ry changes including elevated liver enzymes, neutropenia, and thrombocytopenia [see DOSAGE AND ADMINISTRATION (2.7), WARNINGS AND PRECAUTIONS (5.3), and ADVERSE REACTIONS (6.2)].
2.2 Polyarticular Juvenile Idiopathic Arthritis
ACTEMRA may be used alone or in combination with methotrexate. The recommended dosage of ACTEMRA for PJIA patients given once every 4 weeks as a 60-minute single intravenous drip infusion is:
Recommended Intravenous PJIA Dosage Every 4 Weeks
Patients less than 30 kg weight 10 mg per kg
Patients at or above 30 kg weight 8 mg per kg
Do not change dose 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 [see DOSAGE AND ADMINISTRATION (2.7)].
Subcutaneous administration is not approved for PJIA.
2.3 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:
Recommended Intravenous SJIA Dosage Every 2 Weeks
Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg weight 8 mg per kg
Do not change a dose 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 [see DOSAGE AND ADMINISTRATION (2.7)].
Subcutaneous administration is not approved for SJIA.
2.4 General Considerations for Administration
ACTEMRA has not been studied 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. Avoid using ACTEMRA with biological DMARDs.
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).
2.5 Preparation and Administration Instructions for Intravenous Infusion
ACTEMRA for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:
PJIA and SJIA patients less than 30 kg: use a 50 mL infusion bag or bottle of 0.9% or 0.45% Sodium Chloride, and then follow steps 1 and 2 below.
Adult RA, PJIA and SJIA patients at or above 30 kg weight: use a 100 mL infusion bag or bottle, and then follow steps 1 and 2 below.
–
Step 1. Withdraw a volume of 0.9% or 0.45% Sodium Chloride injection, equal to the volume of the ACTEMRA injection required for the patient's dose from the infusion bag or bottle [see DOSAGE AND ADMINISTRATION (2.1, 2.2, 2.3)].
For Intravenous Use: Volume of ACTEMRA Injection per kg of Body Weight
Dosage Indication Volume of ACTEMRA injection per kg of body weight
4 mg/kg Adult RA 0.2mL/kg
8 mg/kg Adult RA SJIA and PJIA (≥30 kg of body weight) 0.4mL/kg
10 mg/kg PJIA (< 30 kg of body weight) 0.5 mL/kg
12 mg/kg SJIA (< 30 kg of body weight) 0.6mL/kg –
Step 2. Withdraw the amount of ACTEMRA for intravenous inf |
