ganciclovir (Rx)

Brand and Other Names:Cytovene
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 500mg

CMV Retinitis

Indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adults, including patients with acquired immunodeficiency syndrome (AIDS)

Induction: 5 mg/kg IV q12hr, infused over 1 hr for 14-21 days

Maintenance

  • Following induction treatment, 5 mg/kg IV qDay OR
  • 6 mg/kg IV qDay for 5 days/week

CMV Prevention in Transplant Recipients

Indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease

Induction: 5 mg/kg IV qDay infused over 1 hr for 7-14 days

Maintenance

  • 5 mg/kg IV qDay for 100-120 days after transplant OR
  • 6 mg/kg IV qDay for 5 day/week for 100-120 days after transplant

CMV Prevention in HIV Infected (Off-label)

1000 mg PO TID (primary/recurrence)

5-6 mg/kg 5-7x/week IV (recurrence)

CMV Colitis or Esophagitis in HIV-Infected Patients (Off-label)

Treat initially with ganciclovir 5 mg/kg/dose IV q12hr; once therapy is tolerated, change to valganciclovir 900 mg PO q12hr for 21-42 days or until signs and symptoms have resolved

Dosage Modifications

Renal impairment

  • Induction dose
    • CrCl 50-69 mL/min: 2.5 mg/kg IV q12hr
    • CrCl 25-49 mL/min: 2.5 mg/kg IV qDay
    • CrCl 10-24 mL/min: 1.25 mg/kg IV qDay
    • CrCl <10 mL/min: 1.25 mg/kg IV 3 x per week following hemodialysis
  • Maintenance dose
    • CrCl 50-69 mL/min: 2.5 mg/kg IV qDay
    • CrCl 25-49 mL/min: 1.25 mg/kg IV qDay
    • CrCl 10-24 mL/min: 0.625 mg/kg IV qDay
    • CrCl <10 mL/min: 0.625 mg/kg IV 3 x per week following hemodialysis

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 500mg

CMV Prevention in HIV-infected (off-label)

5 mg/kg IV qDay (recurrence)

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Interactions

Interaction Checker

and ganciclovir

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              Serious - Use Alternative (8)

              • abacavir

                ganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.

              • bacitracin

                ganciclovir and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs

              • imipenem/cilastatin

                ganciclovir, imipenem/cilastatin. unknown mechanism. Avoid or Use Alternate Drug. Coadministration may increase risk of seizures. Avoid unless potential benefit outweighs the risk.

              • imipenem/cilastatin/relebactam

                ganciclovir, imipenem/cilastatin/relebactam. unknown mechanism. Avoid or Use Alternate Drug. Coadministration may increase risk of seizures. Avoid unless potential benefit outweighs the risk.

              • pretomanid

                pretomanid will increase the level or effect of ganciclovir by Other (see comment). Avoid or Use Alternate Drug. In vitro studies demonstrated that pretomanid significantly inhibits OAT3; monitor for increased adverse effects and consider dosage reduction for OAT3 substrates.

              • talimogene laherparepvec

                ganciclovir decreases effects of talimogene laherparepvec by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Although no drug interactions studies have been performed, antiherpetic viral agents may interfere with the effectiveness of talimogene laherparepvec.

              • trilaciclib

                trilaciclib will decrease the level or effect of ganciclovir by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.

              • zidovudine

                ganciclovir increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.

              Monitor Closely (18)

              • acalabrutinib

                acalabrutinib, ganciclovir. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • dichlorphenamide

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

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

              • didanosine

                ganciclovir increases levels of didanosine by decreasing renal clearance. Use Caution/Monitor.

                ganciclovir, didanosine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

              • doxorubicin

                ganciclovir increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              • doxorubicin liposomal

                ganciclovir increases toxicity of doxorubicin liposomal by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                ganciclovir, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Either increases toxicity of the other by decreasing renal clearance. Use Caution/Monitor. Toxicity may result from coadministration of emtricitabine and tenofovir with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion .

              • emtricitabine

                ganciclovir, emtricitabine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

                ganciclovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

              • hydroxyurea

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

              • ifosfamide

                ifosfamide, ganciclovir. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.

              • lamivudine

                ganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Increased risk of hematologic toxicity.

              • mycophenolate

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

              • peramivir

                ganciclovir increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.

              • pivmecillinam

                pivmecillinam, ganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • probenecid

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

              • temocillin

                temocillin, ganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • tenofovir DF

                ganciclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.

              • ticarcillin

                ticarcillin, ganciclovir. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

              • voclosporin

                voclosporin, ganciclovir. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              Minor (63)

              • aceclofenac

                aceclofenac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acemetacin

                acemetacin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • acyclovir

                acyclovir will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aminohippurate sodium

                aminohippurate sodium will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • amphotericin B deoxycholate

                ganciclovir increases toxicity of amphotericin B deoxycholate by pharmacodynamic synergism. Minor/Significance Unknown.

              • aspirin

                aspirin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin rectal

                aspirin rectal will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • balsalazide

                balsalazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • bendroflumethiazide

                bendroflumethiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefadroxil

                cefadroxil will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefamandole

                cefamandole will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cefpirome

                cefpirome will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ceftibuten

                ceftibuten will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • celecoxib

                celecoxib will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cephalexin

                cephalexin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorothiazide

                chlorothiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorpropamide

                chlorpropamide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • chlorthalidone

                chlorthalidone will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • cyclopenthiazide

                cyclopenthiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • dapsone

                ganciclovir increases toxicity of dapsone by pharmacodynamic synergism. Minor/Significance Unknown.

              • diclofenac

                diclofenac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • diflunisal

                diflunisal will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • entecavir

                ganciclovir, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

              • etodolac

                etodolac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • fenoprofen

                fenoprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • flucytosine

                ganciclovir increases toxicity of flucytosine by pharmacodynamic synergism. Minor/Significance Unknown.

              • flurbiprofen

                flurbiprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • hydrochlorothiazide

                hydrochlorothiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ibuprofen

                ibuprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ibuprofen IV

                ibuprofen IV will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indapamide

                indapamide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • indomethacin

                indomethacin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketoprofen

                ketoprofen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac

                ketorolac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • ketorolac intranasal

                ketorolac intranasal will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • lornoxicam

                lornoxicam will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meclofenamate

                meclofenamate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • mefenamic acid

                mefenamic acid will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • meloxicam

                meloxicam will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • mesalamine

                mesalamine will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • methyclothiazide

                methyclothiazide will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • metolazone

                metolazone will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • nabumetone

                nabumetone will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • naproxen

                naproxen will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • oxaprozin

                oxaprozin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • parecoxib

                parecoxib will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • pentamidine

                ganciclovir increases toxicity of pentamidine by pharmacodynamic synergism. Minor/Significance Unknown.

              • piroxicam

                piroxicam will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • rose hips

                rose hips will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • salicylates (non-asa)

                salicylates (non-asa) will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • salsalate

                salsalate will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sulfamethoxazole

                ganciclovir increases toxicity of sulfamethoxazole by pharmacodynamic synergism. Minor/Significance Unknown.

              • sulfasalazine

                sulfasalazine will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • sulindac

                sulindac will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolfenamic acid

                tolfenamic acid will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • tolmetin

                tolmetin will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • valganciclovir

                ganciclovir will increase the level or effect of valganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

              • vinblastine

                ganciclovir increases toxicity of vinblastine by pharmacodynamic synergism. Minor/Significance Unknown.

              • vincristine

                ganciclovir increases toxicity of vincristine by pharmacodynamic synergism. Minor/Significance Unknown.

              • vincristine liposomal

                ganciclovir increases toxicity of vincristine liposomal by pharmacodynamic synergism. Minor/Significance Unknown.

              • willow bark

                willow bark will increase the level or effect of ganciclovir by acidic (anionic) drug competition for renal tubular clearance. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Neutropenia w/ ANC <1000/cu.mm (25-50%)

              Thrombocytopenia (20%)

              1-10%

              Elevated LFTs

              Anemia

              Confusion

              Headache

              Nausea/vomiting

              Neuropathy

              Paresthesia

              Pruritus

              Retinal detachment,

              Rash

              Sepsis

              Weakness

              Frequency Not Defined

              Blood and lymphatic disorders: Pancytopenia, bone marrow failure

              Cardiac disorders: Arrhythmias

              Ear and labyrinth disorders: Tinnitus, ear pain, deafness

              Eye disorders: Visual impairment, vitreous disorders, eye pain, conjunctivitis, macular edema

              Gastrointestinal disorders: Abdominal pain, dyspepsia, flatulence, constipation, mouth ulceration, dysphagia, abdominal distention, pancreatitis, gastrointestinal perforation, eructation, dry mouth

              General disorders and administration site conditions: Fatigue, injection site inflammation, edema, pain, malaise, asthenia, chest pain, multiple organ failure

              Blood Immune system disorders: Hypersensitivity Infections and infestations: Candida infections including oral candidiasis, upper respiratory infection, influenza, urinary tract infections, cellulitis

              Investigations: Blood alkaline phosphatase increased, hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, creatinine clearance decreased

              Metabolism and nutrition disorders: Weight decreased

              Musculoskeletal and connective tissue disorders: Back pain, myalgia, arthralgia, muscle spasms, leg cramps, myasthenia

              Nervous system disorders: Headache, insomnia, dizziness, paresthesia, hypoaesthesia, seizures, somnolence, dysgeusia (taste disturbance), tremor

              Psychiatric disorders: Depression, confusional state, anxiety, agitation, psychotic disorder, thinking abnormal, abnormal dreams

              Renal and urinary disorders: Kidney failure, renal function abnormal, urinary frequency, hematuria

              Respiratory, thoracic and mediastinal disorders: Cough, dyspnea

              Skin and subcutaneous tissues disorders: Dermatitis, alopecia, dry skin, urticaria, rash

              Vascular disorders: Hypotension, hypertension, phlebitis, vasodilation

              Postmarketing Reports

              Hemolytic anemia, agranulocytosis, granulocytopenia

              Cardiac arrest, conduction disorder, torsade de pointes, ventricular tachycardia

              Congenital anomaly

              Inappropriate antidiuretic hormone secretion

              Cataracts, dry eyes

              Intestinal ulcer

              Cholelithiasis, cholestasis, hepatic failure, hepatitis

              Anaphylactic reaction, allergic reaction, vasculitis

              Blood triglycerides increased

              Acidosis, hypercalcemia, hyponatremia Arthritis, rhabdomyolysis

              Dysesthesia, dysphasia, extrapyramidal disorder, facial paralysis, amnesia, anosmia, myelopathy, cerebrovascular accident, third cranial nerve paralysis, aphasia, encephalopathy, intracranial hypertension

              Irritability, hallucinations

              Renal tubular disorder, hemolytic uremic syndrome

              Infertility, testicular hypotrophy

              Bronchospasm, pulmonary fibrosis

              Exfoliative dermatitis, Stevens Johnson syndrome Peripheral ischemia

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              Warnings

              Black Box Warnings

              Hematologic toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia reported

              Impairment of fertility: Based on animal data and limited human data, ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females

              Fetal toxicity: Based on animal data, ganciclovir has the potential to cause birth defects in humans

              Mutagenesis and carcinogenesis: Based on animal data, ganciclovir has the potential to cause cancers in humans

              Contraindications

              Hypersensitivity reaction (eg, anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation

              Cautions

              Also see Black Box Warnings

              Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia observed; not recommended if the absolute neutrophil count (ANC) <500 cells/mcL, hemoglobin <8 g/dL, or the platelet count <25,000 cells/mcL

              Exercise caution patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation

              Renal impairment should be used with caution in patients with impaired renal function because the half-life and plasma/serum concentrations of ganciclovir will be increased due to reduced renal clearance; increased serum creatinine levels have been reported in elderly patients and in transplant recipients receiving concomitant nephrotoxic medications (eg, cyclosporine and amphotericin B); monitor renal function during therapy is essential, especially for elderly patients and those patients receiving concomitant agents that may cause nephrotoxicity

              Based on animal data and limited human data, recommended human dose (RHD) may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females (see Pregnancy)

              Fetal toxicity may occur when administered to pregnant women based on findings in animal studies (see Pregnancy)

              Animal data indicate that ganciclovir is mutagenic and carcinogenic, may potentially be carcinogenic in humans

              Drug interactions overview

              • Coadministration with imipenem-cilastatin is not recommended because generalized seizures reported
              • Monitor renal function when coadministered with cyclosporine or amphotericin B because of potential increase in serum creatinine
              • Based on increased risk, monitor for hematological and renal toxicity when concomitantly using mycophenolate mofetil with ganciclovir
              • Other drugs associated with myelosuppression or nephrotoxicity: Consider only if the potential benefits outweigh the risks
              • Coadministration with didanosine will potentially increase plasma levels and toxicities of didanosine; closely monitor
              • Concomitant use with probenecid may increase ganciclovir levels; consider reducing dose of ganciclovir and monitor possible toxicities
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              Pregnancy & Lactation

              Pregnancy

              Placental transfer of ganciclovir has been shown to occur based on ex vivo experiments with human placenta and in at least 1 case report in a pregnant woman; however, no adequate human data are available to establish whether ganciclovir poses a risk to pregnancy outcomes

              In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures 2 times the exposure at the recommended human dose (RHD)

              Disease-associated maternal and/or embryo-fetal risk

              • Most maternal CMV infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome; however, in immunocompromised patients, CMV infections may be symptomatic and may result in significant maternal morbidity and mortality
              • CMV fetal transmission results from maternal viremia and transplacental infection
              • Perinatal infection can also occur from exposure of the neonate to CMV shedding in the genital tract ~10% of children with congenital CMV infection are symptomatic at birth
              • Mortality in symptomatic infants is ~10% and ~50-90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems
              • Risk of congenital CMV infection resulting from primary maternal CMV infection may be higher and of greater severity than that resulting from maternal reactivation of CMV infection

              Contraception

              • Test for pregnancy in females of reproductive potential before initiating treatment
              • Females: Because of ganciclovir’s mutagenic and teratogenic potential, use effective contraception during treatment and for at least 30 days following treatment
              • Males: Because of ganciclovir’s mutagenic and teratogenic potential, use barrier contraception during treatment and for at least 90 days following treatment

              Infertility

              • Based on animal data and limited human data, may cause temporary or permanent inhibition of spermatogenesis in males, and may cause suppression of fertility in females at recommended human dose (RHD); advise patients that fertility may be impaired with use

              Lactation

              No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production

              Ganciclovir was present in milk in lactating rats following administration

              Breastfeeding is not recommended during treatment owing to the potential for serious adverse reactions in nursing infants

              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 of viral DNA polymerases resulting in chain termination

              Absorption

              AUC: 22.1-26.8 mcg·hr/mL

              Distribution

              Vd (steady-state): 0.74 L/kg

              Diffuses across the placenta

              Protein binding: 1-2% over ganciclovir concentrations of 0.5-51 mcg/mL

              Elimination

              Clearance: 3.2 mL/min/kg (renal); 3.52 mL/min/kg (systemic)

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              Administration

              IV Compatibilities

              Solution: compatible w/ most common solvents

              Y-site (partial list): allopurinol, fluconazole, linezolid, propofol

              IV Incompatibilities

              Y-site: aldesleukin, amifostine, amsacrine, aztreonam, cefepime, cisatracurium(?), cytarabine, doxorubicin, fludarabine, foscarnet, gemcitabine, ondansetron, piperacillin/tazobactam, sargramostim, tacrolimus, vinorelbine

              IV Preparation

              Reconstitute vial with 10 mL of Sterile Water for Injection

              Do not use bacteriostatic water for injection containing parabens; it is incompatible with ganciclovir and may cause precipitation

              Gently swirl the vial in order to ensure complete wetting of the product; continue swirling until a clear reconstituted solution is obtained

              Visually inspect solution for particulate matter and discoloration prior to proceeding with infusion

              Discard the vial if particulate matter or discoloration is observed

              IV Administration

              Also see Storage

              Same precautions as antineoplastic agents should be followed with ganciclovir

              Do not administer IM, SC, rapid infusion or IVP

              Administer by slow IV infusion over at least 1 hr at a final concentration not to exceed 10 mg/mL

              Too rapid infusion can cause increased toxicity and excessive plasma levels

              Handling and disposal

              • Exercise caution in the handling and preparation of solutions
              • Reconstituted solutions are alkaline (pH 11)
              • Avoid direct contact of the skin or mucous membranes with solution
              • If such contact occurs, wash thoroughly with soap and water; rinse eyes thoroughly with plain water
              • Wearing disposable gloves is recommended
              • Because ganciclovir shares some of the properties of antitumor agents (eg, carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs

              Storage

              Unused vials: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)

              Reconstituted vials: Store at 25°C (77°F) for no longer than 12 hr; do not refrigerate or freeze

              Diluted solutions: Refrigerate at 2-8°C (36-46°F) for no longer than 24 hr; do not freeze

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Zirgan ophthalmic (eye)
              -
              0.15 % gel
              ganciclovir intravenous
              -
              500 mg/250 mL (2 mg/mL) solution

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              ganciclovir ophthalmic (eye)

              GANCICLOVIR - OPHTHALMIC

              (gan-SYE-klo-veer)

              COMMON BRAND NAME(S): Zirgan

              USES: Ganciclovir is used to treat herpes infection of the eye. Although ganciclovir stops the growth of the virus, it is not a cure for the herpes infection. Herpes virus continues to live in the body even between outbreaks of infection. However, treating an outbreak may help the sores in the eye to heal faster and lower the risk of complications (such as decreased vision, blindness).Ganciclovir is an anti-viral drug. This medication treats only herpes eye infections. It will not work for other types of eye infections, such as those caused by bacteria. Unnecessary use or misuse of any anti-infective drug can lead to its decreased effectiveness.

              HOW TO USE: Apply this medication to the affected eye as directed by your doctor, usually 5 times a day (about every 3 hours while awake) until the eye has healed, and then 3 times a day for 7 more days.To apply eye medication, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.Do not wear contact lenses while you have an eye infection or while using this medication. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. Repeat these steps for your other eye if so directed. Wait several minutes for your vision to clear before driving or operating machinery.Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes between applying each medication. Use eye drops before eye ointments to allow the drops to enter the eye.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed. Stopping the medication too early may allow the virus to continue to grow.Tell your doctor if your condition persists or if it worsens (for example, you develop eye pain/itching/swelling).

              SIDE EFFECTS: Temporary blurred vision after you apply this medication and mild eye irritation/redness may occur. If any of these effects persist or worsen, 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.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: Before using ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir; 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.This drug may cause temporary blurred vision after each application. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: 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.

              OVERDOSE: This medicine may be harmful if swallowed. 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.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Laboratory and/or medical tests (such as eye exams) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

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

              STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C). Protect from freezing. 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 for more details about how to safely discard your product.

              Information last revised August 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.
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              • 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.