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Multiple sclerosis Clinical criteria: Treatment Phase: Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient, AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition, AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition, AND Patient must be ambulatory (without assistance or support). Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner in consultation with a specialist physician. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
“Preclinical studies indicate that diroximel fumarate pharmacodynamic responses appear to be mediated, at least in part, through activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway, which is the primary cellular defense system for responding to a variety of potentially toxic stimuli through up-regulation of antioxidant response genes.”
“The terminal half-life (t1/2) of monomethyl fumarate is approximately 1 hour, and no accumulation in monomethyl fumarate plasma exposures occurred with multiple doses of VUMERITY.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“In humans, diroximel fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid (TCA) cycle, with no involvement of the cytochrome P450 (CYP) system.”