Midostaurin (RYDAPT)

Acute myeloid leukemia

Acute myeloid leukemia

• Oral: 50 mg twice daily on days 8 to 21 of induction and consolidation chemotherapy, up to a maximum of 4 courses of therapy (1 induction cycle and up to 3 consolidative cycles)
• Given in combination with chemotherapy

Available as 25 mg liquid-filled gelatin capsules. Capsules contain benzyl alcohol and ethanol. Capsules should NOT be opened. Store at room temperature in original packaging away from moisture.

FLT3 Inhibitor

Take with food to help prevent nausea

If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.

Common: Anemia, Febrile neutropenia, Leucopenia, Lymphopenia, Neutropenia, Thrombocytopenia, Nausea, Vomiting , Stomatitis, Pyrexia, Device related infection, Pneumonia, ALT increase, AST increase, Lipase increase, Hypocalcemia, Hypokalemia, Hypomagnesemia, Exfoliative dermatitis.

Less Common: Cardiac failure, Myocardial infarction, Gastrointestinal hemorrhage, Hypersensitivity, Sepsis, QT interval prolongation, Renal insufficiency, Interstitial lung disease/pneumonitis, Rash, Hypotension.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC, LVEF, liver function tests, serum creatinine, blood glucose, ECG.

During treatment: CBC, liver function tests, serum creatinine.

• May increase the risk for QT interval prolongation. Avoid concurrent therapy with drugs associated with QTc prolongation and/or Torsades de pointes, if possible. If unavoidable, monitor for QT prolongation or cardiac arrhythmias.
• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.
• Cases of interstitial lung disease and pneumonitis, some fatal, have occurred in patients treated with Midostaurin. Monitor patients for pulmonary symptoms. Discontinue Midostaurin in patients who experience signs or symptoms of interstitial lung disease or pneumonitis without an infectious etiology.

BC Cancer. BC Cancer Drug Manual. Midostaurin.  Vancouver, British Columbia: BC Cancer Agency. Available at:  http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Midostaurin_monograph.pdf.Updated December 1, 2018.  Accessed February 2, 2024.

Lexicomp. Midostaurin Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Available at: https://online-lexi-com.qe2a-proxy.mun.ca/lco/action/doc/retrieve/docid/patch_f/6479094?cesid=9Ceuhtwb1LA&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dmidostaurin%26t%3Dname%26acs%3Dtrue%26acq%3Dmidostau. Updated January 24, 2024. Accessed February 2, 2024.

Cancer Care Ontario. Midostaurin Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/44496. Updated April 2022. Accessed January 22, 2024.

Novartis Pharmaceuticals Canada Inc. RYDAPT® Product Monograph. Dorval, Quebec. Updated March 31, 2023.