NEVIRAPINE - nevirapine tablet 
Camber Pharmaceuticals, Inc.

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SPL MEDGUIDE SECTION


MEDICATION GUIDE

Nevirapine Tablets, USP

Read this Medication Guide before you start taking nevirapine 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 nevirapine?
   Nevirapine 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 nevirapine 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 nevirapine treatment have a higher risk of liver problems, especially:


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 nevirapine 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 nevirapine treatment and people with hepatitis B or C also have a greater chance of getting liver problems.

You may get a rash if you have liver problems.

Stop taking nevirapine and call your doctor right away if you have any of the following symptoms of liver problems:

• dark (tea colored) urine                                      • nausea (feeling sick to your stomach)

• yellowing of your skin or whites of your eyes  • feel unwell or like you have the flu

• light-colored bowel movements (stools)          • pain or tenderness on your right side below your ribs

• fever                                                                    • 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 nevirapine. You should continue to have your liver checked regularly during your treatment with nevirapine. 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 nevirapine. Most rashes happen in the first 6 weeks of taking nevirapine. Rashes and skin reactions may be severe, life-threatening, and in some people, may lead to death. Stop using nevirapine and call your doctor right away if you get a rash with any of the following symptoms:

• blisters                                                                                • swelling of your face

• mouth sores                                                                        • fever

• red or inflamed eyes, like “pink eye” (conjunctivitis)      • feel unwell or like you have the flu

• liver problems (see symptoms of liver problems above) • tiredness

                                                                                              • muscle or joint aches

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

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

What is nevirapine?


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

When used with other HIV medicines, nevirapine 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).

    Nevirapine does not cure HIV infection or AIDS.

    Nevirapine 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 nevirapine.

      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:


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

Who should not take nevirapine?

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

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

What should I tell my doctor before taking nevirapine?

Before you take nevirapine, tell your doctor if you:


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

You should not take nevirapine if you also take:

      Also tell your doctor if you take:


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 nevirapine?


o Nevirapine tablets

o Nevirapine oral suspension

o Nevirapine extended-release tablets


Starting nevirapine tablets:
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 nevirapine each day for the first 14 days.

• Call your doctor right away if you get a skin rash during the first 14 days of nevirapine 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 nevirapine.

2. Day 15, you will take 1 nevirapine tablet two times a day.

Switching from nevirapine tablets to nevirapine extended-release tablets:

   Take nevirapine extended-release tablet 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 nevirapine extended-release tablets. This will not affect the way your medicine works.

What are the possible side effects of nevirapine?
Nevirapine may cause serious side effects, including:

The most common side effect of nevirapine 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 nevirapine. 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 nevirapine?

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

General information about nevirapine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use nevirapine for a condition for which it was not prescribed. Do not give nevirapine 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 nevirapine. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about nevirapine that is written for health professionals.

What are the ingredients in nevirapine?

Active ingredient: nevirapine

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, corn starch, povidone, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.

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

Revised: May 2013


All brand names listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited. The makers of these brands are not affiliated with and do not endorse Hetero Labs Limited or its products.




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Manufactured for:

Camber Pharmaceuticals, Inc.                         2020955

Piscataway, NJ 08854.

By: HETEROTM

Hetero Labs Limited

Jeedimetla, Hyderabad - 500 055, India.

Revised: 08/2013
 
Camber Pharmaceuticals, Inc.