belimumab, Benlysta

 Indications

Treatment of active autoantibody-positive systemic lupus

erythematosus (SLE) in patients currently receiving

standard therapy.

Action

A monoclonal antibody produced by recombinant DNA

technique that specifically binds to B-lymphocyte stimulator

protein (BLyS), thereby inactivating it. Therapeutic

Effects:psurvival of B cells, including autoreactive

ones andpdifferentiation into

immunoglobulin-producing plasma cells. Result isp

disease activity with lessened damage/improvement in

mucocutaneous, musculoskeletal, and immunologic

manifestations of SLE.

Pharmacokinetics

Absorption: IV administration results in complete

bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: 19.4 days.

TIME/ACTION PROFILE (reduction in

activated B cells)

ROUTE ONSET PEAK DURATION

IV 8 wk unknown 52 wk†

†With continuous treatment.

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Concurrent

use of other biologicals or cyclophosphamide; Concurrent

use of live vaccines; Receiving therapy for chronic

infection.

Use Cautiously in: Infections (consider temporary

withdrawal for acute infections, treat aggressively); Previous

history of depression or suicidal ideation (may

worsen); Geri: May be more sensitive to drug effects,

consider age-related changes in renal, hepatic and cardiac

function, concurrent drug therapy, and chronic

disease states; OB, Lactation: Use only if potential maternal

benefit outweighs potential fetal risk; Rep:

Women of reproductive potential (use effective contraception).

Adverse Reactions/Side Effects

CNS: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

(PML), depression, insomnia, migraine, fatigue. GI:

nausea, diarrhea. GU: cystitis. Hemat: leukopenia.

MS: extremity pain, myalgia. Derm: rash. Misc: allergic

reactions including ANAPHYLAXIS, INFECTION, infusion

reactions, fever, facial edema.

Interactions

Drug-Drug:qrisk of adverse reactions andpimmune

response to live vaccines; should not be given

concurrently.

Route/Dosage

IV (Adults): 10 mg/kg every 2 wk for 3 doses, then

every 4 wk.

Availability

Lyophilized powder for IV administration (requires

reconstitution and dilution): 120 mg/vial,

400 mg/vial.