VIRAMUNE- nevirapine suspension 
VIRAMUNE- nevirapine tablet 
Boehringer Ingelheim Pharmaceuticals Inc.

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MEDICATION GUIDE

VIRAMUNE® (VIH-rah-mune)
(nevirapine)
tablets

VIRAMUNE® (VIH-rah-mune)
(nevirapine)
oral suspension

VIRAMUNE XR® (VIH-rah-mune)
(nevirapine)
extended-release tablets

Read this Medication Guide before you start taking VIRAMUNE and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about VIRAMUNE?

 
VIRAMUNE can cause serious side effects. These include severe liver and skin problems that can cause death. These problems can happen at any time during treatment, but your risk is higher during the first 18 weeks of treatment.

1.
Severe liver problems: Anyone who takes VIRAMUNE may get severe liver problems. In some cases these liver problems can lead to liver failure and the need for a liver transplant, or death.

 
People who have a higher CD4+ cell count when they begin VIRAMUNE treatment have a higher risk of liver problems, especially:
  • Women with CD4+ counts higher than 250 cells/mm3. This group has the highest risk.
  • Men with CD4+ counts higher than 400 cells/mm3.

 
If you are a woman with CD4+ counts higher than 250 cells/mm3 or a man with CD4+ counts higher than 400 cells/mm3, you and your doctor will decide whether starting VIRAMUNE is right for you.

 
In general, women have a higher risk of liver problems compared to men.

 
People who have abnormal liver test results before starting VIRAMUNE treatment and people with hepatitis B or C also have a greater risk of getting liver problems.

 
You may get a rash if you have liver problems.

 
Stop taking VIRAMUNE and call your doctor right away if you have any of the following symptoms of liver problems:
  • dark (tea colored) urine
  • yellowing of your skin or whites of your eyes
  • light-colored bowel movements (stools)
  • fever
  • nausea (feeling sick to your stomach)
  • feel unwell or like you have the flu
  • pain or tenderness on your right side below your ribs
  • tiredness
  • loss of appetite

 
Your doctor should see you and do blood tests often to check your liver function during the first 18 weeks of treatment with VIRAMUNE. You should continue to have your liver checked regularly during your treatment with VIRAMUNE. It is important for you to keep all of your doctor appointments.

2.
Severe rash and skin reactions: Skin rash is the most common side effect of VIRAMUNE. Most rashes happen in the first 6 weeks of taking VIRAMUNE. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death. Stop using VIRAMUNE and call your doctor right away if you get a rash with any of the following symptoms:
  • blisters
  • mouth sores
  • red or inflamed eyes, like "pink eye" (conjunctivitis)
  • liver problems (see symptoms of liver problems above)
  • swelling of your face
  • fever
  • feel unwell or like you have the flu
  • tiredness
  • muscle or joint aches


If your doctor tells you to stop treatment with VIRAMUNE because you have had any of the serious liver or skin problems described above, you should never take VIRAMUNE again.

 
See the section "What are the possible side effects of VIRAMUNE?" for more information.

What is VIRAMUNE?

VIRAMUNE XR extended-release tablets are not for use in children less than 6 years of age.

When used with other HIV medicines, VIRAMUNE may:

  1. Reduce the amount of HIV in your blood (called “viral load”).
  2. Help increase the number of CD4 (T) cells in your blood which 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).

VIRAMUNE does not cure HIV infection or AIDS.
VIRAMUNE does not cure HIV or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using VIRAMUNE.


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 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 safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.


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

Who should not take VIRAMUNE?

Tell your doctor if you have or have had liver problems. Your doctor may tell you not to take VIRAMUNE if you have certain liver problems.

VIRAMUNE is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take VIRAMUNE.

What should I tell my doctor before taking VIRAMUNE?


Before you take VIRAMUNE, tell your doctor if you:
  • have or have had hepatitis (inflammation of your liver) or problems with your liver. See "What is the most important information I should know about VIRAMUNE?" and "Who should not take VIRAMUNE?"
  • receive dialysis
  • have skin problems, such as a rash
  • or your child has trouble swallowing pills
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if VIRAMUNE will harm your unborn baby.
    Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the 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 breast-feeding or plan to breast-feed. VIRAMUNE can pass into your breast milk and may harm your baby. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Do not breast-feed during treatment with VIRAMUNE. Talk to your doctor about the best way to feed your baby.


Tell your doctor and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. VIRAMUNE may affect the way other medicines work, and other medicines may affect how VIRAMUNE works.


You should not take VIRAMUNE if you also take:
  • St. John's Wort.  St. John's Wort can lower the amount of VIRAMUNE in your body.
  • efavirenz (Sustiva®, Atripla®) , etravirine (Intelence®), rilpivirine (Edurant® Complera®), or delavirdine (Rescriptor®)
  • boceprevir (Victrelis®)
  • telaprevir (Incivek®)
  • atazanavir (Reyataz®)
  • lopinavir and ritonavir (Kaletra®) once daily
  • fosamprenavir calcium (Lexiva®) without ritonavir (Norvir®)
  • itraconazole (Sporanox®)
  • ketoconazole (Nizoral®)
  • rifampin (Rifadin®, Rifamate®, Rifater®)
  • birth control pills. Birth control pills taken by mouth (oral contraceptives) and other hormone types of birth control may not work to prevent pregnancy. Talk with your doctor about other types of birth control that you can use to prevent pregnancy during treatment with VIRAMUNE.


Also tell your doctor if you take:
  • clarithromycin (Biaxin®)
  • fluconazole (Diflucan®)
  • indinavir sulfate (Crixivan®)
  • methadone
  • nelfinavir mesylate (Viracept®)
  • rifabutin (Mycobutin®)
  • warfarin (Coumadin®, Jantoven®)
  • saquinavir mesylate (Invirase®)
  • amiodarone, disopyramide (Norpace®), lidocaine
  • carbamazepine, clonazepam (Klonopin®), ethosuximide (Zarontin®)
  • diltiazem, nifedipine, verapamil
  • cyclophosphamide
  • ergotamine
  • cyclosporine, tacrolimus, sirolimus (Rapamune®)
  • cisapride (Propulsid®)
  • fentanyl


If you are not sure if you take a medicine above, ask your doctor or pharmacist.

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

How should I take VIRAMUNE?

What are the possible side effects of VIRAMUNE?

The most common side effect of VIRAMUNE is rash.

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

These are not all the possible side effects of VIRAMUNE. 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 1-800-FDA-1088.

How should I store VIRAMUNE?

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

General information about VIRAMUNE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take VIRAMUNE for a condition for which it was not prescribed. Do not give VIRAMUNE to other people, even if they have the same condition you have. It may harm them.

This Medication Guide summarizes the most important information about VIRAMUNE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about VIRAMUNE that is written for health professionals.

For more information, go to www.viramune.com or www.viramunexr.com or call Boehringer Ingelheim Pharmaceuticals, Inc., at 1-800-542-6257, or (TTY) 1-800-459-9906.

What are the ingredients in VIRAMUNE?

Active ingredient: nevirapine
Inactive ingredients:
VIRAMUNE tablets: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate
VIRAMUNE oral suspension: carbomer 934P, methylparaben, propylparaben, sorbitol, sucrose, polysorbate 80, sodium hydroxide, and purified water
VIRAMUNE XR tablets: lactose monohydrate, hypromellose, iron oxide, and magnesium stearate

This Medication Guide has been approved by the U.S. Food and Drug Administration

Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Revised: January 2014

The brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.

Copyright 2014 Boehringer Ingelheim Pharmaceuticals, Inc.

ALL RIGHTS RESERVED

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Revised: 01/2014
 
Boehringer Ingelheim Pharmaceuticals Inc.