Skip to content Skip to footer

Make undetectable possible1

Take Action With TROGARZO®

For HTE patients with HIV whose current ARV regimen is failing and who need additional support to achieve long‑term suppression.1

Resources

For you and your patients.

THERA patient support® Program Resources

PATIENT ENROLLMENT FORM

Use the TROGARZO® Enrollment Form to enroll your patients into the THERA patient support® Program.

Download

TROGARZO® BILLING & CODING GUIDE

The Billing & Coding Guide for TROGARZO® outlines the information needed to file a health insurance claim.

Download

TROGARZO® THERA patient support® HCP LEAVE BEHIND

The TROGARZO® THERA patient support® Program HCP leave behind explains the THERA patient support® Program benefits and services to you and your patients.

Download

TROGARZO® THERA patient support® PATIENT BROCHURE

The TROGARZO® THERA patient support® Patient Leave Behind explains the THERA patient support® Program and the benefits to your patients.

Download

TROGARZO® HCP & Patient Resources

TROGARZO® PRESCRIBING INFORMATION

Access the full Prescribing Information for TROGARZO® for complete product information.

Download

TROGARZO® DOSING & ADMINISTRATION GUIDE

The Dosing & Administration Guide for TROGARZO® provides an overview of the dosing and administration process for TROGARZO®.

Download

TROGARZO® REAL‑WORLD EVIDENCE: OPERA COHORT POSTER

The ACTHIV OPERA Data poster describes the virologic effectiveness of ibalizumab clinical trial experience compared to real‑world clinical care without ibalizumab in the OPERA® Cohort.

Download

TROGARZO® HCP LEAVE BEHIND

The TROGARZO® HCP leave behind describes the key data, dosing and administration, and benefits of TROGARZO® for you and your patients.

Download

TROGARZO® PATIENT INFORMATION BROCHURE

The TROGARZO® Patient Information Brochure provides all pertinent information about TROGARZO® to your patients.

Download

FOR MORE INFORMATION

Talk to your Theratechnologies Representative

OR

Call the THERA patient support® Program at 1‑833‑238-4372

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

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.