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

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

Ibalizumab is usually given after other treatments have failed.

Ibalizumab may also be used for purposes not listed in this medication guide.

Ibalizumab 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.

Ibalizumab is given as an infusion into a vein. A healthcare provider will give you this injection, usually once every 2 weeks.

The infusion can take at least 15 minutes to complete.

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 ibalizumab if you are allergic to it.

Before you receive ibalizumab, 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 ibalizumab injection.

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

Using ibalizumab 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: 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 ibalizumab). 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 side effects of ibalizumab 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 affect 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.