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Nevirapine Dosage

This dosage information may not include all the information needed to use Nevirapine safely and effectively. See additional information for Nevirapine.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

Initial dose (lead-in dosing period):
Immediate-release formulation: 200 mg orally once a day for 14 days

Maintenance dose (following the lead-in dosing period):
Immediate-release formulation: 200 mg orally twice a day
Extended-release formulation: 400 mg orally once a day

Usual Adult Dose for Reduction of Perinatal Transmission of HIV

(Not approved by FDA)

HIV-infected women in labor who have not received antepartum antiretroviral therapy: The U.S. Department of Health and Human Services (DHHS) Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission no longer recommends intrapartum single dose nevirapine. IV zidovudine is recommended for these women.

Usual Pediatric Dose for HIV Infection

Initial dose (lead-in dosing period):
Immediate-release formulation:
15 days or older: 150 mg/m2 orally once a day for 14 days
Maximum initial dose: 200 mg/day

Maintenance dose (following the lead-in dosing period):
Immediate-release formulation:
15 days or older: 150 mg/m2 orally twice a day

Extended-release formulation:
6 years or older:
BSA 0.58 to 0.83 m2: 200 mg orally once a day
BSA 0.84 to 1.16 m2: 300 mg orally once a day
BSA 1.17 m2 or greater: 400 mg orally once a day

Maximum maintenance dose: 400 mg/day

Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children recommendations:
Immediate-release formulation:
15 days to less than 8 years:
Initial dose: 200 mg/m2 orally once a day for 14 days
Maintenance dose: 200 mg/m2 orally twice a day
Maximum dose: 200 mg/dose

8 years or older:
Initial dose: 120 to 150 mg/m2 orally once a day for 14 days
Maintenance dose: 120 to 150 mg/m2 orally twice a day
Maximum dose: 200 mg/dose

As long as there are no side effects, the mg dose does not need to be decreased when the child reaches 8 years; the mg dose is left the same to achieve the appropriate mg/m2 dosage as the child grows larger.

The total daily dose should not exceed 400 mg.

Usual Pediatric Dose for Reduction of Perinatal Transmission of HIV

(Not approved by FDA)

DHHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission recommendations for infants born to HIV-infected women who have not received antepartum antiretroviral therapy:
Immediate-release formulation:
Birth weight 1.5 to 2 kg: 8 mg/dose orally for 3 doses
Birth weight greater than 2 kg: 12 mg/dose orally for 3 doses

The 3 doses are recommended in the first week of life:
First dose: Within 48 hours of birth
Second dose: 48 hours after the first dose
Third dose: 96 hours after the second dose

Triple dose nevirapine may be given to the neonate in addition to 6 weeks of zidovudine therapy. The neonatal regimen (oral zidovudine plus nevirapine) should be started as soon as possible after birth.

Renal Dose Adjustments

CrCl 20 mL/min or more and not requiring dialysis: No adjustment recommended.
CrCl less than 20 mL/min: Data not available

Liver Dose Adjustments

Moderate or severe hepatic impairment (Child Pugh Class B or C): Contraindicated

Dose Adjustments

If nevirapine treatment is interrupted for more than 7 days, it should be restarted at the lower lead-in dose (using the immediate-release formulation) for the first 14 days.

Nevirapine should be discontinued if a severe rash or any rash accompanied by constitutional findings develops. Patients experiencing mild to moderate rash without constitutional symptoms during the 14-day lead-in period with immediate-release nevirapine should not have their dose increased until the rash has resolved. The total duration of the once daily lead-in period must not exceed 28 days, at which point another regimen should be used.

Nevirapine should be permanently discontinued if a clinical (symptomatic) hepatic event occurs.

Precautions

Nevirapine use as part of occupational and nonoccupational postexposure prophylaxis regimens is contraindicated.

The most serious side effects associated with nevirapine are hepatitis/hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be associated with signs of hypersensitivity. Transaminases should be checked at once if signs or symptoms suggestive of hepatitis and/or hypersensitivity reaction develop or if a rash develops in the first 18 weeks of therapy. The diagnosis of hepatotoxicity should be considered, even if transaminases are initially normal or alternative diagnoses are possible. Nevirapine should not be restarted following clinical hepatitis, or transaminase elevations combined with rash or other systemic symptoms, or following severe skin rash or hypersensitivity reactions.

Due to the risk of severe hepatotoxicity, treatment should not be initiated in women with CD4+ cell counts greater than 250 cells/mm3 or men with CD4+ cell counts greater than 400 cells/mm3 unless benefit outweighs risk.

Severe, life-threatening, and in some cases fatal, hepatotoxicity has been reported in patients treated with nevirapine. If signs or symptoms of hepatitis develop, nevirapine should be discontinued and medical evaluation (which should include liver enzyme tests) should be sought immediately. Nevirapine should be permanently discontinued if clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms develop. Hepatic injury may progress despite discontinuation of treatment.

Patients with hepatic impairment, such as hepatic fibrosis or cirrhosis, should be monitored carefully for nevirapine-induced toxicity as elevated nevirapine trough levels have been reported in some of these patients. Patients with worsening hepatic function and ascites may be at risk of nevirapine accumulation.

Severe and life-threatening skin reactions, including fatal cases, have occurred. Patients who develop signs or symptoms of severe skin reactions or hypersensitivity reactions must permanently discontinue nevirapine and seek medical evaluation immediately. All patients who develop a rash within the first 18 weeks of therapy should have their transaminase levels checked at once. Patients with rash-associated transaminase elevations should discontinue nevirapine permanently.

The 14-day lead-in period with immediate-release nevirapine has been shown to lessen the frequency of rash and must be strictly followed. Patients must be monitored closely if isolated rash of any severity develops. Delay in discontinuing nevirapine after the onset of rash may result in a more serious reaction.

Patients should be monitored intensively during the first 18 weeks of therapy with nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. The greatest risk of such events occurs in the first 6 weeks of therapy; therefore, extra vigilance is warranted during this period. Intensive clinical and laboratory monitoring (including liver enzyme tests) is essential at baseline and during the first 18 weeks of therapy. The optimal frequency of monitoring has not been determined. Some experts recommend clinical and laboratory monitoring more often than once per month and include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at 2 weeks after dose escalation. The risk of any hepatic event, with or without rash, continues past the initial 18 weeks and clinical and laboratory monitoring should continue at frequent intervals throughout nevirapine therapy.

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

Nevirapine should always be used in combination with other antiretroviral agents. It should generally not be added as a single agent when antiretroviral regimens are changed due to the development of drug resistance and loss of virological response.

Strict adherence to the prescribed antiretroviral regimen is essential. Patients should not alter the dosages or discontinue therapy without consulting their physician.

Nevirapine interacts with some nonprescription and prescription drugs, including supplements. Some of the interactions can be serious. Patients should be advised to report all concurrent medications they are taking.

Safety and efficacy of the extended-release formulation have not been established in pediatric patients less than 6 years of age.

Dialysis

Immediate-release formulation: A supplemental 200 mg dose should be given after each hemodialysis session.

Other Comments

Nevirapine may be taken without regard to meals. If nevirapine suspension is used, it should be shaken gently before each use and an oral syringe should be used to measure an accurate dose. Nevirapine extended-release tablets must be swallowed whole and must not be chewed, crushed, or divided. Ability to swallow tablets should be considered before the extended-release formulation is prescribed.

The manufacturer's Medication Guide should be dispensed with each new and refill prescription.

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