Nevirapine

Nevirapine is a prescription medication used to treat the symptoms of HIV Infection.

• Nevirapine is available under the following different brand names: NVP, Viramune, Viramune XR

Adult and pediatric dosage

Oral suspension

• 10mg/mL

Tablet, immediate-release

• 200mg

Tablet, extended-release

• 100mg
• 400mg

HIV Infection

Adult dosage

• 200 mg orally once a day for 14 days, THEN
• If no rash, increase to 200 mg every 12 hours; if rash occurs wait until it is resolved before increasing
• Prevention of maternal-fetal HIV transmission: 200 mg orally as a single dose at the onset of labor, in combination with Intravenous zidovudine

Extended-release tablets

• Initial therapy: When initiating therapy, give an immediate-release tablet of 200 mg orally once a day for 14 days, then an extended-release tablet of 400 mg orally once a day thereafter
• Switch from immediate-release: If already taking an immediate-release regimen, may switch to extended-release 400 mg orally once a day without a 14-day lead-in period of immediate-release nevirapine

Pediatric dosage

Immediate-release

• Children below 15 days: Safety and efficacy not established
• Children above 15 days to 16 years: 150 mg/m² orally once a day for 2 weeks; if no rash, then increase to 150 mg/m² orally every12hour; not to exceed 200 mg/dose  
• Children above 16 years: As adults; 200 mg orally once a day for 2 weeks; if no rash or untoward effect occurs, then increase to 200 mg orally every 12 hours

Extended-release

• Children below 6 years: Safety and efficacy not established
• Children 6-18 years
• Switch from immediate-release tabs: If already taking immediate-release, may switch to extended-release without a 14-day lead-in period of immediate-release nevirapine
• Initial therapy: Initiate with immediate-release 150 mg/m² orally once a day for 14 days (not to exceed 200 mg/day), THEN  

Extended-release dose based on BSA as follows:

• 0.58-0.83 m²: 200 mg orally once a day
• 0.84-1.16 m²: 300 mg orally once a day
• above1.17 m²: 400 mg orally once a day
• Alternate dosing based on HIV treatment guidelines (March 2016)

Immediate-release and suspension formulations

Children below1 month (investigational dose)

• 34-37 weeks gestational age: 4 mg/kg/dose orally two times a day for 1 week, then increase to 6 mg/kg/dose two times a day thereafter
• Above 37 weeks gestational age: 6 mg/kg/dose orally two times a day

Children above1 month

• Children above 1 month to children below 8 years: 200 mg/m² orally two times a day
• Children above 8 years: 120-150 mg/m² orally two times a day
• Not to exceed 200 mg two times a day

Prevention of Maternal-Fetal HIV Transmission in Neonates

Pediatric dosage

• Birth weight 1.5-2 kg: 8 mg/dose orally
• Birth weight above 2 kg: 12 mg/dose orally
• Administer 3 doses in the first week of life; 1st dose 48 hr after birth, give 2nd dose 48 hours after the 1st dose, and 3rd dose 96 hr after 2nd dose
• Recommended in combination with 6 weeks of zidovudine

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Nevirapine include:

• tiredness,
• nausea,
• vomiting,
• diarrhea,
• stomach pain,
• muscle pain,
• headache,
• changes in the shape or location of body fat (especially in the arms, legs, face, neck, breasts, and waist), or
• rarely, drowsiness

Serious side effects of Nevirapine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• joint or muscle pain,
• fever,
• mouth sores,
• blistering skin rash,
• flu symptoms,
• swollen glands,
• weakness,
• tiredness,
• severe tingling or numbness,
• pain or burning while urinating,
• swelling in the  legs or feet,
• cough,
• chest pain,
• facial swelling,
• nausea,
• loss of appetite,
• upper stomach pain,
• unexplained muscle pain or weakness,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• sore throat,
• burning in the eyes,
• skin pain,
• red or purple skin rash that spreads and causes blistering and peeling,
• any signs of a new infection,
• night sweats,
• diarrhea,
• stomach pain,
• weight loss,
• dry cough,
• wheezing,
• shortness of breath,
• cold sores,
• sores on the genital or anal area,
• rapid heart rate,
• anxiety,
• irritableness,
• prickly feeling,
• problems with balance or eye movement,
• trouble speaking or swallowing,
• severe lower back pain,
• loss of bladder or bowel control,
• swelling in the neck or throat (enlarged thyroid),
• menstrual changes,
• impotence, and
• loss of interest in sex

Rare side effects of Nevirapine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Nevirapine has severe interactions with at least 21 other drugs.
• Nevirapine has serious interactions with at least 92 other drugs.
• Nevirapine has moderate interactions with at least 195 other drugs.
• Nevirapine has minor interactions with at least 55 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity 
• Moderate or severe hepatic impairment (Child-Pugh class B or C)
• Coadministration with drugs (e.g., CYP inducers) where significant decreases in nevirapine plasma concentrations may occur, may result in loss of virologic response and possible resistance and cross-resistance to other NNRTIs
• Use as part of post-exposure prophylaxis (PEP) regimens

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nevirapine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nevirapine?”

Cautions

• Do not restart therapy following severe skin rash, skin rash combined with increased transaminases or other symptoms, or hypersensitivity reaction
• Risk of severe, life-threatening skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity
• Discontinue if severe rash or any rash accompanied by constitutional findings occurs
• Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs
• Redistribution/accumulation of body fat may occur (cushingoid appearance)
• Limited human data are insufficient to determine the risk of infertility in humans; based on results from animal fertility studies conducted in rats, therapy may reduce fertility in females of reproductive potential; not known if these effects on fertility are reversible
• Risk of hepatotoxicity
  • Rhabdomyolysis is reported in some patients experiencing skin and/or liver reactions associated with therapy; hepatitis/hepatic failure may be associated with signs of hypersensitivity which can include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction; patients with signs or symptoms of hepatitis must be advised to discontinue therapy and immediately seek medical evaluation, which should include liver enzyme tests
  • The first 18 weeks of therapy are a critical period during which intensive clinical and laboratory monitoring of patients is required to detect potentially life-threatening hepatic events; some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, include monitoring of liver enzyme tests at baseline, before dose escalation and at two weeks post-dose escalation; after the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout treatment
  • Hepatic injury may progress despite treatment discontinuation
  • Female gender and higher CD4 are higher risk factors

Pregnancy & Lactation

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263
• Available data from the APR show no difference in risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP); the rate of miscarriage is not reported in the APR
• Severe hepatic events, including fatalities, were reported in pregnant women receiving chronic therapy as part of combination treatment of HIV-1 infection; regardless of pregnancy status, women with CD4+ cell counts greater than 250 cells/mm3 should not initiate therapy unless the benefit outweighs the risk; it is unclear if pregnancy augments risk observed in non-pregnant women
• Lactation
  • The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection; published data report that nevirapine is present in human milk; there are limited data on the effects of nevirapine on the breastfed infant; there is no information on effects of nevirapine on milk production; because of potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving therapy; published literature indicates that rash and hyperbilirubinemia have been seen in infants exposed to nevirapine through breastmilk