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BENLYSTA Gateway is available through BENLYSTA Cares. BENLYSTA Gateway helps patients and healthcare professionals understand authorization*, access, distribution, and reimbursement for BENLYSTA.

1-877-4-BENLYSTA (1-877-423-6597)
Monday-Friday, 8 AM to 8 PM, ET

Select option 1 for BENLYSTA Gateway


BENLYSTA is available through a variety of options


BENLYSTA Gateway can complete a patient-specific benefits investigation with the patient's payer and provide PA research and support

For benefits investigation, BENLYSTA Gateway can:

  • Contact insurance companies to obtain specific coverage information
  • Determine whether payer requires prior authorization
  • Determine estimated patient out-of-pocket responsibility

Once BENLYSTA Gateway completes a benefit verification, you and your patient will receive a Summary of Benefits that will review the patient's coverage.

Please note that investigations do not guarantee a result and it is the provider's responsibility to check with the payer. The patient's payer is the most accurate source of information about the patient's coverage.

For PA research and support, BENLYSTA Gateway can:

  • Research plan requirements
  • Outline steps required for obtaining a PA from the patient’s plan
  • Obtain unique and plan-specific PA forms (where applicable)

BENLYSTA Gateway can also follow up with the plan to help determine the status of the PA submission (if requested).

Remember, BENLYSTA Gateway cannot complete PA forms or submit related information to plans. Instead, it is the responsibility of the office and prescribing physician to provide the plan with patient-specific clinical documentation.


BENLYSTA Gateway can evaluate eligibility for the BENLYSTA Co-pay Program

Approved patients may pay as little as $0 for BENLYSTA

Who may be eligible?

Your patients may be eligible for the Program if they:

  • Have commercial medical or prescription insurance plan
  • Are not insured
  • Are a resident of the US (including the District of Columbia, Puerto Rico, and the US Virgin Islands)

Who is not eligible?

Your patients are not eligible for the Program if they are:

  • Eligible for Medicare or have a state- or federal government-funded medical or prescription insurance plan such as Medicare, Medicaid, VA, or TRICARE.
  • Age 65 or older (patients are considered eligible for Medicare and therefore not eligible for the Co-pay Program).
  • Enrolled in a commercial health plan that does not permit the use of Co-pay assistance programs.

BENLYSTA Gateway can help eligible uninsured and some Medicare patients who meet eligibility requirements obtain access to BENLYSTA free of charge through GSK's Patient Assistance Program.

Learn more about the Co-pay Program

BENLYSTA Gateway can also provide general information about coverage and out-of-pocket costs through completion of a benefit investigation on behalf of the patient (see section above).

*BENLYSTA Gateway CANNOT complete prior authorization forms or submit related information directly to Payers on behalf of physician .

The BENLYSTA Co-pay Program helps eligible approved patients with their out-of-pocket costs for BENLYSTA up to $15,000 for 12 months. If approved, patients could pay as little as $0 for BENLYSTA. Medicare eligible patients, and patients enrolled in government-funded programs, are not eligible for the BENLYSTA Co-pay Program. Patients must submit a BENLYSTA Gateway Enrollment Form or complete application online at benlystacopayprogram.com to determine eligibility. Click here for full Program Terms & Conditions.


BENLYSTA is indicated for the treatment of patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who receive standard therapy. BENLYSTA is approved as an intravenous infusion in patients 5 years and older and as a subcutaneous injection in patients 18 years and older.

Limitations of Use: The efficacy of BENLYSTA has not been evaluated and is not recommended in patients with severe active lupus nephritis, or severe active central nervous system lupus, or in combination with other biologics or intravenous cyclophosphamide.

How supplied: BENLYSTA for intravenous use (IV) is available as 120 mg in a 5-mL single-dose vial and 400 mg in a 20-mL single-dose vial. BENLYSTA for subcutaneous use (SC) is available as 200 mg in a 1-mL single-dose prefilled autoinjector and 200 mg in a 1-mL single-dose prefilled glass syringe.

Important Safety Information


Previous anaphylaxis with BENLYSTA.



In controlled clinical trials in adults (N=2,133), death occurred in 0.8% (11/1,458) of patients treated with BENLYSTA IV and in 0.4% (3/675) of patients receiving placebo. Etiologies included infection, cardiovascular disease, and suicide.

In the controlled trial in adults (N=836), death occurred in 0.5% (3/556) of patients receiving BENLYSTA SC and 0.7% (2/280) of patients receiving placebo. Infection was the most common cause of death.


Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The most frequent serious infections in adults were pneumonia, including bacterial pneumonia, urinary tract infection, cellulitis, herpes zoster, and bronchitis. Use caution in patients with severe or chronic infections. Consider interrupting therapy with BENLYSTA in patients who develop 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.


Acute hypersensitivity reactions, including anaphylaxis and death, have been reported in association with infusions and injections of BENLYSTA, including in patients who have previously tolerated BENLYSTA. These events generally occurred within hours of the infusion; however, they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most recent infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Premedication may mitigate or mask an infusion reaction or hypersensitivity response. In the controlled trial of BENLYSTA SC in adults, systemic hypersensitivity reactions were similar to those observed in the IV clinical trials. Anaphylaxis was observed in 0.6% and 0.4% of adult patients receiving BENLYSTA IV and placebo, respectively. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea.

Serious infusion reactions in adults (excluding hypersensitivity reactions) were reported in 0.5% and 0.4% of patients receiving BENLYSTA and placebo, respectively and included bradycardia, myalgia, headache, rash, urticaria, and hypotension. BENLYSTA IV should be administered by healthcare providers prepared to manage infusion reactions and anaphylaxis. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. In the event of a serious reaction, administration of BENLYSTA must be discontinued immediately and appropriate medical therapy administered. Patients should be closely monitored during and for an appropriate period of time after IV administration of BENLYSTA. Patients receiving BENLYSTA should be informed of the signs and symptoms of hypersensitivity reactions and seek immediate medical care should a reaction occur.


In the controlled clinical trials of BENLYSTA IV in adults, psychiatric events were reported more frequently with BENLYSTA than with placebo, related primarily to depression-related events, insomnia and anxiety. Serious psychiatric events were reported in trials with BENLYSTA. Serious depression and suicidality (including two completed suicides) were reported in trials with BENLYSTA IV. There were no serious depression-related events or suicides reported in the BENLYSTA SC trial in adults. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.


The impact of treatment with BENLYSTA on the development of malignancies is not known. The mechanism of action of BENLYSTA could increase the risk for the development of malignancies.


Live vaccines should not be given for 30 days before or concurrently with BENLYSTA. BENLYSTA may interfere with the response to immunizations.


BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with these therapies.


The most common serious adverse reactions were serious infections (6.0% and 5.2% in adult patients receiving BENLYSTA IV and placebo, respectively), some of which were fatal. Adverse reactions, regardless of causality, occurring in at least 3% of adult patients with SLE who received BENLYSTA 10 mg/kg and placebo respectively and, at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies, were: nausea 15% and 12%; diarrhea 12% and 9%; pyrexia 10% and 8%; nasopharyngitis 9% and 7%; bronchitis 9% and 5%; insomnia 7% and 5%; pain in extremity 6% and 4%; depression 5% and 4%; migraine 5% and 4%; pharyngitis 5% and 3%; cystitis 4% and 3%; leukopenia 4% and 2%; viral gastroenteritis 3% and 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 plus standard therapy in adults was consistent with the known safety profile of BENLYSTA IV plus standard therapy, with the exception of local injection site reactions.



Pregnancy: There are insufficient data on use of BENLYSTA in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Following an assessment of benefit versus risk, if prevention is warranted, women of childbearing potential should use effective contraception during treatment and for at least 4 months after the final treatment.

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

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

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

Black/African American Patients: In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Consider the risks and benefits when prescribing BENLYSTA in black/African American patients.

Please see full Prescribing Information and Medication Guide for BENLYSTA.

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