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dostarlimab

Jemperli · ATC code L01FF07

Key facts
Active substance
dostarlimab
ATC code
L01FF07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
JEMPERLI 500 mg concentrate for solution for infusion
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited
Information as of
2026-10-27

Key facts

Dostarlimab is an anti-PD-1 monoclonal antibody used to treat advanced or recurrent endometrial cancer in adults.

What it is used for

  • First-line treatment of primary advanced or recurrent endometrial cancer in combination with carboplatin and paclitaxel
  • Monotherapy for dMMR/MSI-H recurrent or advanced endometrial cancer after a platinum-containing regimen

Dosing

  • Initiated and supervised by experienced oncologists; dMMR/MSI-H status determined by a validated test
  • Combination: 500 mg every 3 weeks with carboplatin and paclitaxel for 6 cycles, then 1000 mg every 6 weeks as monotherapy, for up to 3 years
  • Monotherapy: 500 mg every 3 weeks for 4 cycles, then 1000 mg every 6 weeks until progression or unacceptable toxicity
  • No dose reduction; delay or discontinuation for adverse reactions (see full text)

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Immune-related adverse reactions in any organ, possibly severe or fatal, also after discontinuation
  • Blood counts and liver, kidney and thyroid function at baseline and periodically
  • Infusion-related reactions may occur
  • Tradename and batch number recorded for traceability

Side effects

  • Monotherapy, most common: anaemia, diarrhoea, nausea, vomiting, arthralgia, pruritus, rash, pyrexia, AST increased and hypothyroidism
  • Serious adverse reactions were mostly immune-related
  • Most immune-related reactions resolved with treatment or withdrawal

Interactions

  • No interaction studies; pharmacokinetic interactions with small-molecule substances are not expected

Pregnancy and breastfeeding

  • Women of childbearing potential must use effective contraception during treatment and until 4 months after the last dose
  • Based on its mechanism, foetal harm is possible

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)

  • JemperliGlaxoSmithKline Trading Services Limited · EMEA/H/C/005204

Source: European Medicines Agency (EMA), product information

Turkey

  • JemperliGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 1 register entry

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

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

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. Jemperli – 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/jemperli-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.