A NOVEL MECHANISM OF ACTION

TROGARZO® (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor.¹

TROGARZO® is a humanized monoclonal antibody that binds to domain 2 of CD4 on the surface of immune cells.

The HIV-1 envelope glycoprotein (gp120) binds to domain 1 of CD4. Through steric hindrance, TROGARZO® blocks the steps required for viral entry without interfering in normal CD4-mediated immune functions.

THE FIRST MONOCLONAL ANTIBODY FOR HIV-1, ACTIVE AGAINST STRAINS RESISTANT TO ALL APPROVED ANTIRETROVIRALS.

Is Trogarzo^® Right For Your Patients?

ACTIVITY AMONG CLASSES

TROGARZO® is active against HIV-1 strains resistant to all approved antiretrovirals.
There is no evidence of cross-resistance between TROGARZO® and any of the other approved classes of antiretrovirals (NRTI, NNRTI, PI, INSTI, CCR5 antagonist, fusion inhibitor).

HIV-1 TROPISM

TROGARZO® activity is independent of co-receptor tropism (CXCR4 vs. CCR5).

EXPLORE DOSING AND ADMINISTRATION

CCR5 = C-C chemokine receptor type 5; CXCR4 = C-X-C chemokine receptor type 4; INSTI = Integrase Strand Transfer Inhibitor;
NNRTI = Non-Nucleoside Reverse Transcriptase Inhibitor; NRTI = Nucleoside Reverse Transcriptase Inhibitor; PI = Protease Inhibitor

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