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 tablet is used together with another antiviral called rilpivirine for treatment of HIV in people 12 years and older weighing at least 77 pounds (35 kg) to replace their current HIV medicines.

Cabotegravir is also used in HIV negative patients to lower the chance of getting HIV infection in people 12 years and older weighing at least 77 pounds (35 kg). You must be HIV negative to start and keep using cabotegravir to lower the chance of getting HIV infection.

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 an injection.

Cabotegravir and rilpivirine may also be given short-term in place of the 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.

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.

Cabotegravir comes as a tablet to take by mouth. For treatment of HIV-1 infection, it is usually taken along with rilpivirine once daily with food. Take cabotegravir along with rilpivirine at around the same time every day. Cabotegravir is taken along with rilpivirine for about one month (for at least 28 days) prior to starting treatment with the long-acting injectable forms of these medications or for up to 2 months if the injectable treatment schedule is missed for more than 7 days. For prevention of HIV-1 infection, it is usually taken alone once daily with food. Take cabotegravir at around the same time every day. Cabotegravir is taken for about one month (at least 28 days) prior to starting the long-acting injectable form or for up to 2 months if the injectable schedule is missed for more than 7 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cabotegravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take cabotegravir even if you feel well. Do not stop taking cabotegravir or your other anti-HIV medications without talking to your doctor. If you stop taking cabotegravir or skip doses, your condition may become worse and the virus may become resistant to treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

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

Cabotegravir injection is injected into the muscle of your buttock once every month for the first 2 months, then once every 2 months.

Take cabotegravir and rilpivirine tablet with a meal. If you take the medicines at separate times, cabotegravir may be taken with or without food.

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

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

You must remain under the care of a doctor while using 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.

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 cabotegravir.

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

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 using 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.

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

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.

Call your doctor for instructions if you miss a dose of Cabotegravir injection.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Using cabotegravir may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using cabotegravir and get medical help at once if you have a skin rash with any of the following symptoms:

• 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.

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

• 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 of cabotegravir 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cabotegravir.

Keep a supply of cabotegravir on hand. Do not wait until you run out of medication to refill your prescription.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.