oclonal 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).
ACTEMRA for intravenous infusion should be diluted by a healthcare professional using aseptic technique as follows:
Systemic Juvenile Idiopathic Arthritis Patients less than 30 kg: utilize a 50 mL infusion bag or bottle, then follow steps 1 and 2 below.
Adult Rheumatoid Arthritis and SJIA patients at or above 30 kg weight: utilize a 100 mL infusion bag or bottle, then follow steps 1 and 2 below.
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Step 1. Withdraw a volume of 0.9% Sodium Chloride Injection, USP, equal to the volume of the ACTEMRA solution required for the patient's dose from the infusion bag or bottle.
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Step 2. Slowly add ACTEMRA for intravenous infusion from each vial into the infusion bag or bottle. To mix the solution, gently invert the bag to avoid foaming.
The fully diluted ACTEMRA solutions for infusion may be stored at 2° to 8°C (36° to 46°F) or room temperature for up to 24 hours and should be protected from light. ACTEMRA solutions do not contain preservatives; therefore, unused product remaining in the vials should not be used.
Allow the fully diluted ACTEMRA solution to reach room temperature prior to infusion.
The infusion should be administered over 60 minutes, and must be administered with an infusion set. Do not administer as an intravenous push or bolus.
ACTEMRA should not be infused concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to eva luate the co-administration of ACTEMRA with other drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, the product should not be used. Fully diluted ACTEMRA solutions are compatible with polypropylene, polyethylene and polyvinyl chloride infusion bags and polypropylene, polyethylene and glass infusion bottles.
2.4Dosage Modifications
ACTEMRA treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Rheumatoid Arthritis
Liver Enzyme Abnormalities [see Warnings and Precautions (5.3)]:
Lab Value Recommendation
Greater than 1 to 3x ULN Dose modify concomitant DMARDs if appropriate
For persistent increases in this range, reduce ACTEMRA dose to 4 mg per kg or interrupt ACTEMRA until ALT or AST have normalized
Greater than 3 to 5x ULN
(confirmed by repeat testing) Interrupt ACTEMRA dosing until less than 3x ULN and follow recommendations above for greater than 1 to 3x ULN
For persistent increases greater than 3x ULN, discontinue ACTEMRA
Greater than 5x ULN Discontinue ACTEMRA
Low Absolute Neutrophil Count (ANC) [see Warnings and Precautions (5.3)]:
Lab Value
(cells per mm3) Recommendation
ANC greater than 1000 Maintain dose
ANC 500 to 1000 Interrupt ACTEMRA dosing
When ANC greater than 1000 cells per mm3 resume ACTEMRA at 4 mg per kg and increase to 8 mg per kg as clinically appropriate
ANC less than 500 Discontinue ACTEMRA
Low Platelet Count [see Warnings and P
