ibalizumab

Contraindicated in:

Hypersensitivity;
Lactation: Breastfeeding not recommended mothers with HIV infection.

Use Cautiously in:

OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

Endo: hyperglycemia, hyperuricemia

GI: diarrhea, hyperbilirubinemia, ↑lipase, nausea

GU: ↑serum creatinine

Hemat: anemia, leukopenia, neutropenia, thrombocytopenia

Neuro: dizziness

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), immune reconstitution inflammatory syndrome, INFUSION REACTIONS

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Solution for injection: 150 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults ): 2000 mg single dose (loading dose), then 800 mg every 2 wk (maintenance dose).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Monoclonal antibody that blocks HIV-1 from infecting CD4+ T cells by binding to CD4 and interfering with postattachment steps required for the entry of HIV-1 virus particles into host cells and preventing viral transmission. Blocks viral entry into host cells without causing immunosuppression. Active against CCR5 and CXCR4 isolates.

Therapeutic effects:

Reduction in viral load.

Classifications ⬆ ⬇

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: CD4-directed post-attachment HIV-1 inhibitor

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 2.7–64 hr (dose dependent).

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of ibalizumab and importance of every 2 wk infusions to patient; do not change dosing schedule without consulting health care professional. Advise patient to read Patient Information before starting therapy and periodically in case of changes.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions (trouble breathing, cough, swelling in throat, hot flush, wheezing, nausea, chest pain, vomiting, chest tightness) or immune reconstitution syndrome (signs and symptoms of an infection) occur.
Caution patient to avoid crowds and persons with known infections.
Inform patient that ibalizumab does not cure HIV and may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and avoid sharing needles or donating blood to prevent spreading HIV to others.
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 notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. May cause reversible immunosuppression (CD4+ T-cell and B-cell lymphocytopenia) in infants exposed to ibalizumab in utero. Inform pregnant women of the pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiretrovirals during pregnancy. Register patient in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

62064- Theratechnologies Inc.
- 62064-122- TROGARZO
  - 62064-122-02- 2 VIAL, SINGLE-USE in 1 CARTON (62064-122-02) / 1.33 mL in 1 VIAL, SINGLE-USE (62064-122-01)

71124- Samsung BioLogics Co. LTD
- 71124-0024-
  - 71124-0024-0- 1 SOLUTION in 1 VIAL (71124-0024-0)

71851- WuXi Biologics Co., Ltd.
- 71851-001-
  - 71851-001-01- 49 CARTON in 1 BOX (71851-001-01) / 36 VIAL, SINGLE-USE in 1 CARTON / 1.33 mL in 1 VIAL, SINGLE-USE

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Indications ⬇

Contraind./Precautions ⬆ ⬇