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Viramune Medication Guide Information

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 this medication?

• This Medication 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 this drug 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.
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:

People who have a higher CD4+ cell count when they begin treatment with this drug 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 this medication and call your doctor right away if you have any of the
following symptoms of liver problems:

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

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

What is VIRAMUNE?

• Tablets and the oral solution are prescription HIV medicines used with other HIV medicines to treat HIV (Human Immunodeficiency Virus). HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
•  XR extended-release tablets are a prescription medicine used with other HIV medicines to treat HIV (Human Immunodeficiency Virus) in adults and in children who are 6 years of age to less than 18 years of age.
• VIRAMUNE and  XR are a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI).

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

When used with other HIV medicines, this medication 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).

This medication 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 this medication if you have certain liver problems.  This medication is only for people diagnosed with HIV. If you have not been diagnosed as HIV positive, then do not take this medication.

What should I tell my doctor before taking this medication?

Before you take this medication, tell your doctor if you:

• have or have had hepatitis (inflammation of your liver) or problems with your liver.
• 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 this medication will harm
• your unborn baby.
• are breast-feeding or plan to breast-feed. This medication 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 this medication. Talk to your doctor about the best way to feed your 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.

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

You should not take this medication 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 this medication?

• this medication is always taken in combination with other anti-HIV medications.
• this medication comes in 3 different forms. Your doctor will prescribe the form of this medication that is right for you.
• Take this medication exactly as your doctor tells you to take it. Do not change your dose unless your doctor tells you to.
• You should never take more than one form of this medication at the same time. Talk to your doctor if you have any questions.
• If your child is prescribed this medication, your child’s doctor will tell you exactly how this medication should be taken.
• Swallow XR extended-release tablets whole. Do not chew, crush, or divide.
• You may take this medication with or without food.
• Do not miss a dose of this medication. If you miss a dose of this medication, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose, just take the next dose at your regular time. Do not take two doses at the same time.
• If you stop taking this medication for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to begin taking the VIRAMUNE starting dose again, which is taken 1 time each day for 14 days.

Starting VIRAMUNE tablets or extended-release tablets when this is the first time you are taking any form of this medication:

1. Your doctor should start you with 1 dose each day to lower your chance of getting a serious rash. It is important that you only take 1 dose of this medication each day for the first 14 days.
2. Day 15, you will take 1 VIRAMUNE tablet two times a day.
3. Day 15, take VIRAMUNE XR extended-release tablets 1 time a day as prescribed by your doctor.
   

• Call your doctor right away if you get a skin rash during the first 14 days of VIRAMUNE treatment.
• Do not increase your dose to 2 times a day if you have a rash.
• You should never take your starting dose for longer than 28 days. If after
  28 days you are still receiving this starting dose because you have a rash, you and your doctor should talk about prescribing another HIV medicine for you instead of this medication.

Switching from tablets or oral suspension to XR extended-release tablets:

Take XR extended-release tablets 1 time a day as prescribed by your doctor.
You may sometimes pass a soft mass in your stools (bowel movement) that looks like your  XR extended-release tablets. This will not affect the way your medicine works.

If you take this medication in an oral suspension:

• If you or your child takes this medication in an suspension (liquid), shake it gently before each use. Use an oral dosing syringe or dosing cup to measure the right dose. The oral dosing syringe and dosing cup are not provided with the oral suspension. Ask your pharmacist for a syringe or cup if you do not have one.
• After drinking the medicine, fill the dosing cup with water and drink it to make sure you get all the medicine.
• If the dose is less than 1 teaspoon (5 mL), use the syringe instead of the dosing cup.

What are the possible side effects of VIRAMUNE?

This medication may cause serious side effects, including:

• 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 if you start having new symptoms after starting your HIV medicine.
• Changes in body fat can happen in some people who take antiretroviral therapy. 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 your legs, arms, and face can also happen. The cause and long-term health effects of these problems are not known at this time.
• 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 1800-FDA-1088.

How should I store this medication?

• Store this medication at room temperature between 59°F to 86°F (15°C to 30°C).
• Throw away this medication that is no longer needed or out-of-date.

Keep this medication and all medicines out of the reach of children.

General information about this medication:

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 this medication. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about this medication 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:
• Tablets: microcrystalline cellulose, lactose monohydrate, povidone, sodium
• starch glycolate, colloidal silicon dioxide, and magnesium stearate
• Oral suspension: carbomer 934P, methylparaben, propylparaben, sorbitol, sucrose, polysorbate 80, sodium hydroxide, and purified water
• XR tablets: lactose monohydrate, hypromellose, iron oxide, and magnesium stearate

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

Revised: January 2014

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