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Imatinib, sold under the brand names Gleevec and Glivec (both marketed worldwide by Novartis) among others, is an oral targeted therapy medication used to treat cancer. Imatinib is a small molecule inhibitor targeting multiple tyrosine kinases such as CSF1R, ABL, c-KIT, FLT3, and PDGFR-β. Specifically, it is used for chronic myelogenous leukemia (CML) and acute lymphocytic leukemia (ALL) that are Philadelphia chromosome–positive (Ph+), certain types of gastrointestinal stromal tumors (GIST), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), systemic mastocytosis, and myelodysplastic syndrome.
Read the full article on WikipediaChronic Myeloid Leukaemia (CML) Clinical criteria: Treatment Phase: Initial treatment - first-line therapy The condition must be a primary diagnosis of chronic myeloid leukaemia, AND The condition must be in the chronic phase, AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; OR The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR), AND Patient must not have previously experienced a failure to respond to PBS-subsidised treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with nilotinib as a first-line therapy for this condition, AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction, AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications under this restriction will be limited to provide patients with a maximum of 18 months of therapy with dasatinib, imatinib or nilotinib from the date the first application for initial treatment was approved. Patients should be commenced on a dose of imatinib mesilate of 400 mg (base) daily. Continuing therapy is dependent on patients demonstrating a response to imatinib mesilate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter. A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. The expression of the Philadelphia chromosome should be confirmed through cytogenetic analysis by standard karyotyping; or if standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be documented in the patient's medical records.
Acute lymphoblastic leukaemia Clinical criteria: Treatment Phase: Induction and Consolidation therapy Patient must be newly diagnosed, AND The condition must be expressing the Philadelphia chromosome; OR The condition must have the transcript BCR-ABL, AND The treatment must be in combination with chemotherapy or corticosteroids, AND Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition; OR Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition. A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.
Myelodysplastic or myeloproliferative disorder Clinical criteria: Treatment Phase: Initial treatment Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; OR Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); OR Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript, AND Patient must have previously failed an adequate trial of conventional therapy with cytarabine; OR Patient must have previously failed an adequate trial of conventional therapy with etoposide; OR Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea), AND The treatment must not exceed a maximum dose of 400 mg per day. A bone marrow biopsy report demonstrating the presence of a myelodysplastic or myeloproliferative disorder, a pathology report confirming the platelet-derived growth factor receptor (PDGFR) gene re-arrangement and details of the prior trialled therapy and the response must be documented in the patient's medical records.
Aggressive systemic mastocytosis with eosinophilia Clinical criteria: Treatment Phase: Initial treatment Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene, AND Patient must have previously failed an adequate trial of conventional therapy with corticosteroids; OR Patient must have previously failed an adequate trial of conventional therapy with hydroxycarbamide (hydroxyurea), AND The treatment must not exceed a maximum dose of 400 mg per day. A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a bone marrow biopsy report and/or other tissue biopsy report confirming the diagnosis of aggressive systemic mastocytosis and a full blood examination report demonstrating eosinophilia must be documented in the patient's medical records. The details of symptomatic organ involvement requiring treatment, including radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient's medical records.
Chronic eosinophilic leukaemia or Hypereosinophilic syndrome Clinical criteria: Treatment Phase: Initial treatment Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene, AND The treatment must not exceed a maximum dose of 400 mg per day. A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a full blood examination report and details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient's medical records.
Dermatofibrosarcoma protuberans Clinical criteria: Treatment Phase: Initial treatment The condition must be unresectable; OR The condition must be locally recurrent; OR The condition must be metastatic, AND The treatment must not exceed a maximum dose of 800 mg per day. Details of unresectable tumour or site of the local recurrence or site(s) of metastatic disease must be documented in the patient's medical records.
Malignant gastrointestinal stromal tumour Clinical criteria: Treatment Phase: Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND The treatment must be given at a dose not exceeding 600 mg per day. Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)
Gastrointestinal stromal tumour Clinical criteria: Treatment Phase: Continuing treatment The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST), AND Patient must be at high risk of recurrence following complete surgical resection of primary GIST, AND The treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy), AND Patient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST. Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
“Imatinib is a 2-phenyl amino pyrimidine derivative that functions as a specific inhibitor of a number of tyrosine kinase enzymes. It occupies the TK active site, leading to a decrease in activity.”
“18 h (imatinib)40 h (active metabolite)”
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