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Lenalidomide, sold under the brand name Revlimid among others, is a medication used to treat multiple myeloma, smoldering myeloma, various indolent lymphomas, and myelodysplastic syndromes (MDS). For multiple myeloma, it is a first-line treatment, and is given with dexamethasone. It is taken by mouth.
Read the full article on WikipediaMultiple myeloma Clinical criteria: Treatment Phase: Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation The condition must be newly diagnosed, AND The condition must be confirmed by a histological diagnosis, AND Patient must be ineligible for a primary stem cell transplantation, AND The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma, and (2) confirmation of ineligibility for prior stem cell transplant; and (3) nomination of which disease activity parameters will be used to assess response. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided: (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine - the percentage of plasma cells; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/provided. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Relapsed and/or refractory multiple myeloma Clinical criteria: Treatment Phase: Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone Treatment criteria: Patient must be undergoing concurrent treatment with elotuzumab obtained through the PBS, AND Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.
Untreated multiple myeloma Clinical criteria: Treatment Phase: Triple combination therapy consisting of daratumumab, lenalidomide and dexamethasone Treatment criteria: Patient must be undergoing concurrent treatment with daratumumab obtained through the PBS for the treatment of transplant ineligible, newly diagnosed multiple myeloma, AND Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing.
Myelodysplastic syndrome Clinical criteria: Treatment Phase: Initial treatment The treatment must be limited to a maximum duration of 16 weeks, AND Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS), AND Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, AND Patient must be red blood cell transfusion dependent. Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias. Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations: 1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR 2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR 3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR 4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR 5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR 6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR 7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias. Classification of a patient as red blood cell transfusion dependent requires that: (i) the patient has been transfused within the last 8 weeks; and (ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and (b) details (date, unique identifying number/code or provider number) of the full blood examination report; and (c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and (d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application. All the reports must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include: (a) a completed authority prescription form; and (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
“Lenalidomide changes the substrate specificity of the CRL4CRBN E3 ubiquitin ligase, a complex consisting of DNA-binding protein 1 (DDB1), cullin 4a (CUL4A), regulator of cullins 1 (ROC1), and cereblon (CRBN). Cereblon is the substrate adapter for the complex and is the primary molecular target of the drug. Treatment with lenalidomide changes the targets of the ligase complex. Subsequently, proteins IKZF1, IKZF3, and CK1α are recruited to the complex, ubiquinated, and then degraded by the proteasome.”
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