ACTEMRA Is Associated With Changes in Pharmacodynamic Parameters in Patients
Pharmacodynamic effects of ACTEMRA
- Changes in pharmacodynamic parameters do not necessarily reflect a separate and distinct clinical benefit
Mean CRP levels over 24 weeks19
- CRP normalized in 91% of patients on ACTEMRA 8 mg/kg + DMARD at Week 2420
- Similar data were seen in TNF-IR patients
Mean ESR levels over 24 weeks21*
*P values not calculated.
Demyelinating Disorders
The impact of treatment with ACTEMRA on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Patients should be closely monitored for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of ACTEMRA in patients with preexisting or recent-onset demyelinating disorders.
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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