alk with your healthcare provider.
You can ask your healthcare provider or pharmacist for information about BENLYSTA that is written for healthcare professionals.
For more information about BENLYSTA, go to www.BENLYSTA.com or call 1-877-423-6597.
What are the ingredients in BENLYSTA?
Active ingredient: belimumab.
Inactive ingredients: citric acid, polysorbate 80, sodium citrate, sucrose.
RX Only
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
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued: March 2012
©2011, Human Genome Sciences, Inc. All rights reserved.
PRINCIPLE DISPLAY PANEL
NDC 49401-101-01
Benlysta®
(belimumab)
For Injection
120 mg/vial
For Intravenous Infusion after dilution only
Single-use vial; Discard unused portion
Product must be reconstituted with 1.5 mL of Sterile Water for Injection, USP. After reconstitution, the concentration of BENLYSTA is 80 mg/mL. Further dilute in 250 mL of 0.9% Sodium Chloride Injection, USP before use.
Dispense the enclosed Medication Guide to each patient.
Rx only
©2011 Human Genome Sciences
80040 Rev. 002
(click image for full-size original) PRINCIPAL DISPLAY PANEL
NDC 49401-102-01
Benlysta®
(belimumab)
For Injection
400 mg/vial
For Intravenous Infusion after dilution only
Single-use vial; Discard unused portion
Product must be reconstituted with 4.8 mL of Sterile Water for Injection, USP. After reconstitution, the concentration of BENLYSTA is 80 mg/mL. Further dilute in 250 mL of 0.9% Sodium Chloride Injection, USP before use.
Dispense the enclosed Medication Guide to each patient.
Rx only
©2011 Human Genome Sciences
80036 Rev. 001
(click image for full-size original) BENLYSTA
belimumab injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49401-102
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BELIMUMAB (BELIMUMAB) BELIMUMAB 400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE
POLYSORBATE 80
CITRIC ACID MONOHYDRATE
SUCROSE
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:49401-102-01 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (49401-102-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125370 03/10/2011
BENLYSTA
belimumab injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49401-101
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Stren
