What are the most important things to know about ibalizumab-uiyk?
Ibalizumab-uiyk can cause serious side effects, including allergic reactions.
Contact your health care provider or get medical help right away if you develop any of the following symptoms of an allergic reaction:
- Trouble breathing
- Swelling in your throat
- Chest pain or tightness
- Hot flush
- Nausea or vomiting
While receiving ibalizumab-uiyk, it is important to keep all of your appointments with your health care provider.
What is ibalizumab-uiyk?
Ibalizumab-uiyk (brand name: Trogarzo) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults for whom other HIV medicines have not worked and who meet certain requirements, as determined by a health care provider.
Ibalizumab-uiyk is always used in combination with other HIV medicines.
For more information on the use of ibalizumab-uiyk in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.
HIV medicines cannot cure HIV/AIDS, but using HIV medicines as directed by your healthcare provider helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are using HIV medicines, do not cut down on, skip, or stop using them unless your health care provider tells you to.
What should I tell my health care provider before receiving ibalizumab-uiyk?
Before you receive ibalizumab-uiyk, tell your health care provider:
- If you are allergic to ibalizumab-uiyk or any other medicines.
- If you have any medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of using ibalizumab-uiyk during pregnancy. For more information on the use of ibalizumab-uiyk during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
How will I receive ibalizumab-uiyk?
Ibalizumab comes as 200 mg/1.33 mL single-dose vials of solution for intravenous (IV) use.
Your health care provider will administer ibalizumab-uiyk either as an IV infusion given into your vein over 15 to 30 minutes or as an IV push given into your vein over 30 seconds. Your health care provider will monitor you while you are receiving ibalizumab-uiyk and for a period of time after you have received ibalizumab-uiyk.
You will receive ibalizumab-uiyk every two weeks.
It is important that you receive ibalizumab-uiyk every two weeks as instructed by your health care provider. Do not change the schedule of your ibalizumab-uiyk IV infusion or IV push without talking to your health care provider first. Tell your healthcare provider right away if you stop receiving ibalizumab-uiyk or stop taking any other HIV medicines.
Always use ibalizumab-uiyk in combination with other HIV medicines.
For more information about how you will receive ibalizumab-uiyk, see the FDA drug label.
What should I do if I miss a dose?
If you miss an appointment for your ibalizumab-uiyk IV infusion or IV push, contact your health care provider as soon as possible. Your health care provider will help you resume treatment.
What side effects can ibalizumab-uiyk cause?
Ibalizumab-uiyk may cause side effects. Some side effects of ibalizumab-uiyk can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.
Other possible side effects of ibalizumab-uiyk include:
- Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
- Diarrhea or rash.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ibalizumab-uiyk. To learn more about possible side effects of ibalizumab-uiyk, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
Where can I find more information about ibalizumab-uiyk?
- For more information on the use of ibalizumab-uiyk in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.
- This Patient Version drug summary is based on the following FDA label(s): Injection. The Patient Package Insert includes information for people using ibalizumab-uiyk.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for ibalizumab-uiyk injection available from MedlinePlus.
- Ibalizumab-uiyk-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
- A list of FDA-approved HIV medicines, from HIVinfo.
Main number: 514-336-7800
Patient assistance: 833-238-4372
Last Reviewed: February 24, 2023