IMPORTANT SAFETY INFORMATION
What is TROGARZO®?
TROGARZO® (ibalizumab-uiyk) is a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:
- have received anti-HIV-1 regimens in the past, and
- have HIV-1 virus that is resistant to antiretroviral medicines, and
- who are failing their current antiretroviral therapy
It is not known if TROGARZO® is safe and effective in children.
Do not receive TROGARZO® if you have had an allergic reaction to TROGARZO® or any of the ingredients in TROGARZO®.
TROGARZO® can cause serious side effects, including:
- Allergic reactions. TROGARZO® can cause allergic reactions, including serious reactions, during and after infusion. Tell your healthcare provider or nurse, or get medical help right away if you get any of the following symptoms of an allergic reaction:
- trouble breathing
- swelling in your throat
- chest pain
- chest tightness
- hot flush
- Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your health care provider right away if you start having new symptoms after receiving TROGARZO®.
The most common side effects of TROGARZO® include diarrhea, dizziness, nausea, and rash. These are not all the possible side effects of TROGARZO®.
Before you receive TROGARZO®, tell your healthcare provider about all of your medical conditions, including if you are:
- Pregnant or plan to become pregnant. It is not known if TROGARZO® may harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with TROGARZO®.
- Breastfeeding or plan to breastfeed. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Do not breastfeed if you are receiving TROGARZO® as it is not known if TROGARZO® passes into breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment with TROGARZO®.
Also, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
For more information or medical advice about side effects, ask your healthcare provider. You may report side effects to the FDA at 1-800-FDA-1088 or the THERA patient support® at 1-833-23THERA (1-833-238-4372).
TROGARZO® is a registered trademark of TaiMed Biologics Inc., under license to Theratechnologies Inc.
THERA Patient Support is a trademark of Theratechnologies Inc.