Deferiprone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing deferiprone.
Drugs List
Therapeutic Indications
Uses
Treatment of iron overload in thalassaemia major
Deferiprone monotherapy for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
Deferiprone in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.
Dosage
Adults
The recommended dose is 25mg/kg body weight three times a day to give a total daily dose of 75mg/kg body weight.
The dosage should be calculated to the nearest half tablet or 2.5ml of the oral solution.
The maximum recommended total daily dose should not exceed 100mg/kg body weight due to a potential increased risk of adverse effects.
Children
Children aged 10 to 18 years
The recommended dose is 25mg/kg body weight three times a day to give a total daily dose of 75mg/kg body weight.
The dosage should be calculated to the nearest half tablet or 2.5ml of the oral solution.
The maximum recommended total daily dose should not exceed 100mg/kg body weight due to a potential increased risk of adverse effects.
Children aged 6 to 10 years
The data on the use of deferiprone in children aged 6 to 10 years is limited, however, alternative sources suggest the same dose can be used as in adults and children aged 10 to 18 years.
Additional Dosage Information
Gastrointestinal symptoms are most frequent at the start of treatment and in most resolve within a few weeks. In some patients it may be beneficial to reduce the dose and then scale the dose back up again.
Contraindications
Children under 6 years
Breastfeeding
History of agranulocytosis
History of recurrent neutropenia
Neutropenia
Pregnancy
Precautions and Warnings
Children aged 6 to 10 years
Zinc deficiency
End stage renal disease
Hepatitis C
Immunodeficiency syndromes
Positive HIV status
Severe hepatic impairment
Start antimicrobial regime if infection suspected during neutropenia
Consider zinc supplement if deficient
Treatment to be initiated and supervised by a specialist
Some formulations contain sunset yellow (E110); may cause allergic reaction
Obtain baseline absolute neutrophil count before initiating treatment
Daily FBC, differential WBC and platelet count during neutropenia
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor neutrophil count weekly
Monitor serum ferritin levels
Monitor serum zinc levels
Weekly FBC, diff WBC and platelet count for 3 weeks after neutropenia
Advise patient to inform physician if severe diarrhoea occurs
Advise patient to report symptoms of infection immediately
Advise patient/carer to see Dr immed'ly if signs of blood disorder develop
Consider G-CSF in severe neutropenia / agranulocytosis
Do not rechallenge treatment if neutropenia or agranulocytosis occur
Discontinue if neurological toxicity occurs
Discontinue if patient is attempting to conceive
Interrupt therapy if infection occurs & monitor neutrophil count more often
Interrupt therapy if serum ferritin levels fall below 500mcg/l
Pregnancy confirmed: Discontinue this medication
Suspend treatment if persistent increase in serum ALT occurs
Advise patient not to self-medicate with vitamin C
Female: Ensure adequate contraception during treatment
Advise patient urine may be coloured reddish brown
In thalassaemia patients there is an association between liver fibrosis and iron overload and/or hepatitis C. Iron chelation should be optimised in patients with hepatitis C and liver histology carefully monitored.
Deferiprone has been shown to cause neutropenia, including agranulocytosis, which resolved on treatment withdrawal. The risk of neutropenia and agranulocytosis is greater if the absolute neutrophil count (ANC) is less than 1.5 x 10 to the power 9 per litre.
If neutropenia occurs, discontinue deferiprone and all other medications with a potential to cause neutropenia.
If there is evidence of infection, carry out appropriate cultures and diagnostic procedures and start antimicrobial treatment.
Whilst no carcinogenicity studies have been undertaken in animals, a carcinogenic potential cannot be excluded due to clastogenic characteristics (structural changes to chromosomes) in in-vitro assays and in-vivo in animals, although it did not show mutagenic properties.
Ascorbic acid given in conjunction with deferiprone has not been formally studied. Manufacturer advises use with caution due to the known adverse reaction when deferoxamine is administered with ascorbic acid.
Pregnancy and Lactation
Pregnancy
Deferiprone is contraindicated during pregnancy.
Use of deferiprone during pregnancy is contraindicated by the manufacturer. Animal studies have shown reproductive toxicity. At the time of writing, there is no adequate data on deferiprone use in pregnancy and the potential risk for humans is unknown.
Lactation
Deferiprone is contraindicated during breastfeeding.
Use of deferiprone when breastfeeding is contraindicated by the manufacturer. If treatment is unavoidable, breastfeeding must be stopped. No prenatal or postnatal reproductive studies have been conducted in animals. It is not known whether deferiprone is excreted in human milk.
Side Effects
Abdominal pain
Agranulocytosis
Arthralgia
Arthropathy
Chromaturia
Diarrhoea
Difficulty in walking
Fatigue
Headache
Hepatic fibrosis
Hypersensitivity reactions
Hypertonia
Hypotonia
Increase in ALT level
Increased appetite
Increases in hepatic enzymes
Low zinc levels
Nausea
Neutropenia
Postural instability
Rash
Reddish/brown urine
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2019
Reference Sources
Summary of Product Characteristics: Ferriprox 100mg/ml oral solution. Apotex B.V. Revised June 2019.
Summary of Product Characteristics: Ferriprox 500mg film-coated tablets. Apotex B.V. Revised June 2019.
Summary of Product Characteristics: Ferriprox 1000mg film-coated tablets. Apotex.B.V. Revised June 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 July 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.