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

Interactions
PK
Renal impairment
References

Sofosbuvir

Generic name
Sofosbuvir
Brand name
ATC Code
J05AP08

Pharmacokinetics in children

No information is present at this moment.

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

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Available formulations

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Dosages

Chronic hepatitis C
  • Oral
    • ≥ 3 years and ≥ 35 kg
      [1]
      • 400 mg/day in 1 - 2 doses. in combination with ribavirin.
      • Duration of treatment:

        Patients with CHC genotype 2: 12 weeks
        Patients with CHC genotype 3: 24 weeks

        Possible extension of the duration of the therapy to longer than 12 weeks and 24 weeks at most should be taken into account; especially for subgroups with one or more factors that are historically associated with lower response percentages to interferon-based therapies (for example advanced fibrosis/cirrhosis, high viral concentrations at baseline, Negroid race, genotype IL28B non-CC, earlier non-response to therapy with pegylated interferon-alpha and ribavirin).

      • Directions for administration:

        In the event of vomiting within two hours after intake, the drug must be taken again. In the event of vomiting more than 2 hours after intake, no new dose is needed.

    • ≥ 3 years and 17 up to 35 kg
      [1]
      • 200 mg/day in 1 dose in combination with ribavirin.
      • Duration of treatment:

        Patients with CHC genotype 2: 12 weeks
        Patients with CHC genotype 3: 24 weeks

        Possible extension of the duration of the therapy to longer than 12 weeks and 24 weeks at most should be taken into account; especially for subgroups with one or more factors that are historically associated with lower response percentages to interferon-based therapies (for example advanced fibrosis/cirrhosis, high viral concentrations at baseline, Negroid race, genotype IL28B non-CC, earlier non-response to therapy with pegylated interferon-alpha and ribavirin).

      • Directions for administration:

        In the event of vomiting within two hours after intake, the drug must be taken again. In the event of vomiting more than 2 hours after intake, no new dose is needed.

    • ≥ 3 years and < 17 kg
      [1]
      • 150 mg/day in 1 dose in combination with ribavirin.
      • Duration of treatment:

        Patients with CHC genotype 2: 12 weeks
        Patients with CHC genotype 3: 24 weeks

        Possible extension of the duration of the therapy to longer than 12 weeks and 24 weeks at most should be taken into account; especially for subgroups with one or more factors that are historically associated with lower response percentages to interferon-based therapies (for example advanced fibrosis/cirrhosis, high viral concentrations at baseline, Negroid race, genotype IL28B non-CC, earlier non-response to therapy with pegylated interferon-alpha and ribavirin).

      • Directions for administration:

        In the event of vomiting within two hours after intake, the drug must be taken again. In the event of vomiting more than 2 hours after intake, no new dose is needed.

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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

The side effects observed in children are the same as the side effects in adults.

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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

No information available on specific warnings and precautions in children.

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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
Non-nucleoside reverse transcriptase inhibitors
J05AG01
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
J05AP55

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Reference

  1. Gilead Sciences International Ltd. , SmPC Sovaldi (EU/1/13/894/001 ) 16-10-2018, www.geneesmiddeleninformatiebank.nl

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Changes

Changes