cabotegravir

What is the most important information I should know about cabotegravir?

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

What is cabotegravir?

Cabotegravir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. HIV is the virus that can cause acquired immunodeficiency syndrome (AIDS).

Cabotegravir is used together with another antiviral called rilpivirine in adults with HIV. Cabotegravir and rilpivirine are to be used without any other antiviral medicines to treat HIV.

Cabotegravir and rilpivirine are given as a daily "lead-in dose" to help determine that you can safely use a combination form of these medicines given as a monthly injection.

Cabotegravir and rilpivirine may also be given short-term in place of the monthly injectable combination if you plan to miss an injection by more than 7 days.

Cabotegravir and rilpivirine is for use in adults who have already used other antiviral HIV medications that have controlled their viral load. These medicines are not a cure for HIV or AIDS.

Cabotegravir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking cabotegravir?

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with cabotegravir. Your doctor may change your treatment plan if you also use:

• certain antibiotics --rifabutin, rifampin, rifapentine; or
• seizure medicine --carbamazepine, oxcarbazepine, phenobarbital, phenytoin.

Tell your doctor if you have ever had:

• a skin rash or an allergic reaction after taking medicine that contains cabotegravir;
• liver disease; or
• mental illness.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether cabotegravir will harm an unborn baby. However, HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of cabotegravir on the baby.

How should I take cabotegravir?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Cabotegravir with rilpivirine is usually given once per day starting at least 28 days before you switch to the injectable combination.

On the last day you take cabotegravir and rilpivirine tablets, you will receive your first injectable dose of these medicines.

If you take cabotegravir with rilpivirine to replace a missed dose of the injectable combination, take cabotegravir and rilpivirine tablets each day until your next monthly injection is due.

If you plan to miss a monthly injection by more than 7 days, start taking cabotegravir and rilpivirine tablets about 1 month after your last injection was given. Keep taking the tablets each day until your next monthly injection is due.

If needed, daily cabotegravir and rilpivirine tablets can replace the injectable combination for up to 2 months in a row.

You will need frequent medical tests.

You must remain under the care of a doctor while taking cabotegravir and rilpivirine in tablet or injection form. Stay on schedule to get the most benefit. Missing doses can increase your risk of HIV that is resistant to medication.

What happens if I miss a dose?

Take the medicine as soon as you can. Do not take two doses at one time.

Try not to miss any doses, and be sure you have enough tablets for required doses.

What happens if I overdose?

What should I avoid while taking cabotegravir?

Cabotegravir and rilpivirine is a complete treatment. Do not use other HIV medications unless your doctor tells you to.

What are the possible side effects of cabotegravir?

• extreme tiredness, fever, not feeling well;
• muscle or joint pain;
• blisters or sores in or around your mouth;
• red or puffy eyes; or
• swelling in your face or mouth, trouble breathing.

• unusual changes in mood such as feeling sad, hopeless, anxious, or restless;
• suicidal thoughts or actions; or
• liver problems --loss of appetite, nausea, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea;
• abnormal dreams;
• feeling anxious;
• headache; or
• sleep problems.

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.

What other drugs will affect cabotegravir?

Some antacids can make cabotegravir much less effective when taken at the same time. If you take an antacid, take it at least 2 hours before or 4 hours after you take cabotegravir.

Other drugs may affect cabotegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about cabotegravir.