Rilpivirine (Oral route)
Non-Nucleoside Reverse Transcriptase Inhibitor
Uses of This Medicine:
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.
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. It will not keep you from spreading HIV to other people. 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.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of rilpivirine in children younger than 12 years of age or weighing less than 35 kilograms (kg). Safety and efficacy have not been established.
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 rilpivirine.
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.
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.
- St John's Wort
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.
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Arsenic Trioxide
- Calcium Carbonate
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- Sodium Bicarbonate
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.
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 of This Medicine:
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.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
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, ranitidine, Axid®, Pepcid®, Tagamet®, or Zantac®), 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.
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:
- Adults and children 12 years of age and older and weighing at least 35 kilograms (kg)—25 milligrams (mg) once a day.
- Children younger than 12 years of age—Use is not recommended.
- For treatment of HIV infection:
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.
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 While Using This Medicine:
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 the following medicines: 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 can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.
This medicine may cause serious types of allergic reactions, including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Anaphylaxis can be life-threatening and requires 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 more than one of these symptoms: 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.
This medicine may cause you to have extra body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from your legs, arms, or face.
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 such as 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.
This medicine does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. 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 of This Medicine:
- Less common
- Changes in behavior
- cloudy or bloody urine
- feeling sad or empty
- gaseous abdominal or stomach pain
- 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
- trouble concentrating
- trouble sleeping
- yellow eyes or skin
- Incidence not known
- Blurred vision
- hives, itching, skin rash
- joint pain, stiffness, or swelling
- 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
- tightness in the chest
- troubled breathing or swallowing
- Less common
- Abnormal dreams
- sleepiness or unusual drowsiness
- stomach discomfort
- unusual tiredness or weakness
- Incidence not known
- Decreased amount of fat from your legs, arms, or face
- increased amount of fat in the upper back and neck, or around the chest and stomach area
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:
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:
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.
Last Updated: 9/5/2019