cabotegravir and rilpivirine

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

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 and rilpivirine?

Cabotegravir and rilpivirine are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. HIV is the virus that can cause acquired immunodeficiency syndrome (AIDS).

Cabotegravir and rilpivirine is a combination medicine that is used without any other antiviral medicines to treat HIV. This medicine is not a cure for HIV or AIDS.

Cabotegravir and rilpivirine is used in people 12 years of age and older who weigh at least 77 pounds (35 kg) to replace their current anti-HIV medications when the doctor determines it is appropriate.

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

What should I discuss with my healthcare provider before receiving cabotegravir and rilpivirine?

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

• dexamethasone (in more than 1 dose);
• methadone;
• St. John's wort;
• certain antibiotics --azithromycin, clarithromycin, erythromycin, rifabutin, rifampin, rifapentine; or
• seizure medicine --carbamazepine, oxcarbazepine, phenobarbital, phenytoin.

Cabotegravir and rilpivirine can stay in your system for 12 months or longer. If you stop using cabotegravir and rilpivirine, follow your doctor's instructions about using any other medicines during the first year after the last dose.

Tell your doctor if you have ever had:

• a skin rash or an allergic reaction after taking medicine that contains cabotegravir or rilpivirine;
• liver disease, including hepatitis B or C (cabotegravir and rilpivirine can affect the results of your liver function tests);
• mental illness; or
• long QT syndrome (in you or a family member).

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether this medicine 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 and rilpivirine on the baby.

How is cabotegravir and rilpivirine given?

On the last day you take the tablets, you will receive your first injectable dose of this medicine. Cabotegravir and rilpivirine is injected into a muscle once per month or once every 2 months. A healthcare provider will give you this medicine as 2 separate injections in opposite sides of your buttocks.

One month after your first injectable dose, you will begin regular monthly cabotegravir and rilpivirine injections. You will be watched closely for about 10 minutes after each injection, to make sure you do not have a serious reaction.

The timing of your monthly injections is very important to the success of your HIV treatment. Your doctor may set a calendar day as your "target treatment date" to help keep you on schedule. If needed, you may receive an injection early or late, up to 7 days before or 7 days after your target date.

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

You will need frequent medical tests. Cabotegravir and rilpivirine can have long lasting effects on your body (up to 12 months after your last dose). You may still need medical tests for a short time after you stop using this medicine.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving cabotegravir and rilpivirine?

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

Using this medicine may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of cabotegravir and rilpivirine?

Your cabotegravir and rilpivirine injections may be permanently discontinued if you have an allergic reaction.

Some side effects may occur within a few minutes after an injection. Tell your caregiver if you feel anxious, warm, light-headed, sweaty, or have stomach pain, or numbness in your mouth.

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

Common side effects may include:

• pain, redness, swelling, itching, bruising, warmth, or a hard lump where an injection was given;
• fever;
• nausea;
• pain in your bones, joints or muscles;
• feeling tired, sleep problems;
• headache, dizziness; or
• rash.

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 and rilpivirine?

Other drugs may affect cabotegravir and rilpivirine, 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 doctor or pharmacist can provide more information about cabotegravir and rilpivirine.