• Medication Guide
• Prescribing Information
• Important Safety Information

What type of patient are you treating?

Dose:

Patient Weight:  or 

Pediatric Dose and Vial Combination

  or 

400 mg/20mL	200 mg/10mL	80 mg/4mL

Unused Dose:

ACTEMRA should not be infused concomitantly in the same intravenous line with other drugs.

ACTEMRA must be administered with an infusion set.

Do not administer as an intravenous push or bolus.

Do not administer to patients with known hypersensitivity to ACTEMRA

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.

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 changes to certain lab parameters. Common adverse reactions in RA studies included upper respiratory infection, nasopharyngitis, headache, hypertension, and increased ALT.

Common adverse reactions in SJIA studies included upper respiratory tract infection, headache, nasopharyngitis and diarrhea.

Please see full Prescribing Information, including Boxed Warning for additional important safety information.

© 2012 Genentech USA, Inc. All rights reserved. ACT0000348600

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.

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 changes to certain lab parameters.

Common adverse reactions in RA studies included upper respiratory infection, nasopharyngitis, headache, hypertension, and increased ALT.

Common adverse reactions in SJIA studies included upper respiratory tract infection, headache, nasopharyngitis and diarrhea.

Rheumatoid Arthritis

ACTEMRA may be used as monotherapy or concomitantly with methotrexate or other DMARDs. The recommended dose of ACTEMRA for adult patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:

• Reduction of dose from 8 mg per kg to 4 mg per kg is recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.
• Doses exceeding 800 mg per infusion are not recommended in RA patients

Systemic Juvenile Idiopathic Arthritis

ACTEMRA may be used alone or in combination with methotrexate. The recommended dose of ACTEMRA for SJIA patients given once every 2 weeks as a 60-minute single intravenous drip infusion is:

• A change in dose should not be made based solely on a single visit body weight measurement, as weight may fluctuate.
• Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia.

Administration

• ACTEMRA has not been studied and its use should be avoided in combination with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators because of the possibility of increased immunosuppression and increased risk of infection.
• It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).

Please see full Prescribing Information including Boxed Warning for additional important safety information.

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