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TROGARZO® (ibalizumab-uiyk): For heavily treatment-experienced patients with virologic failure who need additional support to achieve long-term suppression.

New, convenient 30 second IV push administration option

* TROGARZO® is first administered with a 30-minute loading dose by intravenous (IV) infusion.
All subsequent doses can be given in 30 seconds every 2 weeks with the IV push or in 15 minutes every 2 weeks through IV infusion.

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Proven efficacy and safety profile²
Potency: Fully active agent with NO baseline resistance and NO known drug-drug interactions^2,4
Durability: Long-acting efficacy

AFTER INITIAL LOADING DOSE INFUSION,

new convenient 30-second iv push administration for maintenance dose^3‡

Administration simplicity for HCPs and patients
No dilutions required
Less preperation time compared to current method of IV infusion

A POWERFUL
VIROLOGIC RESPONSE

AT 7 DAYS POST-LOADING DOSE

(TROGARZO® functional monotherapy): 83% of patients achieved a virologic response vs. 3% of patients pre-loading dose (p < 0.0001; 95% CI: 67%, 93%).

A DURABLE
VIROLOGIC RESPONSE

PATIENTS WHO ACHIEVED HIV RNA < 50 COPIES/ML AT WEEK 24 MAINTAINED VIRAL SUPPRESSION UP TO WEEK 48.

TROGARZO® IS INCLUDED IN THE DHHS GUIDELINES.

Find Out Why

ITT-MEF = Intent To Treat - Missing Equals Failure.

A single arm, multicenter study of 40 heavily treatment-experienced patients with multidrug resistant HIV-1. Patients were required to have viral load >1,000 copies/mL, documented resistance to at least 1 antiretroviral from each of 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 2,000 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 log10 decrease in viral load during the Functional monotherapy period, as compared to the proportion of patients achieving a –0.5 log10 decrease during the Control period.

‡ Study design and results: Open-label, non-randomized study in clinically stable patients while on TROGARZO®-containing ARV regimens for at least 3 months (N=9) and HIV-uninfected individuals (N=10). All subjects received TROGARZO® maintenance dose as IV infusion and IV Push, and pharmacokinetics (PK), safety, and efficacy were evaluated. Bioequivalence was demonstrated between IV infusion and IV Push methods of administration and IV Push over 30-seconds was safe and well tolerated.

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

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