Contraindications - Deferasirox

Deferasirox contraindications: hypersensitivity, CrCl<60 mL/min, high-risk MDS, combination chelation, severe hepatic impairment, pregnancy.

Deferasirox is contraindicated in a defined set of clinical situations where the benefit-risk balance is unfavourable. Adherence to these contraindications is essential for safe prescribing - and locally approved labelling should always be consulted, as some details vary by market.

Absolute Contraindications #

  • Hypersensitivity to deferasirox or to any of the excipients of the dispersible tablet (e.g. lactose monohydrate, povidone, sodium lauryl sulfate)
  • Estimated creatinine clearance < 60 mL/min (as locally defined; some labels specify < 40 mL/min for the film-coated/granule formulations - refer to local labelling)
  • High-risk MDS or advanced malignancy where treatment benefit-risk is unfavourable (refer to local labelling)
  • Combination with other iron-chelation therapies (deferoxamine or deferiprone) outside of specialist supervision

Excipient-Related Considerations #

The DEFRATAJ dispersible tablet contains lactose monohydrate - patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. The full excipient list is provided on each product page.

Pregnancy #

Deferasirox is not contraindicated in pregnancy in all markets, but use is generally avoided unless clearly necessary. Women of childbearing potential should use effective non-hormonal contraception during therapy and for an appropriate period after discontinuation - because deferasirox can reduce hormonal contraceptive efficacy through CYP3A4 induction.

Breast-Feeding #

It is not known whether deferasirox is excreted in human milk. A decision to discontinue breast-feeding or therapy should be made in consultation with the prescribing physician, taking into account the benefit of therapy to the mother.

Severe Hepatic Impairment #

Avoid deferasirox in severe hepatic impairment (Child-Pugh C). Use with dose reduction and close monitoring in moderate hepatic impairment (Child-Pugh B).

Special Caution Populations #

While not absolute contraindications, the following require careful benefit-risk evaluation:

  • Elderly patients with significant comorbidities (renal, hepatic, GI)
  • Patients with advanced underlying disease and short life expectancy
  • Patients with active GI bleeding or peptic ulcer disease
  • Patients on multiple nephrotoxins or with baseline renal dysfunction approaching the contraindication threshold
Always consult the locally approved Summary of Product Characteristics (SmPC) / package insert for definitive contraindications applicable to your market. Some details vary by country and by formulation (dispersible tablet vs film-coated tablet vs granules).