Rilpivirine

Rilpivirine is used along with other medications to treat human immunodeficiency virus type 1 (HIV-1) in certain adults and children 2 years of age and older who weigh at least 31 lb (14 kg) and have not received antiretroviral treatment in the past and whose viral load is less than 100,000 copies/mL. It is also used along with cabotegravir (Vocabria) as a short-term treatment of HIV-1 infection in certain adults. Rilpivirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood. Although rilpivirine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Rilpivirine comes as a tablet to take by mouth. It also comes as a tablet for suspension (to be mixed with water [Edurant PED]) and given to kids. 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.

Your doctor will decide which rilpivirine product is right for you. Rilpivirine tablets and tablets for suspension cannot be substituted for each other.

To give rilpivirine tablet for suspension:

1. Place the tablet for oral suspension in a cup and then add 5 mL (1 teaspoon) of room temperature drinking water.
2. Swirl the cup for 1-2 minutes to dissolve the tablet. The mixture may look cloudy.
3. Swallow all of the contents right away. You may add 5 mL (1 teaspoon) of water, orange juice, milk or applesauce to the mixture to make it easier to take the medicine. But the entire amount must be swallowed right away. Make sure no medicine is left in the cup. If needed, add 5 mL (1 teaspoon) of water and mix and swallow right away,

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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking rilpivirine,

• tell your doctor and pharmacist if you are allergic to rilpivirine, any other medications, or any of the ingredients in rilpivirine tablets. Ask your pharmacist for a list of the ingredients.
• some medications should not be taken with rilpivirine. Other medications may cause dosing changes or extra monitoring when taken with rilpivirine. Make sure you have discussed any medications you are currently taking or plan to take before starting rilpivirine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking rilpivirine, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with rilpivirine: St.John's wort; medications for heartburn such as omeprazole (Prilosec), rabeprazole (Aciphex), esomeprazole (Nexium), lansoprazole (Prevacid). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking rilpivirine. Do not start any of these medications while taking rilpivirine without discussing with your healthcare provider.
• if you are taking antacids containing calcium, magnesium, or aluminum (Maalox, Mylanta, Tums, others), take them at least 2 hours before or 4 hours after rilpivirine.
• if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine (Zantac), take it at least 12 hours before or at least 4 hours after rilpivirine.
• if you are taking didanosine (Videx), take it at least2 hours before or at least 4 hours after rilpivirine.
• tell your doctor if you have or have ever had depression or other mental illness, liver disease, including hepatitis B or C, or kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rilpivirine, call your doctor. Tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking rilpivirine.
• you should know that your body fat may increase or move to different areas of your body such as your breasts, upper back and neck, or around the middle of your body. Loss of fat from the legs, arms, and face can also happen.
• you should know that rilpivirine may cause changes in your thoughts, behavior, or mental health. Call your doctor immediately if you develop any of the following symptoms while you are taking rilpivirine: new or worsening depression; feeling sad, hopeless, anxious, or restless; or thinking about killing yourself or planning or trying to do so. Be sure your family knows which symptoms may be serious so that they can call your doctor if you are unable to seek treatment on your own.
• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms after starting treatment with rilpivirine, be sure to tell your doctor.

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

Take the missed dose as soon as you remember it, with a meal. However, if it has been more than 12 hours since your last dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Rilpivirine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty falling asleep or staying asleep
• headache
• nausea
• vomiting
• dizziness
• abdominal pain
• drowsiness

Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• rash
• yellowing of skin or eyes, pain on the right side of the stomach, nausea, vomiting, light colored stools, dark colored urine

Some side effects can be serious. If you experience any of these symptoms stop taking rilpivirine and call your doctor immediately or get emergency medical treatment:

• rash along with fever, swelling of the face, lips, mouth, tongue, or throat, blisters, trouble breathing or swallowing, mouth sores, redness or swelling of the eyes (conjunctivitis), pain on the right side of the stomach (abdominal) area, or dark colored urine

Rilpivirine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.

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