"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
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Important: Ask your doctor or pharmacist about medicines that should not be taken with EDURANT. For more information, see the section “What should I tell my doctor 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?
- who have never taken HIV medicines before, and
- who have an amount of HIV in their blood (this is called 'viral load') that is no more than 100,000 copies/mL . Your doctor will measure your viral load.
HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). It is not known if EDURANT is safe and effective in children.
When used with other HIV medicines, EDURANT may help:
- Reduce the amount of HIV in your blood.
- Increase the number of white blood cells called CD4+ (T) cells in your blood that help fight off other infections.
Reducing the amount of HIV and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
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.
Who should not take EDURANT?
Do not take EDURANT if:
- your HIV infection has been previously treated with HIV medicines
- you are taking any of the following medicines:
- anti-seizure medicines:
- carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®, Epitol®) o oxcarbazepine (Trileptal®)
- phenobarbital (Luminal®)
- phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
- anti-tuberculosis (anti-TB) medicines:
- rifabutin (Mycobutin)
- rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
- rifapentine (Priftin®)
- proton pump inhibitor (PPI) medicine for certain stomach
or intestinal problems:
- esomeprazole (Nexium®, Vimovo®)
- lansoprazole (Prevacid®) o omeprazole (Prilosec®, Zegerid)
- pantoprazole sodium (Protonix®)
- rabeprazole (Aciphex®)
- more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John's wort (Hypericum perforatum)
- anti-seizure medicines:
What should I tell my doctor before taking EDURANT?
Before taking EDURANT, tell your doctor if you:
- have or had liver problems, including hepatitis B or C virus infection.
- 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. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Do not breastfeed if you take EDURANT. We do not know if EDURANT can be passed to your baby in your breast milk and whether it could harm your baby. Talk with 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.
Especially tell your doctor if you take:
- medicines used to treat HIV
- an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. If you take an antacid during treatment with EDURANT, take the antacid at least 2 hours before or at least 4 hours after you take EDURANT.
- a medicine to block the acid in your stomach, including cimetidine (Tagamet®), famotidine (Pepcid®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). If you take one of these medicines during treatment with EDURANT, take the acid blocking medicine at least 12 hours before or at least 4 hours after you take EDURANT.
- Any of these medicines (if taken by mouth or injection):
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?
- 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. Stay under the care of your doctor while taking EDURANT.
- 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, call your doctor or go to the nearest hospital emergency room right away.
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.
What are the possible side effects of EDURANT?
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 who take HIV medicine. These changes may include 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. Tell your doctor right away if you start having any new symptoms after starting your HIV medicine.
The most common side effects of EDURANT include:
- trouble sleeping (insomnia)
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 room temperature between 68°F to 77°F (20°C to 25°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 1-800-5267736 or go to www.EDURANT.com.
What are the ingredients in EDURANT?
Active ingredient: rilpivirine.
Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose. The tablet coating contains hypromellose 2910 6 mPa.s, lactose monohydrate, PEG 3000, titanium dioxide, and triacetin.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/11/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Edurant Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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