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Deferasirox

AEMPS

Iron chelating agents

ATC code: V03AC03

Brand names: Deferasirox Stada, Exjade, Jadenu, Deferasirox Mylan

Updated · Methodology

Indications

A

Iron overload in thalassemia

First line

First-line iron-overload therapy in transfusion-dependent anemias (beta-thalassemia major, sickle cell disease, lower-risk MDS) per TIF 2023 and Spanish SEHH 2022. Starting dose 14 mg/kg once daily on empty stomach 30 minutes before food (Jadenu/film-coated tablets), or 20 mg/kg for the original Exjade form (dispersible tablets). Target – ferritin <1000 ng/mL, LIC (T2* MRI liver iron concentration) <7 mg/g dry weight.

Sources

  1. AEMPS: Ficha técnica de Deferasirox (2024)
  2. TIF: Guidelines for the Management of Transfusion-Dependent Thalassaemia (2021)

ICD-10: E83.1 · ICD-11: 5C64.10

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Body detoxification and cleansing

Not recommended

Deferasirox is an oral iron chelator. It is prescribed for confirmed iron overload associated with chronic blood transfusions (thalassemia, sickle cell anemia, myelodysplastic syndrome) and hereditary hemochromatosis (AEMPS Ficha Técnica). In alt detox circles, deferasirox is occasionally promoted to remove heavy metals or for iron overload in healthy people without confirmed hyperferritinemia. In healthy adults, no clinical studies of such use exist, and use is dangerous. The drug has serious risks: acute kidney injury, hepatotoxicity up to acute liver failure ( boxed warning), gastrointestinal bleeding, and myelosuppression. If deferasirox was prescribed for detox without confirmed iron overload, seek a second opinion immediately.

Sources

  1. AEMPS: Ficha técnica de Deferasirox (2024)
  2. J Hum Nutr Diet (Klein and Kiat): Detox diets for toxin elimination and weight management: a critical review of the evidence (2015)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Oral selective iron chelator. Forms a "2 deferasirox molecules – 1 Fe3+ ion" complex excreted in feces via bile. Unlike parenteral deferoxamine, deferasirox is orally active – convenient for patients with lifelong transfusion dependence. Half-life 8–16 hours allows once-daily dosing.

Safety

Boxed warning

FDA boxed warning 2010: risk of acute kidney injury, hepatic failure, and GI hemorrhage. Particularly in older patients with advanced MDS and multiple comorbidities.

Contraindications

  • Hypersensitivity
  • Severe renal impairment (eGFR <40 mL/min/1.73m²)
  • Platelets <50×10⁹/L in MDS
  • Severe hepatic impairment Child-Pugh C

Serious adverse effects

  • Acute kidney injury (FDA boxed warning 2010)
  • Hepatic failure (FDA boxed warning)
  • GI hemorrhage and ulcers (FDA boxed warning)
  • Cytopenias

Common adverse effects

  • Nausea
  • Diarrhea
  • Rash
  • Creatinine elevation (20–30% of patients)
  • ALT/AST elevation
  • Abdominal pain

Pregnancy: can you take Deferasirox?

AEMPS summary of product characteristics (section 4.6): there are no clinical data on deferasirox exposure during pregnancy. Animal studies have shown some reproductive toxicity at doses toxic to the mother, and the potential risk in humans is unknown. As a precaution, deferasirox is not recommended during pregnancy unless clearly necessary. It may reduce the efficacy of hormonal contraceptives, so women of childbearing potential are advised to use additional or non-hormonal contraceptive methods.

Breastfeeding: can you take Deferasirox?

No milk excretion data. Discontinue breastfeeding during therapy.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Empty stomach 30 minutes before food. Jadenu (film-coated) is swallowed whole with water. Exjade (dispersible tablets) is dissolved in water or apple juice, thoroughly mixed, and drunk in one draught. Monitor creatinine (weekly for the first month, then monthly), ALT/AST (monthly), CBC (monthly), ferritin (monthly). Dose adjusted every 3–6 months by ferritin and LIC.

Drug interactions

Aluminum-containing antacids reduce absorption – separate by 2 hours. Strong UGT inducers (rifampicin, phenytoin, ritonavir) reduce deferasirox levels – adjust dose. With repaglinide – significant repaglinide rise (hypoglycemia risk), monitor glucose. With warfarin – variable, monitor INR.
Label mentions21 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majorantiácidosclass named in the label
    «Otra información: No se ha estudiado formalmente la administración concomitante de deferasirox y antiácidos que contengan aluminio. Aunque deferasirox tiene una afinidad menor para el aluminio que…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorClozapine
    «Interacción con teofilina y otros medicamentos que se metabolizan por CYP1A2: En un estudio con voluntarios sanos, la administración concomitante de deferasirox como un inhibidor del CYP1A2 (a dosis…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorRepaglinide
    «Interacción con repaglinida y otros medicamentos que se metabolizan por CYP2C8: En un estudio con voluntarios sanos, la administración concomitante de deferasirox como inhibidor moderado de CYP2C8…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorTheophylline
    «Interacción con teofilina y otros medicamentos que se metabolizan por CYP1A2: En un estudio con voluntarios sanos, la administración concomitante de deferasirox como un inhibidor del CYP1A2 (a dosis…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAcetylsalicylic acid
    «Otra información: La administración conjunta de deferasirox con sustancias con capacidad ulcerogénica conocida, como los AINEs (incluyendo ácido acetilsalicílico a dosis altas), corticosteroides o…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateAINEclass named in the label
    «Otra información: La administración conjunta de deferasirox con sustancias con capacidad ulcerogénica conocida, como los AINEs (incluyendo ácido acetilsalicílico a dosis altas), corticosteroides o…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticoagulantesclass named in the label
    «Otra información: La administración conjunta de deferasirox con sustancias con capacidad ulcerogénica conocida, como los AINEs (incluyendo ácido acetilsalicílico a dosis altas), corticosteroides o…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateanticonceptivos hormonalesclass named in the label
    «Interacción con midazolam y otros medicamentos que se metabolizan por CYP3A4: En un ensayo con voluntarios sanos, la administración concomitante de deferasirox comprimidos dispersables y midazolam…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatebifosfonatosclass named in the label
    «Otra información: La administración conjunta de deferasirox con sustancias con capacidad ulcerogénica conocida, como los AINEs (incluyendo ácido acetilsalicílico a dosis altas), corticosteroides o…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCarbamazepine
    «Medicamentos que pueden disminuir la exposición a deferasirox: El metabolismo de deferasirox depende de los enzimas UGT. En un estudio con voluntarios sanos, la administración concomitante de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateCiclosporin
    «Interacción con midazolam y otros medicamentos que se metabolizan por CYP3A4: En un ensayo con voluntarios sanos, la administración concomitante de deferasirox comprimidos dispersables y midazolam…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatecorticosteroidesclass named in the label
    «Otra información: La administración conjunta de deferasirox con sustancias con capacidad ulcerogénica conocida, como los AINEs (incluyendo ácido acetilsalicílico a dosis altas), corticosteroides o…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateErgotamine
    «Interacción con midazolam y otros medicamentos que se metabolizan por CYP3A4: En un ensayo con voluntarios sanos, la administración concomitante de deferasirox comprimidos dispersables y midazolam…»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePhenobarbital
    «Medicamentos que pueden disminuir la exposición a deferasirox: El metabolismo de deferasirox depende de los enzimas UGT. En un estudio con voluntarios sanos, la administración concomitante de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePhenytoin
    «Medicamentos que pueden disminuir la exposición a deferasirox: El metabolismo de deferasirox depende de los enzimas UGT. En un estudio con voluntarios sanos, la administración concomitante de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRifampicin
    «Medicamentos que pueden disminuir la exposición a deferasirox: El metabolismo de deferasirox depende de los enzimas UGT. En un estudio con voluntarios sanos, la administración concomitante de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRitonavir
    «Medicamentos que pueden disminuir la exposición a deferasirox: El metabolismo de deferasirox depende de los enzimas UGT. En un estudio con voluntarios sanos, la administración concomitante de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateSimvastatin
    «Interacción con midazolam y otros medicamentos que se metabolizan por CYP3A4: En un ensayo con voluntarios sanos, la administración concomitante de deferasirox comprimidos dispersables y midazolam…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • MajorRepaglinide
    «En un ensayo de interacción realizado con voluntarios sanos, la coadministración de deferasirox (30 mg/kg/día, 4 días), un inhibidor moderado de CYP2C8 y CYP3A4, y repaglinida (una única dosis, 0,5…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDexketoprofen
    «Deferasirox: el uso concomitante con AINEs puede aumentar el riesgo de toxicidad gastrointestinal. Se requiere un estricto control clínico cuando se combina deferasirox con estas sustancias.»

    AEMPS, section 4.5 · Open on CIMA

  • Repaglinide
    «DRUG INTERACTIONS: Examples: Drugs that are known to inhibit CYP3A4 include antifungal agents (ketoconazole, itraconazole) and antibacterial agents (clarithromycin, erythromycin). Drugs that are…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Deferasirox used for?

Deferasirox is evaluated for the following indications with varying evidence strength: Iron overload in thalassemia (evidence tier A), Body detoxification and cleansing (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Deferasirox?

Common side effects of Deferasirox (≥ 1 in 100): Nausea, Diarrhea, Rash, Creatinine elevation (20–30% of patients), ALT/AST elevation, Abdominal pain. See the Safety section for uncommon and serious reactions.

Is Deferasirox safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are no clinical data on deferasirox exposure during pregnancy. Animal studies have shown some reproductive toxicity at doses toxic to the mother, and the potential risk in humans is unknown. As a precaution, deferasirox is not recommended during pregnancy unless clearly necessary. It may reduce the efficacy of hormonal contraceptives, so women of childbearing potential are advised to use additional or non-hormonal contraceptive methods.

Is Deferasirox compatible with breastfeeding?

No milk excretion data. Discontinue breastfeeding during therapy.

Who should not take Deferasirox?

Deferasirox is contraindicated in: Hypersensitivity; Severe renal impairment (eGFR <40 mL/min/1.73m²); Platelets <50×10⁹/L in MDS; Severe hepatic impairment Child-Pugh C. Full list in the Safety section.

Does Deferasirox carry an FDA boxed warning?

FDA boxed warning 2010: risk of acute kidney injury, hepatic failure, and GI hemorrhage. Particularly in older patients with advanced MDS and multiple comorbidities.

Official sources

Direct links to regulator labels. Open in a new tab.

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Ergoferon (antibodies to γ-interferon, CD4, and histamine in homeopathic dilutions), Methylthioninium chloride (methylene blue), Ethylmethylhydroxypyridine succinate, Naloxone, Antibodies to S-100 brain-specific protein (homeopathic), Anaferon (anti-human interferon gamma antibodies in homeopathic dilutions), Anas Barbariae Hepatis et Cordis Extractum (homeopathic), Deproteinized hemoderivative from calf blood