Brand Name: Trogarzo
Other Name(s): Hu5A8, IBA, Ibalizumab-uiyk, TMB-355, TNX-355
Drug Class: Post-attachment Inhibitor
Company: TaiMed Biologics USA Corp.
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:
- who have taken several HIV medicines in the past, and
- who have a strain of HIV that is resistant to many HIV medicines, and
- whose HIV infection is not well controlled by ongoing treatment with other HIV medicines.
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:
- If you are allergic to ibalizumab or any other medicines.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Whether ibalizumab can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking ibalizumab when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking ibalizumab.
- 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 AIDS_info_ 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 may affect the way other medicines or products work, and other medicines or products may affect ibalizumab works. Taking ibalizumab together with certain medicines or products may cause serious side effects.
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 AIDS_info_ 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?
- Refrigerate vials of ibalizumab between 36°F and 46°F (2°C and 8°C). Do not freeze the vials.
- Keep ibalizumab in the glass vial that it came in and keep the container tightly closed. Protect the vial from light.
- Do not use ibalizumab if the original seal over the container opening is broken or missing.
- Throw away ibalizumab that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep ibalizumab and all medicines out of reach of children.
Where Can I Find More Information About Ibalizumab?
More information about ibalizumab is available:
- The ibalizumab drug label, from Drugs@FDA. The Patient Counseling Information section of the label includes information for people taking ibalizumab.
- Ibalizumab-related research studies, from the AIDS_info_ database of ClinicalTrials.gov study summaries.
- A list of FDA-approved HIV medicines, from AIDS_info_.
TaiMed Biologics USA Corp.
Main number: 1-949-769-6543
Patient assistance: 1-833-238-4372