ne-VEER-a-peen

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: non nucleoside reverse transcriptase inhibitors

• HIV infection (in combination with other antiretroviral agents).

• Binds to the enzyme reverse transcriptase, which results in disruption of DNA synthesis.

• Slowed progression of HIV infection and decreased occurrence of sequelae.

Absorption: >90% absorbed after oral administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme; minor amounts excreted unchanged in urine.

Half-life: 25–30 hr (during multiple dosing).

(plasma concentrations)

Contraindicated in:

• Hypersensitivity
• Concurrent use of ketoconazole, rifampin, or St. John's wort
• Moderate or severe hepatic impairment
• As part of occupational and nonoccupational postexposure prophylaxis regimens
• Women with CD4+ cell counts >250 cells/mm³ (↑ risk of liver toxicity).
• Lactation: Breastfeeding not recommended in women with HIV

Use Cautiously in:

• Women (↑ risk of liver toxicity)
• Mild renal impairment
• Mild hepatic impairment
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Pedi: Children <6 yr or with a body surface area (BSA) <1.17 m² (extended-release nevirapine) and <15 days (immediate-release nevirapine) (safety and effectiveness not established).

Reflects combination therapy

Derm: rash (may progress to toxic epidermal necrolysis), DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME.

GI: ↑liver enzymes, nausea, abdominal pain, diarrhea, hepatitis, HEPATOTOXICITY, ulcerative stomatitis.

GU: ↓fertility (females).

Hemat: granulocytopenia (↑ in children).

MS: myalgia.

Neuro: headache, paresthesia, peripheral neuropathy.

Misc: fever, immune reconstitution syndrome.

Drug-Drug:

• Significantly ↓ ketoconazole levels; concurrent use contraindicated.
• Rifampin significantly ↓ levels and effectiveness; concurrent use contraindicated.
• May induce methadone withdrawal within 2 wk of starting therapy in patients physically dependent on methadone.
• May ↓ levels and effectiveness of hormonal contraceptives ; avoid concurrent use of hormonal contraceptives.
• May ↓ levels and effectiveness of clarithromycin, lopinavir, fosamprenavir, nelfinavir, efavirenz, amiodarone, disopyramide, lidocaine, itraconazole, carbamazepine, clonazepam, ethosuximide, diltiazem, nifedipine, verapamil, cyclosporine, tacrolimus, sirolimus, cyclophosphamide, ergotamine, fentanyl , and rifabutin.
• Fluconazole↑ levels and risk of toxicity.
• May ↑ levels of and risk of bleeding with warfarin.
• Use of prednisone during first 2 wk of therapy may ↑ risk of rash.
• Simultaneously initiating other drugs that often cause rash, including trimethoprim/sulfamethoxazole and abacavir may ↑ risk of rash.
• Concurrent use with atazanavir may ↓ atazanavir levels and ↑ nevirapine levels; concurrent use not recommended.
• May ↑ levels and risk of toxicity of darunavir/ritonavir and maraviroc.

Drug-Natural Products:

• St. John’s wort may ↓ levels and effectiveness; concurrent use contraindicated.

• PO (Adults): Immediate-release (IR): 200 mg daily for the first 2 wk, then 200 mg twice daily (in combination with a nucleoside analogue antiretroviral); Extended-release (ER) (for patients not currently taking IR nevirapine): 200 mg of IR nevirapine for the first 2 wk (to ↓ risk of rash), then 400 mg of ER nevirapine once daily; ER (for patients currently taking IR nevirapine): switch to 400 mg of extended-release nevirapine once daily.
• PO (Children 15 days): IR: 150 mg/m² once daily for first 2 wk, then 150 mg/m² twice daily.
• PO (Children 6–<18 yr and BSA 1.17 m²): ER: 150 mg/m² of IR nevirapine once daily (max = 200 mg/day) for the first 2 wk (to ↓ risk of rash), then 400 mg of ER nevirapine once daily.

(Generic available)

• Extended-release tablets: 100 mg; 400 mg;
• Immediate-release tablets: 200 mg;
• Oral suspension: 50 mg/5 mL;

• Assess for change in severity of HIV symptoms and for symptoms of opportunistic infections throughout therapy.
• Assess for rash (mild to moderate rash — erythema or maculopapular rash; urticaria, pruritic raised rash with welts; constitutional symptoms — fever, blistering, oral erosive lesions, conjunctivitis, facial edema, myalgia, arthralgia), especially during first 6 wk of therapy. If rash is severe (extensive erythematous or maculopapular rash with moist desquamation or angioedema) or accompanied by systemic symptoms (serum sickness-like reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis), therapy must be discontinued immediately. Prednisone and antihistamines are not effective in preventing or treating the rash. If mild to moderate rash occurs during 2-wk lead-in period, do not increase dose until rash resolves. If not resolved within 28 days, reconsider therapy.

• Monitor viral load and CD4 cell count regularly during therapy.
  • Monitor for liver function at baseline and frequently during the first 18 wk for toxicity, especially during first 6 wk of therapy. May be asymptomatic with ↑ AST and ALT without clinical signs or symptoms, or symptomatic with ↑ liver enzymes and at least one symptom (rash, flu-like symptoms, fever). May progress to liver failure and death. If signs of liver toxicity occur, permanently discontinue nevirapine.
  • Assess patient for hepatitis B and C. Patients with hepatitis B virus and/or hepatitis C virus are at risk for liver toxicity.

• Do not confuse Viramune with Viracept.
• PO: May be administered with or without food. DNC: Swallow extended-release tablets whole; do not crush, break, or chew.
  • Shake oral solution prior to administration. Use an oral dosing syringe for amounts <5 mL. Rinse syringe or cup and readminister to ensure patient receives full dose.
  • If therapy is interrupted for more than 7 days, restart therapy at 200 mg daily for 14 days, then increase dose to 200 mg twice daily.

• Emphasize the importance of taking nevirapine as directed, at evenly spaced times throughout day. Instruct patient to read the Medication Guide prior to initiating therapy and with each Rx refill. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses as soon as remembered; do not double doses.
• Instruct patient not to share nevirapine with others.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Inform patient that nevirapine does not cure HIV or prevent associated or opportunistic infections. Nevirapine may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and avoid sharing needles or donating blood to prevent spreading HIV to others.
• Instruct patient to notify health care professional immediately if signs and symptoms of hepatitis (flu-like symptoms, tiredness, nausea, lack of appetite, yellow skin or eyes, dark urine, pale stools, pain or sensitivity to touch on right side below ribs), skin reactions with symptoms (flu-like symptoms, fever, muscle aches, conjunctivitis, blisters, mouth sores, swelling of face, tiredness), or signs of immune reconstitution syndrome (signs and symptoms of an infection) occur. Nevirapine should be discontinued immediately.
• Rep: Advise patient taking oral contraceptives to use a nonhormonal method of birth control during nelfinavir therapy. If pregnancy is suspected, notify health care professional promptly. Encourage pregnant women to enroll in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263. Advise female patient to avoid breastfeeding during therapy. Nevirapine may decrease fertility in females.
• Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

• Delayed progression of HIV and decreased opportunistic infections in patients with HIV.
• Decrease in viral load and increase in CD4 cell counts.

Viramune

NDC Code^*

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-4050- Nevirapine
    • 0378-4050-91- 60 TABLET in 1 BOTTLE, PLASTIC (0378-4050-91)

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-4890- Nevirapine
    • 0378-4890-93- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93)

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0046- Viramune
    • 0597-0046-60- 60 TABLET in 1 BOTTLE (0597-0046-60)

• 0597- Boehringer Ingelheim Pharmaceuticals Inc.
  • 0597-0047- Viramune
    • 0597-0047-24- 1 BOTTLE, PLASTIC in 1 CARTON (0597-0047-24) > 240 mL in 1 BOTTLE, PLASTIC

• 0597- Boehringer Ingelheim Pharmaceuticals, Inc.
  • 0597-0123- Viramune
    • 0597-0123-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0123-30)

• 0781- Sandoz Inc
  • 0781-5893- Nevirapine
    • 0781-5893-05- 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5893-05)

• 0781- Sandoz Inc
  • 0781-5893- Nevirapine
    • 0781-5893-31- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5893-31)

• 31722- Camber Pharmaceuticals, Inc.
  • 31722-505- Nevirapine
    • 31722-505-01- 100 TABLET in 1 BOTTLE (31722-505-01)

• 31722- Camber Pharmaceuticals, Inc.
  • 31722-505- Nevirapine
    • 31722-505-05- 500 TABLET in 1 BOTTLE (31722-505-05)

• 31722- Camber Pharmaceuticals, Inc.
  • 31722-505- Nevirapine
    • 31722-505-10- 1000 TABLET in 1 BOTTLE (31722-505-10)

• 31722- Camber Pharmaceuticals, Inc.
  • 31722-505- Nevirapine
    • 31722-505-60- 60 TABLET in 1 BOTTLE (31722-505-60)

• 33342- Macleods Pharmaceuticals Limited
  • 33342-004- Nevirapine
    • 33342-004-09- 60 TABLET in 1 BOTTLE (33342-004-09)

• 33342- Macleods Pharmaceuticals Limited
  • 33342-004- Nevirapine
    • 33342-004-24- 6 BLISTER PACK in 1 CARTON (33342-004-24) > 10 TABLET in 1 BLISTER PACK

• 33342- Macleods Pharmaceuticals Limited
  • 33342-004- Nevirapine
    • 33342-004-25- 12 BLISTER PACK in 1 CARTON (33342-004-25) > 10 TABLET in 1 BLISTER PACK

• 33342- Macleods Pharmaceuticals Limited
  • 33342-238- NEVIRAPINE
    • 33342-238-07- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-238-07)

• 33342- Macleods Pharmaceuticals Limited
  • 33342-238- NEVIRAPINE
    • 33342-238-12- 10 BLISTER PACK in 1 CARTON (33342-238-12) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

• 42571- Micro Labs Limited
  • 42571-131- NEVIRAPINE
    • 42571-131-29- 6 BLISTER PACK in 1 CARTON (42571-131-29) > 10 TABLET in 1 BLISTER PACK

• 42571- Micro Labs Limited
  • 42571-131- NEVIRAPINE
    • 42571-131-60- 60 TABLET in 1 BOTTLE (42571-131-60)

• 47781- Alvogen Inc.
  • 47781-317- Nevirapine Extended Release
    • 47781-317-30- 30 TABLET in 1 BOTTLE (47781-317-30)

• 51991- Breckenridge Pharmaceutical, Inc.
  • 51991-331- Nevirapine
    • 51991-331-06- 60 TABLET in 1 BOTTLE (51991-331-06)

• 53104- Cipla Ltd.
  • 53104-0166- nevirapine
    • 53104-0166-2- 60 TABLET in 1 BOTTLE (53104-0166-2)

• 53104- Cipla Ltd.
  • 53104-0166- nevirapine
    • 53104-0166-6- 1000 TABLET in 1 BOTTLE (53104-0166-6)

• 53808- State of Florida DOH Central Pharmacy
  • 53808-0680- Nevirapine
    • 53808-0680-1- 30 TABLET in 1 BLISTER PACK (53808-0680-1)

• 64380- Strides Pharma Science Limited
  • 64380-709- Nevirapine
    • 64380-709-03- 60 TABLET in 1 BOTTLE, PLASTIC (64380-709-03)

• 65162- Amneal Pharmaceuticals of New York, LLC
  • 65162-209- Nevirapine
    • 65162-209-06- 60 TABLET in 1 BOTTLE (65162-209-06)

• 65862- Aurobindo Pharma Limited
  • 65862-027- Nevirapine
    • 65862-027-10- 6 BLISTER PACK in 1 CARTON (65862-027-10) > 10 TABLET in 1 BLISTER PACK

• 65862- Aurobindo Pharma Limited
  • 65862-027- Nevirapine
    • 65862-027-60- 60 TABLET in 1 BOTTLE (65862-027-60)

• 65862- Aurobindo Pharma Limited
  • 65862-057- Nevirapine
    • 65862-057-11- 100 mL in 1 BOTTLE (65862-057-11)

• 65862- Aurobindo Pharma Limited
  • 65862-057- Nevirapine
    • 65862-057-24- 240 mL in 1 BOTTLE (65862-057-24)

• 65862- Aurobindo Pharma Limited
  • 65862-932- NEVIRAPINE
    • 65862-932-05- 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-932-05)

• 65862- Aurobindo Pharma Limited
  • 65862-932- NEVIRAPINE
    • 65862-932-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-932-90)

• 65862- Aurobindo Pharma Limited
  • 65862-932- NEVIRAPINE
    • 65862-932-99- 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-932-99)

• 65862- Aurobindo Pharma Limited
  • 65862-933- NEVIRAPINE
    • 65862-933-05- 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-933-05)

• 65862- Aurobindo Pharma Limited
  • 65862-933- NEVIRAPINE
    • 65862-933-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-933-30)

• 65862- Aurobindo Pharma Limited
  • 65862-933- NEVIRAPINE
    • 65862-933-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-933-90)

• 65862- Aurobindo Pharma Limited
  • 65862-933- NEVIRAPINE
    • 65862-933-99- 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65862-933-99)

• 69097- Cipla USA Inc.
  • 69097-233- nevirapine
    • 69097-233-44- 100 mL in 1 BOTTLE (69097-233-44)

• 69097- Cipla USA Inc.
  • 69097-233- nevirapine
    • 69097-233-46- 240 mL in 1 BOTTLE (69097-233-46)

• 69097- Cipla USA Inc.
  • 69097-403- NEVIRAPINE
    • 69097-403-02- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-403-02)

• 69097- Cipla USA Inc.
  • 69097-403- NEVIRAPINE
    • 69097-403-11- 480 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-403-11)