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Trogarzo (Ibalizumab): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
150 mg/mL
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Trogarzo

What is TROGARZO?

TROGARZO is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:

  • have received several anti-HIV-1 regimens in the past, and
  • have HIV-1 virus that is resistant to many antiretroviral medicines, and
  • who are failing their current antiretroviral therapy

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

It is not known if TROGARZO is safe and effective in children.

Do not receive TROGARZO if you have had an allergic reaction to TROGARZO or any of the ingredients in TROGARZO. See the end of this leaflet for a complete list of ingredients in TROGARZO.

Before you receive TROGARZO, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if TROGARZO may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with TROGARZO. Pregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

  • are breastfeeding or plan to breastfeed. Do not breastfeed if you are receiving TROGARZO.

    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

    • It is not known if TROGARZO passes into breast milk.

      Talk with your healthcare provider about the best way to feed your baby during treatment with TROGARZO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive TROGARZO?

  • You will receive TROGARZO by your healthcare provider as an intravenous infusion (IV infusion) or as an intravenous push (IV push). The first dose will be given over 30 minutes by IV infusion or 90 seconds by IV push. After the first dose, the dose will be given over 15 minutes by IV infusion or 30 seconds by IV push. A healthcare provider will monitor you during the TROGARZO IV infusion or IV push and for a period of time after your IV infusion or IV push.
  • You will receive TROGARZO every two weeks.
  • It is important that you receive TROGARZO every two weeks as instructed by your healthcare provider. Do not change the schedule of your TROGARZO IV infusion or IV push, or any of your antiretroviral medicines without talking to your healthcare provider first.
  • Tell your healthcare provider right away if you stop receiving TROGARZO or stop taking any other antiretroviral medicines.

What are the possible side effects of TROGARZO?

TROGARZO can cause serious side effects, including:

  • Allergic reactions. TROGARZO can cause allergic reactions, including serious reactions, during and after IV infusion or IV push. Tell your healthcare provider or nurse, or get medical help right away if you get any of the following symptoms of an allergic reaction:
  • trouble breathing
  • cough
  • swelling in your throat
  • hot flush
  • wheezing
  • nausea
  • chest pain
  • vomiting
  • chest tightness

  • Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after receiving TROGARZO.

    The most common side effects of TROGARZO include:

    • diarrhea
    • nausea
    • dizziness
    • rash

These are not all of the possible side effects of TROGARZO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to at 1-833-23THERA (1-833-238-4372).

General information about the safe and effective use of TROGARZO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider for information about TROGARZO that is written for health professionals.

What are the ingredients in TROGARZO?

Active ingredient: ibalizumab-uiyk

Inactive ingredients: L-histidine, polysorbate 80, sodium chloride, and sucrose.

TROGARZO does not contain any preservative. TROGARZO vial stopper is not made with natural rubber latex.

Manufactured by Theratechnologies Inc., 2015 Peel Street, Suite 1100, Montréal, Québec Canada H3A 1T8

US License No. 2091 for Theratechnologies Inc.

For more information, call 1-833-23THERA (1-833-238-4372) or go to www.TROGARZO.com.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 12/2023

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761065 · View the label on DailyMed

Revision date stated in the text: December 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Trogarzo

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class CD4-directed Blocking Antibody, Human Immunodeficiency Virus 1 Post-attachment Fusion Inhibitor
Active ingredient Ibalizumab 150 mg/mL
Dosage form Injection, solution
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) THERATECHNOLOGIES
FDA approval BLA 761065Biologics License Application (BLA) Approved March 6, 2018
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
150 mg/mL – 1.33 ml in 1 vial, single-use / 2 in 1 carton NDC 62064-122-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.