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• Laboratoires Boiron
  

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  Sedalia | Aurobindo Pharma Limited

  

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  2.1 Adult Patients
  

  The recommended dose for nevirapine oral suspension is 200 mg daily for the first 14 days, followed by 200 mg twice daily, in combination with other antiretroviral agents. The lead-in period has been observed to decrease the incidence of rash. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed.

  2.2 Pediatric Patients
  

  The recommended oral dose for pediatric patients 15 days and older is 150 mg/m2 once daily for 14 days followed by 150 mg/m2 twice daily thereafter. The total daily dose should not exceed 400 mg for any patient.

  
  
  Table 1 Calculation of the Volume of Nevirapine Oral Suspension (50 mg per 5 mL) Required for Pediatric Dosing Based on Body Surface and a Dose of 150 mg/m2 BSA range (m2) Volume (mL) 0.06 – 0.12
  1.25
  0.12 – 0.25
  2.5
  0.25 – 0.42
  5
  0.42 – 0.58
  7.5
  0.58 – 0.75
  10
  0.75 – 0.92
  12.5
  0.92 – 1.08
  15
  1.08 – 1.25
  17.5
  1.25+
  20
  

  Nevirapine suspension should be shaken gently prior to administration. It is important to administer the entire measured dose of suspension by using an oral dosing syringe or dosing cup. An oral dosing syringe is recommended, particularly for volumes of 5 mL or less. If a dosing cup is used, it should be thoroughly rinsed with water and the rinse should also be administered to the patient.

  2.3 Monitoring of Patients
  

  Intensive clinical and laboratory monitoring, including liver enzyme tests, is essential at baseline and during the first 18 weeks of treatment with nevirapine oral suspension. The optimal frequency of monitoring during this period has not been established. Some experts recommend clinical and laboratory monitoring more often than once per month, and in particular, would include monitoring of liver enzyme tests at baseline, prior to dose escalation, and at two weeks post-dose escalation. After the initial 18-week period, frequent clinical and laboratory monitoring should continue throughout nevirapine oral suspension treatment [see Warnings and Precautions (5)]. In some cases, hepatic injury has progressed despite discontinuation of treatment.

  2.4 Dosage Adjustment
  

  Patients with Rash
  
  Discontinue nevirapine oral suspension if a patient experiences severe rash or any rash accompanied by constitutional findings [see Boxed Warning and Warnings and Precautions (5.2)].

  Do not increase nevirapine oral suspension dose if a patient experiences mild to moderate rash without constitutional symptoms during the 14-day lead-in period of 200 mg/day (150 mg/m2/day in pediatric patients) until the rash has resolved [see Warnings and Precautions (5.2)]. The total duration of the once daily lead-in dosing period should not exceed 28 days at which point an alternative regimen should be sought.
  
  Patients with Hepatic Events
  
  If a clinical (symptomatic) hepatic event occurs, permanently discontinue nevirapine oral suspension. Do not restart nevirapine oral suspension after recovery [see Warnings and Precautions (5.1)].
  
  Patients with Dose Interruption
  
  For patients who interrupt nevirapine oral suspension dosing for more than 7 days, restart the recommended dosing, 200 mg daily (150 mg/m2/day in pediatric patients) for the first 14 days (lead-in) followed by 200 mg twice daily (150 mg/m2 twice daily for pediatric patients).
  
  Patients with Renal Impairment
   
  Patients with CrCL greater than or equal to 20 mL per min do not require an adjustment in nevirapine oral suspension dosing. The pharmacokinetics of nevirapine have not been evaluated in patients with CrCL less than 20 mL per min. An additional 200 mg dose of nevirapine oral suspension following each dialysis treatment is indicated in patients requiring dialysis. Nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known [see Clinical Pharmacology (12.3)].

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