Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Nevirapine

Generic name
Nevirapine
Brand name
ATC Code
J05AG01

Pharmacokinetics in children

T½ = in chronic use:
T½(children aged 2 months - 1 year): 32 hours;
T½(children of 1 year - 4 years): 21 hours;
T½(children of 4 years - 8 years): 18 hours;
T½(children > 8 years): 28 hours.

Elimination: The clearance increases with factor 1½-2; the clearance (adapted to the weight) in children aged < 8 years is about two times higher compared to adults.

 

 

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Neonatal prophylaxis in an HIV-positive mother
  • Oral
    • Term neonate
      [8]
      • Initial dose: WEEK 1: 2 mg/kg/day in 1 dose
      • Maintenance dose: WEEK 2: 4 mg/kg/day in 1 dose After week 2: stop nevirapine.
        • In antenatal exposure to nevirapine of > 3 days:    Start on 4 mg/kg once daily immediately after the birth (neonatal metabolization in the new-born is then already induced).
        • As a supplement to prophylaxis with zidovudine and lamivudine.
        • Treatment must always be in consultation with a specialist child HIV treatment centre
Treatment HIV infection
  • Oral
    • Normal preparation (immediate release)
      • Gestational age 34 weeks up to 37 weeks
        [7]

        • Birth to 1 week PNA: 8 mg/kg/day in 2 doses
          1-4 weeks PNA 12 mg/kg/day in 2 doses
          ≥ 4 weeks PNA: 400 mg/m2 /day in 2 doses (only make this dose increase for infants with confirmed HIV infection)

      • Term neonate
        [7]
        • 12 mg/kg/day in 2 doses.
      • 1 month up to 8 years
        [7]
        • Initial dose: Days 0 to 14:  200 mg/m²/day in 1 dose
        • Maintenance dose: After 14 days: 400 mg/m²/day in 2 doses. Max: 400 mg/day.
      • ≥ 8 years
        [7]
        • Initial dose: Days 0 to 14: 120 - 150 mg/m²/day in 1 dose
        • Maintenance dose: After 14 days: 240 - 300 mg/m²/day in 2 doses. Max: 400 mg/day.
      • Gestational age 32 weeks up to 34 weeks
        [4]

        • Birth to 2 weeks PNA: 4 mg/kg/day in 2 doses
          2-4 weeks PNA: 8 mg/kg/day in 2 doses
          4-6 weeks PNA: 12 mg/kg/day in 2 doses
          ≥ 6 weeks PNA: 400 mg/m2 /day in 2 doses (only make this dose increase for infants with confirmed HIV infection)

    • Extended release tablet
      • ≥ 6 years
        [4] [7]

        • Maintenance dose (initial dose with the normal preparation, without slow or extended release)
          BSA 0.58-0.83 m²: 200 mg once daily
          BSA 0.84-1.16 m²: 300 mg once daily
          BSA> 1.17 m²: 400 mg once daily

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Skin reactions, transaminase increase.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Watch out for skin reactions and transaminase increases.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB04
J05AB11
J05AB14
Protease inhibitors
J05AE10
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10
J05AF05
J05AF01
Neuraminidase inhibitors
J05AH02
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR10
Other antivirals
J05AX12
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR10
Antivirals for treatment of HCV infections
J05AP57
J05AP08
J05AP55

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References

  1. CBO, Richtlijn antiretrovirale therapie, www.cbo.nl, herziene versie december 2007
  2. 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., http://aidsinfo.nih.gov, May 24, 2010, http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf.
  3. Boehringer Ingelheim BV, SPC Viramune (EU/1/97/055/001), www.ema.europa.eu, Geraadpleegd 20 okt 2010, http://www.ema.europa.eu/docs/nl_NL/document_library/EPAR_-_Product_Information/human/000183/WC500051481.pdf
  4. The Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV., Guideline for the use of Antiretroviral agents in pediatric HIV infection - Nevirapine Rev April 2022, https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv, 2022
  5. PENTA Steering Commitee, PENTA 2009 guidelines for the use of antiretroviral therapy, HIV Medicine, 2009, 10, 591-613
  6. Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life. , HIV Med, 2015, doi:10.1111/hiv.12217
  7. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. , Guideline for the use of Antiretroviral agents in pediatric HIV infection, www.aidsinfo.nig.gov/contentfiles/lvguidelines/pediatricguidelines.pdf, Geraadpleegd 12 sept 2016, O1-O140
  8. British HIV Association, British HIV Association guidelines for the management of HIV infection in pregnant women 2018, 2018

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Changes

Changes