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APO-DEFERASIROX 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: APO-DEFERASIROX (deferasirox dispersible tablets for oral suspension) 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.
3 Pediatrics (2 to 16 years of age) 09/2023 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...............................................................................................................
12 5 OVERDOSAGE .............................................................................................................. 12
). Auditory testing is recommended before the start of APO-DEFERASIROX treatment and thereafter at regular intervals. The frequency of auditory adverse events irrespective of causality was increased among pediatric patients who received deferasirox doses greater than 25 mg/kg/day 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 APO-DEFERASIROX (Deferasirox Dispersible Tablets for Oral Suspension) Page 14 of 58 DOSAGE AND ADMINISTRATION).
Gastrointestinal Gastrointestinal irritation may occur during APO-DEFERASIROX 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 APO-DEFERASIROX 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 APO-DEFERASIROX in combination with drugs that have known ulcerogenic potential, such as NSAIDs, corticosteroids, or oral bisphosphonates, and in patients receiving anticoagulants (see
3 Pediatrics (2 to 16 years of age) 09/2023 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...............................................................................................................
12 5 OVERDOSAGE .............................................................................................................. 12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 12 7 WARNINGS AND PRECAUTIONS ...................................................................................
APO-DEFERASIROX 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. APO-DEFERASIROX (Deferasirox Dispersible Tablets for Oral Suspension) Page 5 of 58 • 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.
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) ..................................................................................... 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 ................................................................................. 29 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.......................................................................................................
33 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......................................................................................... 37 β-Thalassemia And Transfusional Hemosiderosis ..................................................................
37 Chronic anemias and transfusional hemosiderosis ............................................................... 37 Sickle cell disease and transfusional hemosiderosis ..............................................................
2 Comparative Bioavailability Studies […]