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lenacapavir

Sunlenca, Yeytuo · ATC code J05AX

Key facts
Active substance
lenacapavir
Drug class
Enisamium iodide
ATC code
J05AX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Sunlenca 464 mg solution for injection · Sunlenca 300 mg film-coated tablets · Yeytuo 464 mg solution for injection · Yeytuo 300 mg film-coated tablets
Marketing authorisation holder
Gilead Sciences Ireland Unlimited Company
Information as of
2026-10-27

Key facts

Lenacapavir is a long-acting HIV-1 capsid inhibitor used to treat multidrug-resistant HIV-1 infection (Sunlenca) and for HIV-1 pre-exposure prophylaxis (Yeytuo).

What it is used for

  • Sunlenca: multidrug-resistant HIV-1 in adults when no other suppressive regimen is possible, combined with other antiretrovirals
  • Yeytuo: pre-exposure prophylaxis (PrEP) against sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg, with safer sex practices

Dosing

  • Sunlenca: Day 1 and Day 2 600 mg orally, Day 8 300 mg orally, Day 15 927 mg subcutaneously.
  • Sunlenca maintenance: 927 mg subcutaneously every 6 months (26 weeks) +/- 2 weeks.
  • Yeytuo: Day 1 927 mg subcutaneously plus 600 mg orally, Day 2 600 mg orally; then 927 mg subcutaneously every 6 months.
  • Yeytuo: if an injection will be delayed, oral bridging with 300 mg once every 7 days is possible.
  • More than 28 weeks since the last injection: restart from Day 1.
  • No adjustment in elderly patients or with CrCl ≥15 mL/min.

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Co-administration with strong inducers of CYP3A, P-gp and UGT1A1 (e.g. rifampicin, carbamazepine, phenytoin, St. John's wort)
  • Yeytuo: unknown HIV-1 status

Important warnings

  • Yeytuo only in individuals confirmed HIV-negative; re-test before each injection
  • Risk of resistance: after stopping Sunlenca, start a fully suppressive regimen no later than 28 weeks after the final injection
  • Residual levels may affect other CYP3A substrates for months after discontinuation
  • Immune reconstitution inflammatory syndrome and autoimmune disorders may occur (Sunlenca)
  • Moderate CYP3A and P-gp inducers (e.g. efavirenz) not recommended

Side effects

  • Sunlenca: injection site reactions (76%) and nausea (6%)
  • Yeytuo: injection site reactions (71% and 85% in the trials)
  • Injection site reactions include nodule, pain, induration, erythema and swelling
  • Yeytuo tablets: no adverse reactions to oral dosing identified

Interactions

  • Strong inducers of CYP3A, P-gp and UGT1A1: contraindicated (loss of effect, resistance)
  • Moderate CYP3A and P-gp inducers (e.g. efavirenz): not recommended
  • Strong inhibitors of all three pathways (e.g. atazanavir/cobicistat): not recommended
  • Lenacapavir may increase exposure to sensitive CYP3A substrates

Pregnancy and breastfeeding

  • Sunlenca: preferably avoided in pregnancy unless clinically required; women living with HIV should not breast-feed.
  • Yeytuo: limited data (130 birth outcomes); may be considered if the expected benefit outweighs the potential risk to the foetus.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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

Package leaflet for patients →

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)

  • SunlencaGilead Sciences Ireland Unlimited Company · EMEA/H/C/005638
  • YeytuoGilead Sciences Ireland Unlimited Company · EMEA/H/C/006658

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Sunlenca, Yeytuo
Liechtenstein
Sunlenca, Yeytuo
Norway
Sunlenca, Yeytuo

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

Other substances in the same group

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Sources

  1. European Medicines Agency. Sunlenca – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/sunlenca-epar-product-information_en.pdf
  2. European Medicines Agency. Yeytuo – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/yeytuo-epar-product-information_en.pdf
  3. Wikidata (CC0): ATC J05AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.