在56年来第一个批准的新狼疮药物
在Benlysta之前，FDA在1955年批准治疗狼疮药物，羟基氯喹[hydroxychloroquine](商品名氯奎宁) [Plaquenil]和皮质激素。1948年批准阿司匹林治疗狼疮。
FDA药物评价和研究中心药物评价II部主任Curtis Rosebraugh, M.D., M.P.H. 说“Benlysta，当与使用已有治疗，对寻求帮助处理与这种疾病相关症状的医疗保健人员和患者可能是重要新治疗方法”
BENLYSTA- belimumab injection, powder, lyophilized, for solution
Human Genome Sciences, Inc.
1 INDICATIONS AND USAGEBENLYSTA® (belimumab) is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Limitations of Use
The efficacy of BENLYSTA has not been eva luated 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.
2 DOSAGE AND ADMINISTRATION2.1 Dosage ScheduleBENLYSTA is for intravenous infusion only and must be reconstituted and diluted prior to administration [see Dosage and Administration (2.3)]. 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 (4), Warnings and Precautions (5.4)].
2.2 Premedication Recommendations
Prior to dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions. [see Warnings and Precautions (5.4, 5.5) and Adverse Reactions (6.1)].
2.3 Preparation of SolutionsBENLYSTA 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:
Reconstitution Instructions
1.
Remove BENLYSTA from the refrigerator and allow to stand 10 to 15 minutes for the vial to reach room temperature.
2.
Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab.
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Reconstitute the 120 mg vial with 1.5 mL Sterile Water for Injection, USP.
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Reconstitute the 400 mg vial with 4.8 mL Sterile Water for Injection, USP.
3.
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.
4.
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.
5.
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.
Dilution Instructions
6.