An Overview of Viramune (Nevirapine)

ne-VYE-ra-peen

Brand Name: Viramune XR, Viramune
Other Name(s): BI-RG-587, Extended-Release Nevirapine, NVP, Nevirapina

Drug Class: Non-nucleoside Reverse Transcriptase Inhibitors

Nevirapine, also known as Viramune or Viramune XR, is a type of medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). Nevirapine works by disrupting one of the early steps in the HIV life cycle, called reverse transcription. During normal reverse transcription, HIV's reverse transcriptase enzyme (a type of protein) converts HIV's RNA -- a single strand of genetic information -- into DNA -- a double strand of genetic information. It does this by recoding the RNA building blocks into complementary DNA building blocks. As the HIV life cycle proceeds, the newly formed DNA is used to make more copies of HIV virus.

When nevirapine is present, however, it attaches directly to reverse transcriptase, blocking the conversion of RNA into DNA. This process prevents virus replication and halts the HIV life cycle.

Indications and Usage

Nevirapine was approved by the U.S. Food and Drug Administration (FDA) on June 21, 1996 for use in combination with other antiretroviral agents for the treatment of HIV infection. Extended-release nevirapine received FDA approved on March 25, 2011.

Nevirapine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

Dosage Form/Administration

Always take this medication as your doctor instructs. Nevirapine is taken by mouth, with or without food, and it is always used with other anti-HIV medications.

Dosage forms and strengths:

• Tablets (immediate-release): 200 mg
• Extended-release tablets: 400 mg
• Oral suspension (liquid): 50 mg/5 mL

What storage conditions are needed for this medication?

• Store nevirapine between 59°F to 86°F (15°C to 30°C)

Keep this medication in the container it came in, tightly closed, and out of reach of children. Throw away any medication that is outdated or no longer needed.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.

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.
• It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Recommended Daily Dose

FDA Recommended Dosage (Adults)

• Starting Nevirapine (Immediate-Release) Tablets:
  • Starting dose: One 200 mg tablet taken once daily for the first 14 days, in combination with other antiretroviral medications.
  • At day 15, increase your dose to one 200 mg tablet taken twice daily.
  • If you develop a skin rash during the first 14 days of nevirapine treatment, contact your doctor immediately. Do not increase your dose to 2 times a day if you have a rash.
  • You should not take your starting dose for longer than 28 days. If after 28 days you are still receiving a starting dose because of skin rash, you should talk with your doctor about other treatment options.
• Starting Extended-Release Nevirapine Tablets in Patients Not Currently Taking Nevirapine:
  • Starting dose: One 200 mg tablet taken once daily for the first 14 days, in combination with other antiretroviral medications.
  • At day 15, you will take one 400 mg extended-release tablet once daily.
  • If you develop a skin rash during the first 14 days of nevirapine treatment, contact your doctor immediately. Do not start extended-release nevirapine tablets if you have a rash.
  • You should not take your starting dose for longer than 28 days. If after 28 days you are still receiving a starting dose because of skin rash, you should talk with your doctor about other treatment options.
• Switching from Nevirapine (Immediate-Release) Tablets to Extended-Release Nevirapine Tablets
  • Patients taking nevirapine (immediate-release) tablets twice daily can be switched to extended-release nevirapine 400 mg taken once daily (without the 14-day lead-in period starting dose).

FDA Recommended Dosage (Pediatric Patients)

• The oral dose for pediatric patients will be calculated by your doctor.
• It is important to give nevirapine to your child exactly as prescribed by your doctor.

Notes

• If you or your child takes nevirapine oral suspension (liquid), shake it gently before each use. Use an oral dosing syringe or dosing cup to measure the right dose. The oral dosing syringe and dosing cup are not provided with nevirapine suspension. Ask your pharmacist for a syringe or cup if you do not have one.
• After drinking the medicine, fill the dosing cup with water and drink it to make sure you receive all the medicine.
• Dosage adjustments or discontinuation of nevirapine treatment may be necessary depending on certain factors. Your doctor will determine the appropriate dose for you.
• Extended-release nevirapine should not be used in children.

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 dose.
• If you stop taking nevirapine for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to begin taking the nevirapine starting dose again.

Contraindications

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 other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking nevirapine, call your doctor. Tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking nevirapine.
• Tell your doctor about any medical problems you may have had or currently have (liver problems, skin problems [rash], dialysis therapy).

Possible Side Effects

Nevirapine may cause side effects.

The following life-threatening side effects have been reported. Contact your doctor immediately if you experience:

• Severe Liver Problems (Hepatotoxicity and Hepatic Impairment). Cases of severe liver problems leading to liver failure and even death have been reported in people taking nevirapine. Liver problems can occur at any time during treatment, but your risk is highest during the first 18 weeks of treatment. Individuals with a higher CD4+ cell count when they start nevirapine have a higher risk of liver problems, especially women with CD4+ counts higher than 250 cells/mm3 and men with CD4+ counts higher than 400 cells/mm3. In general, women have a higher risk of liver problems compared to men. Also, those who have abnormal liver tests before starting nevirapine and those with hepatitis B or C have a greater chance of experiencing liver problems. Contact your doctor immediately and stop taking nevirapine if you develop any of the following symptoms:
  • dark (tea colored) urine
  • yellowing of your skin or whites of your eyes
  • light-colored bowel movements
  • fever
  • nausea
  • feeling like you have the flu
  • pain or tenderness on your right side below your ribs
  • unusual tiredness
  • loss of appetite
• Severe Rash and Skin Reactions. Skin problems can happen at any time during treatment,you're your risk is highest during the first 6 weeks of starting nevirapine. Although skin rash is the most common side effect of nevirapine, some rashes and skin reactions may be severe or life-threatening, leading to death. Stop using nevirapine and call your doctor right away if you get a rash with any of the following symptoms:
  • blisters
  • mouth sores
  • red or inflamed eyes (like "pink eye")
  • liver problems
  • swelling of the face
  • fever
  • feeling like you have the flu
  • unusual tiredness
  • muscle or joint aches

Some side effects can be serious. The following side effects have occurred:

• Changes in Your Immune System (Immune Reconstitution Syndrome). When starting HIV medicines, your immune system may get stronger, fighting infections that have been in your body for a long time. Tell your doctor if you begin to experience new symptoms after starting your HIV medicine.
• Changes in Body Fat (Fat Redistribution). Fat accumulation/redistribution may occur in some people taking antiretroviral therapy. Changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Also, loss of fat from your legs, arms, and face may occur.

Nevirapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the U.S. FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088.

Drug Interactions

Nevirapine may interact with other medicines. Before taking nevirapine, it is important to tell your doctor about any prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

You should not take nevirapine with the following medicines:

• St. John's wort (Hypericum perforatum)
• efavirenz

Other medicines that may interact with nevirapine and should be used with caution include the following:

• atazanavir
• lopinavir/ritonavir
• fosamprenavir
• itraconazole
• ketoconazole
• rifampin
• rifabutin
• clarithromycin
• fluconazole
• indinavir
• methadone
• warfarin
• nelfinavir
• saquinavir
• birth control pills (Birth control pills taken by mouth and other hormone types of birth control may not work to prevent pregnancy. Talk with your doctor about alternate birth control options that you can use while you are taking nevirapine)

In addition to the lists above, there are other medicines that may interact with nevirapine. For a complete list of all medicines that may interact with nevirapine, talk with your doctor or pharmacist and check the manufacturer's website for the full prescribing information.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet. Nevirapine can be taken with or without food.

Clinical Trials

Click here to search ClinicalTrials.gov for trials that use Nevirapine.

Manufacturer Information

Extended-Release Nevirapine
Boehringer Ingelheim Pharmaceuticals Inc
900 Ridgebury Rd / PO Box 368
Ridgefield, CT 06877-0368
Phone: 800-542-6257

Nevirapine
Boehringer Ingelheim Pharmaceuticals Inc
900 Ridgebury Rd / PO Box 368
Ridgefield, CT 06877-0368
Phone: 800-542-6257

Viramune
Boehringer Ingelheim Pharmaceuticals Inc
900 Ridgebury Rd / PO Box 368
Ridgefield, CT 06877-0368
Phone: 800-542-6257

Viramune XR
Boehringer Ingelheim Pharmaceuticals Inc
900 Ridgebury Rd / PO Box 368
Ridgefield, CT 06877-0368
Phone: 800-542-6257