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Vismodegib, sold under the brand name Erivedge, is a medication used for the treatment of basal-cell carcinoma (BCC). The approval of vismodegib on January 30, 2012, represents the first Hedgehog signaling pathway targeting agent to gain U.S. Food and Drug Administration (FDA) approval. The drug is also undergoing clinical trials for metastatic colorectal cancer, small-cell lung cancer, advanced stomach cancer, pancreatic cancer, medulloblastoma and chondrosarcoma as of June 2011[update]. The drug was developed by the biotechnology/pharmaceutical company Genentech.
Read the full article on WikipediaMetastatic or locally advanced basal cell carcinoma (BCC) Clinical criteria: Treatment Phase: Initial treatment The condition must be inappropriate for surgery, AND The condition must be inappropriate for curative radiotherapy, AND Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; OR Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal, AND Patient must not receive more than 16 weeks of treatment under this restriction. 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 histological confirmation of BCC and whether the condition is metastatic or locally advanced; and (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and (c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. 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) 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). Inappropriate for surgery is defined as: (i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or (ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or (iii) Medical contraindication to surgery. Inappropriate for curative radiotherapy is defined as: (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.
“The substance acts as a cyclopamine-competitive antagonist of the smoothened receptor (SMO) which is part of the Hedgehog signaling pathway. SMO inhibition causes the transcription factors GLI1 and GLI2 to remain inactive, which prevents the expression of tumor mediating genes within the hedgehog pathway. This pathway is pathogenetically relevant in more than 90% of basal-cell carcinomas.”
“4 days (continuous use),12 days (single dose)”
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