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deferasirox

Exjade · ATC code V03AC03

Also known as: Deferasiroks · Brand names: Exjade, Deferasirox G.L., Deferasirox Ratiopharm, Deferasirox Stada, Ferupantil, Deferasi Puren, Deferasirox Abdi, Deferasirox Abz, Deferasirox Al, Deferasirox Amarox, Deferasirox Axiromed, Deferasirox Basics, Deferasirox Beta, Deferasirox Glenmark, Deferasirox Heumann …

Key facts
Active substance
deferasirox
ATC code
V03AC03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
EXJADE 90 mg film-coated tablets / EXJADE 180 mg film-coated tablets / EXJADE 360 mg film-coated tablets · EXJADE 90 mg granules in sachet / EXJADE 180 mg granules in sachet / EXJADE 360 mg granules in sachet
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-28

Key facts

Deferasirox is an oral iron chelator that binds excess iron for excretion. It is used for chronic iron overload, mainly due to blood transfusions.

What it is used for

  • Chronic iron overload due to frequent blood transfusions in beta thalassaemia major aged 6 years and older.
  • Transfusional chronic iron overload when deferoxamine is contraindicated or inadequate: beta thalassaemia major aged 2 to 5 years (frequent transfusions), aged 2 years and older with infrequent transfusions, and other anaemias aged 2 years and older.
  • Chronic iron overload requiring chelation in non-transfusion-dependent thalassaemia syndromes aged 10 years and older, when deferoxamine is contraindicated or inadequate.

Dosing

  • Exjade film-coated tablets and Exjade granules, transfusional iron overload: recommended starting dose 14 mg/kg/day (e.g. after approximately 20 units of packed red blood cells or serum ferritin >1 000 µg/l); alternative starting doses 7 or 21 mg/kg/day depending on transfusion needs.
  • A 30% lower dose of the film-coated tablets or granules is needed compared with deferasirox dispersible tablets.
  • Monitor serum ferritin monthly; adjust every 3 to 6 months in steps of 3.5 to 7 mg/kg/day; maximum dose 28 mg/kg/day.
  • Non-transfusion-dependent thalassaemia: separate scheme based on liver iron concentration and serum ferritin – see the full text.
  • Moderate hepatic impairment (Child-Pugh B): considerably reduced dose, increased up to at most 50% of the recommended dose; not recommended in severe hepatic impairment (Child-Pugh C). Creatinine clearance <60 ml/min: contraindicated.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Estimated creatinine clearance <60 ml/min.

Important warnings

  • Kidney: dose-dependent serum creatinine increases in about 36% of patients; acute renal failure, sometimes requiring dialysis, has been reported. Monitor renal function regularly.
  • Liver: liver test elevations and cases of hepatic failure, some fatal, including hyperammonaemic encephalopathy; monitor liver tests regularly.
  • Upper gastrointestinal ulceration and haemorrhage, including fatal cases; caution with NSAIDs, corticosteroids and oral bisphosphonates.
  • Severe cutaneous adverse reactions (SJS, TEN, DRESS) have been reported.
  • Auditory and ophthalmic testing before treatment and annually. Take care to minimise the risk of overchelation.

Side effects

  • Most frequent: gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea, abdominal pain) and skin rash, mostly mild to moderate and transient.
  • Dose-dependent serum creatinine increase, increased transaminases.
  • Uncommon: decreased hearing, lens opacities. Serious: hepatic failure, gastrointestinal haemorrhage or perforation, SJS/TEN/DRESS.

Interactions

  • Potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may reduce efficacy; monitor serum ferritin.
  • Avoid repaglinide (CYP2C8 substrate); caution with narrow-therapeutic-index CYP1A2 substrates (e.g. theophylline, clozapine) and CYP3A4 substrates (e.g. ciclosporin, simvastatin, hormonal contraceptives).
  • Do not take with aluminium-containing antacids; busulfan exposure may increase.

Pregnancy and breastfeeding

  • Not to be used in pregnancy unless clearly necessary; may decrease the efficacy of hormonal contraceptives – additional or alternative non-hormonal contraception is recommended.
  • Breast-feeding is not recommended.

Summary of the official product information, written with AI on 2026-10-29. 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

This product has no separate US patient information.

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)

Source: European Medicines Agency (EMA), product information

Austria

  • Deferasirox G.L.G.L. Pharma Gmbh · 1 register entry
  • Deferasirox RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
  • Deferasirox StadaStada Arzneimittel Gmbh · 1 register entry
  • FerupantilSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Deferasi PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Deferasirox AbdiAbdi Farma Gmbh · 1 register entry
  • Deferasirox AbzAbz-Pharma Gmbh · 1 register entry
  • Deferasirox AlAliud Pharma Gmbh · 1 register entry
  • Deferasirox AmaroxAmarox Pharma Gmbh · 1 register entry
  • Deferasirox AxiromedMedical Valley Invest Ab · 1 register entry
  • Deferasirox BasicsBasics Gmbh · 1 register entry
  • Deferasirox BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Deferasirox GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
  • Deferasirox HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Deferasirox HexalHexal Ag · 1 register entry
  • Deferasirox HolstenHolsten Pharma Gmbh · 1 register entry
Show all 18 brand names
  • Deferasirox JubilantJubilant Pharmaceuticals Nv · 3 register entries
  • Deferasirox RatiopharmRatiopharm Gmbh · 1 register entry
  • Deferasirox StadaStadapharm Gmbh · 1 register entry
  • Deferasirox UmedicaUmedica Netherlands B.V · 1 register entry
  • Deferasirox VivantaVivanta Generics S.R.O. · 1 register entry
  • Deferasirox ZentivaZentiva Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • CelactASET İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • DefeceoDR. SERTUS İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
  • DefejactWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • DefirinalPHARMİNAL MEDİKAL İLAÇ A.Ş. · 1 register entry
  • DefroniTEVA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • DeniraxCOSTA SAĞLIK SPOR HİZMETLERİ TİC. LTD. ŞTİ. · 3 register entries
  • EnferoxİLKO İLAÇ SAN.VE TİC. A.Ş. · 6 register entries
  • ExjadeNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 3 register entries
  • FebindFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • FenobisNOBİS SCİENTİFİC İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • FeroutALİ RAİF İLAÇ SAN. A.Ş. · 6 register entries
  • FesorSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
Show all 17 brand names
  • FuarteABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • JadiroxBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • OxfetSANTA FARMA İLAÇ SAN. A.Ş. · 6 register entries
  • VexperdaFARMANOVA SAĞLIK HİZMETLERİ LTD. ŞTİ. · 3 register entries
  • ZenoNOBEL İLAÇ SAN. VE TİC. A.Ş. · 6 register entries

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

Brand names in 23 more European countries
Belgium
Deferasirox Ab
Bulgaria
Deferasirox Synthon, Ziadex, Деферазирокс Тева, Деферазирокс Фармасайънс, Ферупантил
Croatia
Deferasiroks Pliva, Deferasiroks Umedica, Roxofor, Zeoks, Zilart
Cyprus
Deferasirox Msn, Issoferrol, Sidipast
Czechia
Deferasirox Auxpharma, Deferasirox Glenmark, Deferasirox Msn, Deferasirox Sandoz, Deferasirox Zentiva, Exferana
Denmark
Deferasirox Deferasirox "jubilant", Deferasirox Glenmark, Deferasirox Medical Valley, Deferasirox Pharmathen, Deferasirox Sandoz, Deferasirox Sigillata, Deferasirox Stada, Deferasirox Teva
Finland
Deferasirox Glenmark, Deferasirox Stada
France
Deferasirox Arrow, Deferasirox Bgr, Deferasirox Biogaran, Deferasirox Eg, Deferasirox Sandoz, Deferasirox Teva, Deferasirox Zentiva
Greece
Deferasirox Pharmathen, Deferasirox Rafarm, Deferasirox Sandoz, Deferasirox Teva, Issoferrol, Sidipast
Hungary
Deferasirox Msn, Deferasirox Pharmascience, Deferasirox Sandoz, Exferana
Iceland
Deferasirox Accord, Deferasirox Medical Valley, Deferasirox Mylan, Exjade, Zeoks
Italy
Deferasirox Abdi, Deferasirox Aurobindo, Deferasirox Doc, Deferasirox Glenmark, Deferasirox Pharmathen, Deferasirox Sandoz, Deferasirox Sigillata, Deferasirox Sun, Deferasirox Zentiva
Latvia
Deferasirox Umedica
Liechtenstein
Deferasirox Accord, Deferasirox Mylan, Exjade
Malta
Deferasirox Pharos
Netherlands
Deferasirox Abdi, Deferasirox Amarox, Deferasirox Aurobindo, Deferasirox Betapharm, Deferasirox Cf, Deferasirox Doc, Deferasirox Msn, Deferasirox Rafarm, Deferasirox Sandoz, Deferasirox Stada, Deferasirox Sun, Deferasirox Synthon, Deferasirox Teva, Deferasirox Umedica, Deferasirox Vivanta, Deferasirox Xiromed, Exferana, Sidipast
Norway
Deferasirox Accord, Deferasirox Medical Valley, Deferasirox Mylan, Deferasirox Sandoz, Deferasirox Teva, Exjade
Poland
Deferasirox Msn, Exferana
Portugal
Deferasirox
Romania
Deferasirox Msn Laboratories, Deferasirox Sanexcel, Deferasirox Stada, Reditens, Zeoks
Slovakia
Deferasirox, Exferana
Spain
Deferasirox Abdi, Deferasirox Aurovitas, Deferasirox Ratiopharm, Deferasirox Stada, Deferasirox Sun, Deferasirox Tarbis, Deferasirox Teva-Ratiopharm, Deferasirox Umedica, Deferasirox Viso Farmacéutica, Deferasirox Vivanta, Deferasirox Zentiva, Ferupantil
Sweden
Deferasirox

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Another question about this substance?

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Sources

  1. European Medicines Agency. Exjade – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/exjade-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. 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 2026-10-28 · 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.