Pronunciation:

eye-ba-LIZ-ue-mab - uiyk

Brand Names:

• Trogarzo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Ibalizumab

Uses of This Medicine:

Ibalizumab-uiyk injection is used together with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV) in patients who have received anti-HIV medicines that did not work well, who are resistant to many antiretroviral medicines, or who are failing their current antiretroviral treatment. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Ibalizumab-uiyk injection will not cure or prevent HIV infection or AIDS, however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Ibalizumab-uiyk injection will not keep you from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ibalizumab-uiyk injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of ibalizumab-uiyk have not been performed in the geriatric population.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cabotegravir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or medical facility. It is given through a needle placed into one of your veins. This 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 seconds (IV push). You will receive this medicine every 2 weeks.

Your doctor may want you stay for at least 15 minutes to 1 hour after receiving the injection to check for any unwanted effects.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine could harm unborn baby while you are pregnant. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

This medicine may cause infusion-related reactions and serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a back pain, chest tightness, fever or chills, flushing, rash, itching, headache, hoarseness, nausea and vomiting, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after using this medicine.

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 (eg, fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination).

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Back pain

blurred vision

chest tightness

chills

confusion

cough

difficulty swallowing

dizziness

drowsiness

fast heartbeat

fever

flushing

headache

hives, itching, skin rash

nausea and vomiting

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

trouble breathing

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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