BENLYSTA Dosage & Rx Info | Uses, Side Effects

Benlysta Generic Name & Formulations

Legal Class

General Description

Belimumab 120mg, 400mg; per vial; pwd for IV infusion after reconstitution and dilution; 200mg/mL prefilled autoinjector or syringe; soln for SC inj; preservative-free.

Pharmacological Class

B-lymphocyte stimulator (BLyS)-specific inhibitor.

How Supplied

Single-dose vial (120mg/5mL, 400mg/20mL)—1; single-dose prefilled autoinjector (200mg/mL)—4 (w. needle); single-dose prefilled syringe (200mg/mL)—4 (w. needle)

Manufacturer

GlaxoSmithKline

Generic Availability

Mechanism of Action

Benlysta is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. Benlysta does not bind B cells directly, but by binding BLyS, it inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

Benlysta Indications

Indications

Active systemic lupus erythematosus (SLE) or active lupus nephritis in patients ≥5yrs receiving standard therapy.

Limitations of Use

Not evaluated in severe active CNS lupus.

Benlysta Dosage and Administration

Adults and Children

For IV regimen (use vials only): give over 1hr; slower if infusion reaction occurs. <5yrs: not established. ≥5yrs (SLE or lupus nephritis): 10mg/kg every 2 weeks for 3 doses, then 10mg/kg every 4 weeks. May consider premedication for infusion/hypersensitivity reactions prior to initiation. For SC regimen (use prefilled autoinjectors or syringes only): inject into abdomen or thigh. <18yrs: not established. ≥18yrs (SLE): 200mg once weekly; (lupus nephritis): 400mg (two 200mg injections) once weekly for 4 doses, then 200mg once weekly thereafter. Transitioning from IV to SC: (SLE) give first SC dose 1–4 weeks after last IV dose; (lupus nephritis): give first SC dose 1–2 weeks after last IV dose.

Benlysta Contraindications

Not Applicable

Benlysta Boxed Warnings

Not Applicable

Benlysta Warnings/Precautions

Warnings/Precautions

Supervise 1^st SC inj. Intravenous use should be administered by healthcare providers. Have resuscitative equipment available to manage infusion/hypersensitivity reactions. Discontinue immediately if a serious hypersensitivity reaction occurs. Infusion rate may be slowed or interrupted if infusion-related reactions occur. Severe or chronic infections. Consider interrupting if new infection develops during treatment; monitor closely. Evaluate if new-onset or deteriorating neurological signs/symptoms develop. Suspend if progressive multifocal leukoencephalopahy (PML) is suspected; discontinue if PML is confirmed. Depression. Suicidality. Assess patient's medical history, current psychiatric status prior to initiation and monitor during therapy. Reevaluate periodically. Malignancy. Elderly. Pregnancy. Advise females of reproductive potential to use effective contraception during and for ≥4mos after the last dose. Nursing mothers.

Benlysta Pharmacokinetics

Absorption

Peak concentration (C_max): 313 mcg/mL (IV); 108 mcg/mL (SC). Area under the curve (AUC_0-∞): 3,083 day•mcg/mL (IV); 726 day•mcg/mL (SC).

Distribution

Distribution half-life: 1.8 days (IV); 1.1 days (SC). Volume of distribution: 5 L (IV); 5 L (SC).

Elimination

Half-life: 19.4 days (IV); 18.3 days (SC).

Benlysta Interactions

Interactions

Concomitant IV cyclophosphamide: not recommended. Caution when concomitant with other biologics. Immunizations (may get suboptimal response); avoid live vaccines for 30 days prior to and during treatment.

Benlysta Adverse Reactions

Adverse Reactions

Nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, inj site reactions (SC form); serious infections (may be fatal), PML, psychiatric disorders, infusion and/or hypersensitivity reactions.

Benlysta Clinical Trials

See Literature

Benlysta Note

Notes

To register pregnant women exposed to Benlysta call (877) 681-6296.

Benlysta Patient Counseling