Active Ingredient: Midostaurin
Midostaurin is indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
100 - 100 mg
From 50 To 50 mg 2 time(s) per day every day
The recommended dose of midostaurin is 50 mg orally twice daily.
Midostaurin is dosed on days 8-21 of induction and consolidation chemotherapy cycles, and then for patients in complete response every day as single agent maintenance therapy until relapse for up to 12 cycles of 28 days each. In patients receiving a haematopoietic stem cell transplant (SCT), midostaurin should be discontinued 48 hours prior to the conditioning regimen for SCT.
Recommendations for dose modifications of midostaurin in patients with AML are provided in the following table.
Midostaurin dose interruption, reduction and discontinuation recommendations in patients with AML:
| Phase | Criteria | Midostaurin dosing |
|---|---|---|
| Induction, consolidation and maintenance | Grade ¾ pulmonary infiltrates | Interrupt midostaurin for the remainder of the cycle. Resume midostaurin at the same dose when infiltrate resolves to Grade ≤1. |
| Other Grade ¾ non-haematological toxicities | Interrupt midostaurin until toxicities considered at least possibly related to midostaurin have resolved to Grade ≤2, then resume midostaurin. | |
| QTc interval >470 msecs and ≤500 msecs | Decrease midostaurin to 50 mg once daily for the remainder of the cycle. Resume midostaurin at the initial dose in the next cycle provided that QTc interval improves to ≤470 msecs at the start of that cycle. Otherwise continue midostaurin 50 mg once daily. | |
| QTc interval >500 msecs | Withhold or interrupt midostaurin for the remainder of the cycle. If QTc improves to ≤470 msecs just prior to the next cycle, resume midostaurin at the initial dose. If QTc interval is not improved in time to start the next cycle do not administer midostaurin during that cycle. Midostaurin may be held for as many cycles as necessary until QTc improves. | |
| Maintenance only | Grade 4 neutropenia (ANC <0.5 × 109/l) | Interrupt midostaurin until ANC ≥1.0 × 109/l, then resume at 50 mg twice daily. If neutropenia (ANC <1.0 × 109/l) persists >2 weeks and is suspected to be related to midostaurin, discontinue midostaurin. |
| Persistent Grade ½ toxicity | Persistent Grade 1 or 2 toxicity that patients deem unacceptable may prompt an interruption for as many as 28 days. |
ANC: Absolute Neutrophil Count
It should be taken with food.
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