Edurant

Edurant is a prescription medicine used in combination with other medications to treat human immunodeficiency virus (HIV) in certain adults and children 12 years of age and older (weighing at least 35 kg).

This medication is also approved for pregnant patients who were stable on Edurant before becoming pregnant. 

Edurant is in a class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It blocks an enzyme that the virus needs in order to reproduce.

Edurant comes in tablet form and is usually taken once a day, with food. 

Common side effects include depression, insomnia (trouble sleeping), headache, and rash.

Edurant is a prescription medication used to treat adults and children 12 years of age and older (weighing at least 35 kg) with HIV who have not taken any HIV medications before and who have an amount of HIV in their blood (called the "viral load") that is less than or equal to 100,000 copies/mL.

Edurant may also be used to treat HIV-positive pregnant women who were stable on Edurant treatment prior to becoming pregnant.

Edurant must be taken with other HIV medicines.

Edurant is not recommended for patients less than 12 years of age.

This medication may be prescribed for other uses. Ask you doctor or pharmacist for more information.

• Janssen Products, LP

Edurant can cause serious side effects including:

• Depression or mood changes. Tell your doctor right away if you have any of the following symptoms:
  • feeling sad or hopeless
  • feeling anxious or restless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself
• Liver problems can happen in people who take Edurant. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with Edurant. Liver problems have also been reported during treatment with Edurant in people without history of liver disease. Your doctor may need to do tests to check liver function before and during treatment with Edurant.
• Changes in body fat can happen in people taking HIV medicines. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long- term health effects of these problems are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your doctor right away if you start having new symptoms after starting your HIV medicine.

Common side effects of Edurant include:

• depression
• trouble sleeping (insomnia)
• headache
• rash

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects with Edurant. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Edurant may affect the way other medicines work, and other medicines may affect how Edurant works, and may cause serious side effects. If you take certain medicines with Edurant, the amount of Edurant in your body may be too low and it may not work to help control your HIV infection. The HIV virus in your body may become resistant to Edurant or other HIV medicines that are like it.

Do not take Edurant if you also take these medicines:

• the anti-seizure medications carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol- XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek)
• the anti-tuberculosis medications rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin) and rifapentine (Priftin)
• a proton pump inhibitor medication used for certain stomach or intestinal problems, including esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex)
• more than one dose of the steroid medicine dexamethasone or dexamethasone
• St. John's wort (Hypericum perforatum)

Also tell your doctor if you take:

• rifabutin (a medicine to treat some bacterial infections). Talk to your doctor or pharmacist about the right amount of Edurant you should take.
• metformin
• medicines used to treat HIV
• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take Edurant.
• a histamine-2 blocker medicine, including famotidine (Pepcid), cimetidine (Tagamet), nizatidine (Axid), or ranitidine hydrochloride (Zantac). Take these medicines at least 12 hours before or at least 4 hours after you take Edurant.
• the antibiotic medicines clarithromycin (Biaxin), erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Iloson), telithromycin (Ketek) and troleandomycin (TAO)
• an antifungal medicine by mouth, including fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), voriconazole (Vfend)
• methadone (Dolophine)

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Your doctor and your pharmacist can tell you if you can take these medicines with Edurant. Do not start any new medicines while you are taking Edurant without first talking with your doctor or pharmacist. You can ask your doctor or pharmacist for a list of medicines that can interact with Edurant.

Edurant can cause depressive disorders (depressed mood, depression, dysphoria, major depression, altering of mood, negative thoughts, suicide thoughts, and suicidal attempt). If you have severe depressive symptoms, tell your doctor immediately. Your doctor will determine if these symptoms are related to Edurant and will determine what the best course of action is for you. 

Do not take Edurant if your HIV infection has been previously treated with HIV medicines.

Edurant does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Avoid doing things that can spread HIV-1 infection to others.

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Ask your doctor if you have any questions about how to prevent passing HIV to other people.

Grapefruit and grapefruit juice may interact with Edurant and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Edurant, tell your doctor if you:

• are allergic to Edurant or to any of its ingredients
• have had or currently have liver problems, including hepatitis B or C
• have ever had a mental health problem
• are pregnant or planning to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. Your health care provider will determine the risks versus benefit of this medication as well as determine the best treatment for you. 

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

Tell your doctor if you are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their milk to the baby. It is not known if Edurant passes through your breast milk and can harm your baby. Talk to your doctor about the best way to feed your baby.

• Stay under the care of your doctor during treatment with Edurant.
• Take Edurant every day exactly as prescribed by your doctor.
• Always take Edurant with a meal. Taking Edurant with a meal is important to help get the right amount of medicine in your body. A protein drink alone does not replace a meal.
• Do not change your dose or stop taking Edurant without first talking with your doctor. See your doctor regularly while taking Edurant.
• When your supply of Edurant starts to run low, get more from your doctor or pharmacy. It is important not to run out of Edurant. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
• If you miss a dose of Edurant within 12 hours of the time you usually take it, take your dose of Edurant with a meal as soon as possible. Then, take your next dose of Edurant at the regularly scheduled time.
• If you miss a dose of Edurant by more than 12 hours of the time you usually take it, wait and then take the next dose of Edurant at the regularly scheduled time.
• Do not take more than your prescribed dose to make up for a missed dose.
• If you take too much Edurant, go to your local emergency room right away.

Take Edurant exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on other medications you are taking.

The recommended dose of Edurant is one 25 mg tablet once daily taken orally with a meal.

If you take too much Edurant, go to your local emergency room right away.

• Store Edurant at 59°F to 86°F (15°C to 30°C).
• Keep Edurant in the original bottle to protect from light.

Keep Edurant and all medicines out of the reach of children.