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PMS-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: pms-DEFERASIROX (TYPE J) (deferasirox) film-coated tablets 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 adequately…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 03/2023
2 Clinical Trial Adverse Reactions 03/2023 PATIENT MEDICATION INFORMATION, Children and adolescents (age 2 years to 16 years), Usual dose 03/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................................................
2 TABLE OF CONTENTS ........................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................................
4 1 INDICATIONS ........................................................................................................................... 1 Pediatrics ............................................................................................................................
2 Geriatrics ............................................................................................................................ 4 2 CONTRAINDICATIONS ..............................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................ 5 4 DOSAGE AND ADMINISTRATION .............................................................................................
1 Dosing Considerations ........................................................................................................ 2 Recommended Dose and Dosage Adjustment ....................................................................
4 Administration .................................................................................................................. 5 Missed Dose .....................................................................................................................
3 Pediatrics (2 to 16 years of age) 03/2023
pms-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.
Pms-DEFERASIROX (TYPE J) Page 5 of 57
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Deferasirox in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
11 5 OVERDOSAGE ........................................................................................................................ 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...........................................
12 7 WARNINGS AND PRECAUTIONS............................................................................................. 1 Special Populations ...........................................................................................................
1 Pregnant Women.............................................................................................................. 2 Breast-feeding ..................................................................................................................
3 Pediatrics (2 to 16 years of age): ...................................................................................... 4 Geriatrics (≥ 65 years of age): ..........................................................................................
20 8 ADVERSE REACTIONS............................................................................................................. 1 Adverse Reaction Overview ..............................................................................................
2 Clinical Trial Adverse Reactions ........................................................................................ 3 Less Common Clinical Trial Adverse Reactions .................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .................................................................................................................................. 5 Post-Market Adverse Reactions ........................................................................................
30 9 DRUG INTERACTIONS ............................................................................................................ 4 Drug-Drug Interactions .....................................................................................................
5 Drug-Food Interactions ..................................................................................................... 6 Drug-Herb Interactions .....................................................................................................
7 Drug-Laboratory Test Interactions .................................................................................... 32 10 CLINICAL PHARMACOLOGY ....................................................................................................
1 Mechanism of Action........................................................................................................ 2 Pharmacodynamics ...........................................................................................................
3 Pharmacokinetics.............................................................................................................. 34 11 STORAGE, STABILITY AND DISPOSAL .....................................................................................
35 12 SPECIAL HANDLING INSTRUCTIONS ....................................................................................... 35 PART II: SCIENTIFIC INFORMATION ...................................................................................................
36 13 PHARMACEUTICAL INFORMATION ........................................................................................ 36 14 CLINICAL TRIALS ....................................................................................................................
1 Clinical Trials by Indication ................................................................................................. 2 Comparative Bioavailability Studies....................................................................................
45 15 MICROBIOLOGY […]