Ibalizumab

Ibalizumab-uiyk is an HIV-1 antiretroviral drug [see Microbiology ( 12.4 )] .

• TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.ICD-10: B20

• TROGARZO is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO or any components of the product [see Warnings and Precautions ( 5.1 )]. Prior hypersensitivity reaction to TROGARZO or any components of the product.contraindicated

The recommended dosage regimen is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks administered as a diluted intravenous infusion (IV infusion) or undiluted intravenous push (IV push). ( 2.1 , 2.2 , 2.3 ) Duration of IV Infusion or IV Push IV Infusion (Diluted) IV Push (Undiluted) Loading Dose 2,000 mg Over at least 30 minutes Over at least 90 seconds Maintenance Dose 800 mg Over at least 15 minutes Over at least 30 seconds 2.1 Recommended Dosage The recommended dosage regimen is a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks administered as a diluted intravenous infusion (IV infusion) or undiluted intravenous push (IV push) [ see Dosage and Administration ( 2.2 , 2.3 ) ]. TROGARZO is available in a single-dose, 2 mL vial containing 150 mg/mL of ibalizumab-uiyk. Each vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk. Dose modifications of TROGARZO are not required when administered with any other antiretroviral or any other treatments. 2.2 Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard vial if solution is cloudy, if there is pronounced discoloration or if there is foreign particulate matter. See Table 1 for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg. Table 1.

Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO. ( 5.1 ) Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in patients treated with combination antiretroviral therapies. ( 5.2 ) Embryo-Fetal Toxicity: Monitor infants exposed to TROGARZO in utero for signs and symptoms of immunosuppression. ( 5.3 , 8.1 ) 5.1 Hypersensitivity Including Infusion-Related and Anaphylactic Reactions Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO during post-approval use. Symptoms may include dyspnea, angioedema, wheezing, chest pain, chest tightness, cough, hot flush, nausea, and vomiting. If signs and symptoms of an anaphylactic or other clinically significant hypersensitivity reaction occur, immediately discontinue administration of TROGARZO and initiate appropriate treatment. The use of TROGARZO is contraindicated in patients with known hypersensitivity with TROGARZO [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )]. 5.2 Immune Reconstitution Inflammatory Syndrome Immune reconstitution inflammatory syndrome has been reported in one patient treated with TROGARZO in combination with other antiretrovirals. During the initial phase of combination antiretroviral therapies, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections, which may necessitate further evaluation and treatment.

The following adverse drug reactions are discussed in other sections of the labeling: Immune Reconstitution Inflammatory Syndrome [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (incidence ≥ 5%) were diarrhea, dizziness, nausea, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact THERA patient support ® at 1-833-23THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 350 subjects have been exposed to TROGARZO in the ibalizumab clinical development program, including 45 subjects who received TROGARZO through expanded access programs. A total of 19 subjects received TROGARZO via IV push. The safety profile of TROGARZO administered via IV push (Trial TMB-302) was similar to that seen with IV infusion administration (Trial TMB-301) [see Clinical Pharmacology ( 12.3 )]. Trial TMB-301 The primary safety assessment of TROGARZO is based on 24 weeks of data from Trial TMB-301. TMB-301 was a single-arm trial of TROGARZO which enrolled 40 heavily treatment-experienced subjects with multidrug resistant HIV-1 on a failing HIV treatment regimen.

Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiretrovirals during pregnancy. This registry does not include Trogarzo, but likely includes patients’ concomitant antiretroviral drugs. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1–800–258–4263. Risk Summary Based on animal data, ibalizumab-uiyk use during pregnancy may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants exposed to ibalizumab-uiyk in utero. Immunoglobulin G (IgG) antibodies, such as ibalizumab-uiyk, are transported across the placenta in significant amounts, especially near term; therefore, ibalizumab-uiyk has the potential to be transferred from the mother to the developing fetus (see Clinical Considerations). There are no available data on ibalizumab-uiyk use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Ibalizumab-uiyk administered as a single agent exhibits nonlinear pharmacokinetics. Following single-dose administrations of ibalizumab-uiyk as 0.5 to 1.5-hour infusions, the area under the concentration-time curve increased in a greater than dose-proportional manner, clearance decreased from 9.54 to 0.36 mL/h/kg and elimination half-life increased from 2.7 to 64 hours as the dose increased from 0.3 to 25 mg/kg.

• Mar 6, 2018BLABLA761065Theratechnologies

1. 1Product Dose Omission Issue458.5%
2. 2Viral Load Increased458.5%
3. 3Drug Ineffective448.3%
4. 4Rash427.9%
5. 5Hospitalisation336.2%
6. 6Fatigue305.7%
7. 7Diarrhoea285.3%
8. 8Off Label Use285.3%
9. 9Death254.7%
10. 10Nausea244.5%
11. 11Pruritus244.5%
12. 12Dizziness203.8%
13. 13Pain183.4%
14. 14Virologic Failure183.4%
15. 15Pyrexia173.2%

The 10 most recently updated of 16 ClinicalTrials.gov registrations naming Ibalizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIV
  Not yet recruiting · Phase 1 · Interventional · 18 enrolled · First Affiliated Hospital of Zhejiang University
  NCT07635992updated 2026-06-09
• 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
  Active not recruiting · Phase 1 · Interventional · 20 enrolled · David Ho
  NCT05890963updated 2026-06-02
• CD4CAR for CD4+ Leukemia and Lymphoma
  Recruiting · Phase 1 · Interventional · 20 enrolled · Huda Salman
  NCT03829540updated 2026-04-27
• Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.
  Recruiting · Phase 1 · Interventional · 30 enrolled · Huda Salman
  NCT06071624updated 2026-03-18
• Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant
  Recruiting · Phase 1 · Interventional · 30 enrolled · Huda Salman
  NCT06197672updated 2026-01-22
• A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
  Active not recruiting · Observational · 168 enrolled · Theratechnologies
  NCT05388474updated 2026-01-02
• Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
  Completed · Phase 3 · Interventional · 43 enrolled · TaiMed Biologics Inc.
  NCT03913195updated 2025-10-20
• Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 689 enrolled · Gilead Sciences
  NCT05502341updated 2025-10-14
• External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA
  Completed · Observational · 141 enrolled · Epividian
  NCT05495204updated 2023-09-07
• Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
  Completed · Phase 3 · Interventional · 79 enrolled · TaiMed Biologics Inc.
  NCT02707861updated 2021-03-11

Frequently asked questions

How does Ibalizumab work?

Ibalizumab-uiyk is an HIV-1 antiretroviral drug [see Microbiology ( 12.4 )] .

What is Ibalizumab used for?

According to FDA labeling, Ibalizumab carries indications including: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ibalizumab?

Ibalizumab is classified as Other antivirals, CD4-directed Blocking Antibody, Human Immunodeficiency Virus 1 Post-attachment Fusion Inhibitor, CD4-directed Antibody Interactions, HIV 1 Post-attachment Fusion Inhibitors.

What are the brand names for Ibalizumab?

Ibalizumab is marketed under brand names including Trogarzo.

What are the contraindications for Ibalizumab?

Ibalizumab labeling lists contraindications including: TROGARZO is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO or any components of the product [see Warnings and Precautions ( 5.1 )]. Prior hypersensitivity reaction to TROGARZO or any components of the product.. Always consult the full prescribing information and a clinician.