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The first available long‑acting antiretroviral1

Take Action with TROGARZO®

The only antiretroviral that keeps patients engaged with an HCP‑patient interaction every 2 weeks1

TROGARZO® IV Push Dosing & Administration

  • Simplified administration for HCPs and patients
  • No dilution required
  • Less preparation time compared to IV infusion
TROGARZO® is administered as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks as an undiluted IV push:

Each vial contains 200 mg ibalizumab‑uiyk. TROGARZO® is used in combination with other antiretroviral(s).

† All patients must be observed for 1 hour after completion of TROGARZO® loading dose. If no administration‑associated adverse reactions are observed, the post‑administration observation time for subsequent maintenance doses can be reduced to 15 minutes.
‡ TROGARZO® can also be administered as a diluted IV infusion. Administration time for IV infusion differs from that of IV push. Consult the TROGARZO® Prescribing Information for complete posology.

Watch the administration tutorial to learn more.

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CONVENIENT OPTIONS FOR PATIENT ADMINISTRATION1§

OFFICE

HOME

HOSPITAL/
IV CENTERS

§ Dependent on insurance coverage.

TROGARZO® Patient Satisfaction Study13,14†

OF TROGARZO® PATIENTS SURVEYED‡

93% recommend TROGARZO® (ibalizumab‑uiyk) to other suitable patients with HIV‑1
80% reported that having a 2‑week touchpoint with an HCP helped them adhere to their other HIV medications13

All patient survey data was collected prior to the FDA approval of TROGARZO® IV Push administration.

Here’s what one patient had to say:14

If you have taken other drugs with nominal results, I strongly suggest TROGARZO® if you are looking to lower your viral load toward becoming undetectable.

Statement reflective of the individual’s experience only.

† This single‑blinded study required patients (n=30) to complete a brief online survey regarding patient experience with TROGARZO®. Respondents had been taking TROGARZO® an average of 8.5 months and average duration of treatment ranged from 1 to 18 months. The survey included 20 questions of various types (i.e., Likert scale, dichotomous, multiple choice, open‑ended), which were analyzed in aggregate and by infusion setting (i.e., HCP clinic, infusion center, or at home). All surveys were completed from December 2020 – March 2021 (prior to the availability of the IV push administration method), and all participants were compensated for their time.13,14
‡ Applies to 15/30 respondents. Information for the remaining 15 respondents was not available.13

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.