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JADENU 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: JADENU (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 treated with…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 07/2022
2 Clinical Trial Adverse Reactions 07/2022 PATIENT MEDICATION INFORMATION, Children and adolescents (age 2 years to 16 years), Usual dose 07/2022 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 ...........................................................................................................
11 5 OVERDOSAGE.......................................................................................................... 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 11 7 WARNINGS AND PRECAUTIONS ...............................................................................
3 Pediatrics (2 to 16 years of age) 07/2022
JADENU 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.
PrJADENU® (Deferasirox) Tablets Page 5 of 54
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.
1 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics (2 to 16 years of age): ..................................................................... 4 Geriatrics (≥ 65 years of age): .......................................................................... 19 PrJADENU® (Deferasirox) Tablets Page 3 of 54 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.............................................................................
28 9 DRUG INTERACTIONS .............................................................................................. 4 Drug-Drug Interactions ..........................................................................................
5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions.........................................................................
30 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ..........................................................................................
3 Pharmacokinetics ............................................................................................. 31 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 33 12 SPECIAL HANDLING INSTRUCTIONS..........................................................................
33 PART II: SCIENTIFIC INFORMATION ..................................................................................... 34 13 PHARMACEUTICAL INFORMATION .......................................................................... 34 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .............................................................................. 35 β-thalassemia and transfusional hemosiderosis ............................................................. 35 Chronic anemias and transfusional hemosiderosis .........................................................
35 sickle cell disease and transfusional hemosiderosis ........................................................ 2 Comparative Bioavailability Studies ................................................................ 43 15 MICROBIOLOGY ......................................................................................................
44 16 NON-CLINICAL TOXICOLOGY .................................................................................... 44 PATIENT MEDICATION INFORMATION […]