Pronunciation: tro-gar-zo
Generic name: ibalizumab-uiyk
Dosage form: injectable injection
Drug class: Miscellaneous antivirals

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 21, 2023.

What is Trogarzo?

Trogarzo ((ibalizumab-uiyk) is an antiviral medicine that is used in combination with other antiviral 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.

Trogarzo ((ibalizumab-uiyk) is a recombinant humanized monoclonal antibody that works by binding to domain 2 of CD4 and blocking HIV-1 from infecting CD4+ T cells and preventing the viral transmission that occurs via cell-cell fusion.

HIV-1 is a virus that attacks the body’s immune system. If HIV is not treated, people typically progress through three phases (acute HIV infection, chronic HIV infection, and Acquired Immune Deficiency Syndrome [AIDS]). Untreated, people with AIDS usually only survive about 3 years.

Trogarzo was FDA approved on March 6, 2018.

Warnings

Trogarzo may cause hypersensitivity reactions including infusion-related reactions and anaphylactic reactions. You should not use Trogarzo if you are allergic to ibalizumab. Tell your healthcare provider or nurse, or get medical help right away if you get any of the following symptoms of an allergic reaction, such as:

• trouble breathing
• cough
• swelling in your throat
• hot flush
• wheezing
• nausea
• chest pain
• vomiting
• chest tightness.

Immune Reconstitution Inflammatory Syndrome (IRIS) is a state of hyperinflammatory response that has been reported in patients treated with combination antiretroviral therapies.

Trogarzo may cause irreversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants born to mothers exposed during pregnancy. Your healthcare provider will monitor exposed infants for signs and symptoms of immunosuppression. The safety of administering live or live-attenuated vaccines in exposed infants is unknown.

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

Related/similar drugs

Biktarvy, Descovy, Truvada, Atripla, Stribild, Complera, Epzicom

Before taking this medicine

Before you receive Trogarzo, tell your doctor about all your medical conditions or allergies.

Trogarzo affects your immune system. Tell your doctor if you have signs of a new infection such as fever, night sweats, swollen glands, cough, diarrhea, or weight loss.

Tell your doctor if you are pregnant or become pregnant while taking Trogarzo or any other medications used to treat HIV. Continue taking your medications throughout pregnancy. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How is Trogarzo administered?

Trogarzo is administered 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 infusion or IV push and for some time afterward.

• You will receive Trogarzo every two weeks.
• Ensure you keep your appointments every two weeks as instructed by your healthcare provider. Do not change the schedule of your IV infusion/IV push, or any of your antiretroviral medicines without talking to your healthcare provider first.

HIV is often treated with a combination of drugs. Use all medications as directed and read all medication guides you receive. Every person with HIV should remain under the care of a doctor.

Dosing information

Usual Adult Dose for HIV Infection

• Loading dose: 2000 mg IV infusion (diluted: over at least 30 minutes) or IV push (undiluted: over at least 90 seconds)
• Maintenance dose: 800 mg IV every 2 weeks IV infusion (diluted: over at least 15 minutes) or IV push (undiluted: over at least 30 seconds).

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Trogarzo injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Trogarzo?

Using this medicine will not prevent you from passing HIV to other people.

• Do not have unprotected sex or share razors or toothbrushes.
• Talk with your doctor about safe ways to prevent HIV transmission during sex.
• Sharing needles is never safe, even for a healthy person.

What are the side effects of Trogarzo?

Get emergency medical help if you have signs of an allergic reaction to Trogarzo which may include hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Trogarzo affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Trogarzo side effects that affect 5% or more of people include:

• nausea

• diarrhea

• dizziness

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trogarzo?

Other drugs may interact with ibalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

Store vials under refrigeration at 2 to 8ºC (36-46 ºF). Do not freeze and protect from light.

Once diluted, administer immediately.

Ingredients

Active: ibalizumab-uiyk (200 mg in 1.33 mL) 
Inactive: 10 mM L-histidine (2.06 mg), 0.045% polysorbate 80 (0.60 mg), 52 mM sodium chloride
(4.04 mg) and 5.2% sucrose (69.2 mg).

The solution has a pH of 6.0 and contains no preservatives. The vial stopper is not made with natural
rubber latex. 

Manufacturer

Theratechnologies Inc.

Frequently asked questions

• How well does Trogarzo work to treat multidrug-resistant (MDR) HIV-1?
• How is Trogarzo used in the treatment of HIV?
• What are the side effects with HIV treatment Trogarzo?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer