rare: diarrhoea.
Skin and subcutaneous tissue disorders
Very rare: rash generalised.
Musculoskeletal and connective tissue disorders
Common: growth retardation and bone disorder (e.g. metaphyseal dysplasia) are common in chelated patients given doses of 60 mg/kg, especially those who begin iron chelation in the first three years of life. If doses are kept to 40 mg/kg or below, the risk is considerably reduced (see 4.4 Special warnings and precautions for use).
Unknown: muscle spasms.
Renal and urinary disorders
Unknown: acute renal failure, renal tubular disorder, blood creatinine increased (see 4.4 Special warnings and precautions for use and section 4.9 Overdose).
Special remarks
At the injection site pain, swelling, infiltration, erythema, pruritus and eschar/crust are very common; vesicles, local oedema and burning are uncommon reactions. The local manifestations may be accompanied by systemic reactions like arthralgia/myalgia (very common), headache (common), urticaria (common), nausea (common), pyrexia (common), vomiting (uncommon), or abdominal pain (uncommon) or asthma (uncommon).
Excretion of the iron complex may cause reddish-brown discoloration of the urine.
Convulsion has been mainly reported in dialysed patients with aluminium overload.
Patients treated for chronic aluminum overload
Desferal chelation therapy aluminum overload may result in hypocalcemia and aggravation of hyperparathyroidism (see section 4.4 Special warnings and precautions for use).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Desferal is usually administered parenterally and acute poisoning is unlikely to occur.
Signs and symptoms: tachycardia, hypotension and gastro-intestinal symptoms have occasionally occurred in patients who received an overdose of Desferal. Accidental administration of Desferal by the i.v. route may be associated with acute but transient loss of vision, aphasia, agitation, headache, nausea, bradycardia, hypotension and acute renal failure (see section 4.8 Undesirable effects).
Acute respiratory distress syndrome has been described following treatment with excessively high i.v. doses of Desferal in patients with acute iron intoxication, and also in thalassemic patients (see also section 4.4 Special warnings and precautions for use).
Treatment: there is no specific antidote to Desferal but signs and symptoms may be eliminated by reducing the dosage and Desferal is dialysable. Appropriate supportive therapy should be instituted.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Chelating agent (ATC code: V03AC01)
Desferal is a chelating agent for trivalent iron and aluminium ions; the resulting chelates (ferrioxamine and aluminoxamine) are stable and non-toxic. Neither chelate undergoes intestinal absorption, and any formed systemically as a result of parenteral administration is rapidly excreted via the kidneys without deleterious effects. Desferal takes up iron either free or bound to ferritin and haemosiderin. Similarly it mobilises and chelates tissue bound aluminium. It does not remove iron fr |
