Active Ingredient: Midostaurin
Midostaurin is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
200 - 200 mg
From 100 To 100 mg 2 time(s) per day every day
The recommended starting dose of midostaurin is 100 mg orally twice daily.
Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
Recommendations for dose modifications of midostaurin in patients with ASM, SM-AHN and MCL are provided in the following table.
Midostaurin dose interruption, reduction and discontinuation recommendations in patients with ASM, SM-AHN or MCL:
| Criteria | Midostaurin dosing |
|---|---|
| ANC <1,0 × 109/l attributed to midostaurin in patients without MCL, or ANC less than 0.5 × 109/l attributed to midostaurin in patients with baseline ANC value of 0.5-1.5 × 109/l | Interrupt midostaurin until ANC ≥1.0 × 109/l, then resume at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily. Discontinue midostaurin if low ANC persists for >21 days and is suspected to be related to midostaurin. |
| Platelet count less than 50 × 109/l attributed to midostaurin in patients without MCL, or platelet count less than 25 × 109/l attributed to midostaurin in patients with baseline platelet count of 25-75 × 109/l | Interrupt midostaurin until platelet count greater than or equal to 50 × 109/l, then resume midostaurin at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily. Discontinue midostaurin if low platelet count persists for >21 days and is suspected to be related to midostaurin. |
| Haemoglobin less than 8 g/dl attributed to midostaurin in patients without MCL, or life-threatening anaemia attributed to midostaurin in patients with baseline haemoglobin value of 8-10 g/dl. | Interrupt midostaurin until haemoglobin greater than or equal to 8 g/dl, then resume midostaurin at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily. Discontinue midostaurin if low haemoglobin persists for >21 days and is suspected to be related to midostaurin. |
| Grade ¾ nausea and/or vomiting despite optimal anti-emetic therapy | Interrupt midostaurin for 3 days (6 doses), then resume at 50 mg twice daily and, if tolerated, gradually increase to 100 mg twice daily. |
| Other Grade ¾ non-haematological toxicities | Interrupt midostaurin until event has resolved to Grade ≤2, then resume midostaurin at 50 mg twice daily and, if tolerated, increase to 100 mg twice daily. Discontinue midostaurin if toxicity is not resolved to Grade ≤2 within 21 days or severe toxicity recurs at a reduced dose of midostaurin. |
ANC: Absolute Neutrophil Count
CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.
If a dose is missed, the patient should take the next dose at the scheduled time.
If vomiting occurs, the patient should not take an additional dose of midostaurin, but should take the next scheduled dose.
It should be taken with food.
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