Ibalizumab

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

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

Ibalizumab is typically given after other treatments have not worked.

Ibalizumab may also be used for reasons not mentioned in this medication guide.

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

The infusion can take at least 15 minutes to finish.

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.

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

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

Before you receive ibalizumab, inform your doctor about all your medical conditions or allergies.

Tell your doctor if you are pregnant, and use your medications correctly to manage your infection. HIV can be transmitted to your baby if the virus is not controlled during pregnancy. Your name may be included in a registry to monitor any effects of antiviral medicine on the baby.

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

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.

Usual Adult Dose for HIV Infection:

Loading dose: 2000 mg IV onceMaintenance dose: 800 mg IV every 2 weeksUse: 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

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 stop you from passing HIV to other people. 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.

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 begin or stop using.

• How well does Trogarzo work to treat multidrug-resistant (MDR) HIV-1?
• How is Trogarzo used in the treatment of HIV?