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Injection, for Intravenous Use. Benlysta (Belimumab)

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Injection, for Intravenous Use. Benlysta (Belimumab) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BENLYSTA safely and effectively. See full prescribing information for ------------------------ WARNINGS AND PRECAUTIONS -------------------------- BENLYSTA. Mortality: There were more deaths reported with BENLYSTA than with placebo during the controlled period of clinical trials. (5.1) BENLYSTA (belimumab) for injection, for intravenous use Serious Infections: Serious and sometimes fatal infections have been BENLYSTA (belimumab) injection, for subcutaneous use reported in patients receiving immunosuppressive agents, including BENLYSTA. Use with caution in patients with severe or chronic Initial U.S. Approval: 2011 infections. Consider interrupting therapy with BENLYSTA if patients ----------------------------- RECENT MAJOR CHANGES ------------------------------ develop a new infection during treatment with BENLYSTA. (5.2) Dosage and Administration, Subcutaneous Dosing Instructions Progressive Multifocal Leukoencephalopathy (PML): Patients (2, 2.2) 07/2017 presenting with new-onset or deteriorating neurological signs and Warnings and Precautions (5) 07/2017 symptoms should be evaluated for PML by an appropriate specialist. If PML is confirmed, consider discontinuation of immunosuppressant ----------------------------- INDICATIONS AND USAGE ------------------------------- therapy, including BENLYSTA. (5.2) BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated Hypersensitivity Reactions, including Anaphylaxis: Serious and fatal for the treatment of adult patients with active, autoantibody-positive, systemic reactions have been reported. BENLYSTA for intravenous use should be lupus erythematosus who are receiving standard therapy. (1) administered by healthcare providers prepared to manage anaphylaxis. Monitor patients during and for an appropriate period of time after Limitations of Use: The efficacy of BENLYSTA has not been evaluated in intravenous administration of BENLYSTA. (2.1, 5.3) patients with severe active lupus nephritis or severe active central nervous Depression: Depression and suicidality have been reported in trials with system lupus. BENLYSTA has not been studied in combination with other BENLYSTA. Patients should be instructed to contact their healthcare biologics or intravenous cyclophosphamide. Use of BENLYSTA is not provider if they experience new or worsening depression, suicidal recommended in these situations. (1) thoughts, or other mood changes. (5.5) Immunization: Live vaccines should not be given concurrently with ------------------------- DOSAGE AND ADMINISTRATION -------------------------- BENLYSTA. (5.7) Intravenous Administration ------------------------------- ADVERSE REACTIONS --------------------------------- 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals Common adverse reactions (5%): nausea, diarrhea, pyrexia, thereafter. Reconstitute, dilute, and administer as an intravenous infusion nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, over a period of 1 hour. (2.1) migraine, pharyngitis, and injection site reactions (subcutaneous Consider administering premedication for prophylaxis against infusion administration). (6.1, 6.2) reactions and hypersensitivity reactions. (2.1) Subcutaneous Administration To report SUSPECTED ADVERSE REACTIONS, contact 200 mg once weekly. (2.2) GlaxoSmithKline at 1-877-423-6597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ----------------------- DOSAGE FORMS AND STRENGTHS ------------------------- Intravenous Infusion See 17 for PATIENT COUNSELING INFORMATION and Medication For Injection: 120 mg or 400 mg lyophilized powder in single-dose vials for Guide. reconstitution and dilution prior to intravenous infusion. (3) Revised: 07/2017 Subcutaneous Injection Injection: 200 mg/mL single-dose prefilled autoinjector or single-dose prefilled syringe. (3) -------------------------------- CONTRAINDICATIONS --------------------------------- Previous anaphylaxis to belimumab. (4) FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8.2 Lactation 2 DOSAGE AND ADMINISTRATION 8.3 Females and Males of Reproductive Potential 2.1 Intravenous Preparation and Dosing Instructions 8.4 Pediatric Use 2.2 Subcutaneous Dosing Instructions 8.5 Geriatric Use 3 DOSAGE FORMS AND STRENGTHS 8.6 Renal Impairment 4 CONTRAINDICATIONS 8.7 Hepatic Impairment 5 WARNINGS AND PRECAUTIONS 8.8 Racial Groups 5.1 Mortality 10 OVERDOSAGE 5.2 Serious Infections 11 DESCRIPTION 5.3 Hypersensitivity Reactions, including Anaphylaxis 12 CLINICAL PHARMACOLOGY 5.4 Infusion Reactions 12.1 Mechanism of Action 5.5 Depression 12.2 Pharmacodynamics 5.6 Malignancy 12.3 Pharmacokinetics 5.7 Immunization 13 NONCLINICAL TOXICOLOGY 5.8 Concomitant Use with Other Biologic Therapies or 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Intravenous Cyclophosphamide 14 CLINICAL STUDIES 6 ADVERSE REACTIONS 14.1 Clinical Trials Experience with Intravenous Administration 6.1 Clinical Trials Experience with Intravenous Administration 14.2 Clinical Trials Experience with Subcutaneous 6.2 Clinical Trials Experience with Subcutaneous Administration Administration 16 HOW SUPPLIED/STORAGE AND HANDLING 6.3 Postmarketing Experience 16.1 Intravenous Infusion 6.4 Immunogenicity 16.2 Subcutaneous Injection 7 DRUG INTERACTIONS 17 PATIENT COUNSELING INFORMATION 8 USE IN SPECIFIC POPULATIONS *Sections or subsections omitted from the full prescribing information are not 8.1 Pregnancy listed. 1 Reference ID: 4127228 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE BENLYSTA (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 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. 2 DOSAGE AND ADMINISTRATION BENLYSTA may be administered as an intravenous infusion or as a subcutaneous injection. Vials are intended for intravenous use only (not for subcutaneous use) and autoinjectors and prefilled syringes are intended for subcutaneous use only (not for intravenous use). 2.1 Intravenous Preparation and Dosing Instructions Recommended Intravenous Dosage Regimen BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus. The recommended intravenous 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 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 (5.3)]. Premedication Recommendations prior to Intravenous Use Prior to intravenous dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions [see Warnings and Precautions (5.3, 5.4), Adverse Reactions (6.1)]. Preparation of Intravenous Solutions BENLYSTA for intravenous use is provided as a lyophilized powder in a single-dose vial and should be reconstituted and diluted by a healthcare professional using aseptic technique as follows. Use of a 21- to 25-gauge needle is recommended when piercing the vial stopper for reconstitution and dilution. 2 Reference ID: 4127228 Reconstitution Instructions for Intravenous Use: 1. Remove the vial of BENLYSTA from the refrigerator and allow to stand for 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. 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. 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 for Intravenous Use: 6. Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP (normal saline), 0.45% Sodium Chloride Injection, USP (half-normal saline), or Lactated Ringer’s Injection, USP to a volume of 250 mL for intravenous infusion. From a 250-mL infusion bag or bottle of normal saline, half-normal saline, or Lactated Ringer’s Injection, withdraw and discard a volume
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