HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA.
CIMZIA (certolizumab pegol)
Lyophilized powder or solution for subcutaneous use
Initial U.S. Approval: 2008
WARNING: RISK OF SERIOUS INFECTIONS
See full prescribing information for complete boxed warning.
Increased risk of serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (5.1).
CIMZIA should be discontinued if a patient develops a serious infection or sepsis (5.1).
Perform test for latent TB; if positive, start treatment for TB prior to starting CIMZIA (5.1).
Monitor all patients for active TB during treatment, even if initial latent TB test is negative (5.1)
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member (5.2). CIMZIA is not indicated for use in pediatric patients.
RECENT MAJOR CHANGES
Boxed Warning 09/2011
Warnings and Precautions, Risk of Serious Infections (5.1) 09/2011
INDICATIONS AND USAGE
CIMZIA is a tumor necrosis factor (TNF) blocker indicated for:
Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy (1.1)
Treatment of adults with moderately to severely active rheumatoid arthritis (1.2)
DOSAGE AND ADMINISTRATION
CIMZIA is administered by subcutaneous injection. The initial dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg).
Crohn's Disease (2.1)
400 mg initially and at Weeks 2 and 4. If response occurs, follow with 400 mg every four weeks
Rheumatoid Arthritis (2.2)
400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered
DOSAGE FORMS AND STRENGTHS
200 mg lyophilized powder for reconstitution, in a single-use glass vial, with 1 mL of sterile Water for Injection, USP (3)
200 mg/mL solution in a single-use prefilled glass syringe (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Serious infections – do not start CIMZIA during an active infection. If an infection develops, monitor carefully, and stop CIMZIA if infection becomes serious (5.1)
Invasive fungal infections – for patients who develop a systemic illness on CIMZIA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic (5.1)
Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers (5.2)
Heart failure, worsening or new onset may occur (5.3)
Anaphylaxis or serious allergic reactions may occur (5.4)
Hepatitis B virus reactivation – monitor HBV carriers during and several months after therapy. If reactivation occurs, stop CIMZIA and begin anti-viral therapy (5.5)
Demyelinating disease, exacerbation or new onset, may occur (5.6)
Cytopenias, pancytopenia – advise patients to seek immediate medical attention if symptoms develop, and consider stopping CIMZIA (5.7)
Lupus-like syndrome – stop CIMZIA if syndrome develops (5.9)
ADVERSE RE