imumab in a 5-mL single-use vial
NDC 49401-101-01
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.
17 PATIENT COUNSELING INFORMATIONSee FDA-approved patient labeling (Medication Guide)
17.1 Advice for the Patient
Patients should be given the Medication Guide for BENLYSTA and provided an opportunity to read it prior to each treatment session. It is important that the patient’s overall health be assessed at each infusion visit and any questions resulting from the patient’s reading of the Medication Guide be discussed.
Mortality: Patients should be advised that more patients receiving BENLYSTA in the main clinical trials died than did patients receiving placebo treatment [see Warnings and Precautions (5.1)].
Serious Infections: Patients should be advised that BENLYSTA may decrease their ability to fight infections. Patients should be asked if they have a history of chronic infections and if they are currently on any therapy for an infection [see Warnings and Precautions (5.2)]. Patients should be instructed to tell their healthcare provider if they develop signs or symptoms of an infection.
Hypersensitivity/Anaphylactic and Infusion Reactions: Educate patients on the signs and symptoms of anaphylaxis, including wheezing, difficulty breathing, peri-oral or lingual edema, and rash. Patients should be instructed to immediately tell their healthcare provider if they experience symptoms of an allergic reaction during or after the administration of BENLYSTA [see Warnings and Precautions (5.4, 5.5)].
Depression: Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes [see Warnings and Precautions (5.6)].
Immunizations: Patients should be informed that they should not receive live vaccines while taking BENLYSTA. Response to vaccinations could be impaired by BENLYSTA [see Warnings and Precautions (5.7)].
Pregnancy and Nursing Mothers: Patients should be informed that BENLYSTA has not been studied in pregnant women or nursing mothers so the effects of BENLYSTA on pregnant women or nursing infants are not known. Patients should be instructed to tell their healthcare provider if they are pregnant, become pregnant, or are thinking about becoming pregnant [see Use in Specific Populations (8.1)]. Patients should be instructed to tell their healthcare provider if they plan to breastfeed their infant [see Use in Specific Populations (8.3)].
BENLYSTA is a registered trademark of Human Genome Sciences, Inc., used under license by GlaxoSmithKline.
Manufactured by:
Human Genome Sciences, Inc.
Rockville, Maryland 20850
US License No. 1820
Marketed by:
Human Genome Sciences, Inc.
Rockville, MD 20850
GlaxoSmithKline
Research Triangle Park, NC 27709
©2011, Human Genome Sciences, Inc. All rights reserved.
Medication GuideadvertisementMedication guide
BENLYSTA® (ben-LIST-ah)
(belimumab)
Injection for intravenous use
Read this Medication Guide before you start receiving BENLYSTA and before each treatment. There may be new information. This information does not take the place of talking wit |
