Generic drug: ibalizumab-uiyk
Brand name: Trogarzo
What is Trogarzo (ibalizumab-uiyk), and how does it work?
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 several anti-HIV-1 regimens in the past, and
- have HIV-1 virus that is resistant to many antiretroviral medicines,and
- who are failing their current antiretroviral therapy
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
It is not known if Trogarzo is safe and effective in children.
What are the side effects of 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
- hot flush
- chest pain
- chest tightness
- 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:
These are not all the possible side effects of Trogarzo.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA- 1088.
What is the dosage for Trogarzo?
- Trogarzo is available in a single-dose, 2 mL vial containing 150 mg/mL of ibalizumab-uiyk. Each vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk.
- Trogarzo is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of 0.9% Sodium Chloride Injection, USP. Patients should receive a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks.
- Dose modifications of Trogarzo are not required when administered with any other antiretroviral or any other treatments.
Is Trogarzo safe to use while pregnant or breastfeeding?
- Based on animal data, ibalizumab-uiyk use during pregnancy may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants exposed to ibalizumab-uiyk in utero.
- Immunoglobulin G (IgG) antibodies, such as ibalizumab-uiyk, are transported across the placenta in significant amounts, especially near term; therefore, ibalizumab-uiyk has the potential to be transferred from the mother to the developing fetus.
- There are no available data on ibalizumab-uiyk use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
- The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid the risk of postnatal transmission of HIV-1 infection.
- No data are available regarding the presence of Trogarzo in human milk, the effects on the breastfed child, or the effects on milk production.
- Human IgG is present in human milk, although published data indicate that antibodies in breast milk do not enter the neonatal or infant circulation system in substantial amounts.
- Because of the potential for HIV-1 transmission, instruct mothers not to breastfeed if they are receiving Trogarzo.
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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. Serious side effects of Trogarzo include allergic reactions and changes in your immune system (Immune Reconstitution Inflammatory Syndrome).
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.