Tenofovir alafenamide

تنوفوویر آلافنامید

⚠ Unverified

🦠 Antiinfectives For Systemic UseNucleotide reverse transcriptase inhibitor (HBV)

Market / country: 🇺🇸 USA

Vemlidy (US)

🧮 Dose calculator

Chronic hepatitis B · Regimen source: FDA Vemlidy · 2.2

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🛡️ Safety & information

Warnings

  • • Boxed warning: severe acute exacerbation of hepatitis B after discontinuation in HBV co-infection — monitor the liver for several months. FDA Vemlidy · Boxed Warning

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

    Label: Antiretroviral Pregnancy Registry data show no difference from the background birth-defect rate. FDA Vemlidy · 8.1

    “Available data from the APR show no statistically significant difference in the overall risk of birth defects for tenofovir alafenamide (TAF) compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP).”
  • 🤱 BreastfeedingUse with caution

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

    “Risk Summary Data from the published literature report the presence of TAF and tenofovir in human milk.”
  • 👶 ChildrenUse with caution

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

    “The pharmacokinetics, safety, and effectiveness of VEMLIDY for the treatment of chronic HBV infection have been established in pediatric patients between the ages of 6 to less than 18 years and weighing at least 25 kg (N=59) in Trial 1092 up to 96 weeks.”
  • 👴 Older adultsUse with caution

    Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Vemlidy · 8.5

    “In clinical trials, VEMLIDY was administered to 89 subjects aged 65 and over.”
  • ⚥ Females & males of reproductive potentialNo data

    The source for this drug has no section for this group.

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