Belimumab (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- BENLYSTA
Indications and Usage
BENLYSTA is indicated for the treatment of patients 5 years of age and older with: •Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and •Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation.
Contraindications
BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.
Adverse Reactions
The following serious adverse reactions are described below and in the Warnings and Precautions section: •Serious Infections [see Warnings and Precautions (5.1)] •Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions (5.2)] •Depression and Suicidality [see Warnings and Precautions (5.3)] •Malignancy [see Warnings and Precautions (5.4)]
Drug Interactions
Formal drug interaction studies have not been performed with BENLYSTA. In clinical trials, BENLYSTA was administered concomitantly with other drugs, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, cyclophosphamide, methotrexate, and mycophenolate), angiotensin pathway antihypertensives, HMG‑CoA reductase inhibitors (statins), and/or non-steroidal anti-inflammatory drugs (NSAIDs) without evidence of a clinically meaningful effect of these concomitant medications on belimumab pharmacokinetics. The effect of belimumab on the pharmacokinetics of other drugs has not been evaluated [see Clinical Pharmacology (12.3)].
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, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
Overdosage
There is limited experience with overdosage of belimumab. Two doses of up to 20 mg/kg have been given intravenously to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.