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. cabotegravir and rilpivirine 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.

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.

At least 28 days before your first injection, you will take cabotegravir and rilpivirine in tablet forms once per day with a meal. This "lead-in dose" will help determine that you can safely use these medicines together. Follow all directions on your prescription label and use the medicines exactly as directed.

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.

If you stop using cabotegravir and rilpivirine, you will need to start using other HIV medicines to prevent your condition from becoming resistant. Call your healthcare provider right away to discuss your treatment options.

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.

You should not use cabotegravir and rilpivirine if you are allergic to it.

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 cabotegravir and rilpivirine 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.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Cabotegravir and rilpivirine are not approved for use by anyone younger than 12 years old or weighing less than 77 pounds (35 kilograms).

If you miss or plan to miss an injection by more than 7 days, call your healthcare provider right away to discuss your treatment options.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Using cabotegravir and rilpivirine 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.

Get emergency medical help if you have signs of an allergic reaction: hives; fever, tiredness, body aches, not feeling well; sores or blisters in your mouth; red or puffy eyes; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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.

Cabotegravir and rilpivirine may cause serious side effects. Call your doctor at once if you have:

• 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 of cabotegravir and rilpivirine 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.

Cabotegravir and rilpivirine can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

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.