belimumab

Contraindicated in:

Hypersensitivity;
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.
SUBQ (Adults and Children ≥5 yr and ≥40 kg): 200 mg once weekly; if transitioning from IV therapy, give 1st SUBQ dose 1–4 wk after last IV dose.
SUBQ (Children ≥5 yr and 15–<40 kg): 200 mg every 2 wk; if transitioning from IV therapy, give 1st 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.
SUBQ (Adults and Children ≥5 yr and ≥40 kg): 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 1st two IV doses; give 1st 200 mg SUBQ dose 1–2 wk after last IV dose.
SUBQ (Children ≥5 yr and 15–<40 kg): 200 mg once weekly for 4 wk; then 200 mg every 2 wk; if transitioning from IV therapy, give 1st SUBQ dose 1–2 wk after last IV dose; then continue with 200 mg every 2 wk.

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 systemic lupus erythematosus.
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 ⬆ ⬇

(↓ in activated B cells)

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

‡With continuous treatment.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient or caregiver in correct technique for SUBQ injection, care, and disposal of equipment. Inject on the same day each week. Inject missed dose 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 two doses on same day.
Caution patient to notify health care provider 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, or swollen face occurs.
Advise patient and caregiver to notify health care provider immediately for signs of suicidality, attempts to die by suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, other changes in mood or behavior, or symptoms of serotonin syndrome.
Caution patient to avoid receiving live vaccines for 30 days before and during belimumab therapy.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Rep: Advise women of reproductive potential to use effective contraception during and for ≥4 mo after final dose and to notify health care provider 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

0409- Hospira, Inc.
- 0409-9966-
  - 0409-9966-01- 192 VIAL in 1 PACKAGE (0409-9966-01) / 5 mL in 1 VIAL (0409-9966-11)

49401- GlaxoSmithKline LLC
- 49401-088- BENLYSTA
  - 49401-088-02- 1 SYRINGE in 1 CARTON (49401-088-02) / 1 mL in 1 SYRINGE (49401-088-01)

49401- GlaxoSmithKline LLC
- 49401-088- BENLYSTA
  - 49401-088-35- 4 SYRINGE in 1 CARTON (49401-088-35) / 1 mL in 1 SYRINGE (49401-088-01)

49401- GlaxoSmithKline LLC
- 49401-088- BENLYSTA
  - 49401-088-47- 4 SYRINGE in 1 CARTON (49401-088-47) / 1 mL in 1 SYRINGE (49401-088-42)

49401- GlaxoSmithKline LLC
- 49401-088- BENLYSTA
  - 49401-088-50- 1 SYRINGE in 1 CARTON (49401-088-50) / 1 mL in 1 SYRINGE (49401-088-42)

49401- GlaxoSmithKline LLC
- 49401-088- BENLYSTA
  - 49401-088-61- 1 SYRINGE in 1 CARTON (49401-088-61) / 1 mL in 1 SYRINGE

49401- GlaxoSmithKline LLC
- 49401-101- BENLYSTA
  - 49401-101-01- 1 VIAL in 1 CARTON (49401-101-01) / 1.5 mL in 1 VIAL

49401- GlaxoSmithKline LLC
- 49401-102- BENLYSTA
  - 49401-102-01- 1 VIAL in 1 CARTON (49401-102-01) / 5 mL in 1 VIAL

71124- SAMSUNG BIOLOGICS Co., Ltd.
- 71124-0025-
  - 71124-0025-0- 16 kg in 1 BAG (71124-0025-0)

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Indications ⬇

Contraind./Precautions ⬆ ⬇