belimumab

Contraindicated in:

Hypersensitivity;
Concurrent use of live vaccines;
Receiving therapy for chronic infection.

Use Cautiously in:

Infections (consider temporary withdrawal for acute infections, treat aggressively);
Concurrent use of immunosuppressant therapy or impaired immune function (↑ risk of progressive multifocal leukoencephalopathy [PML]);
Previous history of depression or suicidal ideation (may worsen);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Safety not established in breastfeeding;
Rep: Women of reproductive potential;
Pedi: Children <5 yr (safety and effectiveness not established);
Geri: Older adults may be more sensitive to drug effects.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

GI: diarrhea, nausea

GU: cystitis

Hemat: leukopenia

MS: extremity pain, myalgia

Neuro: depression, insomnia, migraine, anxiety, fatigue, PML, SUICIDAL IDEATION/BEHAVIOR

Misc: fever, infusion reactions, ANAPHYLAXIS, facial edema, INFECTION

Interactions ⬆ ⬇

Drug-drug:

↑risk of adverse reactions and ↓ immune response to live vaccines; should not be given concurrently.
↑risk of serious infections and postinjection systemic reactions when used with rituximab.

Availability ⬆ ⬇

Lyophilized powder for IV injection: 120 mg/vial; 400 mg/vial
Solution for SUBQ injection (prefilled syringes and autoinjectors): 200 mg/mL

Route/Dosage ⬆ ⬇

Systemic Lupus Erythematosus

IV (Adults and Children ≥5 yr): 10 mg/kg every 2 wk for 3 doses; then 10 mg/kg every 4 wk.
SC (Adults and Children ≥5 yr and ≥40 kg): 200 mg once weekly; if transitioning from IV therapy, give first SUBQ dose 1–4 wk after last IV dose.
SC (Children ≥5 yr and 15–<40 kg): 200 mg every 2 wk; if transitioning from IV therapy, give first SUBQ dose 1–4 wk after last IV dose.

Lupus Nephritis

IV (Adults and Children ≥5 yr): 10 mg/kg every 2 wk for 3 doses; then 10 mg/kg every 4 wk.
SC (Adults ): 400 mg (given as two 200-mg injections) once weekly for 4 wk; then 200 mg once weekly. May transition from IV therapy after completing first two IV doses; give first SUBQ dose 1–2 wk after last IV dose.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

A monoclonal antibody produced by recombinant DNA technique that specifically binds to B-lymphocyte stimulator protein, thereby inactivating it.

Therapeutic effects:

↓survival of B cells, including autoreactive ones and ↓ differentiation into immunoglobulin-producing plasma cells. Result is ↓ disease activity with lessened damage/improvement in mucocutaneous, musculoskeletal, and immunologic manifestations of SLE.
Improvement in or stabilization of renal function in lupus nephritis.

Classifications ⬆ ⬇

Therapeutic Classification: Immunosuppressant agents

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: 74% absorbed after SUBQ administration; IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 19.4 days.

Time/Action Profile ⬆ ⬇

(reduction in activated B cells)

ROUTE	ONSET	PEAK	DURATION
IV or SUBQ	8 wk	unknown	52 wk‡

‡With continuous treatment.

Patient/Family Teaching ⬆ ⬇

Instruct patient in correct technique for SUBQ injection, care, and disposal of equipment. Inject on the same day each wk. Inject missed doses as soon as remembered; then resume on usual day or start a new weekly schedule from the day missed dose was administered. Do not inject 2 doses on same day. Advise patient to read Medication Guide prior to each treatment session in case of changes.
Caution patient to notify health care professional immediately if signs of infection (fever, sweating, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red or painful skin or sores, diarrhea or stomach pain, burning on urination, urinary frequency, feeling tired), PML, severe rash, swollen face, or difficulty breathing occur while taking.
Advise patient, family, and caregivers to look for depression and suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying; attempts to commit suicide; new or worse depression or anxiety; agitation or restlessness; panic attacks; insomnia; new or worse irritability; aggressiveness; acting on dangerous impulses, mania, or other changes in mood or behavior; or symptoms of serotonin syndrome occur.
Caution patient to avoid receiving live vaccines for 30 days before and during belimumab therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise females of reproductive potential to use effective contraception during and for ≥4 mo after final treatment and to notify health care professional if breastfeeding. Encourage pregnant patients to enroll in pregnancy registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

49401- Human Genome Sciences, Inc.
- 49401-088- BENLYSTA
  - 49401-088-02- 1 SYRINGE in 1 CARTON (49401-088-02) > 1 mL in 1 SYRINGE (49401-088-01)

49401- Human Genome Sciences, Inc.
- 49401-088- BENLYSTA
  - 49401-088-35- 4 SYRINGE in 1 CARTON (49401-088-35) > 1 mL in 1 SYRINGE (49401-088-01)

49401- Human Genome Sciences, Inc.
- 49401-088- BENLYSTA
  - 49401-088-47- 4 SYRINGE in 1 CARTON (49401-088-47) > 1 mL in 1 SYRINGE (49401-088-42)

49401- Human Genome Sciences, Inc.
- 49401-088- BENLYSTA
  - 49401-088-50- 1 SYRINGE in 1 CARTON (49401-088-50) > 1 mL in 1 SYRINGE (49401-088-42)

49401- Human Genome Sciences, Inc.
- 49401-101- BENLYSTA
  - 49401-101-01- 1 VIAL in 1 CARTON (49401-101-01) > 1.5 mL in 1 VIAL

49401- Human Genome Sciences, Inc.
- 49401-102- BENLYSTA
  - 49401-102-01- 1 VIAL in 1 CARTON (49401-102-01) > 5 mL in 1 VIAL

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Indications ⬇

Contraind./Precautions ⬆ ⬇