Nevirapine (patient information)

IMPORTANT WARNING

Nevirapine can cause severe, life-threatening liver damage, skin reactions, and allergic reactions. Tell your doctor if you have or have ever had liver disease, especially hepatitis B or C. Tell your doctor if you have a rash or other skin condition before you start taking nevirapine. If you experience any of the following symptoms, stop taking nevirapine and call your doctor immediately: rash, especially if it is severe or comes along with any of the other symptoms on this list; excessive tiredness; lack of energy or general weakness; upset stomach; vomiting; loss of appetite; dark (tea colored) urine; pale stools; yellowing of the skin or eyes; pain in the upper right part of the stomach; fever;sore throat, chills, or other signs of infection; flu-like symptoms; muscle or joint aches; blisters; mouth sores; red or swollen eyes; hives; itching; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; hoarseness; or difficulty breathing or swallowing.

If your doctor tells you to stop taking nevirapine because you had a serious skin or liver reaction, you should never take nevirapine again.

Your doctor will start you on a low dose of nevirapine and increase your dose after 14 days. This will decrease the risk that you will develop a serious skin reaction. If you develop any type of rash or any of the symptoms listed above while you are taking a low dose of nevirapine, call your doctor right away. Do not increase your dose until your rash or symptoms have gone away.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to nevirapine, especially during the first 18 weeks of your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with nevirapine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: http://www.fda.gov.

Talk to your doctor about the risks of taking nevirapine. There is a greater risk that you will develop serious liver damage during your treatment if you are a woman and if you have a high CD4 count (large number of a certain type of infection fighting cell in your blood).

Why is this medication prescribed

Nevirapine is used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients with or without acquired immunodeficiency syndrome (AIDS). Nevirapine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood. Nevirapine does not cure HIV and may not prevent you from developing HIV-related illnesses. Nevirapine does not prevent the spread of HIV to other people.

How should this medicine be used

Nevirapine comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken with or without food once a day for 2 weeks and twice a day after the first 2 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nevirapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow nevirapine with liquids such as water, milk, or soda.

Shake the liquid gently before each use to mix the medication evenly. Use an oral dosing cup or dosing syringe to measure your dose. It is best to use a syringe, especially if your dose is less than 5 mL (1 teaspoon). If you use a dosing cup, first drink all of the medication that you measured in the dosing cup. Then fill the dosing cup with water and drink the water to be sure that you get your full dose.

Nevirapine may control HIV but will not cure it. Continue to take nevirapine even if you feel well. Do not stop taking nevirapine or any of the other medications that you are taking to treat HIV or AIDS without talking to your doctor.Your doctor will probably tell you to stop taking your medications in a certain order. If you miss doses or stop taking nevirapine, your condition may become more difficult to treat.

If you do not take nevirapine for 7 days or longer, do not start taking it again without talking to your doctor. Your doctor will start you on a low dose of nevirapine, and increase your dose after 2 weeks.

Other uses for this medicine

Nevirapine is also sometimes used to prevent unborn babies whose mothers have HIV or AIDS from becoming infected with HIV during birth.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking nevirapine:

• tell your doctor and pharmacist if you are allergic to nevirapine or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin);certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral) and voriconazole (Vfend); calcium channel blockers such as diltiazem (Cardizem, Dilacor, Tiazac), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin, Verelan); clarithromycin (Biaxin);certain cancer chemotherapy medications such as cyclophosphamide (Cytoxan); cisapride (Propulsid); cyclosporine (Neoral, Sandimmune); ergot alkaloids such as ergotamine (Cafergot, Ercaf, others); fentanyl (Duragesic, Actiq); medications for irregular heartbeat such as amiodarone (Cordarone) and disopyramide (Norpace); medications for seizures such as carbamazepine (Tegretol), clonazepam (Klonopin), and ethosuximide (Zarontin); methadone (Dolophine), other medications for HIV or AIDS such as amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (Sustiva), indinavir (Crixivan); lopinavir and ritonavir combination (Kaletra), nelfinavir (Viracept) and saquinavir (Fortovase, Invirase); prednisone (Deltasone); rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), sirolimus (Rapamune),and tacrolimus (Prograf).Many other medications may interact with nevirapine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• tell your doctor and pharmacist what herbal products you are taking, especially St. John's wort .
• tell your doctor if you have or have ever had kidney disease, especially if you are being treated with dialysis (treatment to clean the blood outside the body when the kidneys are not working well).
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking nevirapine, call your doctor. You should not breastfeed if you are infected with HIV or are taking nevirapine.
• tell your doctor if you are taking oral contraceptives ('birth control pills') to prevent pregnancy. Nevirapine may interfere with the action of oral contraceptives. Talk to your doctor about other methods of birth control that will work for you.
• you should know that your body fat may increase or move to other areas of your body such as your breasts, waist, or upper back.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Nevirapine may cause side effects. Tell your doctor if either of these symptoms is severe or does not go away:

• headache
• diarrhea

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• swelling of the hands, feet, ankles, or lower legs
• painful red bumps on the skin
• excessive tiredness
• fever
• headache
• difficulty falling asleep or staying asleep
• upset stomach
• vomiting
• weight loss
• rash
• dizziness

What other information should I know

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Viramune®