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

Interactions
PK
Renal impairment
References

Sofosbuvir + Velpatasvir

Generic name
Sofosbuvir + Velpatasvir
Brand name
ATC Code
J05AP55

Pharmacokinetics in children

Exposure in children over 3 years of age to sofosbuvir/velpatasvir 400 mg/100 mg, 200 mg/50 mg or 150 mg/37.5 mg is equivalent to adult exposure to sofosbuvir/velpatasvir 400 mg/100 mg.

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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

Chronic hepatitis C
  • Oral
    • 3 years up to 18 years and 17 up to 30 kg
      [1]

      • Sofosbuvir/Velpatasvir: 200/50 mg/day in 1 dose

      • Duration of treatment:

        12 weeks

      • Directions for administration:

        If vomiting occurs within 3 hours, an additional dose should be taken. If vomiting occurs >3 hours after dosing, no additional dose is needed.

    • 3 years up to 18 years and ≥ 30 kg
      [1]

      • Sofosbuvir/Velpatasvir: 400/100 mg/day in 1 dose

      • Duration of treatment:

        12 weeks

      • Directions for administration:

        If vomiting occurs within 3 hours, an additional dose should be taken. If vomiting occurs >3 hours after dosing, no additional dose is needed.

    • 3 years up to 18 years and < 17 kg

      • Sofosbuvir/Velpatasvir: 150/37,5 mg/day in 1 dose

      • Duration of treatment:

        12 weeks

      • Directions for administration:

        If vomiting occurs within 3 hours, an additional dose should be taken. If vomiting occurs >3 hours after dosing, no additional dose is needed.

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Renal impaiment in children > 3 months

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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 safety profile of children 6-18 years is similar to those observed in adults.Vomiting was observed as a very common adverse drug reaction in paediatric patients aged 3 to < 6 years. [SmPC Epclusa®] 

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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

If vomiting occurs within 3 hours of ingestion, an additional dose should be taken. If vomiting occurs >3 hours after ingestion, no additional dose is necessary.

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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
J05AP08

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Reference

  1. Gilead Sciences Ireland UC, SmPC Epclusa (EU/1/16/1116/001-2) Rev 22, 27 sept 2023, www.ema.europa.eu

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Changes

Changes