RAPTIVA Indications, Dosage, Storage, Stability - Efalizumab

RAPTIVA Indications, Dosage, Storage, Stability - Efalizumab

INDICATIONS AND USAGE

RAPTIVA (efalizumab) is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The recommended dose of RAPTIVA is a single 0.7 mg/kg SC conditioning dose followed by weekly SC doses of 1 mg/kg (maximum single dose not to exceed a total of 200 mg).

RAPTIVA is intended for use under the guidance and supervision of a physician. If it is determined to be appropriate, patients may self-inject RAPTIVA after proper training in the preparation and injection technique and with medical follow-up.

RAPTIVA should be administered using the sterile, disposable syringe and needles provided (see HOW SUPPLIED section). Remove the cap from the pre-filled syringe containing sterile water for injection (non-USP) and attach the needle to the syringe. Remove the plastic cap protecting the rubber stopper of the RAPTIVA vial and wipe the top of the rubber stopper with one of the provided alcohol swabs. After cleaning with the alcohol swab, do not touch the top of the vial. To prepare the RAPTIVA solution, using the provided pre-filled diluent syringe slowly inject the 1.3 mL of sterile water for injection (non-USP) into the RAPTIVA vial. Swirl the vial with a GENTLE rotary motion to dissolve the product. DO NOT SHAKE. Shaking will cause foaming of the RAPTIVA solution. Generally, dissolution of RAPTIVA takes less than 5 minutes. RAPTIVA is provided as a single-use vial and contains no antibacterial preservatives. Reconstitute immediately before use and use only once. If the reconstituted RAPTIVA is not used immediately, store the RAPTIVA vial at room temperature and use within 8 hours. The reconstituted solution should be clear to pale yellow and free of particulates.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to subcutaneous administration. If particulates or discolorations are noted, the product should not be used.

Replace the needle on the syringe with a new needle. Insert the needle into the vial containing the RAPTIVA solution, invert the vial, and keeping the needle below the level of the liquid, withdraw the dose to be given into the syringe.

No other medications should be added to solutions containing RAPTIVA, and RAPTIVA should not be reconstituted with other diluents.

Sites for injection include thigh, abdomen, buttocks, or upper arm. Injection sites should be rotated.

Following administration, discard any unused reconstituted RAPTIVA solution.

Do not use a vial beyond the expiration date stamped on the carton or vial label. RAPTIVA (lyophilized powder) must be refrigerated at 2-8 C (36-46° F). Protect the vial from exposure to light. Store in original carton until time of use.

RAPTIVAä (efalizumab) is supplied as a lyophilized, sterile powder to deliver 125 mg of efalizumab per single-use vial.

Each RAPTIVA carton contains four trays. Each tray contains one single-use vial designed to deliver 125 mg of efalizumab, one single-use prefilled diluent syringe containing 1.3 mL sterile water for injection (non-USP), two 25 gauge ´ 5/8 inch needles, two alcohol prep pads, a package insert with an accompanying patient information insert. The NDC number for the four administration dose pack carton is 50242-058-04.

1. Werther WA, Gonzalez TN, O'Connor SJ, McCabe S, Chan B, Hotaling T, et al. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and reengineering of the humanized antibody for binding to rhesus LFA-1. J Immunol 1996;157:4986–95.

Updated Nov 04, 2003