"March 9, 2011 -- The FDA has approved Benlysta, the first new lupus treatment in 50 years.
An FDA advisory panel last November voted 13-2 in favor of approval. But the panel noted that Benlysta is no wonder drug. Overall, it offered a"...
Limitations Of Use
The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
DOSAGE AND ADMINISTRATION
BENLYSTA is for intravenous infusion only and must be reconstituted and diluted prior to administration [see Preparation Of Solutions]. Do not administer as an intravenous push or bolus.
The recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute, and administer as an intravenous infusion only, over a period of 1 hour. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
Preparation Of Solutions
BENLYSTA is provided as a lyophilized powder in a single-use vial for intravenous infusion only and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows:
- Remove BENLYSTA from the refrigerator and allow to stand 10 to 15 minutes for the vial to reach room temperature.
- Reconstitute the BENLYSTA
powder with Sterile Water for Injection, USP, as follows. The reconstituted
solution will contain a concentration of 80 mg/mL belimumab.
- Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP.
- Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP.
- The stream of sterile water should be directed toward the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved. Do not shake. Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from sunlight.
- If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, it should not exceed 500 rpm and the vial swirled for no longer than 30 minutes.
- Once reconstitution is
complete, the solution should be opalescent and colorless to pale yellow, and
without particles. Small air bubbles, however, are expected and acceptable.
- Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP. Dilute the reconstituted product to 250 mL in 0.9% Sodium Chloride Injection, USP (normal saline) for intravenous infusion. From a 250-mL infusion bag or bottle of normal saline, withdraw and discard a volume equal to the volume of the reconstituted solution of BENLYSTA required for the patient's dose. Then add the required volume of the reconstituted solution of BENLYSTA into the infusion bag or bottle. Gently invert the bag or bottle to mix the solution. Any unused solution in the vials must be discarded.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.
- The reconstituted solution of BENLYSTA, if not used immediately, should be stored protected from direct sunlight and refrigerated at 2° to 8°C (36° to 46°F). Solutions of BENLYSTA diluted in normal saline may be stored at 2° to 8°C (36° to 46°F) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.
- No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.
- The diluted solution of BENLYSTA should be administered by intravenous infusion only, over a period of 1 hour.
- BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis [see WARNINGS AND PRECAUTIONS].
- BENLYSTA should not be infused concomitantly in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of BENLYSTA with other agents.
Dosage Forms And Strengths
Single-use vials of belimumab lyophilized powder for injection:
- 120 mg per vial
- 400 mg per vial
Storage And Handling
BENLYSTA is a sterile, preservative-free, lyophilized powder for reconstitution, dilution, and intravenous infusion provided in single-use glass vials with a rubber stopper (not made with natural rubber latex) and a flip-off seal. Each 5-mL vial contains 120 mg of belimumab. Each 20-mL vial contains 400 mg of belimumab.
BENLYSTA is supplied as follows:
120 mg belimumab in a 5-mL single-use vial
400 mg belimumab in a 20-mL single-use vial NDC 49401-102-01
Store vials of BENLYSTA refrigerated between 2° to 8°C (36° to 46°F). Vials should be protected from light and stored in the original carton until use. Do not freeze. Avoid exposure to heat. Do not use beyond the expiration date.
Manufactured by : Human Genome Sciences, Inc., (a subsidiary of GlaxoSmithKline), Rockville, Maryland 20850, US License No. 1820. Marketed by : GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Nov 2015.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/22/2016
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