Edurant

The recommended dose of rilpivirine is one 25 mg tablet taken once daily. Edurant must be taken with a meal to allow your body to absorb as much of the medication as possible. Swallow the tablet whole with water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Edurant exactly as prescribed by your doctor. The effectiveness of the medication depends on there being the right amount of Edurant in the bloodstream.

If you miss a dose within 12 hours of the usual time you take the dose, take it as soon as possible with a meal, and then continue with your regular schedule. If you miss a dose by more than 12 hours, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Edurant at room temperature, in its tightly closed, original container. Protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each white-to-off-white, film-coated, round, biconvex tablet, engraved with "TMC" on one side and "25" on the other side, contains 25 mg of rilpivirine as rilpivirine hydrochloride. Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, lactose monohydrate, povidone K30, polysorbate 20, and silicified microcrystalline cellulose; tablet coating: hypromellose 2910 6 mPa.s, lactose monohydrate, polyethylene glycol 3000, titanium dioxide, and triacetin.

Do not take Edurant if you:

• are allergic to rilpivirine or any ingredients of Edurant
• are taking any of the following medications:
  • Carbamazepine
  • Dexamethasone (more than one dose)
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • proton pump inhibitors (Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole)
  • rifampin
  • rifapentine
  • St. John's wort

Do not give Edurant to children under 12 years of age.

There may be an interaction between rilpivirine and any of the following:

• Amiodarone
• antacids (e.g., aluminum hydroxide, calcium carbonate)
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• Aprepitant
• "azole" antibiotics (e.g., itraconazole, ketoconazole, Voriconazole)
• Cobicistat
• Deferasirox
• Degarelix
• dexamethasone
• didanosine
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• Enzalutamide
• ergonovine
• Flecainide
• grapefruit or grapefruit juice
• H2 antagonists (e.g., Cimetidine, Famotidine, Ranitidine)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Methadone
• mifepristone
• Mitotane
• Modafinil
• Orlistat
• procainamide
• protein kinase inhibitors (e.g., Dabrafenib, Lapatinib, Nilotinib, Pazopanib, Sunitinib)
• proton pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)
• rifabutin
• rifampin
• rifapentine
• quinidine
• quinine
• St. John's wort
• Sarilumab
• seizure medications (e.g., carbamazepine, phenobarbital, phenytoin, oxcarbazepine)
• Tocilizumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Edurant. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Edurant.

Abnormal heart rhythms: Edurant can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, gatifloxacin, moxifloxacin, Mefloquine, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with rilpivirine.

If you have heart disease and abnormal heart rhythms, or are taking certain medications that can affect heart rhythm, discuss with your doctor how Edurant may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Edurant, and whether any special monitoring is needed.

Depression: Antiretroviral medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Edurant may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Edurant, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Edurant contact your doctor as soon as possible.

Galactose intolerance: Rilpivirine contains lactose. If you have hereditary galactose intolerance you should not take Edurant.

Hypersensitivity syndrome: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome can occur with the use of rilpivirine. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Immune reconstitution inflammatory syndrome: Edurant may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes or Tuberculosis). Report any new symptoms to your doctor immediately.

Kidney function: If you have reduced kidney function, discuss with your doctor how Edurant may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Edurant, and whether any special monitoring is needed.

Liver function: Rilpivirine is largely removed from the body by the liver and may cause liver problems. Decreased liver function may cause Edurant to build up in the body, causing increased side effects. People with hepatitis B or C may be at increased risk for liver problems. If you have liver disease or decreased liver function, discuss with your doctor how Edurant may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Edurant, and whether any special monitoring is needed.

Edurant should not be used by people with severely reduced liver function.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Stopping the medication: If you stop taking Edurant, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: Edurant should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Edurant, contact your doctor immediately.

Breast-feeding: It is not known if rilpivirine passes into breast milk. Women who have HIV infection should not breast-feed because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using Edurant have not been established for children less than 12 years of age or weighing less than 35 kg.

Seniors: The effects of Edurant on seniors have not been well studied. It is likely that people over the age of 65 will experience more side effects and should report any unusual effects to their doctor as soon as possible.