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Ruxolitinib (sold under the brand names Jakafi and Jakavi among others, and as Opzelura in cream form) is a medication used for the treatment of intermediate or high-risk myelofibrosis, a type of myeloproliferative neoplasm that affects the bone marrow; polycythemia vera, when there has been an inadequate response to or intolerance of hydroxyurea; and steroid-refractory acute graft-versus-host disease. Ruxolitinib is a Janus kinase inhibitor. It was developed and marketed by Incyte Corp in the US under the brand name Jakafi, and by Novartis elsewhere in the world, under the brand name Jakavi.
Read the full article on WikipediaHigh risk and intermediate-2 risk myelofibrosis Clinical criteria: Treatment Phase: Initial treatment The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report, AND The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition. Details of the following must be documented in the patient's medical records: (a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and (b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.
Intermediate-1 risk myelofibrosis Clinical criteria: Treatment Phase: Initial treatment The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report, AND Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; OR Patient must have intolerance to prior treatment with a JAK inhibitor for this condition, AND The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition. Details of the following must be documented in the patient's medical records: (a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and (b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.
Grade II to IV acute graft versus host disease (aGVHD) Clinical criteria: Treatment Phase: Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response. Treatment criteria: Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
Moderate to severe chronic graft versus host disease (cGVHD) Clinical criteria: Treatment Phase: Initial treatment Patient must have received prior systemic steroid treatment for this condition, AND Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment, AND The treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors. Treatment criteria: Must be treated by a haematologist; OR Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types, AND Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation. The severity of cGVHD is defined by the National Institutes of Health (NIH) criteria (Jagasia et al., 2015): (a) Moderate cGVHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1 (b) Severe cGVHD: at least 1 organ with a score of 3, or lung score of 2 or 3 Steroid-refractory disease is defined as: (a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 week (or equivalent); or (b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent). Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent). Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 24 weeks after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
Polycythemia vera Clinical criteria: Treatment Phase: Initial treatment Patient must be resistant to hydroxycarbamide (hydroxyurea); OR Patient must have an intolerance to hydroxycarbamide (hydroxyurea) of a severity necessitating permanent treatment withdrawal; OR Patient must have developed a clinically important adverse event/contraindication to hydroxycarbamide (hydroxyurea) as defined in the TGA-approved Product Information necessitating permanent treatment withdrawal, AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Population criteria: Patient must be at least 18 years of age. Hydroxycarbamide (hydroxyurea) resistance is defined as a minimum of 12 consecutive weeks treatment at a dose of at least 1.5 grams/day or at the maximum tolerated that still results in one of the following: (i) the need to reduce haematocrit levels to below 45% through phlebotomy; or (ii) a platelet count greater than 400 x 109/L and a white blood cell count greater than 10 x 109/L If applicable, details of prior systemic treatment with hydroxycarbamide (hydroxyurea) that caused either (i) an intolerance, (ii) an adverse event as listed in the TGA-approved Product Information, or (iii) a contraindication as listed in the TGA-approved Product Information necessitating permanent treatment withdrawal should be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; 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).
“Ruxolitinib is a Janus kinase inhibitor (JAK inhibitor) with selectivity for subtypes JAK1 and JAK2. Ruxolitinib inhibits dysregulated JAK signaling associated with myelofibrosis. JAK1 and JAK2 recruit signal transducers and activators of transcription (STATs) to cytokine receptors leading to modulation of gene expression.”
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