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BENLYSTA SC IS THE FIRST AND ONLY SUBCUTANEOUS OPTION APPROVED FOR WEEKLY TREATMENT OF SLE

Subcutaneous injection: 200 mg once weekly

BENLYSTA SC is not indicated for use in patients under 18 years of age.

Administration Instructions

  • It is recommended that the first subcutaneous injection of BENLYSTA should be under the supervision of a healthcare professional. The healthcare provider should provide proper training in subcutaneous injection technique and education about signs and symptoms of hypersensitivity reactions. A patient may self-inject or the patient caregiver may administer BENLYSTA subcutaneously after the healthcare provider determines it is appropriate.
  • Instruct the patient or patient caregiver to follow the directions for administration provided in the Instructions for Use.
  • Instruct the patient to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to the subcutaneous injection. Do not warm BENLYSTA in any other way.
  • Prior to administration, instruct the patient or patient caregiver to visually inspect the window of the autoinjector or the prefilled syringe for particulate matter or discoloration. BENLYSTA should be clear to opalescent and colorless to pale yellow. Do not use BENLYSTA if the product exhibits discoloration or particulate matter. Instruct the patient not to use the BENLYSTA autoinjector or prefilled syringe if dropped on a hard surface.
  • When injecting in the same body region, advise the patient to use a different injection site each week; never give injections into areas where the skin is tender, bruised, red, or hard.
  • Instruct the patient to administer BENLYSTA 200 mg once a week, preferably on the same day each week.
  • If a dose is missed, instruct the patient to administer a dose as soon as the patient remembers. Thereafter, the patient can resume dosing on their usual day of administration or start a new weekly schedule from the day that the missed dose was administered. It is not recommended to administer 2 doses on the same day.

Indication

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

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

MORTALITY

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 INFECTIONS

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.

HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) AND INFUSION REACTIONS

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.

DEPRESSION

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.

MALIGNANCY

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.

IMMUNIZATION

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

USE WITH BIOLOGIC THERAPIES OR IV CYCLOPHOSPHAMIDE

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.

ADVERSE REACTIONS

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.

OTHER IMPORTANT INFORMATION FOR BENLYSTA

USE IN SPECIFIC POPULATIONS

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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