Nevirapine

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Warning

Rarely, nevirapine has caused severe (sometimes fatal) liver problems. Get medical help right away if you develop symptoms of liver problems such as nausea that doesn't go away, 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 sore throat that doesn't go away, rash, itching/swelling/redness (especially of the eyes/face), blisters, fever, unusual tiredness, mouth sores, severe dizziness, trouble breathing, signs of kidney problems (such as 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. 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 lab 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.

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, lactose or galactose intolerance.

This drug may rarely make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and nevirapine may be part of that treatment. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Tiredness, nausea, vomiting, or diarrhea may occur. Drowsiness may rarely occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, 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 unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).

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. 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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