Composition: Deferiprone 500mg.
Presentation: Film-coated, white tablets.
Storage and stability: Do not store above 30C.
Action: Iron chelator.
Indications: Treatment of iron overload in patients with thalassemia major for
whom desferrioxamine therapy is contra-
indicated or who present serious toxicity with desferrioxamine therapy.
Contraindications: Hypersensitivity to active substance or excipients; history
of recurrent episodes of neutropenia; history of agranulocytosis.
Dosage and administration: 25mg/kg body weight three times a day. Dosage per
kilogram body weight should be calculated to the nearest half tablet (see SPC
for dosage table). Doses above 100mg/kg daily are not recommended because of
the potentially increased risk of adverse reactions.
Renal and hepatic impairment, no data available (see SPC).
Children aged 6-10 years, limited data. No data on use in children under six
years of age.
Pregancy and lactation, should not be used.
Overdosage: No reports of acute overdose.
Precautions: Neutrophil count should be monitored every week. In trials, this
has been effective in identifying cases of neutropenia and agranulocytosis,
which have resolved once therapy was withdrawn. If an infection develops, deferiprone
should be interrupted and neutrophil count monitored more frequently. Patients
should report symptoms indicative of infection such as fever, sore throat and
“’flu-like” symptoms immediately. See SPC for management of neutropenia.
Serum ferritin concentrations should be monitored monthly, or at least every
two months, to assess the long-term effectiveness of the chelation regimen in
controlling body iron load. If serum ferritin measurements fall below 500µg/L,
interruption of deferiprone should be considered. Plasma Zn2+ should be monitored
in addition to zinc supplementation. Therapy in immune compromised patients
should not be initiated unless potential benefit outweighs potential risks.
Careful monitoring of liver histology is recommended in patients with hepatitis
C.
Drug interactions: Interactions have not been reported. However, the potential
exists for interactions between deferiprone and trivalent cation-dependent medicinal
products, such as aluminium-based antacids. Based on reported adverse interactions
that can occur between desferrioxamine and vitamin C, caution should be used
when administering concurrent deferiprone and vitamin C.
Side effects: The most common adverse effect is reddish/
brown urine. Other effects include agranulocytosis, neutropenia, nausea, vomiting,
abdominal pain, increased appetite, arthralgia and increased alanine transaminase
(ALT) levels.
Net price: 100 tablets £152.39.
Supplier: Swedish Orphan International
The White House
Wilderspool Park
Greenalls Avenue
Stockton Heath
Warrington
WA4 6HL
Tel +44(0)1925 438 028
Fax +44(0)1925 438 001
For ordering contact
Healthcare Logistics (tel 01753 850099).
Legal class: POM.