rilpivirine

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

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) and have never before taken an HIV medicine. 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.

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

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.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. 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 antiviral medicine on the baby.

How should I take rilpivirine?

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

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 take rilpivirine with cabotegravir to replace a missed dose of the injectable combination, take rilpivirine and cabotegravir 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 rilpivirine and cabotegravir 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 rilpivirine and cabotegravir tablets can replace the injectable combination for up to 2 months in a row.

You may need frequent medical tests while taking rilpivirine, and for several months after you stop.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking rilpivirine?

Using this medicine will 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 rilpivirine?

• 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 this medicine). 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 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.

What other drugs will affect 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.

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.

Where can I get more information?

Your pharmacist can provide more information about rilpivirine.