Sofosbuvir + velpatasvir

سوفوسبوویر + ولپاتاسویر

⚠ Unverified

🦠 Antiinfectives For Systemic UsePangenotypic anti-HCV

Market / country: 🇺🇸 USA

Epclusa (US)

🧮 Dose calculator

Chronic hepatitis C · Regimen source: FDA Epclusa · 2.3FDA Epclusa · 2.4, Table 2

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🛡️ Safety & information

Contraindications

  • ⛔ Combination with ribavirin where ribavirin is contraindicated. FDA Epclusa · 4

Warnings

Important interactions

  • • Amiodarone: severe bradycardia needing pacing; a fatal cardiac arrest with a sofosbuvir regimen. FDA Epclusa · 5.2

Formulations

  • Sofosbuvir 400 mg + velpatasvir 100 mg tablet — tablet 🇺🇸 USA FDA Epclusa · 3
  • Sofosbuvir 200 mg + velpatasvir 50 mg tablet — tablet 🇺🇸 USA FDA Epclusa · 3

👥 Special populations

  • 🤰 PregnancyUse with caution

    Label: contraindicated only in combination with ribavirin (pregnant women and men whose partners are pregnant); limited data for Epclusa alone. FDA Epclusa · 8.1

    “Risk Summary If EPCLUSA is administered with ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partners are pregnant.”
  • 🤱 BreastfeedingUse with caution

    Label: use with caution while breastfeeding; see the label text. FDA Epclusa · 8.2

    “The predominant circulating metabolite of sofosbuvir (GS-331007) was the primary component observed in the milk of lactating rats administered sofosbuvir, without effect on nursing pups.”
  • 👶 ChildrenUse with caution

    The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Epclusa · 8.4

    “The pharmacokinetics, safety, and effectiveness of EPCLUSA for treatment of HCV genotype 1, 2, 3, 4, or 6 infection in treatment-naïve and treatment-experienced pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial …”
  • 👴 Older adultsNo specific problem stated

    Label: no specific difference or dose adjustment stated for older adults. FDA Epclusa · 8.5

    “No dosage adjustment of EPCLUSA is warranted in geriatric patients [see Clinical Pharmacology (12.3) ] .”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Epclusa · 8.3

    “If EPCLUSA is administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen.”

📚 Reference status for this drug

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