usion from the vial(s) and add slowly into the 0.9% or 0.45% Sodium Chloride infusion bag or bottle. To mix the solution, gently invert the bag to avoid foaming.
The fully diluted ACTEMRA solutions for infusion using 0.9% Sodium Chloride 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.
The fully diluted ACTEMRA solutions for infusion using 0.45% Sodium Chloride may be stored at 2° to 8°C (36° to 46°F) for up to 24 hours or room temperature for up to 4 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.
2.6 Preparation and Administration Instructions for Subcutaneous Injection for RA
ACTEMRA for subcutaneous injection is only indicated in the treatment in patients with adult RA and is not indicated for the treatment of patients with PJIA or SJIA. ACTEMRA for subcutaneous injection is not intended for intravenous drip infusion.
ACTEMRA subcutaneous injection is intended for use under the guidance of a healthcare practitioner. After proper training in subcutaneous injection technique, a patient may self-inject ACTEMRA or the patient's caregiver may administer ACTEMRA if a healthcare practitioner determines that it is appropriate. Patients, or patient caregivers, should be instructed to follow the directions provided in the Instructions for Use (IFU) for additional details on medication administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use ACTEMRA prefilled syringes (PFS) exhibiting particulate matter, cloudiness, or discoloration. ACTEMRA for subcutaneous administration should be clear and colorless to pale yellow. Do not use if any part of the PFS appears to be damaged.
Patients using ACTEMRA for subcutaneous administration should be instructed to inject the full amount in the syringe (0.9 mL), which provides 162 mg of ACTEMRA, according to the directions provided in the IFU.
Injection sites should be rotated with each injection and should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.
2.7 Dosage Modifications due to Serious Infections or Laboratory Abnormalities
Hold ACTEMRA treatment 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
Grea |
