Midostaurin

Both indications in this page's identity (AML and mastocytosis) are covered by the fetched SPC, and both are stated in the dose above with their indication named. Treatment should be initiated by a physician experienced in the use of anti-cancer therapies. Before taking midostaurin, AML patients must have confirmation of FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. Prophylactic antiemetics should be administered in accordance with local medical practice as per patient tolerance. In patients receiving a haematopoietic stem cell transplant, midostaurin should be discontinued 48 hours prior to the conditioning regimen. DOSE MODIFICATION IN AML: QTc >470 msec and <=500 msec - decrease to 50 mg once daily for the remainder of the cycle, resuming the initial dose in the next cycle if QTc improves to <=470 msec; QTc >500 msec - withhold or interrupt for the remainder of the cycle; Grade 3/4 pulmonary infiltrates - interrupt for the remainder of the cycle and resume at the same dose when the infiltrate resolves to Grade <=1; other Grade 3/4 non-haematological toxicity - interrupt until resolved to Grade <=2; in maintenance, Grade 4 neutropenia (ANC <0.5 x 10^9/l) - interrupt until ANC >=1.0 x 10^9/l then resume at 50 mg twice daily, and discontinue if neutropenia (ANC <1.0 x 10^9/l) persists >2 weeks and is suspected to be related to treatment. DOSE MODIFICATION IN ASM/SM-AHN/MCL: after interruption for haematological toxicity, Grade 3/4 nausea/vomiting despite optimal anti-emetics, or other Grade 3/4 non-haematological toxicity, resume at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily; discontinue if the abnormality persists for >21 days and is suspected to be related to treatment. MISSED DOSE: take the next dose at the scheduled time; if vomiting occurs, do not take an additional dose but take the next scheduled dose. SPECIAL POPULATIONS: no dose adjustment for age over 65 (but in patients aged >=60 years use only in those eligible for intensive induction chemotherapy with adequate performance status and without significant comorbidities), for mild or moderate renal impairment, or for mild or moderate (Child-Pugh A or B) hepatic impairment; clinical experience in severe renal impairment is limited and there are no data in end-stage renal disease. Use is not recommended in acute promyelocytic leukaemia. PAEDIATRIC: the SPC gives no paediatric dose - it states only that 'Rydapt should not be used in combination with intensive paediatric AML combination chemotherapy regimens including anthracyclines, fludarabine and cytarabine because of the risk of prolonged haematological recovery (such as prolonged severe neutropenia and thrombocytopenia)', so no paediatric figure is stored. Some sections of the product information we used were incomplete — check the full SPC.