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Important Safety Information

Indication

TROGARZO® (ibalizumab‑uiyk), 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.

Contraindications

TROGARZO® is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO® or any components of the product.

Use in Specific Populations

  • Pregnancy: No adequate human data are available to establish whether or not TROGARZO® poses a risk to pregnancy outcomes. Monoclonal antibodies, such as ibalizumab‑uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab‑uiyk has the potential to be transmitted from the mother to the developing fetus.
  • Lactation: No data are available regarding the presence of TROGARZO® in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for HIV‑1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO®.

Warnings and Precautions

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®.

Immune Reconstitution Inflammatory Syndrome

  • Immune Reconstitution Inflammatory Syndrome (IRIS) 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.

Embryo-Fetal Toxicity

  • Based on animal data, TROGARZO® may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants born to mothers exposed to TROGARZO® during pregnancy. Immune phenotyping of the peripheral blood and expert consultation are recommended to provide guidance regarding monitoring and management of exposed infants based on the degree of immunosuppression observed. The safety of administering live or live‑attenuated vaccines in exposed infants is unknown.

Adverse Reactions

  • The most common adverse reactions (all Grades) seen in clinical trial experience, reported in at least 5% of subjects receiving TROGARZO® were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%).
  • Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: one subject had a severe rash and one subject developed IRIS manifested as an exacerbation of progressive multifocal leukoencephalopathy.

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.

References:

  1. TROGARZO® Prescribing Information. Theratechnologies Inc. December 2023.
  2. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV (March, 2023). Department of Health and Human Services. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf.
  3. Elvstam O et al. All‑cause mortality and serious non‑AIDS events in adults with low‑level human immunodeficiency virus viremia during combination antiretroviral therapy: results from a Swedish nationwide observational study. Clin Invest Dis 2020; ciaa413. doi: 10.1093/cid/ciaa413.
  4. Henegar C et al. Trends and characteristics of HIV‑1 drug resistance in the United States (2012‑2018). Poster presentation at Conference on Retroviruses and Opportunistic Infections, Boston MA, March 8‑11, 2020.
  5. Nachega JB et al. Lower pill burden and once‑daily antiretroviral treatment regimens for HIV infection: a meta‑analysis of randomized controlled trials. Clin Infect Dis 2014;58:1297-307.
  6. Tang MW, Shafer RW. HIV‑1 antiretroviral resistance: scientific principles and clinical applications. Drugs 2012;72:e1-e25.
  7. Gardner EM et al. Antiretroviral medication adherence and the development of class‑specific antiretroviral resistance. AIDS 2009;23:1035-46.
  8. Soulie C et al. Prevalence of doravirine‑associated resistance mutations in HIV‑1‑infected antiretroviral‑experienced patients from two large databases in France and Italy. J Antimicrob Chemother 2020;75:1026-30.
  9. Gartland M et al. Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment‑Experienced Adults Living with Multidrug‑Resistant HIV‑1. Antimicrob Agents Chemother. 2022;66(6):e01751-21.
  10. Data on file. Theratechnologies Inc.
  11. Towner W et al. Long‑term efficacy, safety, and durability of ibalizumab‑based regimens in subgroup of TMB‑202 participants. Poster presentation at ID Week, Philadelphia, PA, October 21‑25, 2020.
  12. Emu B, Fessel J, Schrader S, et al. Phase 3 Study of Ibalizumab for Multidrug‑Resistant HIV‑1. N Engl J Med. 2018;379(7):645-654.
  13. Beesley B et al. Real‑world HIV patient experience with long‑acting ibalizumab. ACTHIV 2021 poster #P-23.
  14. TROGARZO® Patient Satisfaction Study. March 22, 2021.

Please see Important Safety Information throughout and the full Prescribing Information.