An Overview of Trogarzo (Ibalizumab-Uiyk)
March 8, 2018
Brand Name: Trogarzo
Ibalizumab can cause serious, life-threatening 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 that could be signs of IRIS.
While taking ibalizumab, it is important to keep all of your appointments with your health care provider.
What Is Ibalizumab?
Ibalizumab is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat HIV infection in adults:
Ibalizumab is always used in combination with other HIV medicines.
Ibalizumab belongs to a class (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 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 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, 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?
Before taking ibalizumab, tell your health care provider:
How Should I Take Ibalizumab?
Ibalizumab comes in two 150 mg/mL single-use vials for intravenous (IV) injection.
Your health care provider will administer ibalizumab 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 every 2 weeks. It is important that you receive ibalizumab every 2 weeks as instructed by your health care provider. Do not change the schedule of your ibalizumab infusions or any of your HIV medicines without talking to your health care provider first.
Always take ibalizumab in combination with other HIV medicines.
If you take too much ibalizumab, 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, see the FDA drug label from Drugs@FDA.
What Should I Do If I Forget a Dose?
Tell your health care provider right away if you stop receiving ibalizumab infusions or stop taking any other HIV medicines.
What Side Effects Can Ibalizumab Cause?
Ibalizumab 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 can be serious. A serious side effect of ibalizumab includes changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). (See the WARNING box above.)
Other possible side effects of ibalizumab include:
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. To learn more about possible side effects of ibalizumab, 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 at www.accessdata.fda.gov/scripts/medwatch/.
How Should Ibalizumab Be Stored?
Where Can I Find More Information About Ibalizumab?
More information about ibalizumab is available:
TaiMed Biologics USA Corp.
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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