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ALEMBIC-DEFERASIROX (TYPE J) is a brand name for Deferasirox, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Alembic-Deferasirox (Type J) film-coated tablets (deferasirox) is indicated for: • the management of chronic iron overload in patients with transfusion-dependent anemias aged 6 years or older. • the management of chronic iron overload in patients with transfusion-dependent anemias aged two to five who cannot be…
Verbatim from this product's HC label. Tap a section to expand.
). 4 Geriatrics ). The pharmacokinetics of deferasirox have not been studied in elderly patients. In clinical trials, elderly patients experienced a higher frequency of adverse reactions than younger patients and should be monitored closely for adverse reactions that may require a dose adjustment.
2 CONTRAINDICATIONS Alembic-Deferasirox (Type J) is contraindicated in: • patients with estimated creatinine clearance <60 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal (ULN). • high risk myelodysplastic syndrome (MDS) patients, any other MDS patient with a life expectancy < 1 year and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease.
• patients with platelet counts < 50 x 109/L. • patients with hypersensitivity to the active substance, deferasirox, or to any of the excipients. For a complete listing of excipients, see the
). Auditory testing is recommended before the start of Alembic-Deferasirox (Type J) treatment and thereafter at regular intervals. 5 mg/kg/day deferasirox film-coated tablets when serum ferritin was less than 1,000 mcg/L (patients received high doses despite body iron burden being in the target range or consistently below the target range which is not recommended; see 4 DOSAGE AND ADMINISTRATION).
Gastrointestinal Gastrointestinal irritation may occur during Alembic-Deferasirox (Type J) treatment. Upper gastrointestinal (GI) ulceration and haemorrhage and upper and lower GI perforations have been reported uncommonly in patients, including children and adolescents, receiving deferasirox.
There have been rare reports of fatal GI haemorrhages and perforations. Fatal haemorrhages have been reported more frequently in elderly patients who had advanced hematologic malignancies and/or low platelet counts. Multiple ulcers have been observed in some patients and there have been reports of ulcers complicated with gastrointestinal perforation (see 8 ADVERSE REACTIONS).
Physicians and patients should remain alert for signs and symptoms of GI ulceration, perforation and haemorrhage during Alembic-Deferasirox (Type J) therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected.
Caution should be exercised in patients who are taking Alembic-Deferasirox (Type J) in combination with drugs that have known ulcerogenic potential, such as NSAIDs, corticosteroids, or oral bisphosphonates, and in patients receiving anticoagulants (see
3 Pharmacokinetics). Alembic-Deferasirox (Type J) requires a different dosing regimen and method of administration compared to deferasirox dispersible tablets. To avoid dosing errors, it is important that prescriptions of deferasirox specify both the type of formulation (dispersible tablet or film-coated tablet) and the prescribed dose in mg/kg/day.
This medicine is also available as a tablet that is meant to be dissolved in liquid before drinking. The doses of these two formulations are not the same. Be sure you are taking the right type of deferasirox. Check with your doctor, nurse or pharmacist if you are not sure.
1 Dosing Considerations • Deferasirox film-coated tablets and deferasirox dispersible tablets for oral suspension are different formulations of deferasirox. Deferasirox film-coated tablets require a different dosing regimen and method of administration compared to deferasirox dispersible tablets for oral suspension.
If converting from deferasirox dispersible tablets for oral suspension to deferasirox film-coated tablets, see the Dosing Considerations section below. • To avoid dosing errors, it is important that prescriptions of deferasirox specify both the type of formulation (dispersible tablets for oral suspension or film-coated tablets) and the prescribed dose in mg/kg/day.
2 Recommended Dose and Dosage Adjustment Please note: Alembic-Deferasirox (Type J) is not available in the 90 mg and 180 mg tablet strengths. Commercially available deferasirox 90 mg and 180 mg film-coated tablets should be used for dose adjustments.
______________________________________________________________________________ Alembic-Deferasirox (Type J) Product Monograph Page 6 of 54 Unclassified / Non classifié A. Transfusional iron overload The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and as required, to reduce the existing iron burden.
Alembic-Deferasirox (Type J) is contraindicated in: • patients with estimated creatinine clearance <60 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal (ULN). • high risk myelodysplastic syndrome (MDS) patients, any other MDS patient with a life expectancy < 1 year and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease.
• patients with platelet counts < 50 x 109/L. • patients with hypersensitivity to the active substance, deferasirox, or to any of the excipients. For a complete listing of excipients, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
______________________________________________________________________________ Alembic-Deferasirox (Type J) Product Monograph Page 5 of 54 Unclassified / Non classifié
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The decision to remove accumulated iron should be individualized based on anticipated clinical benefit and risks of chelation therapy. It is recommended that therapy with Alembic-Deferasirox (Type J) (deferasirox) be started when a patient has evidence of chronic iron overload, such as the transfusion of approximately 100 mL/kg of packed red blood cells (approximately 20 units for a 40 kg patient) and a serum ferritin consistently >1000 mcg/L.
Doses should be in mg/kg and must be calculated and rounded to the nearest whole tablet size. Changes in weight of pediatric patients over time must be taken into account when calculating the dose. Alembic-Deferasirox (Type J) is available in one strength (360 mg).
a. Starting Dose The recommended initial daily dose of Alembic-Deferasirox (Type J) is 7, 14 or 21 mg/kg/day body weight, depending on the patient’s transfusion rate and the goal of treatment: Patients requiring maintenance of an acceptable body iron level: • An initial daily dose of 7 mg/kg/day is recommended for patients receiving less than 7 mL/kg/month of packed red blood cells (approximately <2 units/month for an adult) and for whom the objective is maintenance of an acceptable body iron level.
• An initial daily dose of 14 mg/kg/day is recommended for patients receiving more than 7 mL/kg/month of packed red blood cells (approximately >2 units/month for an adult) and for whom the objective is maintenance of an acceptable body iron level.
Patients requiring reduction of iron overload: • An initial daily dose of 14 mg/kg/day is recommended for patients receiving less than 14 mL/kg/month of packed red blood cells (approximately <4 units/month for an adult) and for whom the objective is gradual reduction of iron overload.
• An initial daily dose of 21 mg/kg/day is recommended for patients receiving more than 14 mL/kg/month of packed red blood cells (approximately >4 units/month for an adult) and for whom the objective is gradual reduction of iron overload.
With deferasirox dispersible tablets for oral suspension, the dose dependent iron excretion (mg/kg/day) was calculated from the change in LIC over one year, the amount of blood transfused and the weight of the patient. Using two example patients of 20 kg and 50 kg, the amount of iron excreted over one year could be calculated in terms of mg/year and transfusion unit-equivalents/year (assuming that one unit of PRBC contains 200 mg iron).
e. 5 units of blood per month, respectively). e. 8 units of blood per month; or 6, 12 and 18 mL/kg/month, respectively). 10 939 ± 726 […]