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pembrolizumab

Keytruda · ATC code L01FF02

Key facts
Active substance
pembrolizumab
ATC code
L01FF02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
KEYTRUDA 25 mg/mL concentrate for solution for infusion · KEYTRUDA 395 mg solution for injection / KEYTRUDA 790 mg solution for injection
Marketing authorisation holder
Merck Sharp & Dohme B.V.
Information as of
2026-10-27

Key facts

Pembrolizumab is a monoclonal antibody against the PD-1 receptor (immune checkpoint inhibitor). It is used alone or in combination for many cancers, including melanoma and non-small cell lung carcinoma.

What it is used for

  • Melanoma: advanced (unresectable or metastatic) and adjuvant after complete resection of Stage IIB, IIC or III, in adults and adolescents 12 years and older
  • Non-small cell lung carcinoma (NSCLC): neoadjuvant/adjuvant for resectable NSCLC, adjuvant after resection, first-line metastatic (monotherapy with PD-L1 TPS ≥50% or combined with chemotherapy)
  • Many further tumour types (e.g. classical Hodgkin lymphoma, renal cell carcinoma, head and neck cancer); full list in the full text

Dosing

  • Intravenous (adults): 200 mg every 3 weeks or 400 mg every 6 weeks as a 30-minute infusion
  • Subcutaneous (adults and adolescents 12 years and older over 40 kg): 395 mg every 3 weeks over 1 minute or 790 mg every 6 weeks over 2 minutes
  • Children aged 3 years and older with cHL or 12 years and older with melanoma (intravenous): 2 mg/kg (up to 200 mg) every 3 weeks
  • Treat until progression or unacceptable toxicity; adjuvant use up to one year
  • Switching between intravenous and subcutaneous use is possible at the next scheduled dose

Contraindications

  • See the full official text (section 4.3) for contraindications.

Important warnings

  • Immune-mediated adverse reactions, including severe and fatal cases, also after the last dose: e.g. pneumonitis, colitis, hepatitis, nephritis, endocrinopathies
  • If suspected, withhold according to severity and give corticosteroids; taper over at least 1 month
  • Severe skin reactions including rare SJS and TEN
  • Severe infusion-related reactions
  • Assess PD-L1 status with a validated method

Side effects

  • Monotherapy most frequent: fatigue (31%), diarrhoea (22%), nausea (20%); mostly Grade 1 or 2
  • Most serious: immune-mediated adverse reactions and severe infusion-related reactions
  • Subcutaneous formulation: additional injection-site reactions

Pregnancy and breastfeeding

  • No data in pregnant women; potential fetal harm based on mechanism; contraception during and for at least 4 months after the last dose
  • Unknown whether secreted in human milk; decide between stopping breast-feeding or stopping treatment

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 →

Common questions – ask Medelix

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)

  • KeytrudaMerck Sharp & Dohme B.V. · EMEA/H/C/003820

Source: European Medicines Agency (EMA), product information

Turkey

  • KeytrudaMERCK SHARP DOHME İLAÇLARI LTD. ŞTİ. · 1 register entry

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

Brand names in 3 more European countries
Iceland
Keytruda
Liechtenstein
Keytruda
Norway
Keytruda

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

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Keytruda – 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/keytruda-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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.