Ferriprox

Ferriprox

deferiprone

Manufacturer:

Apotex

Distributor:

Biogenetech
Concise Prescribing Info
Contents
Deferiprone
Indications/Uses
Fe overload in patients w/ thalassemia major when deferoxamine therapy is contraindicated or inadequate.
Dosage/Direction for Use
FC tab 25 mg/kg tid. Total daily dose: 75 mg/kg. Oral soln 25 mg/kg tid. Total daily dose: 75 mg/kg/day. Max dose: 100 mg/kg/day. Patients weighing 90 kg 2,250 mg (22.5 mL) tid. Total daily dose: 6,750 mg, 80 kg 2,000 mg (20 mL) tid. Total daily dose: 6,000 mg, 70 kg 1,750 mg (17.5 mL) tid. Total daily dose: 5,250 mg, 60 kg 1,500 mg (15 mL) tid. Total daily dose: 4,500 mg, 50 kg 1,250 mg (12.5 mL) tid. Total daily dose: 3,750 mg, 40 kg 1,000 mg (10 mL) tid. Total daily dose: 3,000 mg, 30 kg 750 mg (7.5 mL) tid. Total daily dose: 2,250 mg tid, 20 kg 500 mg (5 mL) tid. Total daily dose: 1,500 mg.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. History of recurrent neutropenia or agranulocytosis. Concomitant use of medicinal products associated w/ neutropenia or those that can cause agranulocytosis. Pregnancy & lactation.
Special Precautions
Neutropenia/agranulocytosis. Monitor neutrophil count every wk. Consider treatment interruption if there is a persistent increase in serum ALT. FC tab: Monitor serum ALT level at regular intervals during therapy; body Fe load. Childn <6 yr. Oral soln: Interrupt therapy if patient develops an infection. Do not initiate treatment if patient is neutropenic or has a baseline ANC <1.5 x 109/L. Obtain CBC, WBC, corrected for the presence of nucleated RBC, neutrophil & platelet count immediately upon diagnosis of neutropenia & repeat daily; continue for 3 consecutive wk following recovery. Rechallenge is not recommended in the event of neutropenia, & contraindicated in agranulocytosis. Monitor serum ferritin every 2-3 mth; plasma Zn conc. Consider interruption of treatment if serum ferritin falls <500 mcg/L. HIV positive or other immunocompromised patients. Carefully monitor liver histology in thalassaemia patients. Reddish/brown discoloration of urine. Neurological disorders in childn. Renal or hepatic impairment. Women of childbearing potential must be advised to avoid pregnancy & take contraceptive measures. Neurological disorders in childn.
Adverse Reactions
Nausea, vomiting, abdominal pain; chromaturia. Increased liver enzymes; diarrhoea; increased appetite; neutropenia, agranulocytosis; arthralgia. FC tab: Joint pain & swelling. Oral soln: Headache; fatigue.
Drug Interactions
Trivalent cation-dependent products eg, Al-based antacids. Vit C. Drugs associated w/ neutropenia or agranulocytosis.
ATC Classification
V03AC02 - deferiprone ; Belongs to the class of iron chelating agents. Used in iron overload.
Presentation/Packing
Form
Ferriprox FC tab 500 mg
Packing/Price
100's
Form
Ferriprox oral soln 100 mg/mL
Packing/Price
500 mL x 1's
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