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ruxolitinib

Jakavi, Opzelura · ATC code L01EJ01

Brand names: Jakavi, Opzelura, Polink, Ruxib, Ruxolitinib Devatis

Key facts
Active substance
ruxolitinib
ATC code
L01EJ01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Jakavi 5 mg tablets / Jakavi 10 mg tablets / Jakavi 15 mg tablets · Jakavi 5 mg/ml oral solution · Opzelura 15 mg/g cream
Marketing authorisation holder
Novartis Europharm Limited, Incyte Biosciences Distribution B.V.
Information as of
2026-10-27

Key facts

Ruxolitinib is a Janus kinase (JAK) inhibitor. As Jakavi (tablets, oral solution) it is used for myelofibrosis, polycythaemia vera and graft versus host disease; as Opzelura cream for vitiligo and atopic dermatitis.

What it is used for

  • Jakavi: splenomegaly or symptoms in primary myelofibrosis and post-PV or post-ET myelofibrosis (adults)
  • Jakavi: polycythaemia vera resistant to or intolerant of hydroxyurea (adults)
  • Jakavi: acute GvHD from 28 days and chronic GvHD from 6 months with inadequate response to corticosteroids or other systemic therapies
  • Opzelura: non-segmental vitiligo with facial involvement from 12 years; moderate atopic dermatitis in adults

Dosing

  • Jakavi, myelofibrosis: starting dose by platelet count from 5 mg to 20 mg twice daily; maximum 25 mg twice daily
  • Jakavi, polycythaemia vera: start 10 mg twice daily
  • Jakavi, GvHD: 12 years and above 10 mg twice daily, 6 to less than 12 years 5 mg twice daily, younger children by body surface area
  • Jakavi: blood count before starting and every 2 to 4 weeks until doses are stable; reduce dose with strong CYP3A4 inhibitors
  • Opzelura, vitiligo: thin layer twice daily on up to 10% of body surface area; atopic dermatitis: up to 20% of body surface area

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Pregnancy and breast-feeding (Jakavi and Opzelura)

Important warnings

  • Jakavi: myelosuppression (thrombocytopenia, anaemia, neutropenia); discontinue for platelets below 50 000/mm3 or neutrophils below 500/mm3
  • Jakavi: serious infections including tuberculosis (screen beforehand), herpes zoster and progressive multifocal leukoencephalopathy
  • Jakavi: non-melanoma skin cancer, thrombosis; myelofibrosis symptoms may return after stopping
  • Opzelura: not for ophthalmic, oral or intravaginal use; non-melanoma skin cancer and herpes zoster reactivation reported

Side effects

  • Jakavi, myelofibrosis: anaemia (83.8%), thrombocytopenia (80.5%), neutropenia (20.8%), bruising (33.3%), dizziness (21.9%), increased ALT (40.7%)
  • Jakavi, GvHD: mainly thrombocytopenia, anaemia, neutropenia and raised transaminases
  • Opzelura: most common application site acne (5.8% in vitiligo, 4.4% in atopic dermatitis); uncommon herpes zoster

Interactions

  • Jakavi: metabolised by CYP3A4 and CYP2C9; strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir) increase exposure, reduce dose by approximately 50%
  • Jakavi: avoid fluconazole doses greater than 200 mg daily
  • Opzelura: low interaction potential due to limited systemic exposure

Pregnancy and breastfeeding

  • Pregnancy and breast-feeding: contraindicated (embryotoxic and foetotoxic in animals)
  • Women of childbearing potential must use effective contraception (with Opzelura until 4 weeks after stopping)

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)

  • JakaviNovartis Europharm Limited · EMEA/H/C/002464
  • OpzeluraIncyte Biosciences Distribution B.V. · EMEA/H/C/005843

Source: European Medicines Agency (EMA), product information

Austria

  • Polink+pharma Arzneimittel Gmbh · 1 register entry
  • RuxibG.L. Pharma Gmbh · 1 register entry
  • Ruxolitinib DevatisDevatis Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • JakaviNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 11 register entries

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

Brand names in 23 more European countries
Bulgaria
Руджави, Руксолитиниб Сандоз
Croatia
Ruksolitinib Devatis, Ruksolitinib Msn, Ruksolitinib Sandoz
Cyprus
Ruxolitinib Sandoz
Czechia
Ruxolitinib Msn, Ruxolitinib Sandoz
Denmark
Ruxolitinib Devatis, Ruxolitinib Orion, Ruxolitinib Sandoz, Ruxolitinib Vivanta
Estonia
Ruxolitinib Msn
Finland
Ruxolitinib Devatis, Ruxolitinib Orion, Ruxolitinib Sandoz
France
Ruxolitinib Biogaran, Ruxolitinib Olpha, Ruxolitinib Sandoz
Greece
Jakulya, Ruxolitinib Sandoz
Hungary
Ruxolitinib Sandoz
Iceland
Jakavi, Jakulya, Opzelura, Ruxolitinib Coripharma, Ruxolitinib Sandoz
Italy
Ruxolitinib Vivanta
Latvia
Ruxolitinib Msn, Ruxolitinib Olpha
Liechtenstein
Jakavi, Opzelura
Lithuania
Ruxolitinib Msn, Ruxolitinib Norameda, Ruxolitinib Olpha, Ruxolitinib Sandoz
Malta
Donlize, Ruxolitinib Medichem, Ruxolitinib Sandoz, Ruxolitinib Torrent
Netherlands
Ruxolitinib Accord, Ruxolitinib Advanz Pharma, Ruxolitinib Devatis, Ruxolitinib Medichem, Ruxolitinib Msn, Ruxolitinib Sandoz, Ruxolitinib Vivanta
Norway
Jakavi, Opzelura, Ruxolitinib Accord, Ruxolitinib Devatis, Ruxolitinib Orion, Ruxolitinib Sandoz
Portugal
Ruxolitinib Bluepharma
Romania
Ruxolitinib Msn
Slovenia
Ruksolitinib Msn
Spain
Ruxolitinib Cipla, Ruxolitinib Vivanta
Sweden
Ruxolitinib Devatis, Ruxolitinib Olpha, Ruxolitinib Orion, Ruxolitinib Sandoz

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Jakavi – 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/jakavi-epar-product-information_en.pdf
  2. European Medicines Agency. Opzelura – 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/opzelura-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. 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.