Ibalizumab-uiyk (eye-ba-LIZ-ue-mab - uiyk)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Trogarzo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. The medicine may be given slowly, so the needle will have to stay in place for at least 15 to 30 minutes (IV infusion). This medicine may also be given into your vein for at least 30 to 90 seconds (IV push). Your doctor may want you stay for at least 15 minutes to 1 hour after receiving the injection to check for any unwanted effects.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause infusion-related reactions, which can be life-threatening.
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health, including any symptoms of infection.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, mouth sores, body aches

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea
• Dizziness
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088