In controlled clinical trials, 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... Continued below
BENLYSTA IV is for intravenous infusion and must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus. BENLYSTA IV is administered 10 mg/kg in a 1-hour intravenous infusion at 2-week intervals for the first 3 doses and at 4-week intervals for each dose thereafter.
Loading Phase Dates (3 infusions at 2-week intervals)
Ongoing Dosing Dates (1 infusion every 4 weeks thereafter)
Ongoing Dosing Dates (1 infusion every 4 weeks thereafter)
BENLYSTA IV is for intravenous infusion and must be reconstituted and diluted prior to administration. BENLYSTA IV is administered 10 mg/kg in a 1-hour intravenous infusion at 2-week intervals for the first 3 doses and at 4-week intervals for each dose thereafter.
BENLYSTA is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
How supplied: BENLYSTA (belimumab) for intravenous (IV) use is available as 120 mg in a 5-mL single-dose vial and 400 mg in a 20-mL single-dose vial. BENLYSTA (belimumab) 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.
Previous anaphylaxis with BENLYSTA.
In controlled clinical trials, 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 (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 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, systemic hypersensitivity reactions were similar to those observed in the IV clinical trials. Anaphylaxis was observed in 0.6% and 0.4% of patients receiving BENLYSTA and placebo, respectively. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea.
Serious infusion reactions (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, 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 trials. 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 patients receiving BENLYSTA IV and placebo, respectively), some of which were fatal. Adverse reactions, regardless of causality, occurring in at least 3% of 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%.
The safety profile observed for BENLYSTA SC plus standard therapy 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.
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.
825021R0 October 2017