The ACTEMRA data in RA includes 5 double-blind, controlled, multicenter studies. In these studies, patients received doses of ACTEMRA 8 mg/kg monotherapy (288 patients), ACTEMRA 8 mg/kg in combination with DMARDs (including MTX) (1582 patients), or ACTEMRA 4 mg/kg in combination with MTX (774 patients).
- 90% of eligible patients from the 6-month, controlled studies entered the long-term extension studies
- 4009 patients who received at least one dose of ACTEMRA represent 12,293 patient-years (PY) of exposure
This is not a complete list of the important safety information for ACTEMRA. Please see the full Prescribing Information for additional important safety information including Boxed Warning.
Ongoing monitoring of your patient is important during the treatment of a chronic disease. Please see Patient and Lab Monitoring for more information
- The most common serious adverse reactions were serious infections
- Serious infections leading to hospitalization or death, including tuberculosis, bacterial, invasive fungal, viral and other opportunistic infections, have occurred in patients receiving ACTEMRA
- ACTEMRA should not be administered in patients with an active infection, including localized infections. If a serious infection develops, ACTEMRA should be interrupted until the infection is controlled
- Patients should be closely monitored for signs and symptoms of infection during and after treatment with ACTEMRA
- In the all-exposure population, the most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis.
- 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
- *Rates are based on 14,993.6 PY of observation from the latest safety update as of April 1, 2011.
- The impact of treatment with ACTEMRA on the development of malignancies is not known, but malignancies were observed in clinical studies. ACTEMRA is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies
- *Rates are based on 14,993.6 PY of observation from the latest safety update as of April 1, 2011.
- Hypersensitivity reactions, including anaphylaxis and death, have been reported in association with infusion of ACTEMRA
- Anaphylaxis and other hypersensitivity reactions that required treatment discontinuation were reported in 0.1% (3 out of 2644) of patients in the 6-month controlled trials, and in 0.2% (8 out of 4009) of patients in the all-exposure RA population
- Do not administer ACTEMRA to patients with known hypersensitivity to 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 GI 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
The most common serious adverse reactions were serious infections. In the 24- week, controlled clinical studies, the rate of serious infections was 3.6 per 100 patient-years (PY) in the ACTEMRA group and 1.5 per 100 PY in the MTX group. The rate of serious infections in the 4 mg/kg and 8 mg/kg ACTEMRA plus DMARD groups was 4.4 and 5.3 events per PY, respectively, compared to 3.9 events per 100 PY in the placebo plus DMARD group.
This is not a complete list of the important safety information for ACTEMRA. Please see the full Prescribing Information for additional safety information including Boxed Warning.
In the 5 Phase III clinical trials, the most common adverse reactions (>5% of patients treated with ACTEMRA) through 6 months were:
