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EXJADE is a brand name for Deferasirox, supplied as a tablet for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EXJADE® (deferasirox) dispersible 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 treated with…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 08/2022
2 Clinical Trial Adverse Reactions 08/2022 PATIENT MEDICATION INFORMATION, Children and adolescents (age 2 years to 16 years), Usual dose 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
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..................................................... 3 Reconstitution .................................................................................................
5 Missed Dose .................................................................................................... 11 5 OVERDOSAGE ...........................................................................................................
11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 11 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) ...................................................................... 18 8 ADVERSE REACTIONS ................................................................................................ 1 Adverse Reaction Overview..............................................................................
2 Clinical Trial Adverse Reactions ........................................................................ 3 Less Common Clinical Trial Adverse Drug Reactions .......................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions........................................................................ 26 9 DRUG INTERACTIONS................................................................................................ 4 Drug-Drug Interactions ....................................................................................
5 Drug-Food Interactions .................................................................................... 6 Drug-Herb Interactions .................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
29 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action.................................................................................. 2 Pharmacodynamics ....................................................................................
3 Pharmacokinetics....................................................................................... 30 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
32 PART II: SCIENTIFIC INFORMATION ...................................................................................... 33 13 PHARMACEUTICAL INFORMATION............................................................................ 33 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trial by Indication ........................................................................... 33 β-thalassemia and transfusional hemosiderosis ......................................................... 33 Chronic anemias and transfusional hemosiderosis .....................................................
34 Sickle cell disease and transfusional hemosiderosis .................................................... 34 15 MICROBIOLOGY ........................................................................................................ 41 16 NON-CLINICAL TOXICOLOGY .....................................................................................
41 PATIENT MEDICATION INFORMATION ................................................................................. 44 PrEXJADE® (deferasirox) Product Monograph Page 4 of 51 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS EXJADE® […]
3 Pediatrics (2 to 16 years of age) 08/2022
EXJADE is contraindicated in: patients with estimated creatinine clearance <60 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal. 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
PrEXJADE® (deferasirox) Product Monograph Page 5 of 51
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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