A PROVEN
SAFETY PROFILE

TROGARZO® is generally well tolerated, with a low incidence of adverse reactions.

Overall, most (90%) adverse reactions reported were mild or moderate in severity.
2 patients experienced severe adverse reactions (1 case of severe rash, 1 case of IRIS).

ADVERSE REACTIONS SEEN IN CLINICAL TRIAL EXPERIENCE IN >5% OF PATIENTS RECEIVING TROGARZO® (+ OPTIMIZED background regimen).

Adverse Reaction
Diarrhea
Dizziness
Nausea
Rash*

Incidence (N=40)
8%
8%
5%
5%

* Includes pooled terms “rash”, “rash erythematous”, “rash generalized”, “rash macular”, “rash maculopapular”, and “rash papular”.

A NOVEL MOA IS PART OF A FULLY ACTIVE REGIMEN TO MAKE UNDETECTABLE A POSSIBILITY AGAIN²

TROGARZO® IS INCLUDED IN THE DHHS GUIDELINES FOR MANAGING TREATMENT EXPERIENCED HIV-1 PATIENTS

WHAT THE DHHS GUIDELINES RECOMMEND FOR TREATMENT EXPERIENCED HIV PATIENTS

DEFINE FAILURE: HIV RNA ≥ 200 copies/mL

Persistent HIV RNA ≥ 200 copies/mL is considered virologic failure, and is associated with accumulation of drug-resistance mutations.

BE PROACTIVE: MODIFY AS SOON AS POSSIBLE

When resistance mutations compromise a regimen, it should be modified as soon as possible to avoid progressive accumulation of resistance mutations.

Virologic responses to new regimens are greater in patients with lower HIV RNA levels and/or higher CD4 cell counts.

Thus, a change is best done before viremia worsens or CD4 count declines.

CHOOSE A FULLY ACTIVE REGIMEN

A new regimen should include at least two, and preferably three, fully active agents. A fully active agent is one that is expected to have uncompromised activity on the basis of the patient’s ART history and his or her current and past drug-resistance test results.

CONSIDER A NEWER MOA

The availability of newer ART, including those with new mechanisms of action, makes it possible to suppress HIV RNA to <50 copies/mL in most patients.

IMPORTANT SAFETY INFORMATION

Contraindications

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

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.

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®.

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.

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/.

Please see full Prescribing Information for TROGARZO®.

References:

Theratechnologies Inc. TROGARZO® Prescribing Information. October 2022.
Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. 2021. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. Retrieved September 10, 2021.
DeJesus E, Richmond G, Berhe M, et al. IV Push administration of ibalizumab: Pharmacokinetics, safety and efficacy. [CROI Abstract 429]. Abstracts from CROI2022 Conference on Retroviruses and Opportunistic Infections. CROI 2022 Abstract eBook. 2022;165.
Weinheimer S et al. Ibalizumab susceptibility in patient HIV isolates resistant to antiretrovirals. 25th Conference on Retroviruses and Opportunistic Infections (CROI 2018), Boston, abstract 561, 2018

A PROVENSAFETY PROFILE

ADVERSE REACTIONS SEEN IN CLINICAL TRIAL EXPERIENCE IN >5% OF PATIENTS RECEIVING TROGARZO® (+ OPTIMIZED background regimen).

A NOVEL MOA IS PART OF A FULLY ACTIVE REGIMEN TO MAKE UNDETECTABLE A POSSIBILITY AGAIN2

WHAT THE DHHS GUIDELINES RECOMMEND FOR TREATMENT EXPERIENCED HIV PATIENTS

IMPORTANT SAFETY INFORMATION

A PROVEN
SAFETY PROFILE

A NOVEL MOA IS PART OF A FULLY ACTIVE REGIMEN TO MAKE UNDETECTABLE A POSSIBILITY AGAIN²