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General Medication Fact Sheet for Rydapt
| Field | Information |
|---|---|
| Medication Name | Rydapt |
| Generic Name | Midostaurin |
| Boxed/Label Warning | May cause serious and sometimes fatal infections, cardiac dysfunction, pneumonitis, and embryo-fetal toxicity. |
| Purpose | Treatment of acute myeloid leukemia (AML) with FLT3 mutation and advanced systemic mastocytosis (AdvSM). |
| Mechanism of Action | Inhibits multiple receptor tyrosine kinases, including FLT3, KIT, PDGFR, VEGFR2, and others, disrupting signaling pathways involved in cell growth and survival. |
| Dosage Forms | Oral capsules |
| Available Strengths | 25 mg |
| Dosage Frequency | Twice daily with food, typically in combination with chemotherapy for AML. |
| Common Side Effects | Nausea, vomiting, diarrhea, mucositis, fatigue, edema, headache, musculoskeletal pain, upper respiratory tract infections. |
| Serious Side Effects | QT prolongation, pancreatitis, interstitial lung disease, infections, cardiac dysfunction, tumor lysis syndrome. |
| Drug Interactions | Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole), strong CYP3A4 inducers (e.g., rifampin, phenytoin), CYP3A4 substrates. |
| Important Notes | Must be taken with food. Monitor for signs and symptoms of cardiac dysfunction, pulmonary toxicity, and infections. Requires FLT3 mutation testing for AML. |
| Storage | Store at room temperature, between 20°C to 25°C (68°F to 77°F). |
| Missed Dose | If a dose is missed, take it as soon as you remember unless it is almost time for your next dose. Do not double the dose. |
| Alternatives | For AML: Gilteritinib, Enasidenib, Sorafenib. For AdvSM: Imatinib, Avapritinib. (Alternatives depend on specific mutation profile and disease characteristics) |
Rydapt Alternatives
| Medication | Mechanism of Action | Notes |
|---|---|---|
| Gilteritinib (Xospata) | FLT3 inhibitor | Used for relapsed or refractory AML with FLT3 mutation. |
| Enasidenib (Idhifa) | IDH2 inhibitor | Used for relapsed or refractory AML with IDH2 mutation. Not a direct alternative to Rydapt, but used in AML treatment. |
| Imatinib (Gleevec) | Tyrosine kinase inhibitor | Used for systemic mastocytosis, but less effective in advanced cases. |
| Avapritinib (Ayvakit) | KIT D816V inhibitor | Used for advanced systemic mastocytosis with the KIT D816V mutation. |
Rydapt Side Effects
| Common Side Effects | Serious Side Effects |
|---|---|
| Nausea | QT prolongation |
| Vomiting | Pancreatitis |
| Diarrhea | Interstitial Lung Disease |
| Fatigue | Infections (pneumonia, sepsis) |
| Edema | Cardiac Dysfunction (heart failure) |
| Headache | Tumor Lysis Syndrome |
Rydapt Dosage Guide
| Condition | Starting Dose | Maintenance Dose | Administration Notes |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | 50 mg | 50 mg twice daily | Administer orally with food on days 8-21 of induction chemotherapy and as single agent during consolidation. |
| Advanced Systemic Mastocytosis (AdvSM) | 100 mg | 100 mg twice daily | Administer orally with food. |
