Drugs A - Z

Nevirapine Oral tablet, extended release

It is used with other medicines to treat HIV

Generic Name: nevirapine

Brand Names: Viramune, Viramune XR

There is an FDA Alert for this drug. Click here to view it.

  • Severe, life-threatening (and in some cases fatal) hepatotoxicity reported, particularly during first 18 weeks of therapy. Patients have presented with nonspecific prodromal signs and symptoms of hepatitis and progressed to hepatic failure; these events often associated with rash. Patients with higher CD4+ T-cell counts and women are at increased risk of these hepatic events. Women with CD4+ T-cell counts >250 cells/mm3 (including pregnant women receiving long-term treatment for HIV infection) are at greatest risk, but hepatotoxicity can occur in both genders, all CD4+ T-cell counts, and at any time during treatment Patients with signs or symptoms of hepatitis or with increased serum transaminase concentrations in conjunction with rash or other systemic symptoms must discontinue nelfinavir and seek immediate medical evaluation.
  • Severe, life-threatening skin reaction, including fatal cases, reported. Reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients with signs or symptoms of severe skin reactions or hypersensitivity must discontinue nelfinavir and seek immediate medical evaluation. Immediately measure serum transaminase concentrations if rash occurs during the first 18 weeks of nevirapine therapy.
  • Essential that patients are monitored intensively during the first 18 weeks of nevirapine therapy to detect potential life-threatening hepatotoxicity or skin reactions. Extra vigilance needed during first 6 weeks since this is period of greatest risk.
  • Hepatic injury has progressed despite discontinuation of nevirapine in some patients.
  • Do not restart nevirapine following severe hepatic, skin, or hypersensitivity reactions.
  • Strictly follow the recommendations regarding use of a low initial nevirapine dosage (Adults: 200 mg once daily for the first 14 days). Initiating therapy with this dosage reduces frequency of rash.

REMS:

FDA approved a REMS for nevirapine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

NEVIRAPINE (ne VYE ra peen) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • kidney disease
  • liver disease
  • skin condition or rash
  • an unusual or allergic reaction to nevirapine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years old for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • itraconazole
  • ketoconazole
  • rifampin
  • rifapentine
  • St. John's Wort

This medicine may also interact with the following medications:

  • female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
  • cisapride
  • clarithromycin
  • cyclophosphamide
  • cyclosporine
  • ergotamine
  • fentanyl
  • fluconazole
  • medicines for blood pressure like diltiazem, nifedipine, verapamil
  • medicines for irregular heart beat like amiodarone, disopyramide, lidocaine
  • medicines for seizures like carbamazepine, clonazepam, ethosuximide
  • methadone
  • other medicines for HIV
  • rifabutin
  • sirolimus
  • tacrolimus
  • warfarin

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

Severe liver reactions or skin rashes are seen in some patients taking this medicine. The risk of these reactions is greatest during the first 18 weeks of treatment, but can happen anytime. Be sure to carefully monitor for the mentioned side effects and contact your doctor when necessary.


Last Updated: December 06, 2012
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