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TARO-DEFERIPRONE is a brand name for Deferiprone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). Absolute Neutrophil Counts The absolute neutrophil count (ANC) should be measured before starting Taro-Deferiprone therapy and monitored weekly on therapy (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Hematologic section above).
Hepatic function Hepatic status should be evaluated prior to initiating Taro-Deferiprone treatment. Serum ALT values should be monitored periodically during therapy with Taro-Deferiprone. In patients with hepatic impairment, hepatic enzymes should be monitored periodically.
Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal. In these patients careful monitoring of liver enzymes and of liver histology is recommended. Plasma Zinc concentration Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
5 times the maximum recommended dose, but have also been observed with standard doses of deferiprone. The neurological disorders regressed after deferiprone discontinuation (
). o Measure the absolute neutrophil count (ANC) before starting Taro-Deferiprone and monitor the ANC weekly on therapy (see 7 WARNINGS AND PRECAUTIONS, Hematologic and 8 ADVERSE REACTIONS sections). Interrupt Taro-Deferiprone therapy if neutropenia develops.
o Interrupt Taro-Deferiprone therapy if infection develops and monitor the ANC more frequently (see 7 WARNINGS AND PRECAUTIONS, Hematologic). o Advise patients taking Taro-Deferiprone to immediately seek medical help and present their wallet card if experiencing any symptoms indicative of infection (see 7 WARNINGS AND PRECAUTIONS, Hematologic).
2 Recommended Dose and Dosage Adjustment The recommended starting dosage of Taro-Deferiprone for adults and pediatric patients is 75 mg/kg actual body weight/day orally. The maximum dosage is 100 mg/kg actual body weight/day orally.
Recommended Dosage for Taro-Deferiprone (three times a day) For Taro-Deferiprone 1000 mg tablets taken three times a day, dose per kilogram body weight should be calculated to the nearest half tablet. To obtain a dose of about 75 mg/kg/day, use the number of tablets suggested in the following tables for the body weight of the patient.
5 *rounded to nearest half tablet Dose Modifications for Patients with Hepatic Impairment No adjustment of the Taro-Deferiprone dosage regimen is recommended in patients with mildly (Child-Pugh Class A) or moderately (Child-Pugh Class B) impaired hepatic function.
There are no data in patients with severe (Child-Pugh Class C) hepatic impairment. Liver enzymes should be carefully monitored in this patient population during Taro-Deferiprone therapy. If there is evidence of deterioration in hepatic function, discontinuation of Taro- Deferiprone therapy should be considered (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
, Hematologic). 3. SERIOUS WARNINGS AND PRECAUTIONS BOX 4. 2 Dosage and Administration) • The effect of Taro-Deferiprone in decreasing the body iron load is directly influenced by the dose and the degree of iron overload (pre-existing iron load and amount of iron input (transfusional iron and gastrointestinal iron absorption)).
• The long-term effectiveness of Taro-Deferiprone in controlling body iron load should be evaluated on a regular basis. It is recommended to monitor serum ferritin concentrations every two to three months and to monitor liver and cardiac iron concentrations annually, or as clinically indicated.
• Dose adjustments should be tailored to the individual patient’s response and therapeutic goals (maintenance or reduction of iron burden). Reduction in dose of Taro-Deferiprone should be considered if serum ferritin measurements approach normal.
• In patients who develop gastrointestinal upset, such as nausea, vomiting and abdominal pain, the dose of Taro-Deferiprone should be decreased for one to two weeks. Serious Warnings and Precautions • Deferiprone can cause agranulocytosis/severe neutropenia that may lead to serious and life-threatening infections.
Neutropenia may precede the development of agranulocytosis (see
and 7 WARNINGS AND PRECAUTIONS, Hematologic section above). Hepatic function Hepatic status should be evaluated prior to initiating Taro-Deferiprone treatment. Serum ALT values should be monitored periodically during therapy with Taro-Deferiprone.
In patients with hepatic impairment, hepatic enzymes should be monitored periodically. Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal. In these patients careful monitoring of liver enzymes and of liver histology is recommended.
Plasma Zinc concentration Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended. 5 times the maximum recommended dose, but have also been observed with standard doses of deferiprone. The neurological disorders regressed after deferiprone discontinuation (5 OVERDOSAGE).
Reproductive Health:
Female and Male Potential Women of childbearing potential must be advised to avoid pregnancy. These women should be advised to take highly effective contraceptive measures during treatment with Taro- Deferiprone and for at least six months after the last dose.
1 Pregnant Women). Males with female partners of reproductive potential should use effective contraception during treatment with Taro-Deferiprone and for at least three months after the last dose. • Fertility Deferiprone had no significant effects on fertility and reproductive performance in non- Taro-Deferiprone Page 11 of 42 Protected B / Protégé B iron-loaded male and female rats dosed orally at ≤ 75 mg/kg bid prior to and through mating (males) or through early gestation (females) (see 16 NON-CLINICAL TOXICOLOGY).
1 Pregnant Women Deferiprone is contraindicated in pregnancy (see 2 CONTRAINDICATIONS). No studies in pregnant women have been conducted, and relevant data from clinical use are limited. In animal studies, administration of deferiprone during the period of organogenesis resulted in embryofetal death and malformations at doses lower than equivalent human clinical doses (see 16 NON-CLINICAL TOXICOLOGY).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Deferiprone in Canada.
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Dose Modification for Patients with Renal Impairment No adjustment of Taro-Deferiprone dosage is recommended in patients with mild, moderate or severe renal impairment. There are no data in patients with end-stage renal disease on dialysis.
4 Administration Taro-Deferiprone can be taken with or without food. Taking Taro-Deferiprone with meals may reduce nausea. Allow at least a 4-hour interval between Taro-Deferiprone and other medications or supplements containing polyvalent cations such as iron, aluminum or zinc (see
2 Breast-feeding Deferiprone is contraindicated in nursing women. No studies have been conducted to determine the extent of deferiprone excretion in human milk. No prenatal and postnatal reproductive studies have been conducted in animals.
If treatment is unavoidable, breast- feeding must be stopped. 3 Pediatrics Deferiprone has been studied in 222 pediatric patients with thalassemia syndromes and iron overload participating in clinical trials, including 61 children less than 6 years old.
5%)). Deferiprone has been studied in 113 pediatric patients with sickle cell disease and other anemias and iron overload participating in clinical trials. The age of these patients ranged from 3 to 16 years old (66 patients were 3 to ˂12 years, 47 patients were 12 to 16 years).
Seventy- seven percent of these patients had sickle cell disease. 6%)). 4 Geriatrics Clinical studies of deferiprone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Taro-Deferiprone Page 12 of 42 Protected B / Protégé B 8. 1 Adverse Reaction Overview The most common adverse reactions reported during therapy with deferiprone in clinical trials were chromaturia, nausea, abdominal pain, vomiting, arthralgia, alanine aminotransferase increased, and neutropenia.
5 × 109/L, which occurred in approximately 2% of patients. Less severe episodes of neutropenia were reported in approximately 6% of patients (see 7 WARNINGS AND PRECAUTIONS). 9% of patients. 6% of patients. Chromaturia (reddish/brown discolouration of the urine) is a result of the excretion of deferiprone-iron complex in the urine; it is an expected effect of deferiprone therapy and it is not harmful.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Thalassemia Syndromes Study LA16-0102 Adverse events described in Table 3 below reflect the safety data from Study LA16-0102, a randomized, controlled trial in which 29 patients who were treated with deferiprone for a median duration of 359 days were […]