Drugs

Ibalizumab-uiyk

Ibalizumab-uiyk

Brand Name: Trogarzo Other Names: Hu5A8, IBA, Ibalizumab, TMB-355, TNX-355 Drug Class: Post-attachment Inhibitor

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What are the most important things to know about ibalizumab-uiyk?

What are the most important things to know about ibalizumab-uiyk?

Ibalizumab-uiyk can cause serious side effects, including 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.

Contact your health care provider right away if you start having new symptoms after receiving ibalizumab-uiyk that could be signs of IRIS.

While taking ibalizumab-uiyk, it is important to keep all of your appointments with your health care provider.

What is ibalizumab-uiyk?

What is ibalizumab-uiyk?

Ibalizumab-uiyk is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who meet certain requirements, as determined by a health care provider.

Ibalizumab-uiyk is always used in combination with other HIV medicines.

Ibalizumab-uiyk belongs to a group of HIV drugs called post-attachment inhibitors. Post-attachment inhibitors work by attaching to a protein on the surface of the immune cells. The protein is called the CD4 receptor. When ibalizumab-uiyk attaches to the CD4 receptor, HIV cannot attach to, enter, or infect the cell.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including ibalizumab-uiyk, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking ibalizumab-uiyk?

What should I tell my health care provider before taking ibalizumab-uiyk?

Before taking ibalizumab-uiyk, tell your health care provider:

  • If you are allergic to ibalizumab-uiyk or any other medicines.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether ibalizumab-uiyk can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking ibalizumab-uiyk when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking ibalizumab-uiyk.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Ibalizumab-uiyk may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking ibalizumab-uiyk. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Ibalizumab-uiyk may affect the way other medicines or products work, and other medicines or products may affect how ibalizumab-uiyk works. Taking ibalizumab-uiyk together with certain medicines or products may cause serious side effects.

How should I take ibalizumab-uiyk?

How should I take ibalizumab-uiyk?

Ibalizumab-uiyk comes in two 150 mg/mL single-use vials for intravenous (IV) injection.

Your health care provider will administer ibalizumab-uiyk as an infusion given into your vein over 15 to 30 minutes. Your health care provider will monitor you during the infusion and for a period of time after your infusion.

You will receive ibalizumab-uiyk every 2 weeks. It is important that you receive ibalizumab-uiyk every 2 weeks as instructed by your health care provider. Do not change the schedule of your ibalizumab-uiyk infusions or any of your HIV medicines without talking to your health care provider first.

Always take ibalizumab-uiyk in combination with other HIV medicines.

If you take too much ibalizumab-uiyk, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take ibalizumab-uiyk, see the FDA drug label.

What should I do if I forget a dose?

What should I do if I forget a dose?

Tell your health care provider right away if you stop receiving ibalizumab-uiyk infusions or stop taking any other HIV medicines.

What side effects can ibalizumab-uiyk cause?

What side effects can ibalizumab-uiyk cause?

Ibalizumab-uiyk may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of ibalizumab-uiyk can be serious. A serious side effect of ibalizumab-uiyk is changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). (See section above: What are the most important things to know about ibalizumab-uiyk?)

Other possible side effects of ibalizumab-uiyk include 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.

How should ibalizumab-uiyk be stored?

How should ibalizumab-uiyk be stored?

  • Refrigerate vials of ibalizumab-uiyk between 36°F and 46°F (2°C and 8°C). Do not freeze the vials.
  • Keep ibalizumab-uiyk in the glass vial that it came in and keep the container tightly closed. Protect the vial from light.
  • Do not use ibalizumab-uiyk if the original seal over the container opening is broken or missing.
  • Throw away ibalizumab-uiyk that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep ibalizumab-uiyk and all medicines out of reach of children.

Where can I find more information about ibalizumab-uiyk?

Where can I find more information about ibalizumab-uiyk?

More information about ibalizumab-uiyk is available:

Manufacturer Information

TaiMed Biologics USA Corp.
Main number: 949-769-6543
Patient assistance: 833-238-4372

The above Patient Version drug summary is based on the following FDA label(s): Injection.

Last Reviewed: February 12, 2019

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