Edurant Patient Information

Important: Ask your doctor or pharmacist about medicines that should not be taken with Edurant. For more information, see the section Before taking Edurant.

Read this Patient Information before you start taking Edurant and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. You and your doctor should discuss your treatment with Edurant when you start taking it and at regular checkups. You should not change or stop treatment without first talking with your doctor.

What is Edurant?

• Edurant is a prescription HIV medicine that:
  • helps to treat HIV (Human Immunodeficiency Virus) infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Edurant is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI).
  • is used in adults who have never taken HIV medicines before.
  • Edurant must be taken with other HIV medicines.
• It is not known if Edurant is safe and effective in children.

When used with other HIV medicines, Edurant may help:

1. Reduce the amount of HIV in your blood. This is called your "viral load".
2. Increase the number of white blood cells called CD4+ (T) cells that help fight off other infections.
   Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).

Edurant does not cure HIV infection or AIDS.

Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

• Always practice safer sex.
• Use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
• Never re-use or share needles.

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

Who should not take Edurant?

• Do not take Edurant if your HIV infection has been previously treated with HIV medicines.
• Do not take Edurant if you are taking certain medicines. For more information about medicines that must not be taken with Edurant, see Before taking Edurant.

Before taking Edurant

Before taking Edurant, tell your doctor if you:

• 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.
• It is not known if Edurant will harm your unborn baby.
  Pregnancy Registry: 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.
• 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.

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 medicines carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol- XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek)
• the anti-TB medicines rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin) and rifapentine (Priftin)
• a proton pump inhibitor medicine 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 sodium phosphate
• St. John's wort (Hypericum perforatum)

Also tell your doctor if you take:

• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate.
  Take antacids at least two hours before or at least four hours after you take Edurant.
• histamine-2 blocker medicine, including famotidine (Pepcid), cimetidine (Tagamet), nizatidine (Axid), or ranitidine hydrochloride (Zantac). Take these medicines at least twelve hours before or at least four hours after you take Edurant.
• the antibiotic medicines clarithromycin (Biaxin), erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Iloson), 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.

How should I take Edurant?

• 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 twelve 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.

Edurant side effects

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
• 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:

• 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1­800-FDA-1088.

How should I store Edurant?

• 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.

General information about Edurant

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Edurant for a condition for which it was not prescribed. Do not give Edurant to other people even if they have the same condition you have. It may harm them.

This leaflet summarizes the most important information about Edurant. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Edurant that is written for health professionals. For more information, call 1-877-732­2488 or go to www.Edurant-info.com.

What are the ingredients in Edurant?

Active ingredient: rilpivirine.

Inactive ingredients: croscarmellose sodium, magnesium stearate, lactose monohydrate, povidone K30, polysorbate 20 and silicified microcrystalline cellulose. The tablet coating contains hypromellose 2910 6 mPa.s, lactose monohydrate, PEG 3000, titanium dioxide, and triacetin.