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durvalumab

Imfinzi · ATC code L01XC28

Key facts
Active substance
durvalumab
ATC code
L01XC28
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
IMFINZI 50 mg/ml concentrate for solution for infusion.
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-27

Key facts

Durvalumab (Imfinzi) is a monoclonal antibody against PD-L1 (immune checkpoint inhibitor). It is used in lung cancer, biliary tract cancer, hepatocellular carcinoma and other tumours.

What it is used for

  • Resectable NSCLC at high risk of recurrence: neoadjuvant with platinum-based chemotherapy, then adjuvant monotherapy
  • Locally advanced, unresectable NSCLC with PD-L1 expression after platinum-based chemoradiation
  • Metastatic NSCLC without EGFR/ALK alterations: first-line with tremelimumab and chemotherapy
  • Small cell lung cancer: limited stage after chemoradiation; extensive stage first-line with etoposide and platinum
  • Unresectable or metastatic biliary tract cancer with gemcitabine and cisplatin; hepatocellular carcinoma
  • Further indications (including endometrial cancer) in the full product information

Dosing

  • Intravenous infusion over 1 hour; started and supervised by a physician experienced in cancer treatment
  • Locally advanced NSCLC: 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks, up to 12 months
  • LS-SCLC: 1,500 mg every 4 weeks, up to 24 months; HCC: 1,500 mg every 4 weeks
  • Combination regimens (e.g. with tremelimumab or chemotherapy) have their own schedules, see the full product information

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Immune-mediated adverse reactions (e.g. pneumonitis): withhold or permanently discontinue depending on severity; start corticosteroids or endocrine therapy
  • Taper corticosteroids over at least 1 month after improvement
  • Record tradename and batch number for traceability

Side effects

  • Monotherapy, most common: cough (18.1%), diarrhoea (15.1%), rash (15.0%), pyrexia (12.5%), arthralgia (12.4%), hypothyroidism (11.6%), pruritus (11.1%)
  • Severe reactions: pneumonia (3.4%), increased transaminases (2.5%)
  • Most common reasons for discontinuation: pneumonitis (1.1%) and pneumonia (0.8%)

Interactions

  • Systemic corticosteroids or immunosuppressants before starting are not recommended (except physiological doses); may be used after starting to treat immune-related reactions
  • No metabolic drug-drug interactions expected

Pregnancy and breastfeeding

  • Women of childbearing potential: effective contraception during treatment and for at least 3 months after the last dose
  • No data in pregnant women; based on mechanism of action may affect maintenance of pregnancy

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)

  • ImfinziAstraZeneca AB · EMEA/H/C/004771

Source: European Medicines Agency (EMA), product information

Turkey

  • ImfinziASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 2 register entries

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

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

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. Imfinzi – 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/imfinzi-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.