Rilpivirine 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).

Rilpivirine is used in combination with other antiviral medicines to treat HIV. Rilpivirine is for use in adults and children at least 12 years old who weigh at least 77 pounds (35 kilograms) who have never before taken an HIV medicine and who have an amount of HIV-1 in their blood (this is called 'viral load') that is no more than 100,000 copies/mL. Rilpivirine is not a cure for HIV or AIDS.

Rilpivirine is sometimes used with a medicine called cabotegravir 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. Rilpivirine and cabotegravir may also be given short-term in place of the monthly injectable combination for up to 2 months. When used with cabotegravir for these purposes, rilpivirine is only for adults with HIV who have already used other antiviral medicines that have controlled their viral load.

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.

Rilpivirine comes as a tablet to take by mouth. It is usually taken with a meal (not just a protein drink) once a day. When rilpivirine is taken along with cabotegravir, it is usually taken once daily with a meal. Take rilpivirine alone or along with cabotegravir at around the same time every day. Rilpivirine is taken along with cabotegravir 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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rilpivirine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Rilpivirine controls HIV but does not cure it. Continue to take rilpivirine even if you feel well. Do not stop taking rilpivirine without talking to your doctor. When your supply of rilpivirine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking rilpivirine, your condition may become more difficult to treat.

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.

Rilpivirine is usually taken once per day with a full meal (not just a protein drink). Always take the medicine with food.

When given together, rilpivirine and cabotegravir are usually taken once per day starting at least 28 days before you switch to the monthly injectable combination. On the last day you take rilpivirine and cabotegravir, you will receive your first monthly 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 may need frequent medical tests while taking rilpivirine, and for several months after your last dose.

Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Remain under the care of a doctor.

Store rilpivirine in its original container at room temperature away from moisture, heat, and light.

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

Some medicines can cause unwanted or dangerous effects when used with rilpivirine. Your doctor may change your treatment plan if you also use:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• rifampin, rifapentine;

• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole;

• St John's wort; or

• more than one dose of dexamethasone.

Tell your doctor if you have ever had:

• a serious skin rash or allergic reaction after taking a medcine that contains rilpivirine;

• liver disease (rilpivirine can cause hepatitis B or C to come back or get worse);

• kidney disease; or

• depression or mental illness.

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

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.

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

Take the medicine with food as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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 light, 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.

Using rilpivirine will 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 in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

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, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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

• mood changes, anxiety, feeling sad or hopeless, thoughts about suicide or hurting yourself;

• liver problems--right-sided upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes); or

• symptoms of depression--mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself.

Rilpivirine affects your immune system, which may cause certain side effects (even weeks or months after you've taken rilpivirine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of rilpivirine may include:

• sleep problems (insomnia);

• depression;

• skin rash;

• headache; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 medicines can make rilpivirine much less effective when taken at the same time. If you take any of the following medicines, take them separately from your dose of rilpivirine:

• An antacid or didanosine (Videx EC): take either of these medicines at least 2 hours before or 4 hours after you take rilpivirine.

• A stomach acid reducer (such as cimetidine, famotidine, nizatidine, ranitidine, Pepcid, Tagamet, Zantac): take it at least 12 hours before or 4 hours after you take rilpivirine.

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.

Many drugs can affect rilpivirine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

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

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

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