MedeliX
Start asking

nivolumab

Opdivo · ATC code L01FF01

Key facts
Active substance
nivolumab
ATC code
L01FF01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
OPDIVO 10 mg/mL concentrate for solution for infusion. · OPDIVO 300 mg solution for injection / OPDIVO 600 mg solution for injection
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Information as of
2026-10-27

Key facts

Nivolumab (Opdivo) is a human monoclonal antibody (immune checkpoint inhibitor). It is used alone or in combination for many tumour types, including melanoma, lung cancer and renal cell carcinoma.

What it is used for

  • Melanoma: adjuvant after complete resection and advanced melanoma, alone or with ipilimumab (infusion also from 12 years of age)
  • Non-small cell lung cancer: neoadjuvant with chemotherapy in PD-L1-expressing tumours, and advanced disease after prior chemotherapy
  • Renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, oesophageal and gastric cancers, among others
  • Full list of indications in the product information

Dosing

  • Opdivo concentrate, monotherapy: 240 mg every 2 weeks or 480 mg every 4 weeks intravenously, depending on indication
  • Adolescents 12 years and older weighing less than 50 kg (melanoma): 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks
  • Opdivo solution for injection (subcutaneous), monotherapy: 600 mg every 2 weeks or 1200 mg every 4 weeks
  • Adjuvant therapy: maximum 12 months
  • Combinations (e.g. with ipilimumab or chemotherapy) have their own regimens, see the full product information

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Immune-related adverse reactions, possibly in several body systems at once; more frequent with ipilimumab
  • Most improved or resolved with corticosteroids and treatment modification
  • Assess PD-L1 and MSI/MMR status with validated tests
  • Record name and batch number for traceability

Side effects

  • Monotherapy, most frequent: fatigue (44%), musculoskeletal pain (28%), diarrhoea (26%), rash (24%), cough (22%), nausea (22%), pruritus (19%)
  • Mostly mild to moderate; Grade 3-5 reactions in 44%
  • Immune-related reactions (e.g. lung, bowel, liver, endocrine glands)

Interactions

  • Avoid systemic corticosteroids and immunosuppressants before starting; may be used after starting to treat immune-related reactions
  • No CYP-mediated effects on nivolumab expected

Pregnancy and breastfeeding

  • No data in pregnant women; may pass to the foetus; not recommended unless the benefit outweighs the risk
  • Effective contraception for at least 5 months after the last dose

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)

  • OpdivoBristol-Myers Squibb Pharma EEIG · EMEA/H/C/003985

Source: European Medicines Agency (EMA), product information

Turkey

  • OpdivoBRISTOL-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
Opdivo
Liechtenstein
Opdivo
Norway
Opdivo

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. Opdivo – 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/opdivo-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.