TARO-DEFERASIROX

). 1 . 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 Taro-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. • patients with hypersensitivity to the active substance, deferasirox, or to any of the excipients. For a complete listing of excipients, see

). Auditory testing is recommended before the start of Taro-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 DOSAGE AND ADMINISTRATION).

Gastrointestinal Gastrointestinal irritation may occur during Taro-Deferasirox treatment. Upper gastrointestinal (GI) ulceration and haemorrhage and upper and lower GI perforations have been reported Taro-Deferasirox (deferasirox) Page 14 of 56 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 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 Taro-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 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. Table of Contents RECENT MAJOR LABEL CHANGES ..........................................................................................

2 TABLE OF CONTENTS............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................

4 1 INDICATIONS ............................................................................................................. 4 1 . 1 Pediatrics ........................................................................................................

4 1 . 2 Geriatrics ........................................................................................................ 4 2 CONTRAINDICATIONS................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION ............................................................................... 5 4. 1 Dosing Considerations ....................................................................................

5 4. 2 Recommended Dose and Dosage Adjustment ................................................. 6 4. 11 4. 13 7. 20 8. 20 8. 21 8. 27 8. 28 8. 30 9. 30 9. 31 Taro-Deferasirox (deferasirox) Page 3 of 56 9. 32 9. 32 10. 32 10. 32 10. 36 14. 49 Taro-Deferasirox (deferasirox) Page 4 of 56 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Taro-Deferasirox (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 […]

Taro-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. • 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, Taro-Deferasirox (deferasirox) Page 5 of 56 COMPOSITION AND PACKAGING.