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TARO-IMATINIB is a brand name for Imatinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 09/2022 1 INDICATIONS, 1.2 Geriatrics 09/2022 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 09/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 09/2022 7 WARNINGS AND PRECAUTIONS 09/2022 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 09/2022 TABLE OF CONTENTS Sections or subsections that are not…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
5 1 INDICATIONS ...................................................................................................................... 1 Pediatrics................................................................................................................................
2 Geriatrics ................................................................................................................................ 6 2 CONTRAINDICATIONS .........................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................... 6 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations ...........................................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................................... 5 Missed Dose .........................................................................................................................
10 5 OVERDOSAGE ................................................................................................................... 10
1 Adverse Reaction Overview Imatinib mesylate was generally well tolerated across all studies in CML and GIST. Complications of advanced malignancies and co-administered medications make causality of adverse events difficult to assess in single arm studies.
The majority of imatinib mesylate- treated patients experienced adverse events at some time. Recent published literature revealed cases of musculoskeletal pain symptoms occurring upon imatinib discontinuation following long-term treatment, with a high frequency of 18% to 46% in CML patients.
Those events may persist for months and were referred to as imatinib withdrawal symptoms (IWS). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. TARO-IMATINIB (Imatinib Mesylate Tablets) Page 20 of 76 Chronic Myeloid Leukemia Imatinib mesylate was generally well tolerated with chronic oral daily dosing in patients with CML including pediatric patients.
The majority of patients experienced adverse events at some point in time, however, most events were of mild to moderate Grade. 4% of newly diagnosed patients, in 5 % of patients in chronic phase, 8% in accelerated phase and 9% in blast crisis.
The most frequently reported drug-related adverse events were fluid retention (superficial edema and other fluid retention events), nausea, vomiting, diarrhea, muscle cramps, fatigue and rash (Refer to Table 3 and 4 for newly diagnosed CML and other CML patients, respectively).
4 Geriatrics 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
5 1 INDICATIONS ...................................................................................................................... 1 Pediatrics................................................................................................................................
2 Geriatrics ................................................................................................................................ 6 2 CONTRAINDICATIONS .........................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................... 6 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations ...........................................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................................... 5 Missed Dose .........................................................................................................................
10 5 OVERDOSAGE ................................................................................................................... 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................................ 11 7 WARNINGS AND PRECAUTIONS ........................................................................................
1 Special Populations .............................................................................................................. 1 Pregnant Women ..............................................................................................................
• TARO-IMATINIB is contraindicated in patients with hypersensitivity to imatinib or to any other component of TARO-IMATINIB (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 Imatinib in Canada.
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Superficial edemas were a common finding in all studies described primarily as periorbital edemas or lower limb edemas. 2 Recommended Dose and Dosage Adjustment – Chronic myeloid leukemia (CML)). Other adverse events such as pleural effusion, ascites, pulmonary edema and rapid weight gain with or without superficial edema may be collectively described as “other fluid retention events”.
These events were usually managed by withholding imatinib mesylate treatment temporarily and/or with diuretics and/or other appropriate supportive care measures. However, a few of these events may be serious or life threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
The following tables list the adverse experiences which occurred in ≥ 10% of patients in the clinical trials, regardless of relationship to therapy. 4 Musculoskeletal. 4 (1) All adverse events occurring in ≥10% of patients are listed regardless of suspected relationship to treatment.
4 Dyspepsia 12 0 22 0 27 0 General disorders and administration site conditions Fluid retention¥ 72 11 76 6 69 4 - Superficial edemas¥ 66 6 74 3 67 2 - Other fluid retention events2 ¥ 22 6 15 4 7 2 Pyrexia 41 7 41 8 21 2 Fatigue […]
2 Breast-feeding ................................................................................................................... 3 Pediatrics...........................................................................................................................
4 Geriatrics ........................................................................................................................... 19 8 ADVERSE REACTIONS ........................................................................................................
1 Adverse Reaction Overview ................................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................................
1 Clinical Trial Adverse Reactions – Pediatrics..................................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................................................
5 Post- Market Adverse Reactions .......................................................................................... 34 9 DRUG INTERACTIONS ........................................................................................................
2 Drug Interactions Overview ................................................................................................. 3 Drug-Behavioural Interactions .............................................................................................
4 Drug-Drug Interactions ........................................................................................................ 5 Drug-Food Interactions ........................................................................................................
38 10 CLINICAL PHARMACOLOGY ............................................................................................. 1 Mechanism of Action .........................................................................................................
2 Pharmacodynamics ............................................................................................................ 3 Pharmacokinetics ...............................................................................................................
40 11 STORAGE AND STABILITY ................................................................................................ 43 12 SPECIAL HANDLING INSTRUCTIONS .................................................................................
43 PART II: SCIENTIFIC INFORMATION ...................................................................................... 44 13 PHARMACEUTICAL INFORMATION ..................................................................................
44 14 CLINICAL TRIALS .............................................................................................................. 1 Clinical Trials by Indication.................................................................................................
3 Comparative Bioavailability Studies .................................................................................. 59 15 MICROBIOLOGY ..............................................................................................................
60 16 NON- CLINICAL TOXICOLOGY […]