rilpivirine (Oral route)

ril-pi-VIR-een

Commonly used brand name(s)

In the U.S.

  • Edurant

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

Uses For rilpivirine

Rilpivirine is used together with other medicines to treat human immunodeficiency virus (HIV) infections. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). rilpivirine is usually given to patients who have not received any HIV treatment in the past. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by lowering the amount of HIV in the blood.

Slideshow: Flashback: FDA Drug Approvals 2013

Rilpivirine will not cure HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Rilpivirine will not keep you from spreading HIV to other people. People who receive rilpivirine may continue to have some of the problems usually related to AIDS or HIV disease.

rilpivirine is available only with your doctor's prescription.

Before Using rilpivirine

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 rilpivirine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rilpivirine 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 in the pediatric population. Safety and efficacy have not been established.

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 rilpivirine.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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.

Interactions with Medicines

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 rilpivirine, 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 rilpivirine 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.

  • Carbamazepine
  • Dexamethasone
  • Esomeprazole
  • Fluconazole
  • Fosphenytoin
  • Ketoconazole
  • Lansoprazole
  • Nelfinavir
  • Omeprazole
  • Oxcarbazepine
  • Pantoprazole
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Posaconazole
  • Primidone
  • Rabeprazole
  • Rifampin
  • Rifapentine
  • St John's Wort

Using rilpivirine 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
  • Calcium Carbonate
  • Ceritinib
  • Cimetidine
  • Clarithromycin
  • Crizotinib
  • Dabrafenib
  • Delamanid
  • Delavirdine
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Efavirenz
  • Escitalopram
  • Eslicarbazepine Acetate
  • Etravirine
  • Famotidine
  • Fluoxetine
  • Ivabradine
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Mitotane
  • Nevirapine
  • Nizatidine
  • Ondansetron
  • Pazopanib
  • Quetiapine
  • Ranitidine
  • Rifabutin
  • Sevoflurane
  • Siltuximab
  • Tipranavir
  • Vandetanib
  • Vemurafenib

Using rilpivirine 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
  • Methadone

Interactions with Food/Tobacco/Alcohol

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 rilpivirine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Depression, or history of or
  • Heart rhythm problems (eg, QT prolongation) 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 rilpivirine

Take rilpivirine 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. Also, do not change the dose or stop using rilpivirine without checking first with your doctor. When your supply of rilpivirine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of rilpivirine.

Keep taking rilpivirine for the full time of treatment, even if you begin to feel better.

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.

It is best to take rilpivirine with food.

rilpivirine comes with a patient information insert. Read and follow these instructions carefully before starting rilpivirine and each time you refill your prescription. Ask your doctor if you have any questions.

If you are taking a stomach medicine for heartburn or ulcers (such as cimetidine, famotidine, nizatidine, ranitidine, Axid®, Pepcid®, Tagamet®, or Zantac®), take the heartburn medicine 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 the medicine on an empty stomach and at least 2 hours before or 4 hours after rilpivirine.

Dosing

The dose of rilpivirine 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 rilpivirine. 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—25 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of rilpivirine, 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 or forget to use your medicine and it is less than 12 hours since your last dose, take it as soon as you can and take your next dose at the normal time. If you miss a dose or forget to use it, and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

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 While Using rilpivirine

It is very important that your doctor check your progress at regular visits to make sure that rilpivirine 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: a seizure medicine (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®), medicine to treat tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), certain stomach medicines (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®, or Protonix®), dexamethasone (Decadron®), or St. John's wort.

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.

rilpivirine 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.

When you start taking HIV medicines, your immune system may get stronger. If you already have pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight the infections. If this occurs, be sure to tell your doctor.

Make sure any doctor or dentist who treats you knows that you are using rilpivirine. rilpivirine may affect the results of certain medical tests.

rilpivirine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. rilpivirine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

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.

rilpivirine 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
  • Abdominal or stomach fullness
  • changes in behavior
  • cloudy or bloody urine
  • discouragement
  • feeling sad or empty
  • gaseous abdominal or stomach pain
  • high blood pressure
  • indigestion
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • recurrent fever
  • severe nausea or vomiting
  • sleeplessness
  • swelling of the face, feet, or lower legs
  • thoughts of killing oneself
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • yellow eyes or skin

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
  • Abdominal or stomach discomfort
  • abnormal dreams
  • decreased appetite
  • diarrhea
  • dizziness
  • fear or nervousness
  • headache
  • nausea
  • rash
  • sleepiness or unusual drowsiness
  • unusual tiredness or weakness
  • vomiting
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

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.

See also: Side effects (in more detail)

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