Scroll to view full Important Safety Information.
Click here to view full Prescribing Information and Medication Guide.

 

INDICATION

BENLYSTA is indicated for patients aged ≥5 years with active, autoantibody-positive systemic lupus erythematosus (SLE) who receive standard therapy. The subcutaneous (SC) formulation is approved for patients aged ≥18 years. BENLYSTA is not indicated or recommended in patients with severe active lupus nephritis, or severe active central nervous system lupus, or in combination with other biologics or intravenous cyclophosphamide.


IMPORTANT SAFETY INFORMATION

CONTRAINDICATION
Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The incidence of serious infections was similar in patients receiving BENLYSTA versus placebo, whereas fatal infections occurred more frequently with BENLYSTA. The most frequent serious infections in adults treated with BENLYSTA IV included pneumonia, urinary tract infection, cellulitis, and bronchitis. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.

Hypersensitivity Reactions (including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis (eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea) and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. With BENLYSTA SC, systemic hypersensitivity reactions were similar to those in IV trials.

Healthcare providers (HCPs) should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction. Premedication may mitigate or mask a hypersensitivity response. Advise patients about hypersensitivity symptoms and instruct them to seek immediate medical care if a reaction occurs.

Infusion Reactions: Serious infusion reactions (eg, bradycardia, myalgia, headache, rash, urticaria, and hypotension) were reported in adults. HCPs should monitor patients and manage reactions if they occur. Premedication may mitigate or mask a reaction. If an infusion reaction develops, slow or interrupt the infusion.

Depression and Suicidality: In adult trials, psychiatric events reported more frequently with BENLYSTA IV related primarily to depression-related events, insomnia, and anxiety; serious psychiatric events included serious depression and suicidality, including 2 completed suicides. No serious depression-related events or suicides were reported in the BENLYSTA SC trial. Before adding BENLYSTA, assess patients’ risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts, or other mood changes.

Malignancy: The impact of BENLYSTA on the development of malignancies is unknown; its mechanism of action could increase the risk for malignancies.

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

Use With Biologic Therapies or IV Cyclophosphamide: BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide.

ADVERSE REACTIONS

The most common serious adverse reactions in adults were serious infections: BENLYSTA IV 6.0% (placebo 5.2%). Fatal infections occurred in 0.3% of patients receiving BENLYSTA and in 0.1% of patients receiving placebo. Adverse reactions occurring in ≥3% of adults and ≥1% more than placebo: nausea 15% (12%); diarrhea 12% (9%); pyrexia 10% (8%); nasopharyngitis 9% (7%); bronchitis 9% (5%); insomnia 7% (5%); pain in extremity 6% (4%); depression 5% (4%); migraine 5% (4%); pharyngitis 5% (3%); cystitis 4% (3%); leukopenia 4% (2%); viral gastroenteritis 3% (1%).

Adverse reactions in pediatric patients aged ≥5 years receiving BENLYSTA IV were consistent with those observed in adults.

The safety profile observed for BENLYSTA SC in adults was consistent with the known safety profile of BENLYSTA IV with the exception of local injection site reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy:
There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.

Pregnancy Registry: HCPs are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.

Lactation: No information is available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. Consider developmental and health benefits of breastfeeding with the mother’s clinical need for BENLYSTA and any potential adverse effects on the breastfed child or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness have not been established for BENLYSTA IV in patients <5 years of age and for BENLYSTA SC in patients <18 years of age.

 

Loading your events...

Register for the selected events

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Trademarks are owned by or licensed to the GSK group of companies.

©2020 GSK or licensor.
BELWCNT200046 October 2020
Produced in USA.
This site is intended for US healthcare professionals only.

Thank you for registering!

In the next few minutes, you should receive a confirmation email with your login information for each event you selected. If you do not receive a confirmation email in 15 minutes, please email support.