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

Nevirapine can cause severe or life-threatening effects on the liver. Call your doctor at once if you have any of these liver symptoms while taking nevirapine: skin rash, nausea, stomach pain, loss of appetite, low fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Nevirapine may also cause severe or life-threatening skin reactions. Contact your doctor if you have any type of skin rash. Even a minor skin rash could be an early sign of a serious reaction. Later signs include fever, sore throat, and headache with a severe blistering, peeling, and red skin rash. This type of reaction is a medical emergency.

There are many other medicines that can interact with nevirapine, or make it less effective. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

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What is nevirapine?

Nevirapine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Nevirapine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Nevirapine is not a cure for HIV or AIDS.

Nevirapine may also be used for other purposes not listed in this medication guide.

Precautions

Nevirapine can cause severe or life-threatening effects on the liver. Call your doctor at once if you have any of these liver symptoms while taking nevirapine: skin rash, nausea, stomach pain, loss of appetite, low fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Nevirapine may also cause severe or life-threatening skin reactions. Contact your doctor if you have any type of skin rash. Even a minor skin rash could be an early sign of a serious reaction. Later signs include fever, sore throat, and headache with a severe blistering, peeling, and red skin rash. This type of reaction is a medical emergency.

Do not use this medication if you are allergic to nevirapine, or if you have moderate to severe liver disease.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take nevirapine, tell your doctor if you have:

  • liver disease;
  • kidney disease (or if you are on dialysis); or
  • if you have ever taken delavirdine (Rescriptor) or efavirenz (Sustiva) and they were not effective in treating your condition.

FDA pregnancy category B. Nevirapine is not expected to be harmful to an unborn baby. However, nevirapine may be more likely to cause liver damage in a pregnant woman. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Nevirapine can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking nevirapine.

Your name may need to be listed on an antiviral pregnancy registry when you start using nevirapine. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether nevirapine had any effect on the baby.

You should not breast-feed while you are using nevirapine. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Avoid drinking alcohol while taking nevirapine. Alcohol may increase your risk of liver damage while taking nevirapine.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include skin rash, headache, dizziness, tired feeling, sleep problems, nausea, vomiting , weight loss, fever, joint pain or swelling, red or tender bumps on your shins, wheezing, cough, or trouble breathing.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: tired feeling, joint or muscle pain, muscle weakness, skin rash, bruising, severe tingling, numbness, mouth sores, trouble breathing, or swelling of your face, lips, tongue, or throat.

Stop taking nevirapine and call your doctor at once if you have:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild nausea, vomiting, or stomach pain;
  • headache, tired feeling; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

There are many other medicines that can interact with nevirapine, or make it less effective. Before taking nevirapine, tell your doctor if you are using any of the following drugs:

  • itraconazole (Sporanox);
  • St. John's wort;
  • a blood thinner such as warfarin (Coumadin);
  • an antibiotic such as clarithromycin (Biaxin), rifabutin (Mycobutin), or rifampin (Rifadin, Rifater, Rifamate, Rimactane);
  • ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine);
  • heart or blood pressure medications such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan);
  • medication to prevent organ transplant rejection;
  • other HIV medicines such as nelfinavir (Viracept), efavirenz (Sustiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nevirapine (Viramune), or saquinavir (Invirase); or
  • seizure medication such as carbamazepine (Tegretol), clonazepam (Klonopin), or ethosuximide (Zarontin).

This list is not complete and there may be other drugs that can interact with nevirapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04