WARNINGS AND PRECAUTIONS
Serious Infections – do not administer ACTEMRA during an active infection, including localized infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. (5.1)
Gastrointestinal (GI) perforation – use with caution in patients who may be at increased risk. (5.2)
Laboratory monitoring – recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. (2.3, 5.3)
Hypersensitivity reactions, including anaphylaxis and death have occurred (5.5)
Live vaccines – should not be given with ACTEMRA. (5.8, 7.3)

 
ADVERSE REACTIONS
Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. Pregnancy registry available. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide 

Revised: 04/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed

WARNING: RISK OF SERIOUS INFECTIONS
1INDICATIONS AND USAGE
1.1Rheumatoid Arthritis (RA)
1.2Systemic Juvenile Idiopathic Arthritis (SJIA)
2DOSAGE AND ADMINISTRATION
2.1Rheumatoid Arthritis
2.2 Systemic Juvenile Idiopathic Arthritis
2.3General Considerations for Administration
2.4Dosage Modifications
3DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
5WARNINGS AND PRECAUTIONS
5.1Serious Infections
5.2Gastrointestinal Perforations
5.3Laboratory Parameters
5.4Immunosuppression
5.5Hypersensitivity Reactions, Including Anaphylaxis
5.6Demyelinating Disorders
5.7Active Hepatic Disease and Hepatic Impairment
5.8Vaccinations
6ADVERSE REACTIONS
6.1Clinical Trials Experience
6.2Postmarketing Experience
7DRUG INTERACTIONS
7.1Other Drugs for Treatment of Rheumatoid Arthritis
7.2Interactions with CYP450 Substrates
7.3Live Vaccines
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
8.3Nursing Mothers
8.4Pediatric Use
8.5Geriatric Use
8.6Hepatic Impairment
8.7Renal Impairment
9DRUG ABUSE AND DEPENDENCE
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1Mechanism of Action
12.2Pharmacodynamics
12.3Pharmacokinetics
13NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility
14CLINICAL STUDIES
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
WARNING: RISK OF SERIOUS INFECTIONS
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate