Rilpivirine

Rilpivirine is an antiviral medicine that treats HIV (human immunodeficiency virus). HIV can lead to acquired immunodeficiency syndrome (AIDS). Rilpivirine does not cure HIV or AIDS.

Rilpivirine is taken with other antiviral medicines to treat HIV-1 infection. It is for adults and children who are at least 12 years old and weigh at least 77 pounds (35 kilograms), who have never used HIV-1 medicines before, and who have no more than 100,000 copies/mL of HIV-1 in their blood (this is called 'viral load').

EDURANT and EDURANT PED are also used in adults and children who are at least 2 years old and weigh at least 31 pounds (14 kilograms) and meet the same treatment requirements.

Rilpivirine may also be used with cabotegravir in adults and adolescents who are 12 years of age and older and weigh at least 77 pounds (35 kilograms) and whose HIV-1 is well controlled on their current antiviral medicines.

Rilpivirine may also be used for purposes not listed in this medication guide.

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

Your dose needs may change if you switch to a different brand, strength, or form of rilpivirine. Different forms of rilpivirine are not used in the same way. Use only the form prescribed by your doctor to avoid medication errors.

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

Rilpivirine tablets for oral suspension must be mixed with drinking water before taking them. Do not crush, chew, or swallow the tablets for oral suspension whole.

Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand these instructions.

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 dose of the injectable combination.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

You will need frequent blood tests to check your liver function before and during treatment with rilpivirine.

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 this medicine in its original container or package at room temperature away from moisture, heat, and light.

Tell your doctor about all your other medicines. Some drugs must not be used with rilpivirine.

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

Some drugs should not be taken with rilpivirine. Your treatment plan may change if you also use:

• nefazodone;
• St. John's wort;
• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole;
• an antibiotic--clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;
• antifungal medicine--itraconazole, ketoconazole;
• antiviral medicine for HIV or hepatitis C--boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir, saquinavir, telaprevir, tipranavir;
• cancer medicine--apalutamide, enzalutamide, mitotane;
• seizure medicine--carbamazepine, oxcarbazepine, phenytoin, primidone; or
• steroid medicine--dexamethasone, prednisone.

Tell your doctor if you have or have ever had:

• a serious skin rash or allergic reaction after taking a medicine that contains rilpivirine;
• depression or mental illness;
• liver disease, including hepatitis B or C; or
• kidney disease.

It is not known if rilpivirine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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 should not breastfeed. The virus can pass to your baby in your breast milk.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty 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.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worsening depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

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

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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; or
• headache.

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.

Take the medicine with food as soon as you can. If you are more than 12 hours late for a dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time.

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

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

Using rilpivirine will not stop your disease from spreading. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can change your blood levels of other drugs you take, which may increase side effects or make the medicines less effective.

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

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.

This list is not complete, and many other drugs may affect rilpivirine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.