Trogarzo is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Trogarzo is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Ibalizumab-uiyk is not a cure for HIV or AIDS.

Trogarzo is usually given after other treatments have failed.

Trogarzo affects your immune system. Tell your doctor if you have signs of a new infection such as fever, night sweats, swollen glands, cough, diarrhea, or weight loss.

Before taking this medicine

You should not use Trogarzo if you are allergic to ibalizumab.

Before you receive Trogarzo, tell your doctor about all your medical conditions or allergies.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Trogarzo is given by your healthcare provider as an intravenous infusion (IV infusion) given into your vein over 15 to 30 minutes, or as an intravenous push (IV push) given into your vein over 30 seconds.

A healthcare provider will monitor you during the IV infusion or IV push, and for a period of time after your IV infusion or IV push.

You will receive this injection usually once every 2 weeks.

HIV is often treated with a combination of drugs. Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Usual Adult Dose for HIV Infection:

Loading dose: 2000 mg IV once
Maintenance dose: 800 mg IV every 2 weeks

Use: In combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily therapy-experienced patients with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.

You should not use Trogarzo if you are allergic to ibalizumab.

Before you receive Trogarzo, tell your doctor about all your medical conditions or allergies.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Call your doctor for instructions if you miss an appointment for your Trogarzo injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Trogarzo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ibalizumab affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Trogarzo side effects may include:

• nausea, diarrhea;

• dizziness; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with ibalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.