SPL MEDGUIDE SECTION

Nevirapine Tablets
(ne vir' a peen)

What is the most important information I should know about nevirapine tablets?
Nevirapine tablets can cause severe liver and skin problems that may lead to death. These problems can happen at any time during treatment, but your risk is higher during the first 18 weeks of treatment.
Nevirapine tablets can cause serious side effects, including:
• Severe liver problems. Some people taking nevirapine tablets may develop severe liver problems that can lead to liver failure and the need for a liver transplant, or death. If you have liver problems, you may get a rash.
o Women have a higher risk of developing liver problems during treatment with nevirapine tablets than men.
o People who have abnormal liver test results before starting nevirapine tablets and people with hepatitis B or C also have a greater risk of getting liver problems.
People who have higher CD4+ cell counts when they beginnevirapine tablets have a higher risk of liver problems, especially:
o Women with CD4+ counts higher than 250 cells/mm3. This group has the highest risk.
o Men with CD4+ counts higher than 400 cells/mm3.
Stop takingnevirapine tablets and call your doctor right away if you have any of the following symptoms of liver problems with or without a skin rash:

• dark (tea colored) urine                         • yellowing of your skin or whites of your eyes
• light-colored bowel movements (stools)                  • fever
• feeling sick to your stomach (nausea)                  • feel unwell or like you have the flu
• pain or tenderness on your right side below your ribs  • tiredness
• loss of appetite  

 • Severe skin reactions and rash. Some skin reactions and rashes may be severe, life-threatening, and in some people, may lead to death. Most severe skin reactions and rashes happen in the first 6 weeks of treatment with nevirapine tablets.
o Women have a higher risk of developing a rash during treatment with nevirapine tablets than men.
Stop taking nevirapine tablets and call your doctor right away if you get a rash with any of the following symptoms:

• blisters  • muscle or joint aches
• red or inflamed eyes, like “pink eye” (conjunctivitis)  • mouth sores
• swelling of your face  • fever
• feel unwell or like you have the flu  • tiredness

• Your doctor should do blood tests often to check your liver function and check for severe skin reactions during the first 18 weeks of treatment with nevirapine tablets. You should continue to see your doctor and have your liver checked regularly during your treatment with nevirapine tablets. It is important for you to keep all of your doctor appointments.
● If your doctor tells you to stop treatment with nevirapine tablets because you have had any of the severe liver or skin symptoms listed above, you should never take nevirapine tablets again.
See "What are the possible side effects of nevirapine tablets?" for more information about side effects.
What are nevirapine tablets?
Nevirapine tablets and nevirapine oral solution are prescription HIV-1 medicines used with other HIV-1 medicines to treat HIV-1 (Human Immunodeficiency Virus 1) in adults and in children 15 days of age or older. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Nevirapine extended-release tablets are a prescription medicine used with other HIV-1 medicines to treat HIV-1 (Human Immunodeficiency Virus 1) in adults and in children 6 years of age or older based on the child's weight and height.
• 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 if starting nevirapine tablets is right for you.
• Nevirapine extended-release tablets are not recommended for use in children less than 6 years of age.
Do not take nevirapine tablets:
• if you have liver problems.
• as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens. Nevirapine tablets are only for people diagnosed with HIV-1. If you have not been diagnosed as HIV positive, then do not take nevirapine tablets.

Before taking nevirapine tablets, tell your doctor about all your or your child’s medical conditions, including if you or your child:
• have or have had hepatitis (inflammation of your liver) or problems with your liver. See “What is the most important information I should know aboutnevirapine tablets?”
• receive dialysis
• have trouble swallowing pills
• are pregnant or plan to become pregnant. It is not known if nevirapine tablets will harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for women who take nevirapine tablets 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 breastfeeding or plan to breastfeed. nevirapine can pass into your breast milk and may harm your baby. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Do not breastfeed during treatment with nevirapine tablets. Talk to your doctor about the best way to feed your baby.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take St. John’s wort.
• Some medicines interact with nevirapine tablets. Keep a list of your medicines to show your doctor or pharmacist.

• You can ask your doctor or pharmacist for a list of medicines that interact with nevirapine tablets.
• Do not start taking a new medicine without telling your doctor. Your doctor can tell you if it is safe to take nevirapine tablets with other medicines.
How should I take nevirapine tablets?
• Take nevirapine tablets exactly as your doctor tells you to take it. Do not change your dose unless your doctor tells you to.
•  Nevirapine tablets are always taken in combination with other antiretroviral medicines.
• Nevirapine tablets come in three different forms. Your doctor will prescribe the form of nevirapine tablets that is right for you.
o Nevirapine tablets 
o Nevirapine oral suspension
o Nevirapine extended-release tablets
• You should not take more than one form of nevirapine tablets at the same time. Talk to your doctor if you have any questions.
• If your child is prescribed nevirapine tablets, your child’s doctor will tell you exactly how nevirapine tablets should be taken.
•  Nevirapine tablets can be taken with or without food.
• Swallow nevirapine extended-release tablets whole. Do not chew, crush, or divide nevirapine extended-release tablets.
•  Do not miss a dose of nevirapine tablets. If you miss a dose of nevirapine tablets, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose. You should take the next dose at your regular time. Do not take 2 doses at the same time.
• If you stop taking nevirapine tablets 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 nevirapine tablets starting dose again, which is taken 1 time each day for 14 days.
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 tablets 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 tablets 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-1 medicine for you instead of nevirapine tablets.
2. Day 15, you will take 1 nevirapine tablet 2 times a day.
Starting nevirapine extended-release tablets when this is the first time you are taking any form of nevirapine:
1. Your doctor should start you with 1 dose of nevirapine tablets each day to lower your risk of getting a serious rash. It is important that you only take 1 dose of  nevirapine tablets 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.
•  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-1 medicine for you instead of  nevirapine tablets.
•  Do not start nevirapine extended-release tablets if you have a rash.
2. Day 15, take nevirapine extended-release tablets 1 time a day as prescribed by your doctor.

Switching from nevirapine tablets tonevirapine extended-release tablets:
• Take nevirapine 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 nevirapine extended-release tablets. This will not affect the way your medicine works.

What are the possible side effects of nevirapine tablets?

Nevirapine tablets  may cause serious side effects, including:
See "What is the most important information I should know about nevirapine tablets?"
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 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 new symptoms after starting your HIV-1 medicine.
•  Changes in body fat can happen in people who take HIV-1 medicines. 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 may also happen. The exact cause and long-term health effects of these conditions are not known.

The most common side effect of nevirapine tablets  is rash. Nevirapine tablets may cause decreased fertility in females. Talk to your doctor if you have concerns about fertility.
These are not all the possible side effects of nevirapine tablets. 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 tablets?
• Store nevirapine tablets at room temperature between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of nevirapine tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use nevirapine tablets  for a condition for which it was not prescribed. Do not give nevirapine tablets to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or doctor for information about nevirapine tablets that is written for health professionals.

What are the ingredients in nevirapine tablets?
Active ingredient: nevirapine

Inactive ingredients: Nevirapine tablets: microcrystalline cellulose, lactose monohydrate, povidone, sodium starch glycolate, colloidal silicon dioxide, and magnesium stearate

For additional information you may also call Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384.

Trademarks are the property of their respective owners.

Manufactured for :
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufactured by:
Macleods Pharmaceuticals Ltd
Daman (U.T.), INDIA

Medication Guide available at:
https://www.macleodspharma.com/usa

Revised: 07/2023

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