Trogarzo (Ibalizumab-Uiyk) for HIV

Trogarzo (ibalizumab-uiyk) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) used with other HIV medicines to treat human immunodeficiency virus type 1 (HIV-1) infection in adults who have received many HIV treatments, have HIV-1 that is resistant to many medicines, and are failing their current HIV treatment.

How Trogarzo Works and How It’s Taken

Trogarzo is an HIV-1 medicine that binds to CD4 cells. It blocks steps HIV-1 needs to enter these cells after the virus attaches. This helps stop HIV-1 from infecting more cells and spreading from cell to cell.

Doctors prescribe Trogarzo when adults have received many HIV treatments, have HIV-1 that is resistant to many medicines, and are failing their current HIV treatment.

HIV-1 is the virus that causes acquired immune deficiency syndrome (AIDS).

Trogarzo is given into a vein by a trained healthcare professional. It can be given as an intravenous (IV) infusion or IV push.

Typical Dosing for HIV

The recommended dosing schedule for Trogarzo is:

Starting dose — A single 2,000-milligram dose given by IV infusion over at least 30 minutes or by IV push over at least 90 seconds.
Maintenance dose — 800 milligrams every two weeks, given by IV infusion over at least 15 minutes or by IV push over at least 30 seconds.

Doctors do not need to adjust the Trogarzo dose when it is given with other antiretroviral medicines or other treatments.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Trogarzo Side Effects

In a clinical study of Trogarzo, the most common side effects reported in at least 5 percent of people included:

Diarrhea
Dizziness
Nausea
Rash

Serious Side Effects and Warnings

Trogarzo can cause serious side effects that may require immediate medical attention. These include:

Severe allergic reactions — These can include infusion-related reactions and anaphylaxis (a life-threatening allergic reaction that can cause trouble breathing, swelling in the throat, wheezing, chest tightness, nausea, or vomiting).
Immune reconstitution inflammatory syndrome (IRIS) — This change in your immune system can trigger inflammation as your body starts fighting hidden infections again.

Get medical help right away if you think you are having a serious reaction.

How To Save on Trogarzo

Theratechnologies, the manufacturer of Trogarzo, offers the THERA patient support Program. Eligible people with commercial insurance may be able to lower their out-of-pocket costs through the TROGARZO Co-Pay Program. If you have government insurance or no insurance, the program also provides information about other financial assistance options.

The THERA patient support Program also offers insurance verification, prior authorization and appeals support, treatment coordination, and one-on-one guidance from THERA Nurse Navigators, including administration training.

To learn more, visit the THERA patient support Program or call 833-238-4372.

What To Know Before Taking Trogarzo

Tell your doctor if you have any allergies to ibalizumab-uiyk or any ingredients in Trogarzo.

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

Do not receive Trogarzo if you have had a serious allergic reaction to Trogarzo or any of its ingredients.

Do not miss doses or let your supply of Trogarzo run out. Missing doses may allow the amount of HIV-1 in your blood to increase and may make the virus harder to treat.

If you miss a maintenance dose by three days or more, contact your healthcare provider as soon as possible. You should receive a 2,000-milligram loading dose, then return to 800 milligrams every 14 days.

Tell your healthcare provider if you are pregnant, planning to become pregnant, or think you may be pregnant while receiving Trogarzo.

The Antiretroviral Pregnancy Registry tracks pregnancy outcomes in people exposed to antiretroviral medicines during pregnancy. The registry does not include Trogarzo, but it likely includes other antiretroviral medicines taken with it. Healthcare providers can register pregnancies by visiting the Antiretroviral Pregnancy Registry or calling 800-258-4263.

Do not breastfeed if you are receiving Trogarzo. People with HIV-1 should not breastfeed because HIV-1 can be passed to the baby through breast milk.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Trogarzo for HIV?

In a study of 40 adults with multidrug-resistant HIV-1 who had received many HIV treatments, 83 percent had a meaningful drop in the amount of HIV in their blood after seven days of Trogarzo treatment. During the control period before Trogarzo was given, 3 percent had this level of decrease.

By week 25, 43 percent had fewer than 50 copies of HIV-1 RNA per milliliter of blood, and 50 percent had fewer than 200 copies per milliliter while taking Trogarzo with other HIV medicines. Response rates varied among different groups of people.

How long does Trogarzo take to work for HIV?

In the main clinical study, researchers checked viral load after the seven-day period following the 2,000-milligram loading dose. At that point, 83 percent of participants had a meaningful drop in viral load. Researchers also measured results through week 25.

Can Trogarzo be used with other medicines for HIV?

Yes. Trogarzo is meant to be used with other HIV medicines.

It is used in adults who have already tried several HIV treatment regimens, have HIV-1 that is resistant to many antiretroviral medicines, and are failing their current HIV treatment. This means the medicines they are taking are no longer controlling the virus well enough.

Your healthcare provider will use Trogarzo together with other HIV medicines as part of your treatment plan.