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Nevirapine: Drug information

Nevirapine: Drug information
(For additional information see "Nevirapine: Patient drug information" and see "Nevirapine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Hepatotoxicity:

Severe, life-threatening, and, in some cases, fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. In some cases, patients presented with nonspecific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Female gender and higher CD4+ cell counts at initiation of therapy place patients at increased risk; women with CD4+ cell counts greater than 250 cells/mm3, including pregnant women receiving nevirapine in combination with other antiretrovirals for treatment of HIV-1 infection, are at the greatest risk. However, hepatotoxicity associated with nevirapine use can occur in both genders, at all CD4+ cell counts, and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking nevirapine for postexposure prophylaxis. Use of nevirapine for occupational and nonoccupational postexposure prophylaxis is contraindicated. Patients with signs or symptoms of hepatitis, or with increased transaminases combined with rash or other systemic symptoms, must discontinue nevirapine and seek medical evaluation immediately.

Skin reactions:

Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with nevirapine. These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately. Check transaminase levels immediately for all patients who develop a rash in the first 18 weeks of treatment. The 14-day lead-in period with nevirapine 200 mg immediate release daily dosing has been observed to decrease the incidence of rash and must be followed.

Monitoring for hepatotoxicity and skin reactions

Patients must be monitored intensively during the first 18 weeks of therapy with nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these reactions. Do not restart nevirapine following clinical hepatitis, transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment.

Brand Names: US
  • Viramune XR [DSC];
  • Viramune [DSC]
Brand Names: Canada
  • APO-Nevirapine XR [DSC];
  • Auro-Nevirapine;
  • JAMP Nevirapine;
  • MYLAN-Nevirapine
Pharmacologic Category
  • Antiretroviral, Reverse Transcriptase Inhibitor, Non-nucleoside (Anti-HIV)
Dosing: Adult
HIV-1 infection, treatment

HIV-1 infection, treatment:

Note: Nevirapine should not be initiated in antiretroviral-naive patients with elevated CD4+-cell counts unless the benefit of therapy outweighs the risk of serious hepatotoxicity (adult/postpubertal females: CD4+-cell counts >250 cells/mm3; adult males: CD4+-cell counts >400 cells/mm3). Nevirapine is not recommended as a component of initial therapy for the treatment of adults with HIV (HHS [adult] 2022).

Oral: Initial: 200 mg immediate-release nevirapine once daily for 14 days, followed by 200 mg immediate-release nevirapine twice daily or 400 mg extended-release nevirapine once daily. Use as part of an appropriate combination regimen. Note: If patient experiences a nonsevere rash (without constitutional symptoms) during the 14-day lead-in period with 200 mg/day, do not increase to maintenance dosage until the rash has resolved. If rash continues beyond 28 days on the 200 mg/day dose, use an alternative regimen. The lead-in period must always be done with IR formulation. If therapy with any formulation is interrupted for >7 days, restart with initial dose of IR formulation for 14 days.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Altered kidney function: No dosage adjustment necessary for any degree of renal impairment (HHS [adult] 2022).

Hemodialysis: An additional 200 mg immediate release dose is recommended following dialysis.

Dosing: Hepatic Impairment: Adult

Permanently discontinue if symptomatic hepatic events occur.

Mild impairment (Child-Pugh class A): No dosage adjustment necessary (HHS [adult] 2022).

Moderate to severe impairment (Child-Pugh class B or C): Use is contraindicated.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Nevirapine: Pediatric drug information")

HIV-1 infection, treatment

HIV-1 infection, treatment: Note: Use in combination with other antiretroviral (ARV) agents; evaluate gene mutation and ARV resistance patterns (refer to https://www.iasusa.org and https://hivdb.stanford.edu for more information).

Although lead-in dosing recommended in pediatric patients ≥2 years of age when initiating therapy to allow for enzymatic autoinduction and reduce the occurrence of rash, it may not be necessary in infants and children <2 years of age (HHS [pediatric] 2023). If patient experiences a nonsevere rash (in the absence of transaminase elevations) during the first 14 days of therapy, do not increase dose until rash has resolved. If rash continues beyond 28 days, use an alternative regimen. Discontinue nevirapine if severe rash, rash with constitutional symptoms, or rash with elevated hepatic transaminases occurs. If nevirapine therapy is interrupted for ≤14 days (infants/children) or ≤7 days (adolescents), restart at the full dose due to mechanisms of nevirapine resistance, half-life of CYP enzymes, and clinical trial results (HHS [adult] 2023; HHS [pediatric] 2023).

Immediate release (HHS [pediatric] 2023):

Infants and Children <2 years:

With lead-in dosing: Oral: Initial: 200 mg/m2/dose once daily (maximum dose: 200 mg/dose) for the first 14 days of therapy, then increase to 200 mg/m2/dose twice daily (maximum dose: 200 mg/dose) if no rash or other adverse effects occur.

Without lead-in dosing: Oral: 200 mg/m2/dose twice daily (maximum dose: 200 mg/dose); monitor patients for tolerability (eg, rash).

Children 2 to <8 years: Oral: Initial (lead-in dosing): 200 mg/m2/dose once daily (maximum dose: 200 mg/dose) for the first 14 days of therapy, then increase to 200 mg/m2/dose twice daily (maximum dose: 200 mg/dose) if no rash or other adverse effects occur.

Children ≥8 years: Oral: Initial (lead-in dosing): 120 to 150 mg/m2/dose once daily (maximum dose: 200 mg/dose) for the first 14 days of therapy, then increase to 120 to 150 mg/m2/dose twice daily (maximum dose: 200 mg/dose) if no rash or other adverse effects occur. Note: In a growing child, do not decrease the mg dose when the child reaches 8 years; leave the mg dose the same to achieve the appropriate mg/m2/dose as the child grows larger (as long as there are no adverse effects).

Adolescents: Oral: Initial: 200 mg once daily for the first 14 days, then increase to 200 mg every 12 hours if no rash or other adverse effects occur; if patient able to swallow tablets whole, may convert maintenance dose to the extended-release formulation (400 mg once daily).

Extended release (HHS [pediatric] 2023): Note: For patients established on full-dose nevirapine, may initiate extended-release preparation without lead-in dosing. If initiating nevirapine therapy, begin with the age-appropriate once-daily dose of the immediate-release formulation for the first 14 days of therapy; at 14 days, if no rash or other adverse effects have occurred, increase dose to the age-appropriate dose administered once daily of the extended-release formulation. Extended-release tablets should not be divided to achieve daily dose.

Children ≥6 years: Must be able to swallow tablets whole: BSA-directed dosing (HHS [pediatric] 2023):

BSA 0.58 to 0.83 m2: Oral: 200 mg once daily.

BSA 0.84 to 1.16 m2: Oral: 300 mg once daily.

BSA ≥1.17 m2: Oral: 400 mg once daily.

Adolescents: Oral: 400 mg once daily.

HIV-1 transmission during breastfeeding; prophylaxis

HIV-1 transmission during breastfeeding; prophylaxis: Limited data available; Optimal antiretroviral choice and duration are unclear, and expert recommendations vary:

Note: Shared decision making should be utilized regarding infant feeding options, with considerations of risks, benefits, and personal preferences; breastfeeding is recommended only for individuals who are receiving antiretroviral therapy and have sustained viral suppression; neonates at high risk of transmission should receive a presumptive treatment regimen and negative infant nucleic acid test (NAT) should be verified prior to prophylaxis. Dosing provided is a simplified, fixed-dose regimen (not weight-based). See guidelines for details (HHS [perinatal] 2023).

Infants (HHS [perinatal] 2023): Immediate release:

6 weeks to <6 months: Oral: 20 mg daily.

6 months to <9 months: Oral: 30 mg daily.

≥9 months: Oral: 40 mg daily. Note: Continue through 1 to 4 weeks after weaning.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents:

CrCl ≥20 mL/minute: No dosage adjustment required.

CrCl <20 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Hemodialysis: An additional dose of nevirapine should be given following dialysis (HHS [pediatric] 2023). Note: Nevirapine metabolites may accumulate in patients on dialysis (clinical significance is unknown).

Dosing: Hepatic Impairment: Pediatric

Infants, Children, and Adolescents:

Mild impairment: There are no dosage adjustments provided in manufacturer's labeling; use with caution; monitor for symptoms of drug-induced toxicity (increased trough concentrations have been observed in some patients with hepatic fibrosis or cirrhosis).

Moderate to severe impairment: Use is contraindicated; permanently discontinue if symptomatic hepatic events occur or if any severe transaminase elevations are observed (HHS [pediatric] 2023; manufacturer's labeling).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Endocrine & metabolic: Increased serum cholesterol (3% to 19%), increased LDL cholesterol (5% to 15%)

Hematologic & oncologic: Decreased serum phosphate (≤38%), neutropenia (1% to 13%)

Hepatic: Increased serum alanine aminotransferase (2% to 14%)

1% to 10%:

Central nervous system: Fatigue (2% to 5%), headache (1% to 4%)

Dermatologic: Skin rash (4% to 7%; children: 1%)

Endocrine & metabolic: Increased amylase (≤5%)

Gastrointestinal: Nausea (1% to 9%), abdominal pain (2% to 3%), diarrhea (2% to 4%)

Hematologic & oncologic: Granulocytopenia (≤2%)

Hepatic: Increased serum aspartate aminotransferase (2% to 9%), increased serum transaminases (asymptomatic; >5x ULN: 6%), hepatic disease (4%), hepatitis (2% to 4%; may be hypersensitivity related)

Neuromuscular & skeletal: Arthralgia (2%)

Miscellaneous: Fever (1% to 2%)

Frequency not defined:

Dermatologic: Erythematous maculopapular rash, pruritus

<1%, postmarketing, and/or case reports: Abnormal transaminase, anaphylaxis, anemia, angioedema, aphthous stomatitis, autoimmune disease, bullous rash, cholestatic hepatitis, conjunctivitis, DRESS syndrome, drowsiness, drug withdrawal, eosinophilia, facial edema, flu-like symptoms, fulminant hepatitis, Graves disease, Guillain-Barre syndrome, hepatic encephalopathy, hepatic failure, hepatic necrosis, hepatomegaly, hepatotoxicity, hyperbilirubinemia, hypersensitivity reaction, immune reconstitution syndrome, jaundice, lipotrophy, liver tenderness, lymphadenopathy, malaise, myalgia, oral lesion, paresthesia, polymyositis, prolonged partial thromboplastin time, redistribution of body fat, renal insufficiency, rhabdomyolysis, skin blister, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, vomiting

Contraindications

Moderate to severe hepatic impairment (Child-Pugh class B or C); use in occupational or nonoccupational postexposure prophylaxis (PEP) regimens

Canadian labeling: Additional contraindications (not in US labeling): Clinically significant hypersensitivity to nevirapine or any component of the formulation; therapy rechallenge in patients with prior hypersensitivity reactions, severe rash, rash accompanied by constitutional symptoms, or clinical hepatitis due to nevirapine; severe hepatic dysfunction or AST or ALT >5 times ULN (pretreatment or during prior use of nevirapine); hereditary conditions of galactose intolerance (eg, galactosemia, congenital lactase deficiency, glucose-galactose malabsorption); concomitant use of herbal products containing St John's wort

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Fat redistribution: May cause redistribution/accumulation of fat (eg, central obesity, buffalo hump, peripheral wasting, facial wasting, breast enlargement, cushingoid appearance).

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome, resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation and treatment may be required.

• Rhabdomyolysis: Has been observed in conjunction with skin and/or hepatic adverse events. Discontinuation of therapy is warranted with evidence of severe skin or liver toxicity.

Disease-related concerns:

• Hepatic impairment: Patients with a history of chronic hepatitis (B or C) or increased baseline transaminase levels may be at increased risk of later symptomatic hepatotoxic events (≥6 weeks after treatment initiation) and asymptomatic increases in AST or ALT. Use with caution in patients with preexisting dysfunction; monitor closely for drug-induced hepatotoxicity. Use is contraindicated in patients with moderate to severe impairment (Child-Pugh class B or C).

Concurrent drug therapy issues:

• Prednisone: Coadministration of prednisone during the first 6 weeks of therapy increases incidence and severity of rash; concomitant prednisone is not recommended to prevent rash.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Appropriate use: When initiating therapy, a 14-day lead-in dose with the immediate release formulation should be used to decrease risk of skin reactions. If rash appears during the 14-day lead-in period, do not increase the dose or initiate the extended release formulation until the rash has resolved. An alternative regimen should be used if the lead-in dose period exceeds 28 days. Therapy in antiretroviral naive patients should not be initiated in patients with elevated CD4+-cell counts unless the benefit of therapy outweighs the risk of serious hepatotoxicity (adult/postpubertal females: CD4+-cell counts >250 cells/mm3; adult males: CD4+-cell counts >400 cells/mm3). If CD4+-cell counts increase above these thresholds as a result of nevirapine-containing therapy, therapy may be continued. After the lead-in period, patients may be switched to the extended-release formulation.

• Resistance: Due to rapid emergence of resistance, nevirapine should not be used as monotherapy or the only agent added to a failing regimen for the treatment of HIV. When discontinuing an antiretroviral regimen containing nevirapine, take into account the long half-life of nevirapine. If other agents with shorter half-lives are stopped concurrently, low nevirapine plasma concentrations may persist for a week or longer and virus resistance may subsequently develop.

Warnings: Additional Pediatric Considerations

The incidence of rash in pediatric patients is 21% (manufacturer's labeling); in children, a 3-fold increased risk of rash and hepatotoxicity has been observed when nevirapine is initiated with a CD4 >15% (HHS [pediatric] 2023). Granulocytopenia may occur; it is more common in neonates and young infants (2 weeks to <3 months of age) compared to older children and adults and also more common in pediatric patients receiving concomitant zidovudine. Anemia occurred in 7% of pediatric clinical trial patients; it has been reported more commonly in children in postmarketing reports, but effects of concomitant medications cannot be separated out.

Adverse cardiac effects have been associated with nevirapine therapy in both pediatric and adult patients (HHS [pediatric] 2023). A prospective study of 325 pediatric patients aged 7 to 16 years with perinatally acquired HIV evaluated associations between previous or current antiretroviral agents and cardiac echocardiogram measures. When comparing patients currently receiving nevirapine (n=18) with those who were not, nevirapine therapy was associated with higher left ventricular end-diastolic dimension (Williams 2018). Similarly, a cross-sectional study of pediatric subjects 6 to 16 years of age (n=201) receiving antiretroviral therapy for ≥6 months (median duration: 4.7 years) demonstrated an association between current use of nevirapine (n=103) and left ventricular hypertrophy (adjusted odds ratio: 3.14, P=0.03) (Majonga 2018). However, in an 18-month prospective follow-up of 197 of the previously described patients, no specific antiretroviral agent was associated with echocardiographic abnormalities (nevirapine receipt, n=61) (Majonga 2020). Implications for cardiac outcomes later in life (eg, cardiomyopathy) are unknown (Williams 2018).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Oral:

Viramune: 50 mg/5 mL (240 mL [DSC]) [contains methylparaben, polysorbate 80, propylparaben, sorbitol]

Generic: 50 mg/5 mL (240 mL)

Tablet, Oral:

Viramune: 200 mg [DSC] [scored]

Generic: 200 mg

Tablet Extended Release 24 Hour, Oral:

Viramune XR: 400 mg [DSC]

Generic: 100 mg [DSC], 400 mg

Generic Equivalent Available: US

Yes

Pricing: US

Suspension (Nevirapine Oral)

50 mg/5 mL (per mL): $0.79

Tablet, 24-hour (Nevirapine ER Oral)

100 mg (per each): $7.98

400 mg (per each): $19.83 - $23.55

Tablets (Nevirapine Oral)

200 mg (per each): $10.80 - $10.85

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Generic: 200 mg

Tablet Extended Release 24 Hour, Oral:

Generic: 400 mg [DSC]

Administration: Adult

Oral: May be administered with or without food. Shake suspension gently prior to administration; the use of an oral dosing syringe is recommended, especially if the dose is ≤5 mL; if using a dosing cup, after administration, rinse cup with water and also administer rinse. ER tablets must be swallowed whole and not crushed, chewed, or divided.

Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. IR tablet and oral suspension formulations are available. If safety and efficacy of nevirapine can be effectively monitored, no change in formulation or administration is required after bariatric surgery; however, therapeutic drug monitoring and/or viral load monitoring is recommended in the short-term postoperative period (ie, 10 to 14 days) and at regular follow-up intervals after bariatric surgery to validate drug absorption that may change with small bowel adaption or transit over time.

Administration: Pediatric

Oral: May be administered without regard to food.

Immediate release: Oral suspension: Shake suspension gently prior to administration; the use of an oral dosing syringe is recommended, especially if the dose is <5 mL; if using a dosing cup, after administration rinse cup with water and also administer rinse.

Extended release: Swallow tablet whole; do not chew, crush, or divide.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH recommends single gloving for administration of intact tablets or capsules. NIOSH recommends double gloving, a protective gown, and (if there is a potential for vomit or spit up) eye/face protection for administration of an oral liquid/feeding tube administration (NIOSH 2016).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201152s014lbl.pdf#page=18, must be dispensed with this medication.

Use: Labeled Indications

HIV-1 infection, treatment: Treatment of HIV-1, in combination therapy with other antiretroviral agents, in adults and pediatric patients ≥15 days of age (immediate release) and ≥6 years of age with a BSA of ≥1.17 m2 (ER). Note: Nevirapine is not recommended as a component of initial therapy for the treatment of HIV in adults and adolescents (HHS [adult] 2022).

Limitations of use: Not recommended to be initiated, unless the benefit outweighs the risk, in adult females with CD4+ cell counts >250 cells/mm3 or adult males with CD4+ cell counts >400 cells/mm3.

Use: Off-Label: Adult

Prevention of perinatal HIV transmission

Medication Safety Issues
Sound-alike/look-alike issues:

Nevirapine may be confused with nelfinavir

Viramune, Viramune XR may be confused with Viracept, Viramune (herbal product)

Metabolism/Transport Effects

Substrate of CYP2B6 (minor), CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits MRP2; Induces CYP2B6 (moderate), CYP3A4 (weak)

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Amodiaquine: Nevirapine may decrease the serum concentration of Amodiaquine. Risk C: Monitor therapy

Artemether and Lumefantrine: Nevirapine may decrease serum concentrations of the active metabolite(s) of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. Nevirapine may decrease the serum concentration of Artemether and Lumefantrine. Nevirapine may increase the serum concentration of Artemether and Lumefantrine. Specifically, lumefantrine concentrations may increase. Risk C: Monitor therapy

Artesunate: Nevirapine may decrease serum concentrations of the active metabolite(s) of Artesunate. Nevirapine may increase the serum concentration of Artesunate. Risk C: Monitor therapy

Atazanavir: May increase the serum concentration of Nevirapine. Nevirapine may decrease the serum concentration of Atazanavir. Risk X: Avoid combination

Atogepant: CYP3A4 Inducers (Weak) may decrease the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider therapy modification

Betibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Betibeglogene Autotemcel. Risk X: Avoid combination

BuPROPion: CYP2B6 Inducers (Moderate) may decrease the serum concentration of BuPROPion. Risk C: Monitor therapy

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Risk C: Monitor therapy

CarBAMazepine: May decrease the serum concentration of Nevirapine. Risk X: Avoid combination

Caspofungin: Inducers of Drug Clearance may decrease the serum concentration of Caspofungin. Management: Consider using an increased caspofungin dose of 70 mg daily in adults (or 70 mg/m2, up to a maximum of 70 mg, daily in pediatric patients) when coadministered with known inducers of drug clearance. Risk D: Consider therapy modification

Clarithromycin: Nevirapine may increase serum concentrations of the active metabolite(s) of Clarithromycin. Nevirapine may decrease the serum concentration of Clarithromycin. Management: Consider alternatives to clarithromycin, such as azithromycin, for the treatment of Mycobacterium avium-intracellulare complex in patients taking nevirapine. Risk D: Consider therapy modification

CloZAPine: CYP3A4 Inducers (Weak) may decrease the serum concentration of CloZAPine. Risk C: Monitor therapy

CycloPHOSphamide: CYP2B6 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of CycloPHOSphamide. Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Nevirapine. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Nevirapine. Management: Consider alternatives to this combination when possible. If combined, monitor for reduced nevirapine efficacy. Risk D: Consider therapy modification

Daclatasvir: Nevirapine may decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily if used with nevirapine. Risk D: Consider therapy modification

Darunavir: May increase the serum concentration of Nevirapine. Nevirapine may increase the serum concentration of Darunavir. Management: Avoid coadministration of darunavir/cobicistat and nevirapine. No action is required if darunavir/ritonavir is combined with nevirapine. Risk D: Consider therapy modification

Dolutegravir: Nevirapine may decrease the serum concentration of Dolutegravir. Risk X: Avoid combination

Elivaldogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Elivaldogene Autotemcel. Management: Avoid use of antiretroviral medications for at least one month, or for the amount of time required for elimination of the retroviral medication, prior to stem cell mobilization and until the all apheresis cycles are finished Risk X: Avoid combination

Elvitegravir: Nevirapine may decrease the serum concentration of Elvitegravir. Risk X: Avoid combination

Ergonovine: Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of Ergonovine. Specifically, this would be most likely with delavrdine, while other Non-Nucleoside Reverse Transcriptase Inhibitors may be more likely to decrease the concentration of Ergonovine. Risk X: Avoid combination

Estriol (Systemic): Nevirapine may decrease the serum concentration of Estriol (Systemic). Risk C: Monitor therapy

Estriol (Topical): Nevirapine may decrease the serum concentration of Estriol (Topical). Risk C: Monitor therapy

Fluconazole: May increase the serum concentration of Nevirapine. Risk C: Monitor therapy

Fosamprenavir: Nevirapine may decrease serum concentrations of the active metabolite(s) of Fosamprenavir. Fosamprenavir may increase the serum concentration of Nevirapine. Management: Coadministration of nevirapine and fosamprenavir is not recommended without concurrent ritonavir. However, when nevirapine and fosamprenavir/ritonavir (twice daily) are used in combination, no dose adjustment is required. Risk D: Consider therapy modification

Indinavir: Nevirapine may decrease the serum concentration of Indinavir. Management: Increased indinavir doses may be needed when used with nevirapine; however, specific dosing guidelines have not been established. Risk D: Consider therapy modification

Itraconazole: Nevirapine may decrease the serum concentration of Itraconazole. Risk X: Avoid combination

Ketamine: CYP2B6 Inducers (Moderate) may decrease the serum concentration of Ketamine. Risk C: Monitor therapy

Ketoconazole (Systemic): Nevirapine may decrease the serum concentration of Ketoconazole (Systemic). Management: Avoid use of nevirapine in the 2 weeks prior to and during ketoconazole therapy unless benefits outweigh the risk of diminished ketoconazole efficacy. Monitor ketoconazole efficacy and consider dose increases if combined. Risk D: Consider therapy modification

Lenacapavir: Nevirapine may decrease the serum concentration of Lenacapavir. Risk X: Avoid combination

Letermovir: Nevirapine may diminish the therapeutic effect of Letermovir. Risk X: Avoid combination

Levoketoconazole: Nevirapine may decrease the serum concentration of Levoketoconazole. Risk X: Avoid combination

Levomethadone: Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of Levomethadone. Management: Levomethadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. Risk C: Monitor therapy

Lopinavir: Nevirapine may decrease the serum concentration of Lopinavir. Management: Avoid once daily use of lopinavir/ritonavir with nevirapine. Avoid use of this combination in patients less than 6 months of age. Lopinavir/ritonavir dose adjustments are required for patients taking twice daily lopinavir/ritonavir. See full monograph. Risk D: Consider therapy modification

Methadone: Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the metabolism of Methadone. Management: Methadone dosage adjustments will likely be required with efavirenz and nevirapine, and may be necessary with rilpivirine as well. Risk C: Monitor therapy

Nelfinavir: Nevirapine may decrease the serum concentration of Nelfinavir. Risk X: Avoid combination

NiMODipine: CYP3A4 Inducers (Weak) may decrease the serum concentration of NiMODipine. Risk C: Monitor therapy

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy

QuiNINE: Nevirapine may decrease the serum concentration of QuiNINE. Risk C: Monitor therapy

Reverse Transcriptase Inhibitors (Non-Nucleoside): May enhance the adverse/toxic effect of other Reverse Transcriptase Inhibitors (Non-Nucleoside). Reverse Transcriptase Inhibitors (Non-Nucleoside) may decrease the serum concentration of other Reverse Transcriptase Inhibitors (Non-Nucleoside). Specifically, efavirenz and nevirapine may decrease the serum concentrations of other non-nucleoside reverse transcriptase inhibitors. Reverse Transcriptase Inhibitors (Non-Nucleoside) may increase the serum concentration of other Reverse Transcriptase Inhibitors (Non-Nucleoside). Specifically, delavirdine may increase the serum concentration of etravirine. Risk X: Avoid combination

Rifabutin: Nevirapine may increase serum concentrations of the active metabolite(s) of Rifabutin. Nevirapine may increase the serum concentration of Rifabutin. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Nevirapine. Risk X: Avoid combination

Rivaroxaban: Nevirapine may decrease the serum concentration of Rivaroxaban. Risk C: Monitor therapy

Saquinavir: Nevirapine may decrease the serum concentration of Saquinavir. Risk X: Avoid combination

Selpercatinib: CYP3A4 Inducers (Weak) may decrease the serum concentration of Selpercatinib. Risk C: Monitor therapy

Simeprevir: Nevirapine may decrease the serum concentration of Simeprevir. Risk X: Avoid combination

Sirolimus (Conventional): CYP3A4 Inducers (Weak) may decrease the serum concentration of Sirolimus (Conventional). Risk C: Monitor therapy

Sirolimus (Protein Bound): CYP3A4 Inducers (Weak) may decrease the serum concentration of Sirolimus (Protein Bound). Risk C: Monitor therapy

St John's Wort: May decrease the serum concentration of Nevirapine. Risk X: Avoid combination

Tacrolimus (Systemic): CYP3A4 Inducers (Weak) may decrease the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Ubrogepant: CYP3A4 Inducers (Weak) may decrease the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a weak CYP3A4 inducer. Risk D: Consider therapy modification

Velpatasvir: CYP2B6 Inducers (Moderate) may decrease the serum concentration of Velpatasvir. Risk X: Avoid combination

Voriconazole: Nevirapine may decrease the serum concentration of Voriconazole. Voriconazole may increase the serum concentration of Nevirapine. Risk C: Monitor therapy

Warfarin: Nevirapine may diminish the anticoagulant effect of Warfarin. Risk C: Monitor therapy

Reproductive Considerations

Contraception is not required to initiate or continue antiretroviral therapy.

The US Department of Health and Human Services (HHS) perinatal HIV guidelines do not recommend nevirapine (except in special circumstances) in patients with HIV who are not yet pregnant but are trying to conceive.

Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Optimization of the health of the person who will become pregnant is recommended. Selection of or changes to a specific antiretroviral regimen prior to pregnancy should be done as part of a shared decision-making process. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender-diverse people assigned female sex at birth.

Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).

Pregnancy Considerations

Nevirapine has a high level of transfer across the human placenta.

No increased risk of overall teratogenic effects following first trimester exposure according to data collected by the antiretroviral pregnancy registry. Maternal antiretroviral therapy (ART) may be associated with adverse pregnancy outcomes including preterm birth, low birth weight, and small-for-gestational-age infants. Actual risks may be influenced by maternal factors such as disease severity, GA at initiation of therapy, and specific ART regimen, therefore close fetal monitoring is recommended. Because there is clear benefit to appropriate treatment, maternal ART should not be withheld due to concerns for adverse neonatal outcomes. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children not diagnosed with HIV but who were exposed to ART in utero or as a neonate and develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential metabolic dysfunction.

Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18 weeks, has been reported in patients treated with nevirapine. Female gender and higher CD4+ cell counts at initiation of therapy place patients at increased risk; females with CD4+ cell counts >250 cells/mm3, including patients who are pregnant receiving nevirapine in combination with other antiretrovirals for the treatment of HIV-1 infection, are at the greatest risk. Intensive monitoring must be done during the first 18 weeks of nevirapine therapy with extra vigilance during the first 6 weeks, which is the period of greatest risk of hepatotoxicity and skin reactions.

The US Department of Health and Human Services (HHS) perinatal HIV guidelines do not recommend nevirapine as an initial non-nucleoside reverse transcriptase inhibitor for use in antiretroviral-naive pregnant patients because of the potential for adverse events, complex dosing, and low barrier to resistance. Use is not recommended (except in special circumstances) in pregnant patients with HIV who have had ART therapy in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Patients who become pregnant while taking nevirapine may continue if viral suppression is effective and the regimen is well tolerated.

Pharmacokinetics of the IR formulation are not significantly altered during pregnancy; dose adjustment is not currently recommended (data not available for ER formulation).

ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of detection and reduce the risk of perinatal transmission. Selection of or changes to a specific antiretroviral regimen during pregnancy should be done as part of a shared decision-making process. Patients on fully suppressive regimens prior to pregnancy generally may continue the same regimen considering known pregnancy outcomes and pharmacokinetic data. Monitoring of patients who are pregnant is more frequent than in patients who are not pregnant. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender-diverse people assigned female sex at birth.

Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Health care providers should enroll all patients exposed to antiretroviral medications during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263). Enrollment should be done as early in pregnancy as possible.

Health care providers caring for pregnant patients with HIV and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).

Breastfeeding Considerations

Nevirapine is present in breast milk.

Following maternal use, nevirapine can be detected in the plasma of breastfed infants. Rash and hyperbilirubinemia have been reported in infants exposed to nevirapine via breast milk.

Maintaining maximum viral suppression during pregnancy and postpartum decreases but does not eliminate the risk of HIV transmission via breast milk. In addition, multiclass-resistant virus has been detected in breastfeeding infants who acquire HIV despite maternal therapy. In the United States, where formula is usually accessible, affordable, safe, and sustainable, and the risk of infant mortality due to diarrhea and respiratory infections is low, the US Department of Health and Human Services perinatal HIV guidelines do not recommend breastfeeding for patients with HIV when safer infant feeding options are available. Persons with HIV who maintain an undetectable viral load while taking antiretroviral therapy (ART) should evaluate infant feeding options (formula, banked donor milk, or breastfeeding) as part of a shared decision-making process (if breastfeeding is being considered, see guidelines for measures to reduce the risk of HIV transmission). When the HIV status at delivery is not known, breast milk may be expressed and stored until a negative test is available. If HIV infection is diagnosed after breastfeeding has been initiated, breastfeeding should be discontinued immediately. Breastfeeding is not recommended for persons with HIV who are not taking ART and/or who do not have sustained viral suppression.

Information is available for counseling and managing patients with HIV who are considering breastfeeding (888-448-8765). In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender-diverse people assigned female sex at birth (HHS [perinatal] 2023).

Monitoring Parameters

Monitor CBC and viral load. Intensive monitoring is required during the initial 18 weeks of therapy to detect potentially life-threatening hepatic, dermatologic, and hypersensitivity reactions. Baseline and repeat liver function tests; optimal frequency has not been established, some experts recommend testing at baseline, prior to dose escalation, and 2 weeks post-escalation. Guidelines for adult patients recommend ALT, AST, and bilirubin should be monitored at baseline, 2 to 8 weeks, and every 3 to 6 months (HHS [adult] 2019). Assess/evaluate AST/ALT immediately in any patients with a rash.

Mechanism of Action

As a non-nucleoside reverse transcriptase inhibitor, nevirapine has activity against HIV-1 by binding to reverse transcriptase. It consequently blocks the RNA-dependent and DNA-dependent DNA polymerase activities including HIV-1 replication. It does not require intracellular phosphorylation for antiviral activity.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Rapid and readily absorbed; Immediate release: >90%

Distribution: Widely; Vd: 1.2 L/kg; CSF penetration approximates 40% to 50% of plasma

Protein binding, plasma: ~60%

Metabolism: Extensively hepatic via CYP3A4 and CYP2B6 (hydroxylation to inactive compounds); may undergo enterohepatic recycling; nevirapine is more rapidly metabolized in pediatric patients than in adults

Bioavailability: 93% (immediate release tablet); ~75% (extended release tablet [relative to immediate release]); 91% (oral solution)

Half-life elimination: Decreases over 2- to 4-week time with chronic dosing due to autoinduction (ie, half-life = 45 hours initially [single dose] and decreases to 25 to 30 hours [multiple dosing])

Time to peak, serum: Immediate release: 4 hours; Extended release:~24 hours

Excretion: Urine (~81%, primarily as metabolites, <3% as unchanged drug); feces (~10%)

Clearance: Women have a 13.8% lower clearance compared to men; body size does not totally explain the gender difference

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Viramune;
  • (AR) Argentina: Filide | Nerapin | Nevirapina | Ritvir | Viramune;
  • (AT) Austria: Nevirapin accord | Nevirapin mylan | Nevirapin Sandoz | Viramune;
  • (AU) Australia: Nevipin | Nevirapine Alphapharm | Nevirapine Rbx | Nevirapine xr apotex | Viramune;
  • (BE) Belgium: Nevirapine mylan | Nevirapine sandoz | Viramune;
  • (BG) Bulgaria: Neviparine | Viramune;
  • (BR) Brazil: Farmanguinhos nevirapina | Viramune;
  • (CH) Switzerland: Nevirapin mepha | Nevirapin mylan | Nevirapin sandoz retard | Viramune;
  • (CI) Côte d'Ivoire: Nevek | Nevihope | Nevivir;
  • (CL) Chile: Nevurit | Viramune;
  • (CN) China: Ai tai | Nuo lan pin | Viramune;
  • (CO) Colombia: Ciplanevimune | Evirapin | Godapaus | Nevipan | Neviparina | Nevirapina | Nevivir | Niverin | Viramune | Viravir;
  • (DE) Germany: Nevirapin accord | Nevirapin Aurobindo | Nevirapin axiromed | Nevirapin beta | Nevirapin Hexal | Nevirapin hormosan | Nevirapin mylan | Nevirapin ratiopharm | Nevirapin teva | Nevirapine Heumann | Viramune;
  • (EE) Estonia: Viramune;
  • (ES) Spain: Nevirapina accord | Nevirapina actavis | Nevirapina aurobindo | Nevirapina combino pharm | Nevirapina kern pharma | Nevirapina mylan | Nevirapina normon | Nevirapina Sandoz | Nevirapina Teva | Viramune;
  • (FI) Finland: Nevirapine accord | Nevirapine mylan | Viramune;
  • (FR) France: Nevirapine arrow lab | Nevirapine Cristers | Nevirapine cristers LP | Nevirapine mylan | Nevirapine mylan LP | Nevirapine sandoz | Nevirapine sandoz lp | Nevirapine teva | Viramune;
  • (GB) United Kingdom: Nevirapine Dr. reddy's | Nevirapine mylan | Nevirapine teva | Viramune;
  • (GR) Greece: Nevirapine vocate | Viramune;
  • (HK) Hong Kong: Viramune;
  • (HU) Hungary: Nevirapine Hspt | Nevirapine teva | Nevita | Viramune;
  • (ID) Indonesia: Neviral;
  • (IE) Ireland: Viramune;
  • (IN) India: Neve | Nevihope | Nevimat | Nevimune | Nevipan | Nevir | Neviretro | Nevirex | Nevivir;
  • (IT) Italy: Nevirapina | Nevirapina accord | Nevirapina aurobindo | Nevirapina mylan | Nevirapina Sandoz | Nevirapina teva italia | Viramune;
  • (JP) Japan: Viramune;
  • (KE) Kenya: Aspen nevirapine | Nevimune | Nevipan | Nevir | Neviriv | Nevivir;
  • (KR) Korea, Republic of: Viramune;
  • (LB) Lebanon: Nevimune | Viramune;
  • (LT) Lithuania: Nevirapin accord | Nevirapin hormosan | Viramune;
  • (LU) Luxembourg: Nevirapin | Viramune;
  • (LV) Latvia: Viramune;
  • (MX) Mexico: Nebriprim | Pyari | Viramune;
  • (MY) Malaysia: Hirapine | Nevipan | Viramune;
  • (NG) Nigeria: Nevidek | Nevivir | Nevran | Tyonex nevirapine;
  • (NL) Netherlands: Nevirapine accord | Nevirapine aurobindo | Nevirapine mylan | Nevirapine retard teva | Nevirapine sandoz | Viramune;
  • (NO) Norway: Viramune;
  • (NZ) New Zealand: Nevirapine Alphapharm | Viramune;
  • (PE) Peru: Nevirapina;
  • (PK) Pakistan: Nevimat;
  • (PL) Poland: Nevirapine accord | Nevirapine mylan | Viramune;
  • (PR) Puerto Rico: Viramune;
  • (PT) Portugal: Nevirapina accord | Nevirapina farmoz | Nevirapina Generis | Nevirapina mylan | Nevirapina Sandoz | Nevirapina Teva | Viramune;
  • (PY) Paraguay: Nevimune | Protease | Viramune;
  • (RO) Romania: Nevirapina accord | Nevirapina Teva | Viramune;
  • (RU) Russian Federation: Nevirapine tl | Nevirpine | Viramune;
  • (SA) Saudi Arabia: Viramune;
  • (SE) Sweden: Nevirapin 2care4 | Nevirapin ebb | Nevirapine Medical Valley | Nevirapine mylan | Nevirapine teva b.v. | Viramune;
  • (SG) Singapore: Viramune;
  • (SK) Slovakia: Viramune;
  • (TH) Thailand: Neravir | Viramune;
  • (TR) Turkey: Viramune;
  • (TW) Taiwan: Nevimat | Viramune;
  • (TZ) Tanzania, United Republic of: Nevirapine aurobindo | Nevirapine mylan | Nevivir;
  • (UA) Ukraine: Nevimune | Nevivir | Viramune;
  • (UG) Uganda: Nevihope | Nevimune | Viramune;
  • (UY) Uruguay: Filide | Neviralea | Nevirapina | Protease | Viramune;
  • (ZA) South Africa: Acriptaz | Adco Nevirapine | Aspen nevirapine | Auro nevirapine | Bindopin | Cipla nevirapine | Nevimune | Nevir | Nevivir | Nevran | Sonke nevirapine | Vari nevirapine | Viramune;
  • (ZM) Zambia: Aspen nevirapine | Nevimune | Nevipan | Nevirex | Nevivir | Okamune | Viramune;
  • (ZW) Zimbabwe: Nevimat | Nevimune | Nevipan | Nevivir
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