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tenofovir alafenamide

Vemlidy · ATC code J05AF13

Also known as: Tenofoviralafenamid, Tenofovir alafenamid

Key facts
Active substance
tenofovir alafenamide
Drug class
Direct acting antiviral
ATC code
J05AF13
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Vemlidy 25 mg film-coated tablets.
Marketing authorisation holder
Gilead Sciences Ireland UC
Information as of
2026-10-28

Key facts

Tenofovir alafenamide (Vemlidy) is a nucleotide reverse transcriptase inhibitor for chronic hepatitis B in adults and children aged 6 years and older weighing at least 25 kg.

What it is used for

  • Treatment of chronic hepatitis B (CHB) in adults and paediatric patients 6 years of age and older weighing at least 25 kg.

Dosing

  • One 25 mg tablet once daily with food.
  • HBeAg-positive without cirrhosis: at least 6- 12 months after confirmed HBe seroconversion, or until HBs seroconversion or loss of efficacy; HBeAg-negative without cirrhosis: at least until HBs seroconversion or loss of efficacy.
  • No dose adjustment with CrCl ≥ 15 mL/min or on haemodialysis (take after dialysis); no recommendation for CrCl < 15 mL/min without dialysis.
  • No dose adjustment in hepatic impairment or in patients aged 65 years and older.
  • Take a missed dose within 18 hours; if vomiting within 1 hour, take another tablet.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Does not prevent transmission of HBV to others.
  • Hepatitis exacerbations may occur during and especially after stopping treatment; monitor closely.
  • Limited data in decompensated liver disease (CPT score > 9); monitor hepatic and renal parameters closely.
  • Monitor renal function.

Side effects

  • Most frequent (Week 96): headache (12%), nausea (6%) and fatigue (6%).
  • Common: dizziness and gastrointestinal complaints.
  • Lipid changes after switching from tenofovir disoproxil.

Interactions

  • Do not combine with other medicines containing tenofovir disoproxil, tenofovir alafenamide or adefovir dipivoxil.
  • P-gp inducers (e.g. rifampicin, rifabutin, carbamazepine, phenobarbital, St John's wort) are not recommended; strong P-gp inhibitors are also not recommended.

Pregnancy and breastfeeding

  • A moderate amount of data (300-1000 pregnancy outcomes) shows no malformative toxicity; use may be considered in pregnancy if necessary.
  • Should not be used during breast-feeding.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • VemlidyGilead Sciences Ireland UC · EMEA/H/C/004169

Source: European Medicines Agency (EMA), product information

Germany

  • Tenofoviralafenamid DevatisDevatis Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • Hepa-TafDROGSAN İLAÇLARI SAN. VE TİC. A.Ş. · 1 register entry
  • VemlidyGİLEAD SCİENCES İLAÇ TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 5 more European countries
Iceland
Vemlidy
Liechtenstein
Vemlidy
Netherlands
Tenofoviralafenamide Devatis
Norway
Vemlidy
Portugal
Tenofovir Alafenamida Humanis

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Vemlidy – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/vemlidy-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC J05AF.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.