Neonatal Drug Therapy Manual

Nevirapine (Special Access Program)

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Updated January 26, 2022 - 6:00pm

Alternate Name(s): 
Viramune
Classification: 
Antiretroviral
Original Date: 
August 2003
Revised Date: 
November 2020
Indications: 
  • Prevention of vertical transmission in a baby considered at high risk, when:  
    •  mother has a viral load that is not optimally suppressed at the time of delivery                                                          
    •  mother is not on antiretroviral therapy
Administration: 
  • PO
Dosage: 
Gestational Age (GA) Dose Duration

> 37 weeks

 

 6 mg/kg/dose po q12h 4 weeks
Followed by:
200 mg/m2/dose po q12h 2 weeks
 

34 to < 37 weeks

 

 4 mg/kg/dose po q12h 1 week
Followed by:
6 mg/kg/dose po q12h 3 weeks
Followed by:
200 mg/m2/dose po q12h 2 weeks
 

25 to < 34 weeks

 

 2 mg/kg/dose po once daily * 2 weeks
Followed by:
2 mg/kg/dose po q12h * 2 weeks

* Dose based on expert opinion

Alternative Dosing Method using Body Surface Area (BSA): 

Gestational Age (GA) Dose (based on expert opinion) Duration

> 34 weeks

 

150 mg/m2/dose once daily

 

 2 weeks

1 week after starting Nevirapine:  Send serum sample for therapeutic drug monitoring  (TDM) to McGill University Health Centre, Montreal.

Once TDM confirms serum level less than targeted range, increase dose to:
150 mg/m2/dose po q12h 2 weeks
Followed by:
200 mg/m2/dose po q12h 2 weeks
 

25 to < 34 weeks

 

 75 - 100 mg/m2/dose po once daily 2 weeks

1 week after starting Nevirapine: Send serum sample for therapeutic drug monitoring (TDM) to McGill University Health Centre, Montreal

Once TDM confirms serum level less than targeted range, increase dose to:
100 mg/m2/dose po q12h 2 weeks

 

Formula for Body Surface Area (BSA):

Click here for the BSA Formula

*** Nevirapine is used in combination with Zidovudine and Lamivudine for a six weeks course.  Nevirapine should be started as soon as possible after birth and no later than 2 to 6 hours after delivery.

Side Effects: 
  • Dermatologic: rash
  • GI: abdominal pain, diarrhea
  • Hematologic: neutropenia
  • Hepatic: elevated liver enzymes
Parameters to Monitor: 
  • CBC with differential
  • Liver transaminases (ALT, AST)
Reconstitution and Stability: 

N/A

Compatibility: 

N/A

Notes: 
  • Available as 10 mg/mL oral suspension
    • Health Canada Special Access Program (SAP)
References: 

- Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV.  Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Version Date: April 14, 2020.  Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/pediatricguidelines.pdf.

- Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission.  recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States.  Version Date: Apr14, 2020. Available at: http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf.  (Table 7)

- Guidelines for the Prevention of Mother-to-Child HIV Transmission. Information and Practice Guidance for Health Practitioners in Ontario: Working with HIV-infected Women with Inadequate Control of HIV, and Women with Unknown HIV Status Who Present in Labor. Version Date: January 20, 2017

- Lau E, Brophy J, Samson L, Kakkar F, et al.  Nevirapine Pharmacokinetics and Safety in Neonates Receiving Combination: Antiretroviral Therapy for Prevention of Vertical HIV Transmission. Journal of acquired Immune deficiency Syndromes April 15, 2017;74 (5) 493-498

- de Waal R, Kroon SM, Holgate SL, et al. Nevirapine concentrations in preterm and low birth weight HIV-exposed infants:implications for dosing recommendations. Pediatr Infect Dis J. 2014; 33(12):1231-1233 

-Mugabo P, Els I, Smith J, et al. Nevirapine plasma concentrations in premature infants exposed to single-dose nevirapine for prevention of moth-to-child transmission of HIV-1.  S Afr Med J. Sep 2011; 101 (9): 655-658. Available at http://www.ncbi.nlm.nih.gov/pubmed/21920159

 

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