IMPORANT SAFETY INFORMATION

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Adverse Reactions

Use in Specific Populations

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 https://www.fda.gov/medwatch/.

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. 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®.

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.

Warnings and Precautions

TROGARZO® Prescribing Information. Theratechnologies Inc. October 2022. TROGARZO® is a registered trademark of TaiMed Biologics Inc., under license to Theratechnologies Inc.
© 2024 Theratechnologies Inc. All rights reserved.

US-TRO-2300023

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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.

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Reference:ARV = antiretroviral; HIV = human immunodeficiency virus;
IRIS = immune reconstitution inflammatory syndrome.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.Immune Reconstitution Inflammatory SyndromeImmune 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 ToxicityBased 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. *At 7 days post-loading dose, 83% of patients who received TROGARZO® (functional monotherapy) achieved a virologic response vs. 3% of patients pre-loading dose (p<0.0001; 95% CI: 67%, 93%). A single-arm, multicenter study of 40 heavily treatment-experienced patients with multidrug resistant HIV-1. Patients were required to have viral load >1000 copies/mL, documented resistance to at least 1 antiretroviral from at least 3 classes of antiretrovirals, been treated for at least 6 months and be failing or had recently failed therapy. Days 0- 6 (control period): Patients were monitored on their current failing regimens (or no therapy). Days 7-13 (functional monotherapy period): Patients continued on background failing regimens and received 2000 mg of TROGARZO® (loading dose). Day 14: Background regimen was optimized to include at least one active agent. Day 21-week 25 (maintenance period): Patients received 800 mg of TROGARZO® every 2 weeks (maintenance dose). The primary efficacy endpoint was the proportion of patients achieving a -0.5 log   decrease in viral load during the functional monotherapy period compared with the proportion of patients achieving a -0.5 log   decrease during the control period. 
† 48-week data is not included in the TROGARZO® prescribing information. Patients who achieved HIV RNA
<50 copies/mL at week 24 maintained viral suppression up to week 48. 1010