Trade Names:Cimzia- Injection, lyophilized powder for solution 200 mg- Injection, solution 200 mg/mL
Neutralizes membrane-associated and soluble human tumor necrosis factor alpha (TNF-alpha) in a dose-dependent manner.
T max is between 54 and 171 h postinjection. Bioavailability is approximately 80%. Mean C max is approximately 43 to 49 mcg/mL.
Vd is approximately 6 to 8 L.
Terminal elimination half-life is approximately 14 days. Cl is approximately 17 to 21 mL/h.
Studies have not been performed.
Reduce signs and symptoms of Crohn disease and maintain clinical response in adult patients with moderately to severely active disease who have not responded adequately to conventional therapy; treatment of adults with moderate to severe active rheumatoid arthritis.
Subcutaneous 400 mg, given as 2 injections of 200 mg initially and at weeks 2 and 4. In patients obtaining a clinical response, the recommended maintenance dosage is 400 mg every 4 wk.Rheumatoid ArthritisAdults
Subcutaneous 400 mg, given as 2 injections of 200 mg initially and at weeks 2 and 4, followed by 200 mg every other week. For maintenance dosing, 400 mg every 4 weeks may be considered.
Store in refrigerator at 36° to 46°F. Do not freeze. Do not leave reconstituted product at room temperature for more than 2 h prior to administration. Once reconstituted, vials may be stored for up to 24 h at 36° to 46°F prior to injection. Do not freeze.
Risk of serious infections and neutropenia may be increased.Live vaccines
Do not coadminister with certolizumab.
May cause erroneously elevated aPTT assay results in patients without coagulation abnormalities. This effect has also been observed with the PTT-LA test from Diagnostic stago and the HemosIL APTT-SP liquid and HemosIL lyophilized silica tests from Instrumentation Laboratories.
Hypertension (5%); anginal pectoris, arrhythmias, atrial fibrillation, cardiac failure, hypertensive heart disease, MI, myocardial ischemia, pericardial effusion, pericarditis, stroke, thrombophlebitis, transient ischemic attack, vasculitis.
Headache (5%); fatigue (3%); anxiety, bipolar disorder, suicide attempt.
Rash (3%); alopecia; dermatitis; erythema nodosum; urticaria; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (postmarketing).
Optic neuritis, retinal hemorrhage, uveitis.
UTI (7%); menstrual disorder, nephrotic syndrome, renal failure.
Anemia, bleeding, leukopenia, lymphadenopathy, pancytopenia, thrombophilia.
Elevated liver enzymes, hepatitis.
Antibodies to certolizumab (8%); angioedema.
Positive antinuclear antibody titers (4%).
Upper respiratory tract infection (20%); nasopharyngitis (5%); acute bronchitis, pharyngitis (3%).
Infection (38%); arthralgia (6%); back pain (4%); pyrexia (3%).
Serious and sometimes fatal infections, including tuberculosis (TB) (frequently disseminated or extrapulmonary), invasive fungal infections, and bacterial, viral, and other opportunistic infections, may occur. Evaluate patients for TB risk factors and test for latent TB infection prior to starting and during treatment. Initiate treatment of latent TB infection prior to starting therapy. Discontinue therapy if a patient develops a serious infection or sepsis.
Monitor patients for signs and symptoms of infection during and after treatment. Monitor patients for signs and symptoms of active TB, including patients who tested negative for latent TB infection. Evaluate patients at risk for hepatitis B virus (HBV) infection for prior evidence of HBV infection before starting therapy. Closely monitor HBV carriers for clinical and laboratory signs of active HBV infection throughout therapy and for several months after discontinuing treatment. Monitor CHF patients carefully.
Category B .
Safety and efficacy not established.
Because there is a higher incidence of infection in elderly patients, use with caution.
Angioedema, dermatitis allergic, dizziness (postural), dyspnea, hot flush, hypotension, injection-site reactions, malaria, pyrexia, rash, serum sickness, syncope (vasovagal), and urticaria have been reported.
Formation of autoantibodies and, rarely, a lupus-like syndrome may occur.
Worsening and new-onset CHF have been reported with TNF blockers.
Rare cases of cytopenia, including leukopenia, pancytopenia (including aplastic anemia), and thrombocytopenia, have been reported.
Risk of reactivation of HBV in chronic carriers of this virus may be increased. Use with caution in patients identified as HBV carriers.
Host defenses against infections and malignancies may be affected.
More cases of malignancies have been observed among patients receiving TNF blockers compared with control patients. Patients with Crohn disease requiring chronic exposure to immunosuppressant therapy may be at increased risk for developing lymphoma, even in the absence of TNF-blocker therapy.
Rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease have been reported. Rare cases of neurological disorders, including seizures, optic neuritis, and peripheral neuropathy, have been reported.
Doses of up to 800 mg subcutaneous and 20 mg/kg IV have been administered without serious adverse reactions.
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