travelers diarrhea and cholera vaccine inactivated

              mycophenolate decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • typhoid polysaccharide vaccine

              mycophenolate decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • typhoid vaccine live

              mycophenolate decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ustekinumab

              mycophenolate and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • varicella virus vaccine live

              mycophenolate decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • yellow fever vaccine

              mycophenolate decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • zoster vaccine live

              mycophenolate decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            Monitor Closely (105)

            • aceclofenac

              aceclofenac will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • acemetacin

              acemetacin will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • acyclovir

              acyclovir will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • aluminum hydroxide

              aluminum hydroxide will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • aminohippurate sodium

              aminohippurate sodium will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • aspirin

              aspirin will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • aspirin rectal

              aspirin rectal will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • aspirin/citric acid/sodium bicarbonate

              aspirin/citric acid/sodium bicarbonate will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • astragalus

              mycophenolate increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • balsalazide

              balsalazide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • belatacept

              belatacept increases levels of mycophenolate by Other (see comment). Use Caution/Monitor. Comment: Potential change of mycophenolic acid (MPA) exposure after crossover from cyclosporine to belatacept or from belatacept to cyclosporine in patients concomitantly receiving MMF.

              belatacept and mycophenolate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • bendroflumethiazide

              bendroflumethiazide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • calcium carbonate

              calcium carbonate will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • cefadroxil

              cefadroxil will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • cefamandole

              cefamandole will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • cefpirome

              cefpirome will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • ceftibuten

              ceftibuten will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • celecoxib

              celecoxib will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • cephalexin

              cephalexin will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • chlorothiazide

              chlorothiazide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • chlorpropamide

              chlorpropamide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • chlorthalidone

              chlorthalidone will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • cholera vaccine

              mycophenolate decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • choline magnesium trisalicylate

              choline magnesium trisalicylate will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • cyclopenthiazide

              cyclopenthiazide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • dengue vaccine

              mycophenolate decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • denosumab

              mycophenolate, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • dexlansoprazole

              dexlansoprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Potential interaction applies to mycophenolate mofetil. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction. Clinical significance unclear.

            • dichlorphenamide

              dichlorphenamide and mycophenolate both decrease serum potassium. Use Caution/Monitor.

              dichlorphenamide, mycophenolate. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.

            • diclofenac

              diclofenac will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • dicloxacillin

              dicloxacillin decreases levels of mycophenolate by decreasing metabolism. Use Caution/Monitor. decreases concentrations of active metabolite of mycophenolate possibly by reducing/impairing enterohepatic circulation.

            • didanosine

              didanosine will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration

            • diflunisal

              diflunisal will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • echinacea

              mycophenolate increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • esomeprazole

              esomeprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Potential interaction applies to mycophenolate mofetil. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction. Clinical significance unclear.

            • etodolac

              etodolac will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • famotidine

              famotidine will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • fenoprofen

              fenoprofen will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • fingolimod

              mycophenolate increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • flurbiprofen

              flurbiprofen will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • ganciclovir

              ganciclovir will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • haemophilus influenzae type b vaccine

              mycophenolate decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

            • hydrochlorothiazide

              hydrochlorothiazide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • hydroxyurea

              hydroxyurea, mycophenolate. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.

            • ibuprofen

              ibuprofen will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • ibuprofen IV

              ibuprofen IV will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • ibuprofen/famotidine

              ibuprofen/famotidine will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • indapamide

              indapamide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • indomethacin

              indomethacin will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • influenza virus vaccine quadrivalent, recombinant

              mycophenolate decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • influenza virus vaccine trivalent, recombinant

              mycophenolate decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.

            • isavuconazonium sulfate

              isavuconazonium sulfate will increase the level or effect of mycophenolate by Other (see comment). Use Caution/Monitor. Isavuconazonium substrate (a UGT inhibitor) may increase exposure to mycophenolate mofetil (a UGT substrate). Monitor for mycophenolic acid-related toxicities when coadministered with isavuconazonium sulfate.

              mycophenolate and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • ketoprofen

              ketoprofen will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • ketorolac

              ketorolac will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • ketorolac intranasal

              ketorolac intranasal will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • lansoprazole

              lansoprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Potential interaction applies to mycophenolate mofetil. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction. Clinical significance unclear.

            • levonorgestrel oral

              mycophenolate decreases levels of levonorgestrel oral by unspecified interaction mechanism. Use Caution/Monitor. Consider additional birth control methods during mycophenolate administration.

            • lomustine

              lomustine and mycophenolate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • lornoxicam

              lornoxicam will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • magnesium supplement

              magnesium supplement will decrease the level or effect of mycophenolate by Other (see comment). Modify Therapy/Monitor Closely. Drug may bind to magnesium ions in the GI tract, which decreases absorption; separate administration of drugs to minimize interaction

            • maitake

              mycophenolate increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.

            • mechlorethamine

              mechlorethamine, mycophenolate. immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections. .

            • meclofenamate

              meclofenamate will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • mefenamic acid

              mefenamic acid will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • meloxicam

              meloxicam will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • meningococcal group B vaccine

              mycophenolate decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

            • mercaptopurine

              mercaptopurine and mycophenolate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • mesalamine

              mesalamine will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • methotrexate

              mycophenolate, methotrexate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Infections may occur.

            • methyclothiazide

              methyclothiazide will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • metolazone

              metolazone will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • nabumetone

              nabumetone will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • naproxen

              naproxen will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • nizatidine

              nizatidine will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • ocrelizumab

              mycophenolate and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunosuppressants may increase the risk of immunosuppression.

            • ofatumumab SC

              ofatumumab SC, mycophenolate. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • olaparib

              mycophenolate and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

            • omeprazole

              omeprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Potential interaction applies to mycophenolate mofetil. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction. Clinical significance unclear.

            • oxaprozin

              oxaprozin will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • ozanimod

              ozanimod, mycophenolate. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.

            • pantoprazole

              pantoprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Potential interaction applies to the prodrug mycophenolate mofetil conversion to active mycophenolic acid. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction.

            • parecoxib

              parecoxib will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • piroxicam

              piroxicam will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • poliovirus vaccine inactivated

              mycophenolate decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

            • ponesimod

              ponesimod and mycophenolate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • probenecid

              probenecid increases levels of mycophenolate by decreasing renal clearance. Use Caution/Monitor. Probenecid may interfere with renal tubular secretion of mycophenolate active metabolites.

            • rabeprazole

              rabeprazole will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Potential interaction applies to mycophenolate mofetil. Enteric coated mycophenolate sodium formulation is less sensitive to this interaction. Clinical significance unclear.

            • rose hips

              rose hips will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • salicylates (non-asa)

              salicylates (non-asa) will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • salsalate

              salsalate will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • siponimod

              siponimod and mycophenolate both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              mycophenolate decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • sodium bicarbonate

              sodium bicarbonate will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • sodium citrate/citric acid

              sodium citrate/citric acid will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

            • sodium zirconium cyclosilicate

              sodium zirconium cyclosilicate will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate.

            • sulfasalazine

              sulfasalazine will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • sulindac

              sulindac will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • telmisartan

              telmisartan will decrease the level or effect of mycophenolate by Other (see comment). Use Caution/Monitor. Concommitant administration with telmisartan may result in significant decrease in mycophenolic acid (MPA) concentrations; telmisartan changes MPA?s elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity

            • tolfenamic acid

              tolfenamic acid will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • tolmetin

              tolmetin will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • trastuzumab

              trastuzumab, mycophenolate. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, mycophenolate. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • valganciclovir

              mycophenolate will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • willow bark

              willow bark will increase the level or effect of mycophenolate by acidic (anionic) drug competition for renal tubular clearance. Use Caution/Monitor.

            • zoster vaccine recombinant

              mycophenolate decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

            Minor (9)

            • bazedoxifene/conjugated estrogens

              mycophenolate decreases effects of bazedoxifene/conjugated estrogens by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • conjugated estrogens

              mycophenolate decreases effects of conjugated estrogens by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • conjugated estrogens, vaginal

              mycophenolate decreases effects of conjugated estrogens, vaginal by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • estradiol

              mycophenolate decreases effects of estradiol by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • estrogens conjugated synthetic

              mycophenolate decreases effects of estrogens conjugated synthetic by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • estrogens esterified

              mycophenolate decreases effects of estrogens esterified by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • estropipate

              mycophenolate decreases effects of estropipate by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • mestranol

              mycophenolate decreases effects of mestranol by unknown mechanism. Minor/Significance Unknown. Clinical significance unclear.

            • phenytoin

              mycophenolate increases effects of phenytoin by plasma protein binding competition. Minor/Significance Unknown. Mycophenolate decreased phenytoin protein binding from 90% to 87% in vitro. The clinical significance of this interaction is unknown. .

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            Adverse Effects

            >10%

            Hyperglycemia (44%)

            Hypercholesterolemia (41%)

            Hypomagnesemia (39%)

            Dyspnea (37%)

            Back pain (35%)

            Increased blood urea nitrogen (BUN) (35%)

            Leukopenia (34%)

            Pleural effusion (34%)

            Urinary tract infection (34%)

            Increasing frequency of cough (31%)

            Hypocalcemia (30%)

            Hypertension (28%)

            Abdominal pain (27%)

            Peripheral edema (27%)

            Anemia (26%)

            Fever (23%)

            Nausea (23%)

            Hyperkalemia (22%)

            Diarrhea (21%)

            Infection (21%)

            Headache (16%)

            1-10%

            Melanoma (1.6-4.2%)

            Other malignancies (0.7-2.1%)

            Lymphoma (0.4-1%)

            Opportunistic infection (including herpes)

            Neutropenia

            GI bleeding

            Pulmonary fibrosis

            Progressive multifocal leukoencephalopathy

            Postmarketing Reports

            BK virus-associated nephropathy

            Congenital malformations, including ear, facial, cardiac and nervous system malformations and an increased incidence of first trimester pregnancy

            Colitis (sometimes caused by cytomegalovirus), pancreatitis, isolated cases of intestinal villous atrophy

            Cases of pure red cell aplasia (PRCA) and hypogammaglobulinemia reported when administered in combination with other immunosuppressive agents

            Cardiovascular: Venous thrombosis when therapy administered intravenously

            Hematologic and lymphatic: Bone marrow failure, cases of pure red cell aplasia (PRCA)

            Immune: Hypersensitivity

            Infections: Bronchiectasis, interstitial lung disease

            Vascular: Lymphocele

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            Warnings

            Black Box Warnings

            Increased susceptibility to infection as consequence of immunosuppression

            Drug should be prescribed only by healthcare providers experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients

            Patients receiving drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources

            Drug increases risk of developing lymphoma and risk of skin malignancy

            Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes

            Myfortic and CellCept dosage form absorbed differently; not for use interchangeably

            Healthcare provider responsible for maintenance therapy should have all information required for follow-up

            Risk of first-trimester miscarriage and congenital malformations; avoid if safer treatment options are available; females of reproductive potential must be counseled regarding pregnancy prevention and planning; after negative pregnancy test and follow-up, women of child-bearing age should use 2 forms of reliable contraception (hormone plus barrier) during entire course of mycophenolate therapy and continue until 6 weeks after drug discontinuance

            Contraindications

            Hypersensitivity

            IV formulation (CellCept) in patients allergic to polysorbate 80

            Cautions

            Pure red-cell aplasia reported in patients treated with MMF or MPA in combination with other immunosuppressive agents

            Avoid use in hypoxanthine-guanine phosphoribosyltransferase (HGPRT) deficiency (Lesch-Nyhan, Kelley-Seegmiller syndrome)

            Risk of miscarriage and congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system (see Black Box Warnings); females of reproductive potential must be made aware of risks and must be counseled regarding pregnancy prevention and planning; avoid use of MMF during pregnancy if safer treatment options are available

            Drug increases risk of developing lymphoma; risk appears to be related to intensity and duration of immunosuppression rather than to use of any specific agent; for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor

            MPA not indicated for hepatic or cardiac transplants

            Use may be rarely associated with gastric or duodenal ulcers, GI bleeding and/or perforation

            Safety and effectiveness of MPA for de novo pediatric renal transplant not established

            Neutropenia may occur (may require dose reduction)

            Must not be administered by rapid or bolus IV injection; increases risk of local adverse reactions such as phlebitis and thrombosis

            Toxicity may increase in renal impairment; use caution

            Patients should not donate blood during therapy and for at least 6 weeks following discontinuation of therapy because their blood or blood products might be administered to a female of reproductive potential or a pregnant woman

            Based on animal data, men should not donate semen during therapy and for 90 days following discontinuation of drug Phenylalanine can be harmful to patients with phenylketonuria (PKU)

            Immunosuppression increases risk of developing lymphoma and skin malignancies; majority of post-transplant lymphoproliferative disorder (PTLD) cases appear to be related to Epstein Barr Virus (EBV) infection; the risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children

            A variety of drugs have potential to alter systemic MPA exposure when co-administered with this drug; determination of mycophenolic acid (MPA) concentrations in plasma before and after making any changes to immunosuppressive therapy, or when adding or discontinuing concomitant medications, may be appropriate to ensure MPA concentrations remain stable

            Therapy may impact ability to drive and use machines; patients should avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment

            Oral suspension dosage form contains aspartame, a source of phenylalanine (0.56 mg phenylalanine/mL suspension); before prescribing oral suspension to a patient with PKU, consider combined daily amount of phenylalanine from all sources, including drug

            Use of live attenuated vaccines should be avoided (eg, intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) and patients should be advised that vaccinations may be less effective; advise patients to discuss with physician before seeking any immunizations

            Acute inflammatory syndrome

            • Acute inflammatory syndrome (AIS) reported with the use of MMF and mycophenolate products, and some cases have resulted in hospitalization
            • AIS is a paradoxical pro-inflammatory reaction characterized by fever, arthralgias, arthritis, muscle pain, and elevated inflammatory markers including, C-reactive protein and erythrocyte sedimentation rate, without evidence of infection or underlying disease recurrence
            • Symptoms occur within weeks to months of initiation of treatment or a dose increase; after discontinuation, improvement of symptoms and inflammatory markers are usually observed within 24 to 48 hours
            • Monitor patients for symptoms and laboratory parameters of AIS when starting treatment with mycophenolate products or when increasing the dosage
            • Discontinue treatment and consider other treatment alternatives based on risk and benefit for the patient

            Serious infections and viral reactivation

            • Risk of infection increases with total immunosuppressive load
            • Increased risk of developing bacterial, fungal, protozoal, and new or reactivated viral infections, including opportunistic infections
            • Because of danger of oversuppression of immune system, which can increase susceptibility to infection, combination immunosuppressant therapy should be used with caution
            • May increase risk of new or reactivated viral infections, including polyomavirus-associated nephropathy (PVAN), JC virus-associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, and reactivation of hepatitis B or C
            • PVAN, especially when due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss
            • PML, which is sometimes fatal, typically presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia
            • Consider dose reduction or discontinuation in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft
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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing therapy; to report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191

            Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems

            Consider alternative immunosuppressants with less potential for embryofetal toxicity; risks and benefits of therapy should be discussed with the pregnant woman; the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear

            Animal data

            • Oral administration of mycophenolate to rats and rabbits during period of organogenesis produced congenital malformations and pregnancy loss at doses less than recommended clinical dose (0.02 to 0.1 times the recommended clinical doses in kidney and heart transplant patients)

            Lactation

            There are no data on presence of drug in human milk, or effects on milk production; there are limited data in the National Transplantation Pregnancy Registry on effects of mycophenolate on a breastfed child; studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk

            Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits T- and B-cell proliferation, as well as antibody production

            Acts as noncompetitive, selective, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH)

            Absorption

            Bioavailability: 94% (CellCept); 72% (Myfortic)

            Peak plasma time: 1.5 hr

            Distribution

            Protein bound: 82-97%

            Vd (MMF): IV, 3.6 L/kg; PO, 4.0 L/kg

            Vd (MPA): Steady state, 54 L; elimination phase, 112 L

            Metabolism

            Metabolized via enterohepatic recirculation

            Metabolites: MPA (active form; MMF is prodrug)

            Elimination

            Half-life (MMF): PO, 18 hr; IV, 17 hr

            Half-life (MPA): PO, 8-16 hr; MPA glucuronide (MPAG), 13-17 hr

            Excretion as metabolites: Urine; feces

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            Administration

            Drug is taken on empty stomach 1 hour before or 2 hours after meals

            Once dosage is stabilized, MMF can be taken with food after kidney transplant

            Solid PO forms should be swallowed whole and not chewed, crushed, or split; capsules must not be opened

            IV Preparation

            Does not contain antibacterial preservative; therefore, reconstitution and dilution must be done aseptically in vertical laminar flow hood, with same precautions as for antineoplastic agents

            Step 1

            • To prepare 1-g dose, use 2 vials; to prepare 1.5-g dose, use 3 vials
            • Reconstitute contents of each vial by injecting 14 mL D5W, then gently shake to dissolve
            • Before diluting further, inspect resulting slightly yellow solution for particulate matter and discoloration; discard if either is observed

            Step 2

            • To prepare 1-g dose, further dilute contents of 2 reconstituted vials into 140 mL D5W; to prepare 1.5-g dose, further dilute contents of 3 reconstituted vials into 210 mL D5W; final concentration of both solutions is 6 mg/mL
            • Inspect infusion solution for particulate matter and discoloration; discard if either is observed

            IV Administration

            Infuse over ≥2 hours

            Do not administer via rapid or bolus injection

            Storage

            Infusion solution is stable for 4 hours after reconstitution and dilution

            Store solution at 15-30°C (59-86°F)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            500 mg tablet
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            500 mg tablet
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            500 mg tablet
            mycophenolate mofetil oral
            -
            500 mg tablet
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            500 mg tablet
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            250 mg capsule
            mycophenolate mofetil oral
            -
            200 mg/mL suspension
            mycophenolate mofetil oral
            -
            500 mg tablet
            mycophenolate mofetil oral
            -
            200 mg/mL suspension
            mycophenolate mofetil oral
            -
            250 mg capsule
            CellCept oral
            -
            250 mg capsule
            CellCept oral
            -
            500 mg tablet
            CellCept oral
            -
            200 mg/mL suspension

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            mycophenolate mofetil oral

            MYCOPHENOLATE MOFETIL - ORAL

            (my-coh-FEN-oh-late MOW-fet-ill)

            COMMON BRAND NAME(S): Cellcept

            WARNING: Mycophenolate may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough, burning/painful/urgent urination, change in the amount of urine).Mycophenolate may rarely cause cancer (such as lymphoma, skin cancer). Protect your skin from the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you have any of the following symptoms of cancer: swollen glands, sudden weight loss, night sweats, change in appearance or size of moles, or unusual skin changes/growth.Mycophenolate may harm an unborn baby. When using mycophenolate, all males - and all women of childbearing age - must use reliable forms of birth control. See also Precautions section.

            USES: Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). It belongs to a class of medications called immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking mycophenolate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually twice daily on an empty stomach, 1 hour before or 2 hours after meals.Swallow the medication whole. Do not crush or chew. If you are taking the capsules, do not open them before swallowing.If the capsule comes apart or if there is dust from the tablets, avoid inhaling the powder or dust, and avoid direct contact with the skin or eyes. If contact occurs, wash the affected skin area well with soap and water or rinse your eyes with plain water. Consult your pharmacist for details.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets or powder from the capsules.The dosage is based on your medical condition and response to treatment. In children, it is also based on body size.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Keep taking this medication even if you feel well. Do not stop taking mycophenolate without first talking to your doctor.Certain products may make it harder for your body to absorb mycophenolate if they are taken at the same time. Do not take this medication at the same time as antacids containing aluminum and/or magnesium, cholestyramine, colestipol, or calcium-free phosphate binders (such as aluminum products, lanthanum, sevelamer). Ask your pharmacist for more details.Do not change brands or forms of mycophenolate unless directed by your doctor.

            SIDE EFFECTS: See also Warning section.Constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, tremor, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: unusual tiredness, fast/irregular heartbeat, easy bleeding/bruising, swelling of the feet or ankles, joint pain/stiffness, muscle pain.Get medical help right away if you have any very serious side effects, including: stomach/abdominal pain that doesn't go away, black stools, vomit that looks like coffee grounds, chest pain, shortness of breath/rapid breathing.This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: See also Warning section.Before taking mycophenolate mofetil, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid; or to mycophenolate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, liver disease (such as hepatitis B, hepatitis C), kidney disease, current/past infections (such as herpes, shingles), stomach/intestinal problems (such as ulcers), rare genetic disorders (such as Lesch-Nyhan or Kelley-Seegmiller syndromes).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Mycophenolate can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not donate blood while using mycophenolate and for 6 weeks after stopping this drug. Do not donate sperm while using mycophenolate and for 90 days after stopping this drug.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets or powder from the capsules.This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for 6 weeks after stopping it. If you become pregnant or think you may be pregnant, tell your doctor right away. Women of childbearing age should talk to their doctor(s) about the benefits and risks (such as miscarriage). Women of childbearing age should have a pregnancy test before starting this medication, after 8 to 10 days on treatment, and during routine follow-up visits.Women of childbearing age should ask about using reliable forms of birth control during treatment and for 6 weeks after stopping treatment. Males with female partners of childbearing age should use reliable forms of birth control while using this medication and for 3 months after stopping treatment. See also Drug Interactions section.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. If you are using hormonal birth control, you should use an additional non-hormonal form of birth control while using this medication. Discuss your options with your doctor or pharmacist. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood counts, drug levels, kidney function, pregnancy test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.Attend a transplant education class or support group. Learn to recognize the signs and symptoms of organ rejection and tell your doctor right away if they occur.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised October 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.