Sofosbuvir + velpatasvir
سوفوسبوویر + ولپاتاسویر
🦠 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
- • Shown as the sofosbuvir component. Under 17 kg: 150/37.5 mg oral pellets. Decompensated cirrhosis: add ribavirin. Test HBsAg and anti-HBc before starting. FDA Epclusa · 2.2FDA Epclusa · 2.4FDA Epclusa · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Combination with ribavirin where ribavirin is contraindicated. FDA Epclusa · 4
Warnings
- • Boxed warning: HBV reactivation in HCV/HBV co-infection. FDA Epclusa · Boxed Warning
- • Serious symptomatic bradycardia with amiodarone. FDA Epclusa · 5.2
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 links
- FDA (approval record)NDA208341
- DailyMed (FDA label)FDA Epclusa
- MedlinePlus (NIH)Sofosbuvir
- WHO ATC/DDDJ05AP55
- Darooyab (Iran)Sofosbuvir-Velpatasvir
🇮🇷 Registered in Iran Darooyab · G-5387/Sofosbuvir-Velpatasvir
Dosage forms with Iranian generic codes, per Darooyab.
- 51994 · SOFOSBUVIR / VELPATASVIR TABLET ORAL 400 mg/100 mg · قرص سوفوسبوویر / ولپاتاسویر ۴۰۰ میلیگرم / ۱۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Epclusa · 3FDA Epclusa · 2.3FDA Epclusa · 2.4, Table 2FDA Epclusa · 2.2FDA Epclusa · 2.4FDA Epclusa · 2.1FDA Epclusa · 4FDA Epclusa · Boxed WarningFDA Epclusa · 5.2FDA Epclusa · 8.1FDA Epclusa · 8.2FDA Epclusa · 8.4FDA Epclusa · 8.5FDA Epclusa · 8.3FDA Epclusa · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5387/Sofosbuvir-Velpatasvir
- Clinical review⚠ Unverified