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ipilimumab

Yervoy · ATC code L01FX04

Key facts
Active substance
ipilimumab
ATC code
L01FX04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
YERVOY 5 mg/ml concentrate for solution for infusion
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-27

Key facts

Ipilimumab (Yervoy) is a CTLA-4-directed human monoclonal antibody (checkpoint inhibitor) used alone or, mostly, with nivolumab in several advanced cancers.

What it is used for

  • Advanced melanoma in adults and adolescents 12 years and older (monotherapy or with nivolumab)
  • First-line with nivolumab: intermediate/poor-risk advanced renal cell carcinoma, unresectable malignant pleural mesothelioma
  • First-line metastatic NSCLC without sensitising EGFR mutation or ALK translocation, with nivolumab and 2 cycles of platinum-based chemotherapy
  • dMMR or MSI-H colorectal cancer with nivolumab (further indications in full text)

Dosing

  • Melanoma, monotherapy: 3 mg/kg intravenously over 30 minutes every 3 weeks for a total of 4 doses
  • Melanoma with nivolumab (at least 50 kg): ipilimumab 3 mg/kg plus nivolumab 1 mg/kg every 3 weeks for 4 doses, then nivolumab monotherapy
  • Renal cell carcinoma: ipilimumab 1 mg/kg plus nivolumab 3 mg/kg every 3 weeks for 4 doses, then nivolumab alone
  • Other regimens and withholding/discontinuation for immune-related reactions in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Immune-related adverse reactions, some severe or fatal; more frequent in combination with nivolumab
  • Immune-related gastrointestinal reactions (diarrhoea, colitis); fatal gastrointestinal perforation reported
  • Immune-related hepatitis, endocrinopathies (e.g. hypophysitis, thyroid disorders, adrenal insufficiency), skin reactions
  • PD-L1 and MSI/MMR status should be assessed with validated tests
  • Batch number should be recorded for traceability

Side effects

  • Monotherapy, most frequent: diarrhoea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite, abdominal pain
  • Mostly mild to moderate; most immune-related reactions resolved with appropriate therapy

Interactions

  • Not metabolised by CYP enzymes
  • Avoid systemic corticosteroids at baseline (possible interference with efficacy)
  • Anticoagulants: increased risk of gastrointestinal haemorrhage, monitor closely

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using effective contraception, unless the benefit outweighs the risk

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)

  • YervoyBristol-Myers Squibb Pharma EEIG · EMEA/H/C/002213

Source: European Medicines Agency (EMA), product information

Turkey

  • YervoyBRISTOL-MYERS SQUIBB İLAÇLARI INC. İSTANBUL ŞUBESİ · 2 register entries

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

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

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. Yervoy – 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/yervoy-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.