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Rydapt Dosage

Generic name: MIDOSTAURIN 25mg
Dosage form: capsule, liquid filled

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Patient Selection

Select patients for the treatment of AML with RYDAPT based on the presence of FLT3 mutation positivity [see Clinical Studies (14)]. Information on FDA-approved tests for the detection of FLT3 mutation in AML is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage in Acute Myeloid Leukemia

The recommended dose of RYDAPT for patients with acute myeloid leukemia is 50 mg orally twice daily with food on Days 8 to 21 of each cycle of induction with cytarabine and daunorubicin and on Days 8 to 21 of each cycle of consolidation with high-dose cytarabine [see Clinical Studies (14.1)]. For a description of the experience with single-agent treatment with RYDAPT beyond induction and consolidation, see Clinical Studies (14.1).

Recommended Dosage in ASM, SM-AHN, and MCL

The recommended dose of RYDAPT for patients with ASM, SM-AHN, and MCL is 100 mg orally twice daily with food. Continue treatment until disease progression or unacceptable toxicity occurs. Table 1 provides recommendations for dose modifications of RYDAPT in patients with ASM, SM-AHN, and MCL. Monitor patients for toxicity at least weekly for the first 4 weeks, every other week for the next 8 weeks, and monthly thereafter while on treatment.

Table 1: RYDAPT Dose Modifications for Patients with Systemic Mastocytosis
Criteria RYDAPT Dosing
ANC less than 1 x 109/L attributed to RYDAPT in patients without MCL, or ANC less than 0.5 x 109/L attributed to RYDAPT in patients with baseline ANC value of 0.5-1.5 x 109/L Interrupt RYDAPT until ANC greater than or equal to 1 x 109/L, then resume RYDAPT at 50 mg twice daily, and if tolerated, increase to 100 mg twice daily.
Discontinue RYDAPT if low ANC persists for > 21 days and is suspected to be related to RYDAPT.
Platelet count less than 50 x 109/L attributed to RYDAPT in patients without MCL, or platelet count less than 25 x 109/L attributed to RYDAPT in patients with baseline platelet count of 25-75 x 109/L Interrupt RYDAPT until platelet count greater than or equal to 50 x 109/L, then resume RYDAPT at 50 mg twice daily, and if tolerated, increase to 100 mg twice daily.
Discontinue if low platelet count persists for > 21 days and is suspected to be related to RYDAPT.
Hemoglobin less than 8 g/L attributed to RYDAPT in patients without MCL, or life-threatening anemia attributed to RYDAPT in patients with baseline hemoglobin value of 8 -10 g/L Interrupt RYDAPT until hemoglobin greater than or equal to 8 g/L, then resume RYDAPT at 50 mg twice daily, and if tolerated, increase to 100 mg twice daily.
Discontinue if low hemoglobin persists for > 21 days and is suspected to be related to RYDAPT.
Grade 3/4 nausea and/or vomiting despite optimal anti-emetic therapy Interrupt RYDAPT for 3 days (6 doses), then resume RYDAPT at 50 mg twice daily, and if tolerated, increase to 100 mg twice daily.
Other Grade 3/4 non-hematological toxicities Interrupt RYDAPT until event has resolved to ≤ Grade 2, then resume RYDAPT at 50 mg twice daily, and if tolerated, increase to 100 mg twice daily.
ANC: Absolute Neutrophil Count
CTCAE severity: Grade 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms; 4 = life-threatening symptoms.

Recommended Administration

  • Administer prophylactic anti-emetics before treatment with RYDAPT to reduce the risk of nausea and vomiting.
  • Administer RYDAPT orally with food, twice daily at approximately 12 hour intervals [see Clinical Pharmacology (12.3)]. Do not open or crush RYDAPT capsules.
  • If a dose of RYDAPT is missed or vomited, do not make up the dose; take the next dose at the usual scheduled time.
  • Consider interval assessments of QT by EKG if RYDAPT is taken concurrently with medications that can prolong the QT interval.
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