certolizumab pegol (Rx)

Brand and Other Names:Cimzia
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 200mg/vial

injectable solution, single-dose prefilled syringe

  • 200mg/mL

Crohn Disease

Indicated for maintaining clinical response in patients with moderate to severe active disease who had an inadequate response to conventional therapy

Initial: 400 mg SC (2 injections of 200 mg), repeat at 2 and 4 weeks

Maintenance: 400 mg SC q4Weeks

Rheumatoid Arthritis

Indicated for moderate to severe active rheumatoid arthritis (RA)

Initial: 400 mg SC (2 injections of 200 mg), repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4Weeks

Psoriatic Arthritis

Indicated for active psoriatic arthritis (PsA)

Initial: 400 mg SC (2 injections of 200 mg), repeat at 2 and 4 weeks, followed by 200 mg SC q2Weeks

Maintenance: Consider 400 mg SC q4Weeks

Ankylosing Spondylitis

Indicated for active ankylosing spondylitis (AS)

Initial: 400 mg SC (2 injections of 200 mg), repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4weeks

Spondyloarthritis

Indicated for active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Initial: 400 mg SC (2 injections of 200 mg), repeat at 2 and 4 weeks

Maintenance: 200 mg SC q2Weeks OR 400 mg SC q4Weeks

Plaque Psoriasis

Indicated for moderate-to-severe plaque psoriasis (PsO) in patients who are candidates for systemic therapy or phototherapy

400 every other week

For some patients (≤90 kg), consider starting at 400 mg SC (given as 2 injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg SC every other week

Safety and efficacy not established

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Interactions

Interaction Checker

and certolizumab pegol

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (12)

            • adenovirus types 4 and 7 live, oral

              certolizumab pegol decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • BCG intravesical live

              certolizumab pegol decreases effects of BCG intravesical live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • BCG vaccine live

              certolizumab pegol decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • influenza virus vaccine quadrivalent, intranasal

              certolizumab pegol decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • measles mumps and rubella vaccine, live

              certolizumab pegol decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • measles, mumps, rubella and varicella vaccine, live

              certolizumab pegol decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • rotavirus oral vaccine, live

              certolizumab pegol decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • smallpox (vaccinia) vaccine, live

              certolizumab pegol decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • typhoid vaccine live

              certolizumab pegol decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • varicella virus vaccine live

              certolizumab pegol decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • yellow fever vaccine

              certolizumab pegol decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • zoster vaccine live

              certolizumab pegol decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            Serious - Use Alternative (18)

            • abatacept

              abatacept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • adalimumab

              adalimumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • anakinra

              anakinra and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • baricitinib

              baricitinib, certolizumab pegol. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

            • etanercept

              etanercept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • golimumab

              golimumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • human papillomavirus vaccine, nonavalent

              certolizumab pegol 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

              certolizumab pegol 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.

            • infliximab

              infliximab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • influenza virus vaccine quadrivalent, adjuvanted

              certolizumab pegol 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 trivalent, adjuvanted

              certolizumab pegol 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.

            • natalizumab

              natalizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • rilonacept

              rilonacept and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • rituximab

              rituximab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • rituximab-hyaluronidase

              rituximab-hyaluronidase and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • tocilizumab

              tocilizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.

            • tofacitinib

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

            • vedolizumab

              vedolizumab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

            Monitor Closely (42)

            • anthrax vaccine adsorbed

              certolizumab pegol decreases effects of anthrax vaccine adsorbed by pharmacodynamic antagonism. Use Caution/Monitor.

            • belatacept

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

            • cholera vaccine

              certolizumab pegol 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.

            • dengue vaccine

              certolizumab pegol 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

              certolizumab pegol, 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.

            • diphtheria & tetanus toxoids

              certolizumab pegol decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Use Caution/Monitor.

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

              certolizumab pegol decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

            • fingolimod

              certolizumab pegol 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. .

              fingolimod and certolizumab pegol both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • haemophilus influenzae type b vaccine

              certolizumab pegol 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.

            • hepatitis A vaccine inactivated

              certolizumab pegol decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Use Caution/Monitor.

            • hepatitis a/b vaccine

              certolizumab pegol decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

            • hydroxyurea

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

            • influenza A (H5N1) vaccine

              certolizumab pegol decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

            • influenza virus vaccine (H5N1), adjuvanted

              certolizumab pegol decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor.

            • influenza virus vaccine quadrivalent

              certolizumab pegol decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Use Caution/Monitor.

            • influenza virus vaccine quadrivalent, cell-cultured

              certolizumab pegol decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Use Caution/Monitor.

            • influenza virus vaccine quadrivalent, recombinant

              certolizumab pegol 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

              certolizumab pegol decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Use Caution/Monitor.

            • influenza virus vaccine trivalent, recombinant

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

            • Japanese encephalitis virus vaccine

              certolizumab pegol decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

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

              certolizumab pegol decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Use Caution/Monitor.

            • meningococcal group B vaccine

              certolizumab pegol 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.

            • ocrelizumab

              certolizumab pegol and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with high doses of corticosteroids is expected to increase the risk of immunosuppression.

            • ofatumumab SC

              ofatumumab SC, certolizumab pegol. 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

              certolizumab pegol 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.

            • oxaliplatin

              oxaliplatin and certolizumab pegol both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.

            • ozanimod

              ozanimod, certolizumab pegol. 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.

            • pegloticase

              pegloticase will decrease the level or effect of certolizumab pegol by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknown

            • pegvaliase

              pegvaliase, certolizumab pegol. Other (see comment). Use Caution/Monitor. Comment: The majority of patients treated with pegvaliase develop anti-polyethylene glycol (PEG) IgM and IgG antibodies. Risk of coadministration with different PEGylated products is unknown. There is a case report of anaphylaxis following a medroxyprogesterone acetate injectable suspension that contained PEG 3350. Carefully read all drug labels, including OTC drugs to check contents for PEG. Note: Unable to include an exhaustive product list for this interaction.

            • pneumococcal vaccine 13-valent

              certolizumab pegol decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Use Caution/Monitor.

            • pneumococcal vaccine polyvalent

              certolizumab pegol decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Use Caution/Monitor.

            • poliovirus vaccine inactivated

              certolizumab pegol 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 certolizumab pegol 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.

            • rabies vaccine

              certolizumab pegol decreases effects of rabies vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

            • rabies vaccine chick embryo cell derived

              certolizumab pegol decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Use Caution/Monitor.

            • siponimod

              siponimod and certolizumab pegol 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

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

            • tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine

              certolizumab pegol decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

            • trastuzumab

              trastuzumab, certolizumab pegol. 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, certolizumab pegol. 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. .

            • typhoid polysaccharide vaccine

              certolizumab pegol decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

            • zoster vaccine recombinant

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

            Minor (0)

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              Adverse Effects

              >10%

              URI (20%)

              Headache (7-18%)

              Nasopharyngitis (4-13%)

              Nausea (11%)

              1-10%

              UTI (7%)

              Arthralgia (6%)

              Serious infections (3%)

              Frequency Not Defined

              Opportunistic infections (eg, TB)

              Lupus-like syndrome

              Malignancies

              Immunogenicity

              Hypersensitivity

              Blood/ lymphatic system disorder

              Cardiac disorder

              Ocular disorder

              Psychiatric disorder (anxiety, bipolar d/o, suicide attempt)

              Renal/urinary disorder

              Menstrual disorder

              Skin and subcutaneous disorder

              Postmarketing Reports

              Vascular disorder: Systemic vasculitis

              Skin: Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and new or worsening psoriasis (all sub-types including pustular and palmoplantar), lichenoid skin reaction

              Immune System Disorders: Sarcoidosis

              Lagophthalmos

              Neoplasms benign, malignant and unspecified (including cysts and polyps)

              Melanoma, Merkel cell carcinoma (neuroendocrine carcinoma of the skin)

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              Warnings

              Black Box Warnings

              Serious infection risk

              • Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
              • Patients older than 65 years may be at greater risk
              • Discontinue if patient develops serious infection or sepsis
              • Reported infections include
                • Active TB, including reactivation of latent TB (frequently present with disseminated or extrapulmonary disease); test for latent TB before use and during therapy; treat latent infection prior to use
                • Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may be negative in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops
                • Other bacterial (eg, Legionella, Listeria), mycobacterial (eg, tuberculosis), and viral (eg, hepatitis B) opportunistic pathogens

              Malignancy

              • Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers
              • Cases of acute and chronic leukemia have been reported in association with post-marketing TNF-blocker use in rheumatoid arthritis (RA) and other indications; patients with RA may be at a higher risk (approximately 2-fold) than the general population for leukemia
              • Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer
              • Manufacturer required to report all malignancies to FDA in order for complete and consistent analysis

              Contraindications

              History of hypersensitivity reaction to certolizumab pegol or to any of the excipients; reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria

              Cautions

              Hypersensitivity including anaphylaxis and serious reactions (see Contraindications)

              May interfere with aPPT tests

              The needle shield inside the removable cap of prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex

              Therapy has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome; exercise caution in considering use in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with drug

              Treatment may result in formation of autoantibodies and rarely, in development of a lupus-like syndrome; if a patient develops symptoms suggestive of a lupus-like syndrome following treatment, discontinue treatment

              Cases of worsening congestive heart failure (CHF) and new onset CHF reported; therapy has not been formally studied in patients with CHF; however, in clinical studies in patients with CHF with another TNF blocker, worsening congestive heart failure (CHF) and increased mortality due to CHF were observed; exercise caution in patients with heart failure and monitor them carefully

              Hematological Reactions

              • Pancytopenia, including aplastic anemia, reported with TNF blockers; adverse reactions of hematologic system, including medically significant cytopenia (eg, leukopenia, pancytopenia, thrombocytopenia) reported
              • Causal relationship of these events remains unclear
              • although no high-risk group has been identified, exercise caution in patients who have ongoing, or a history of, significant hematologic abnormalities
              • Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, pallor) while on treatment
              • Consider discontinuation of therapy in patients with confirmed significant hematologic abnormalities

              Increased risk of serious infections

              • Also, see Black Box Warnings
              • An increased risk of serious infections seen in clinical studies of other TNF-blocking agents used in combination with anakinra or abatacept, with no added benefit; no formal drug interaction studies were performed with rituximab or natalizumab; concomitant use of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended
              • A higher risk of serious infections also observed in combination with DMARDs; because of nature of adverse events seen with combination therapy, use in combination with other biological DMARDs not recommended
              • Hepatitis B Virus Reactivation
                • Use of TNF blockers, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus; patients concomitantly receiving immunosuppressives, which may also contribute to HBV reactivation
                • Test patients for HBV infection before initiating treatment; patients who test positive for HBV infection
                • Closely monitor patients who are carriers of HBV and require treatment for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy
                • In patients who develop HBV reactivation, discontinue treatment and initiate effective anti-viral therapy with appropriate supportive treatment
                • Exercise caution when considering resumption of therapy in this situation and monitor patients closely
              • Opportunistic infections
                • TNF blockers increase risk for opportunistic infections, (eg, TB, invasive fungal infections); for patients who develop systemic infections, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic
                • Coadministration with anakinra increases this risk
                • Test for latent TB prior to starting treatment and monitor; treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce risk of tuberculosis reactivation during therapy; induration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis needed prior to initiating therapy with certolizumab, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG); also consider anti-tuberculosis therapy in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection
                • Discontinue if serious infection develops

              Malignancy risk

              • Enhanced safety surveillance requirements to capture malignancy data: (see Black Box Warnings)
              • In the controlled portions of clinical studies of some TNF blockers, more cases of malignancies have been observed among patients receiving TNF blockers compared to control patients
              • Melanoma and Merkel cell carcinoma
                • Melanoma and Merkel cell carcinoma reported with TNF-antagonists, including certolizumab pegol
                • Periodic skin examinations recommended for all patients, particularly those with risk factors for skin cancer
              • Hepatosplenic T-cell lymphomas (HSTCL)
                • Rare postmarketing cases reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers
                • Reports have also included a patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis
                • HSTCL is an aggressive, rare type of T-cell lymphoma (usually fatal)
                • Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-mercaptopurine, although there have been cases reported receiving azathioprine or mercaptopurine alone
                • The following HSTCL cases have been identified in the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), and mercaptopurine (3)

              Drug interaction overview

              • An increased risk of serious infections seen in clinical studies of other TNF-blocking agents used in combination with anakinra or abatacept, with no added benefit; no formal drug interaction studies were performed with rituximab or natalizumab; concomitant use of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended
              • Patients treated may receive vaccinations, except for live or live attenuated vaccines; no data available on response to live vaccinations or secondary transmission of infection by live vaccines in patients receiving therapy
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              Pregnancy & Lactation

              Pregnancy

              Pregnancy exposure registry monitors pregnancy outcomes in women exposed to the drug during pregnancy; MotherToBaby pregnancy studies conducted by the Organization of Teratology Information Specialists (OTIS); OTIS AutoImmune Diseases Study at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/

              Due to its inhibition of TNFalpha, certolizumab pegol administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant; clinical significance of low levels is unknown for in utero-exposed infants; additional data available from one exposed infant suggest that may be eliminated at a slower rate in infants than in adults

              Limited data from ongoing pregnancy registry on use of drug in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes

              Contraception

              • Consider adequate contraception for women of childbearing potential
              • For women planning pregnancy, consider adequate contraception for 5 months after last dose due to its elimination rate

              Lactation

              In a clinical study, minimal transfer of certolizumab pegol from plasma to breast milk was observed

              Percentage of maternal certolizumab pegol dose that was reaching an infant during a 24 hr period was estimated to 0.04-0.3% In addition, since certolizumab pegol is a protein that is degraded in gastrointestinal tract after oral administration, absolute bioavailability is expected to be very low in a breastfed infant; can be used during breastfeeding

              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

              Recombinant humanized antihuman TNF-alpha neutralizing antibody

              Binds to human TNFα with a KD of 90pM; TNF-alpha is a key pro-inflammatory cytokine with a central role in inflammatory processes

              Selectively neutralizes TNF-alpha; cross-reacts poorly with TNF from rodents and rabbits, therefore in vivo efficacy was evaluated using animal models in which human TNF-alpha was the physiologically active molecule

              Absorption

              Peak plasma concentration: 43-49 mcg/mL (RA patients)

              Peak plasma time: 54-171 hr

              Bioavailability: ~80%

              Distribution

              Vd: 4.7-8 L

              Metabolism

              Not studied in humans

              Data from animals indicate that once cleaved from the Fab' fragment the PEG moiety is mainly excreted in urine without further metabolism

              Excretion

              Half-life: 14 days

              Clearance: 17 mL/hr (Crohn disease); 21 mL/hr (RA)

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              Administration

              SC Preparation

              Vials

              • Remove from refrigerator and allow the vial(s) to sit at room temperature for 30 min before reconstituting; do not warm vial in any other way
              • Reconstitute 200 mg vial(s) with 1 mL of sterile water for injection, using the 20-gauge needle provided; water should be directed at vial wall rather than directly to contents
              • Gently swirl each vial for about one min without shaking, assuring that all of powder comes in contact with sterile water; avoid creating a foaming effect
              • Continue swirling every 5 min as long as non-dissolved particles observed; full reconstitution may take as long as 30 min; final reconstituted solution contains 200 mg/mL and should be clear to opalescent, colorless to pale yellow liquid essentially free from particulates
              • Reconstitute each 200 mg vial with 1 mL sterile water for injection, swirl to dissolve; leave vials undisturbed for up to 30 minutes to fully reconstitute

              Syringe

              • Prefilled syringe contains a derivative of natural rubber latex and use caution by latex-sensitive individuals

              SC Administration

              Inject full contents of each syringe SC into separate sites on abdomen or thigh

              Storage

              Unopened vial

              • Refrigerate intact carton between 2-8°C (36-46°F)
              • Do not freeze
              • Do not separate contents of carton prior to use
              • Protect solution from light

              Prefilled syringe

              • Refrigerate intact carton between 2-8°C (36-46°F)
              • Store at room temperature up to 25°C (77°F) in the original carton for a single period of up to 7 days
              • Do not place back in refrigerator; write the date removed from the refrigerator in the space provided on the carton and discard if not used within the 7-day period
              • Do not freeze
              • Do not separate contents of carton prior to use
              • Protect solution from light

              Reconstituted vial

              • Do not leave reconstituted solution at room temperature >2 hr
              • May be stored for up to 24 hr at 2-8°C (36-46°F) prior to injection
              • Do not freeze
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Cimzia Starter Kit subcutaneous
              -
              400 mg/2 mL (200 mg/mL x 2) syringe
              Cimzia Powder for Reconstitution subcutaneous
              -
              400 mg (200 mg x 2 vials) kit
              Cimzia subcutaneous
              -
              400 mg/2 mL (200 mg/mL x 2) syringe

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              certolizumab pegol subcutaneous

              CERTOLIZUMAB - INJECTION

              (SER-toe-LIZ-oo-mab)

              COMMON BRAND NAME(S): Cimzia

              WARNING: This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (e.g., fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (e.g., coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. See Side Effects section for symptoms of infections to watch out for, and seek immediate medical attention if you develop any of these symptoms.If you are diagnosed with TB, you must first be treated for it before you start certolizumab to prevent a serious TB infection.Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, skin changes, swollen glands, swollen or painful abdomen, unexplained weight loss, persistent fever or night sweats.

              USES: This medication is used to reduce pain and swelling due to certain inflammatory conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis). Some brands may also be used to treat a certain type of spine condition (axial spondyloarthritis) or a certain bowel condition (Crohn's disease). Certolizumab belongs to a class of drugs known as tumor necrosis factor (TNF) blockers. It works by blocking TNF, a substance made by the body that causes inflammation.

              HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using certolizumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is given by injection under the skin, in the stomach or thigh area, as directed by your doctor. Follow your doctor's directions and the schedule for your doses very carefully.Remove this medication from the refrigerator and leave at room temperature for 30 minutes before injecting. Do not warm up this medication in any other way such as heating in the microwave or placing in hot water.Do not inject into any areas of skin that are sore, bruised, red, scaly, or hard.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the medication. If you are using the vial, follow the instructions for adding the mixing liquid to the medication. Gently swirl the vial to mix. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Use this medication regularly to get the most benefit from it. To help you remember, mark the days on a calendar when you need to receive the medication.Tell your doctor if your condition persists or worsens.

              SIDE EFFECTS: See also Warning section.Cough, sore throat, stuffy/runny nose, burning/painful/frequent urination, or joint pain 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.Tell your doctor right away if you develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, swollen joints, rash on nose and cheeks, eye pain, vision changes, dizziness, numbness/tingling of arms/legs, seizures, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Certolizumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for several months after your last treatment. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin.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 certolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex found in the rubber syringe cap of some brands), 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: any current/recent infection (such as HIV, hepatitis B, tuberculosis), any infection that keeps coming back, cuts or open sores, cancer, diabetes, heart failure, blood/bone marrow disorders, history of cancer (such as lymphoma), brain/nervous system disorders (such as multiple sclerosis, seizures).Because certolizumab can make you more likely to get infections or may worsen any current infections, do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received the polio vaccine taken by mouth or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.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).Older adults are more sensitive to the effects of this drug, especially the risk of infections.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether 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.Some products that may interact with this drug include: abatacept, anakinra, live vaccines (such as polio vaccine taken by mouth, flu vaccine inhaled through the nose), other drugs that weaken the immune system (such as azathioprine, cancer chemotherapy, cyclosporine).This medication may interfere with certain laboratory tests (including aPTT tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

              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.Laboratory and/or medical tests (such as complete blood count, liver function tests, skin exams) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

              STORAGE: Store in the original package in the refrigerator away from light and moisture. Do not freeze. If needed, this medication may be kept at room temperature. If kept at room temperature, do not put it back in the refrigerator. Use within the time directed in the product instructions. 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 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.
              • 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.