The First and Only FDA-Approved Treatment for Systemic Juvenile Idiopathic Arthritis (SJIA)
A first-line biologic for children 2 years and up
INDICATION
ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
IMPORTANT SAFETY INFORMATION
Serious Infections
Serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving ACTEMRA. ACTEMRA should not be administered during an active infection, including localized infections. If a serious infection develops, ACTEMRA should be interrupted until the infection is controlled.
Prior to initiating ACTEMRA, a test for latent TB should be performed. If the test is positive, treatment for TB should be started prior to starting ACTEMRA. All patients should be monitored for active TB during treatment, even if initial latent TB test is negative.
The benefits and risks of treatment should be considered prior to initiating ACTEMRA in patients:
- with chronic or recurrent infection
- who have been exposed to TB
- who have a history of serious or opportunistic infections
- who have resided or traveled in areas of endemic TB or mycoses
- with underlying conditions that may predispose them to infection
Patients should be closely monitored for signs and symptoms of infection during and after treatment with ACTEMRA.
INDICATION
ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
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 lab abnormalities.
Common adverse reactions include: upper respiratory tract infection, headache, nasopharyngitis and diarrhea.
Please see full Prescribing Information including Boxed Warning for additional important safety information.
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