Safety Profile Based on a Large Phase III Clinical Trial Program in RA With Over 4000 Patients
- 90% of eligible patients from the 6-month, controlled studies entered the long-term extension studies18
- 4009 patients who received at least one dose of ACTEMRA represent 12,293 patient-years of exposure18
Serious adverse reactions
The most common serious adverse reactions were serious infections. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis, and bacterial arthritis. The overall rate of fatal serious infections was 0.17 per 100 patient-years.
During the 6-month, double-blind, placebo-controlled studies, the proportion of patients who discontinued treatment due to any adverse reactions was 5% for patients taking ACTEMRA and 3% for placebo-treated patients.
The most common adverse reactions that required discontinuation of ACTEMRA were increased hepatic transaminase values (per protocol requirement) and serious infections.
See additional Safety InformationSee the full Prescribing Information
- ACTEMRA should not be administered to patients with an active infection, including localized infections
- Reports of GI perforation were primarily reported as complications of diverticulitis
- ACTEMRA should be used with caution in patients who may be at increased risk for GI perforation
- Clinically significant hypersensitivity reactions (eg, anaphylactoid and anaphylactic reactions) associated with ACTEMRA and requiring treatment discontinuation were reported in 0.1% (3/2644) of patients in the 6-month, controlled trials and in 0.2% (8/4009) of patients in the all-exposure population†
- Appropriate medical treatment should be available for immediate use in the event of a serious hypersensitivity reaction
Some important warnings and precautions to consider when prescribing ACTEMRA
- ACTEMRA should not be administered in patients with an active infection, including localized infections
- ACTEMRA should be used with caution in patients who may be at increased risk for gastrointestinal perforation
- It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000/mm3, platelet count below 100,000/mm3 or who have alanine transaminase (ALT) or aspartate transaminase (AST) >1.5x ULN
- Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment
Incidence of adverse events in ≥2% of patients in the ACTEMRA groups and ≥1% of patients in the placebo group
- In the all-exposure population, the most frequent AEs were infections and infestations (including upper respiratory tract infections and nasopharyngitis), hypertension, diarrhea, headache, nausea and back pain 18
INDICATION
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
IMPORTANT SAFETY INFORMATION
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
ACTEMRA should not be administered to patients with known hypersensitivity to ACTEMRA.
- If anaphylaxis or other clinically significant hypersensitivity reaction occurs, administration of ACTEMRA should be stopped immediately and ACTEMRA should be permanently discontinued.
Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations and hypersensitivity reactions. Other potential risks of ACTEMRA include demyelinating disorders, malignancies, and changes to certain lab parameters.
Common adverse reactions include upper respiratory infection, nasopharyngitis, headache, hypertension, and increased ALT.
Please see full Prescribing Information including Boxed Warning for additional important safety information.
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