IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
NEVIRAPINE EXTENDED-RELEASE - ORAL
COMMON BRAND NAME(S): Viramune XR
WARNING: Rarely, nevirapine has caused severe (sometimes fatal) liver problems. Get medical help right away if you develop symptoms of liver problems, such as persistent nausea, loss of appetite, vomiting, stomach/abdominal pain, dark urine, pale stools, yellowing eyes/skin, unusual tiredness, rash. Rarely, nevirapine has also caused serious (sometimes fatal) skin/allergic reactions. Get medical help right away if you have any signs of skin/allergic reactions, including rash, itching/swelling/redness (especially of the eyes/face), blisters, fever, persistent sore throat, unusual tiredness, mouth sores, severe dizziness, trouble breathing, unusual change in the amount of urine, muscle pain/tenderness/weakness, joint pain. Women are at increased risk for developing these severe reactions. To help decrease the risk of skin/allergic reactions in all patients, nevirapine is started at a lower dose for the first 14 days. Also, people with higher T-cell counts at the start of nevirapine treatment are at greater risk for liver problems. Therefore, nevirapine is usually only started if the T-cell count is fewer than 250 in women or fewer than 400 in men. Keep all medical and laboratory appointments so your doctor can monitor how you are responding to nevirapine. The risk of these serious side effects is high in the first 18 weeks and highest during the first 6 weeks of nevirapine treatment. However, these side effects may occur at any time while taking this medication. If you have stopped taking nevirapine because of liver problems or skin/allergic reactions, you must never take any form of nevirapine again. Tell all of your doctors and pharmacists if you have ever stopped taking nevirapine because of these types of reactions.
USES: Nevirapine is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Nevirapine belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Nevirapine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details. Nevirapine should not be used to prevent HIV infection after accidental exposure (such as needle sticks, blood/bodily fluid contact). Different HIV medications are used to prevent infection after exposure.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using nevirapine and each time you get a refill. If you have any questions, talk to your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Do not crush or chew the extended-release tablets. Doing so can release all of the drug at once and increase the risk of side effects. If you have never taken nevirapine before, you must take the immediate-release form of nevirapine for 14 days, before starting to take the extended-release form. If you have already taken the immediate-release form of nevirapine for more than 14 days, you may start taking the extended-release tablets immediately. However, never take two different forms of nevirapine at the same time. The dosage is based on your medical condition and response to treatment. If you stop taking this medication for more than 7 days for reasons other than the serious reactions described in the Warning section, ask your doctor for directions on how to restart treatment. You may need to take the immediate-release form of this medication once daily again for the first 14 days to decrease the risk of serious side effects. It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.
SIDE EFFECTS: See also Warning section. Tiredness, nausea, vomiting, or diarrhea may occur. Drowsiness may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. You may see the empty extended-release tablet shell in your stool. This is harmless. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech). Nevirapine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, get medical help right away if you develop any rash. Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect. A very serious allergic reaction to this drug is rare, but get medical help right away if it occurs. See the Warning section for more details. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking nevirapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C, cirrhosis), kidney dialysis. Rarely, this drug may make some people drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Nevirapine may be part of that treatment. Discuss the risks and benefits with your doctor. Nevirapine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: other NNRTIs (such as efavirenz, etravirine, rilpivirine), rifabutin, warfarin. Other medications can affect the removal of nevirapine from your body, which may affect how nevirapine works. Examples include azole antifungals (such as fluconazole), rifamycins (such as rifampin), St. John's wort, among others. Nevirapine can speed up the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include antiarrhythmics (such as amiodarone), some drugs used to treat seizures (such as carbamazepine, clonazepam), itraconazole, ketoconazole, macrolide antibiotics (such as clarithromycin), methadone, among others. Some other drugs to treat HIV infection (including protease inhibitors such as atazanavir, ritonavir) may also interact with nevirapine. Your doctor will adjust your medications and monitor your treatment to reduce the risk of side effects. Do not use prednisone to prevent a rash because it can actually increase the risk of a rash during the first 6 weeks of nevirapine treatment. Ask your doctor for more details. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as liver tests, viral load, T-cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all medical and laboratory appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.