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|Nevirapine

NEVIRAPINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Viramune

In Canada—

• Viramune

Category

• Antiviral, systemic

Description

Nevirapine (ne-VYE-ra-peen) is used, with other medicines, in the treatment of the infection caused by the human immunodeficiency virus (HIV).

Nevirapine will not cure HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Nevirapine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Oral suspension (U.S.)
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For nevirapine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to nevirapine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Nevirapine crosses the placenta. Studies in pregnant women have shown that nevirapine decreases the chance of passing HIV to your baby during labor and at birth. Studies in animals at high doses have found that it causes decreased body weight of infant animals. However, nevirapine did not cause birth defects in animals.

Breast-feeding—Nevirapine passes into breast milk. Breast-feeding is not recommended in AIDS patients because of the risk of passing the AIDS virus on to the nursing infant and the possibility of serious adverse reactions in nursing infants.

Children—Granulocytopenia may be more likely to occur in children, who are usually more sensitive than adults to this effect of nevirapine.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of nevirapine in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking nevirapine, it is especially important that your health care professional know if you are taking any of the following:

• Clarithromycin (e.g., Biaxin)— Nevirapine may decrease the amount of this medicine in your body. Your doctor may want to try another medicine.

• Fluconazole (e.g., Diflucan)—May increase your risk for side effects from nevirapine

• Ketoconazole (e.g., Nizoral) or
• Methadone (e.g., Dolophine, Methadose) or
• Contraceptives (birth control ) containing estrogen or progesterone—Nevirapine may decrease the amount of these medicines in the body and cause them to be less effective

• Lopinavir and Ritoavir (e.g., Kaletra)— Your doctor may want to change the amount of this medicine that you take

• Rifabutin (e.g., Mycobutin) or
• Rifampin (e.g., Rifadin) or
• St. John"s wort or St. John"s wort containing products—These medicines may decrease the amount of nevirapine in the body

• Prednisone (e.g., Deltasone)—May increase the incidence and severity of a severe rash

• Warfarin— Your doctor will want to monitor your blood levels when you are taking this medicine at the same time as nevirapine.

Other medical problems—The presence of other medical problems may affect the use of nevirapine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Nevirapine may be removed more slowly from the body

• Liver disease—Nevirapine has been reported to cause unwanted and sometimes serious effects in the liver

Proper Use of This Medicine

Nevirapine may be taken with or without food.

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking nevirapine for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day. If you are taking two doses a day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your health care professional.

If you are taking the oral solution shake it gently before use. Use an oral dosing syringe or dosing cup to measure the right dose. After drinking the medicine, rinse the dosing cup with water and drink the rinse to make sure you get all of the medicine. If your dose is less than 5 ml (one teaspoon) use the syringe.

It is important that you read the patient information package insert before you start taking this medicine. Read it again each time you refill your prescription. There may be new information. Reading the patient information leaflet does not take the place of talking to your doctor. You and your doctor should discuss nevirapine when you start taking your medicine and at regular checkups.

Only take medicine that your doctor has prescribed specially for you. Do not share your medicine with others.

Dosing—The dose of nevirapine will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of nevirapine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (suspension or tablets):
  • For treatment of HIV infection:
    • Adults—200 milligrams (mg) once a day for two weeks, followed by 200 mg two times a day, in combination with other medicines.
    • Children 8 years of age and older—Dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (1.8 mg per pound) of body weight once a day for two weeks, followed by 4 mg per kg (1.8 mg per pound) of body weight two times a day, in combination with other medicines.
    • Infants 2 months old and children up to 8 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (1.8 mg per pound) of body weight once a day for two weeks, followed by 7 mg per kg (3.2 mg per pound) of body weight two times a day, in combination with other medicines.

Missed dose—If you miss a dose of this medicine, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light. The oral suspension form of this medicine does not need to be refrigerated.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from nevirapine or other medicines.

Patients taking nevirapine may develop severe liver disease or severe skin reactions that could cause serious side effects. Your doctor will want to check you and do liver function tests in the first 18 weeks of therapy. The risk of serious reactions is greatest during the first 18 weeks of treament. Checks for liver problems should continue regularly during your therapy. Patients with higher liver function tests and patients with hepatitis B or C have a greater chance of liver damage while taking nevirapine. Women and patients with higher CD4 counts (blood counts) seem to have a greater chance of developing liver damage, often accompanied by a rash, while taking nevirapine.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and check for unwanted effects such as serious skin reactions or rashes. Your health care professional may also want to check certain things such as your blood levels, your liver functions, and your response to this medicine.

This medicine may decrease the effects of some contraceptives (birth control). To avoid unwanted pregnancy, it is a good idea to use additional contraceptive measures while being treated with nevirapine.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

It is possible that the fat on your body may distribute itself differently or you may accumulate more body fat while you are taking this medicine. If you have concerns about this, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, nevirapine is used in certain patients with the following medical condition:

• Mother-to-child transmission of HIV during labor and at birth (prevention)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 02/14/2005

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