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ACH-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: 11/2023 Section 1 INDICATIONS, 1.2 Geriatrics 11/2023 Section 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 11/2023 Section 4.2 Recommended Dose and Dosage Adjustment 11/2023 Section 7 WARNINGS AND PRECAUTIONS, Hemorrhage 11/2023 Section 7 WARNINGS AND PRECAUTIONS, Hepatic/biliary/Pancreatic 11/2023 Section 7 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Therapy should be administered under the supervision of a physician experienced in the treatment of patients with hematological malignancies and/or malignant sarcomas. The prescribed dose should be administered orally, during a meal and with a large glass of water to minimize the risk of gastrointestinal disturbances.
Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day in the morning and in the evening. Efficacy data for the 800 mg/day dose are limited. For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of water or apple juice.
The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 mL for a 100 mg tablet, and 200 mL for a 400 mg tablet) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s).
Traces of the disintegrated tablet left in the glass after drinking should also be consumed. Treatment should be continued as long as the patient continues to benefit. Tumour Lysis Syndrome (TLS) Preventative measures should be considered prior to treatment with ACH-IMATINIB in patients with increased risk for TLS (See 7 WARNINGS AND PRECAUTIONS - General and 7 WARNINGS ACH-IMATINIB (imatinib mesylate tablets) Page 7 of 78 AND PRECAUTIONS - Monitoring and Laboratory Tests).
Iron Exposure For daily dosing of 800 mg, ACH-IMATINIB should be administered using the 400 mg tablet twice a day to reduce exposure to iron. 2 Recommended Dose and Dosage Adjustment Recommended Dose Chronic myeloid leukemia (CML) The recommended dosage of ACH-IMATINIB is 400 mg/day for adult patients with newly diagnosed CML or in chronic phase CML.
The recommended dosage for adult patients in accelerated phase or blast crisis is 600 mg/day. e. not to exceed 600 mg). In CML, a dose increase from 400 mg to 600 mg or to 800 mg/day in adult patients with chronic phase disease, or from 600 mg to 800 mg (given as 400 mg twice daily) in adult patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reactions and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory hematologic response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved hematologic and/or cytogenetic response.
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 ACH-IMATINIB (imatinib mesylate tablets) Page 21 of 78 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. 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).
1 Clinical Trials by Indication 11/2023 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 ................................................................................................................ 5 2 CONTRAINDICATIONS ..................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 10 5 OVERDOSAGE.............................................................................................................
11 ACH-IMATINIB (imatinib mesylate tablets) Page 3 of 78 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 11 7 WARNINGS AND PRECAUTIONS .................................................................................
20 8 ADVERSE REACTIONS ................................................................................................. 36 9 DRUG INTERACTIONS .................................................................................................
41 10 CLINICAL PHARMACOLOGY ........................................................................................ 43 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 46 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
• ACH-IMATINIB is contraindicated in patients with hypersensitivity to imatinib or to any other component of ACH-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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Patients with CML should undergo regular response monitoring (see 7 WARNINGS AND PRECAUTIONS - Monitoring and Laboratory Tests). Any changes to patient imatinib therapy (for example, when imatinib dose is lowered due to occurrence of side effects) should be followed by close response monitoring.
Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) The recommended dose of ACH-IMATINIB for use as a single-agent for induction phase therapy in adult patients with newly diagnosed Ph+ALL, or for adult patients with relapsed or refractory Ph+ ALL is 600 mg/day.
Myelodysplastic/Myeloproliferative Diseases (MDS/MPD) The recommended dose of ACH-IMATINIB is 400 mg/day for adult patients with MDS/MPD. Aggressive sub-types of Systemic Mastocytosis (ASM and SM-AHNMD) The recommended dose of ACH-IMATINIB is 400 mg/day for adult patients with ASM or SM- AHNMD without the D816V c-Kit mutation or mutational status unknown and not responding satisfactory to other therapies.
For patients with ASM or SM-AHNMD associated with eosinophilia, a clonal hematological disease related to the fusion kinase FIP1L1-PDGFRα, a starting dose of 100 mg/day is ACH-IMATINIB (imatinib mesylate tablets) Page 8 of 78 recommended.
A dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy. Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL) The recommended dose of ACH-IMATINIB is 100 mg/day for adult patients with HES/CEL.
For HES/CEL patients, a dose increase from 100 mg to 400 mg may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy. Treatment should be continued as long as the patient continues to benefit.
Dermatofibrosarcoma Protuberans (DFSP) The recommended dose of ACH-IMATINIB is 800 mg/day for adult patients with DFSP. Gastrointestinal Stromal Tumors (GIST), Unresectable and/or metastatic malignant GIST The recommended dose of ACH-IMATINIB is 400 mg/day or 600 mg/day for adult patients with unresectable and/or metastatic malignant GIST, depending on the stage and the progression of the disease.
In GIST, a dose increase from 400 mg/day to 600 mg/day or to 800 mg/day for adult patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy. Adjuvant Treatment of GIST The recommended dose of ACH-IMATINIB is 400 mg/day for the adjuvant treatment of adult patients at intermediate to high risk of relapse following complete resection of Kit (CD117) positive GIST.
In the clinical study, imatinib mesylate was administrated for one year. The optimal treatment duration with imatinib mesylate is not known. No dose adjustment of the initial 400 mg a day dose was made in patients with GIST with mild liver function abnormalities.
Dosage Adjustment Hepatotoxicity and Other Non-Hematologic Adverse Drug Reactions If a severe non-hematologic adverse drug reaction develops (such as severe hepatotoxicty or severe fluid retention), ACH-IMATINIB should be withheld until the event has resolved.
Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event. If elevations in […]
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 (1) All adverse events occurring in ≥10% of patients are listed regardless of suspected relationship to treatment.
Table 4 Adverse Experiences Regardless of Relationship to Study Drug Reported in Other CML Clinical Trials (≥10% of All patients in any trial) (1) System Affected Myeloid blast crisis N=260 (%) Accelerated phase N=235 (%) Chronic phase IFN failure N=532(%) All Grades CTC Grades 3/4 All Grades CTC Grades 3/4 All Grades CTC Grades 3/4 Gastrointestinal disorders Nausea 71 5 73 5 63 3 Vomiting 54 4 58 3 36 2 Diarrhea 43 […]
46 PART II: SCIENTIFIC INFORMATION ........................................................................................ 47 13 PHARMACEUTICAL INFORMATION .............................................................................
47 14 CLINICAL TRIALS ......................................................................................................... 55 Aggressive sub-types of Systemic Mastocytosis (ASM and SM-AHNMD) […]