Ibalizumab-uiyk (Intravenous route)
eye-ba-LIZ-ue-mab - uiyk
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 is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all.
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:
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.
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.
Appropriate studies on the relationship of age to the effects of ibalizumab-uiyk have not been performed in the geriatric population.
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.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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 should be given slowly, so the needle will have to stay in place for at least 15 to 30 minutes every 2 weeks.
Your doctor may want you stay for at least 15 minutes to 1 hour after infusion 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.
You should not breastfeed if you have HIV or AIDS because you may give the infection to your baby through your breast milk.
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:
- Incidence not known
- Back pain
- blurred vision
- severe rash
- unusual tiredness or weakness
- More common
- Less common
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:
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:
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.
Last Updated: 6/18/2019