ACTIONS
The most common adverse reactions (incidence ≥7% and higher than placebo): upper respiratory tract infection, rash, and urinary tract infection (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Use with Biological DMARDs – increased risk of serious infections (5.8, 7.1)
Live vaccines – do not give with CIMZIA (5.10, 7.2)
Laboratory tests – may interfere with aPTT tests (7.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 09/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNINGS
1 INDICATIONS AND USAGE
1.1 Crohn's Disease
1.2 Rheumatoid Arthritis
2 DOSAGE AND ADMINISTRATION
2.1 Crohn's Disease
2.2 Rheumatoid Arthritis
2.3 Preparation and Administration Using the Lyophilized Powder for Solution
2.4 Preparation and Administration Using the Prefilled Syringe
2.5 Monitoring to Assess Safety
2.6 Concomitant Medications
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Serious Infections
5.2 Malignancies
5.3 Heart Failure
5.4 Hypersensitivity Reactions
5.5 Hepatitis B Virus Reactivation
5.6 Neurologic Reactions
5.7 Hematological Reactions
5.8 Use with Biological Disease-Modifying Antirheumatic Drugs (Biological DMARDs)
5.9 Autoimmunity
5.10 Immunizations
5.11 Immunosuppression
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Use with Anakinra, Abatacept, Rituximab, and Natalizumab
7.2 Live Vaccines
7.3 Laboratory Tests
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility
14 CLINICAL STUDIES
14.1 Crohn's Disease
14.2 Rheumatoid Arthritis
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Patient Counseling
17.2 Instruction on Prefilled Syringe Self-Injection Technique
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FULL PRESCRIBING INFORMATION
WARNINGS
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
CIMZIA should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatm |
