Ibalizumab-uiyk (Intravenous)

Ibalizumab-uiyk injection is used along with other medicines to treat HIV infection in patients who have not responded well to anti-HIV medicines, are resistant to many antiretroviral medicines, or are not doing well on their current antiretroviral treatment. HIV is the virus that causes AIDS.

Ibalizumab-uiyk injection will not cure or prevent HIV infection or AIDS, but it helps stop HIV from making more copies of itself and seems to slow down the damage to the immune system. This may help postpone issues that usually come with AIDS or HIV disease. Ibalizumab-uiyk injection will not stop you from spreading HIV to others. People who take this medicine may still experience the issues typically associated with AIDS or HIV disease.

This medicine should be given only by your doctor or under their direct supervision.

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

Using this medicine could harm an unborn baby while you are pregnant. Use an effective form of birth control to prevent 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 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 (for example, fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination).

This medicine will not prevent you from transmitting 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 stop you from transmitting HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Studies have not been done to assess how ibalizumab-uiyk injection affects children. Its safety and effectiveness in children have not been established.

Geriatric

Studies on how ibalizumab-uiyk affects older adults have not been conducted.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication if you are breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction is possible. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Cabotegravir

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor or nurse right away if you experience any of the following side effects:

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 require medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also be able to provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects persist, are bothersome, or if you have any questions about them:

More common

• Diarrhea

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

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

In the U.S.

• Trogarzo

Available Dosage Forms:

• Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Ibalizumab

Find detailed information on biosimilars for this medication.

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.

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