Description
Rilpivirine is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have not received any HIV treatment in the past. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor.
Rilpivirine is also used together with cabotegravir for short-term treatment of HIV infection in patients when their healthcare provider determines that they meet certain requirements. It is used to assess how well you tolerate rilpivirine before receiving cabotegravir/rilpivirine combination injection (Cabenuva) or in patients who will miss a planned injection of Cabenuva.
This medicine will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood and helps the immune system. This may help delay problems that result from AIDS or HIV disease. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of rilpivirine tablets in children younger than 2 years of age or weighing less than 14 kilograms (kg). Safety and efficacy have not been established. Use of rilpivirine oral liquid is not recommended in children younger than 2 years of age or weighing less than 14 kg.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rilpivirine in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Carbamazepine
- Cisapride
- Dexamethasone
- Dexlansoprazole
- Dronedarone
- Esomeprazole
- Fluconazole
- Fosphenytoin
- Ketoconazole
- Lansoprazole
- Mesoridazine
- Omeprazole
- Oxcarbazepine
- Pantoprazole
- Phenobarbital
- Phenytoin
- Pimozide
- Piperaquine
- Posaconazole
- Primidone
- Rabeprazole
- Rifabutin
- Rifampin
- Rifapentine
- Saquinavir
- Sparfloxacin
- St John's Wort
- Terfenadine
- Thioridazine
- Vonoprazan
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adagrasib
- Alfuzosin
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atidarsagene Autotemcel
- Avacopan
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Calcium Carbonate
- Calcium Silicate
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cimetidine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasabuvir
- Dasatinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Boceprevir
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Depression, history of or
- Liver disease (eg, hepatitis B or C infection)—Use with caution. May make these conditions worse.
- Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you stop taking this medicine, or do not take it as prescribed, you may spread HIV to others.
Rilpivirine contains a fixed amount of each medicine in the tablet and the tablet for suspension (oral liquid). Do not substitute these dosage forms for each other. Always check your medicine each time your prescription is filled to make sure you receive the correct dosage form.
This medicine comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
To use the oral liquid:
- Gently peel back the foil to remove the tablet. Do not push the tablets out of the foil.
- Place the tablets in a small cup. Do not crush it.
- Add 5 milliliters (mL) of room temperature drinking water. Swirl the cup gently for 1 to 2 minutes to dissolve the tablet. The mixture will become cloudy.
- Swallow the liquid right away or add another 5 mL of drinking water, milk, orange juice, or applesauce to help take the medicine. Swirl the mixture and take all the medicine right away.
- You may add another 5 mL drinking water, milk, orange juice, or applesauce to the cup to make sure your child gets the full dose.
- Do not swallow whole, crush, or chew the tablet for suspension.
Keep taking rilpivirine for the full time of treatment, even if you begin to feel better. Do not stop taking it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.
It is important to take rilpivirine together with other medicines. Take all other medicines your doctor has prescribed at the right time of day. This will make your medicines work better.
Take this medicine with food.
If you are taking a stomach medicine for heartburn or ulcers (eg, cimetidine, famotidine, nizatidine, Axid®, Pepcid®, or Tagamet®), take it at least 12 hours before or 4 hours after rilpivirine.
If you are taking antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after rilpivirine.
If you are taking didanosine (Videx®), take it on an empty stomach and at least 2 hours before or 4 hours after rilpivirine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For treatment of HIV infection:
- For patients who have not received any HIV treatment in the past:
- Adults and children 12 years of age and older and weighing 25 kilograms (kg) or more—25 milligrams (mg) once a day.
- Children younger than 12 years of age or weighing less than 25 kg—Use of oral liquid is recommended.
- For short-term treatment of HIV infection:
- To assess the tolerability of rilpivirine before receiving Cabenuva:
- Adults and children 12 years of age and older and weighing 35 kilograms (kg) or more—25 milligrams (mg) in combination with 30 mg of cabotegravir once a day for at least 28 days. Your last dose should be taken on the same day Cabenuva injections are started.
- Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
- For patients who will miss a monthly planned injection of Cabenuva:
- Adults and children 12 years of age and older and weighing 35 kilograms (kg) or more—If you miss or plan to miss a scheduled monthly injection of Cabenuva injection by more than 7 days, take 25 milligrams (mg) in combination with 30 mg of cabotegravir once a day. Your first dose should be taken at least 1 month after the last Cabenuva injection and continued until the day injection dosing is restarted.
- Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
- For patients who will miss an every-2-month planned injection of Cabenuva:
- Adults and children 12 years of age and older and weighing 35 kilograms (kg) or more—If you miss or plan to miss a scheduled every-2-month injection of Cabenuva injection by more than 7 days, take 25 milligrams (mg) in combination with 30 mg of cabotegravir once a day. Your first dose should be taken at least 2 months after the last Cabenuva injection and continued until the day injection dosing is restarted.
- Children younger than 12 years of age or weighing less than 35 kg—Use and dose must be determined by your doctor.
- To assess the tolerability of rilpivirine before receiving Cabenuva:
- For patients who have not received any HIV treatment in the past:
- For treatment of HIV infection:
- For oral dosage form (tablets for suspension):
- For treatment of HIV infection:
- For patients who have not received any HIV treatment in the past:
- Children 2 years of age and older weighing at least 14 kilograms (kg) to less than 25 kg—Dose is base on body weight and must be determined by your doctor.
- Weighing 20 kg to less than 25 kg—15 milligrams (mg) or 6 tablets once a day.
- Weighing 14 kg to less than 20 kg—12.5 mg or 5 tablets once a day.
- Children younger than 2 years of age or weighing less than 14 kg—Use is not recommended.
- Children 2 years of age and older weighing at least 14 kilograms (kg) to less than 25 kg—Dose is base on body weight and must be determined by your doctor.
- For patients who have not received any HIV treatment in the past:
- For treatment of HIV infection:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose of this medicine and it is less than 12 hours since your regular time, take it as soon as you can and take your next dose at the normal time. If you miss a dose and it is more than 12 hours since your regular time, skip the missed dose and take your next dose at the normal time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use rilpivirine if you are also taking dexamethasone (Decadron®), St. John's wort, medicine to treat tuberculosis (eg, rifampin, rifapentine, Priftin®, Rifadin®, or Rimactane®), seizure medicine (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®), or certain stomach medicines (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®, or Protonix®).
Serious skin reactions (eg, drug reaction with eosinophilia and systemic symptoms (DRESS)) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, lightheadedness or dizziness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.
Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly.
This medicine may cause serious liver problems. This may occur in patients with a history of hepatitis B or C infection. Check with your doctor right away if you have clay-colored stools, dark urine, a decreased appetite, fever, headache, itching, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves disease, polymyositis, and Guillain-Barré syndrome) may also occur.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
It is important to practice safe sex. Wear or have your partner wear a condom. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Changes in behavior
- cloudy or bloody urine
- discouragement
- feeling sad or empty
- gaseous stomach pain
- indigestion
- irritability
- lack of appetite
- loss of interest or pleasure
- recurrent fever
- severe nausea or vomiting
- stomach fullness
- swelling of the face, feet, or lower legs
- thoughts of killing oneself
- tiredness
- trouble concentrating
- trouble sleeping
- yellow eyes or skin
Incidence not known
- Blurred vision
- chest tightness
- chills
- cough
- dizziness
- fever
- headache
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- nervousness
- pounding in the ears
- redness of the skin
- slow or fast heartbeat
- sore throat
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trouble breathing or swallowing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Abnormal dreams
- diarrhea
- fear
- nausea
- sleepiness or unusual drowsiness
- stomach discomfort
- unusual tiredness or weakness
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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