Efavirenz

Generic name
Efavirenz
Brand name
ATC Code
J05AG03
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The bioavailability of the liquid formulation is lower than that of the capsules/tablets.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

General Dose Info

CAVE: The bioavailability of the solution is lower than the bioavailability of the capsules/tablets.

Dosages

Treatment HIV infection
  • Oral
    • Tablet
      • ≥ 3 years and 13 up to 15 kg
        • 200 mg/day in 1 dose
      • ≥ 3 years and 25 up to 33 kg
        • 350 mg/day in 1 dose
      • ≥ 3 years and 33 up to 40 kg
        • 400 mg/day in 1 dose
    • Capsule, hard
      • ≥ 3 months and 15 up to 20 kg
        • 250 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 20 up to 25 kg
        • 300 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and ≥ 40 kg
        • 600 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 3.5 up to 5 kg
        • 100 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 5 up to 7.5 kg
        • 150 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 7.5 up to 15 kg
        • 200 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 15 up to 20 kg
        [8]
        • 250 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 20 up to 25 kg
        [8]
        • 300 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 25 up to 32.5 kg
        • 350 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and 32.5 up to 40 kg
        • 400 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

      • ≥ 3 months and ≥ 40 kg
        [8]
        • 600 mg/day in 1 dose

        • Capsule may be opened and contents mixed with a small amount of food. Take immediately.

    • Liquid solution
      • 3 years up to 5 years and 13 up to 15 kg
        • 360 mg/day in 1 dose
      • 3 years up to 5 years and 15 up to 20 kg
        • 390 mg/day in 1 dose
      • 3 years up to 5 years and 20 up to 25 kg
        • 450 mg/day in 1 dose
      • 3 years up to 5 years and 25 up to 33 kg
        • 510 mg/day in 1 dose
      • 5 years up to 18 years and 13 up to 15 kg
        • 270 mg/day in 1 dose
      • 5 years up to 18 years and 15 up to 20 kg
        • 300 mg/day in 1 dose
      • 5 years up to 18 years and 20 up to 25 kg
        • 360 mg/day in 1 dose
      • 5 years up to 18 years and 25 up to 33 kg
        • 450 mg/day in 1 dose
      • 5 years up to 18 years and 33 up to 40 kg
        • 510 mg/day in 1 dose
      • 5 years up to 18 years and ≥ 40 kg
        • 720 mg/day in 1 dose
CAUTION:
  • Route of administration not applicable
    • 0 years up to 18 years

      • The bioavailability of the liquid formulation is lower than the bioavailability of the capsules/tablets.

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.

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

Rash: More severe rashes are often seen in children. Drowsiness and disrupted concentration.

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

To prevent rashes, prophylaxis with an antihistamine is recommended in children before treatment with efavirenz is commenced. Stop the treatment if a severe rash occurs.
Administer in the evenings because of drowsiness and reduced ability to concentrate.

Interactions

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

DIRECT ACTING ANTIVIRALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB12
J05AB06
J05AB16
J05AB04
J05AB11
J05AB14
Phosphonic acid derivatives
J05AD01
Protease inhibitors
J05AE08
J05AE10
J05AE07
J05AE02
J05AE04
J05AE03
J05AE01
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF06
J05AF02
J05AF09
J05AF10
J05AF05
J05AF04
J05AF07
J05AF13
J05AF13
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG06
J05AG04
J05AG01
J05AG05
Neuraminidase inhibitors
J05AH02
J05AH01
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Other antivirals
J05AX28
J05AX12
J05AX07
J05AX09
J05AX08
J05AX24
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Integrase inhibitors
J05AJ04
Antivirals for treatment of HCV infections
J05AP54
J05AP57
J05AP51
J05AP08
J05AP55

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. CBO, Richtlijn antiretrovirale therapie,, www.cbo.nl, herziene versie december 2007
  3. Merck Sharp & Dome Limited, SPC Stocrin ( EU/1/99/111/001-004), www.ema.europa.eu, Geraadpleegd 26 mei 2011, http://www.ema.europa.eu/docs/nl_NL/document_library/EPAR_-_Product_Information/human/000250/WC500058946.pdf
  4. PENTA Steering Commitee, PENTA 2009 guidelines for the use of antiretroviral therapy., HIV Medicine, 2009, 10, 591-613
  5. Antiretroviral Therapy and Medical Management of HIV-Infected Children, Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, www.aidsinfo.nih.gov, 2010, http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf.
  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. Bristol-Myers Squibb Pharma EEIG, SmPC Sustiva (EU/1/99/110) Rev 48. 25-05-2023, www.ema.europa.eu
  9. 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

Changes

Therapeutic Drug Monitoring


Overdose