Formulary
Deferasirox: Indications, Dosing, Side Effects and Interactions
Deferasirox is an oral iron chelator.
MedNext Academy | 5 min read
Deferasirox: Indications, Dosing, Side Effects and Interactions
Deferasirox is an oral iron chelator.
Drug action
Deferasirox is an oral iron chelator.
Indications and dose
**Transfusion-related chronic iron overload in patients with beta thalassaemia major who receive frequent blood transfusions (7 mL/kg/month or more of packed red blood cells) (specialist use only)**
- **Adult** (By Mouth): Initially 7-21 mg/kg once daily, dose adjusted according to serum-ferritin concentration and amount of transfused blood-consult product literature, then adjusted in steps of 3.5-7 mg/kg every 3-6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 28 mg/kg per day; Usual maximum 21 mg/kg.
**Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with beta thalassaemia major who receive infrequent blood transfusions (less than 7 mL/kg/month of packed red blood cells) (specialist use only),Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with other anaemias (specialist use only)**
- **Adult** (By Mouth): Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with beta thalassaemia major who receive infrequent blood transfusions (less than 7 mL/kg/month of packed red blood cells) (specialist use only), Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with other anaemias (specialist use only) Initially 7-21 mg/kg once daily, dose adjusted according to serum-ferritin concentration and amount of transfused blood-consult product literature, then adjusted in steps of 3.5-7 mg/kg every 3-6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 28 mg/kg per day; Usual maximum 21 mg/kg.
**Chronic iron overload when desferrioxamine is contra-indicated or inadequate in non-transfusion-dependent thalassaemia syndromes (specialist use only)**
- **Adult** (By Mouth): Initially 7 mg/kg once daily, then adjusted in steps of 3.5-7 mg/kg every 3-6 months, maintenance dose adjusted according to serum-ferritin concentration and liver-iron concentration (consult product literature); maximum 14 mg/kg per day.
**Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with beta thalassaemia major who receive frequent blood transfusions (7 mL/kg/month or more of packed red blood cells) (specialist use only) for deferasirox**
- **Child 2-5 years** (By mouth): Initially 7-21 mg/kg once daily, dose adjusted according to serum-ferritin concentration and amount of transfused blood-consult product literature, then adjusted in steps of 3.5-7 mg/kg every 3-6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 28 mg/kg per day; Usual maximum 21 mg/kg.
**Transfusion-related chronic iron overload in patients with beta thalassaemia major who receive frequent blood transfusions (7 mL/kg/month or more of packed red blood cells) (specialist use only) for deferasirox**
- **Child 6-17 years** (By mouth): Initially 7-21 mg/kg once daily, dose adjusted according to serum-ferritin concentration and amount of transfused blood-consult product literature, then adjusted in steps of 3.5-7 mg/kg every 3-6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 28 mg/kg per day; Usual maximum 21 mg/kg.
**Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with beta thalassaemia major who receive infrequent blood transfusions (less than 7 mL/kg/month of packed red blood cells) (specialist use only), Transfusion-related chronic iron overload when desferrioxamine is contra-indicated or inadequate in patients with other anaemias (specialist use only) for deferasirox**
- **Child 2-17 years** (By mouth): Initially 7-21 mg/kg once daily, dose adjusted according to serum-ferritin concentration and amount of transfused blood-consult product literature, then adjusted in steps of 3.5-7 mg/kg every 3-6 months, maintenance dose adjusted according to serum-ferritin concentration; maximum 28 mg/kg per day; Usual maximum 21 mg/kg.
**Chronic iron overload when desferrioxamine is contra-indicated or inadequate in non-transfusion-dependent thalassaemia syndromes (specialist use only) for deferasirox**
- **Child 10-17 years** (By mouth): Initially 7 mg/kg once daily, maintenance dose adjusted according to serum-ferritin concentration and liver-iron concentration (consult product literature); maximum 7 mg/kg per day.
Cautions
Elderly (increased risk of side-effects); history of liver cirrhosis; not recommended in conditions which may reduce life expectancy (e.g. high-risk myelodysplastic syndromes); platelet count less than 50x10 9 /litre; risk of gastro-intestinal ulceration and haemorrhage; unexplained cytopenia-consider treatment interruption
Side effects
Common or very common Constipation; diarrhoea; gastrointestinal discomfort; headache; nausea; skin reactions; urine abnormalities; vomiting Uncommon Anxiety; cataract; cholelithiasis; dizziness; fatigue; fever; gastrointestinal disorders; gastrointestinal haemorrhage (including fatal cases); hearing impairment; hepatic disorders; laryngeal pain; maculopathy; oedema; renal tubular disorders; sleep disorder Rare or very rare Optic neuritis; severe cutaneous adverse reactions (SCARs) Frequency not known Acute kidney injury; alopecia; anaemia aggravated; hyperammonaemic encephalopathy; hypersensitivity vasculitis; lens opacity; leucopenia; metabolic acidosis; nephritis tubulointerstitial; nephrolithiasis; neutropenia; pancreatitis acute; pancytopenia; renal tubular necrosis; thrombocytopenia
Interactions
**Severe interactions:**
- Cholestyramine significantly reduced the deferasirox exposure in a mechanistic study to determine the degree of enterohepatic recycling (see section 5.2).
**Other interactions (25):**
- The safety of deferasirox in combination with other iron chelators has not been established.
- Interaction with food The C max of deferasirox film-coated tablets was increased (by 29%) when taken with a high-fat meal.
- Deferasirox film-coated tablets may be taken either on an empty stomach or with a light meal, preferably at the same time each day (see sections 4.2 and 5.2).
- Agents that may decrease Deferasirox systemic exposure Deferasirox metabolism depends on UGT enzymes.
- In a healthy volunteer study, the concomitant administration of deferasirox (single dose of 30 mg/kg, dispersible tablet formulation) and the potent UGT inducer, rifampicin, (repeated dose of 600...
- Therefore, the concomitant use of deferasirox with potent UGT inducers (e.g.
Pregnancy
Manufacturer advises avoid unless essential- toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution in moderate impairment; avoid in severe impairment. Dose adjustments Manufacturer advises reduce initial dose considerably then gradually increase to max. 50% of normal dose in moderate impairment.
Renal impairment
Manufacturer advises avoid if estimated creatinine clearance less than 60 mL/minute. Dose adjustments See Prescribing in renal impairment . Manufacturer advises reduce dose if creatinine clearance less than 90 mL/minute and serum creatinine increased by more than 33% of baseline measurement on 2 consecutive occasions-consult product literature.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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