Rydapt Capsules — Midostaurin 25 mg (112 Caps) Novartis

Prescribed by a hematologist-oncologist following genetic mutation testing. Indications include:

• 🔹 Acute Myeloid Leukemia (AML): For adult patients with newly diagnosed FLT3-mutated AML (used in combination with standard cytarabine and daunorubicin/idarubicin induction and cytarabine consolidation chemotherapy).
• 🔹 Systemic Mastocytosis: As a monotherapy for adults with Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with Associated Hematological Neoplasm (SM-AHN), or Mast Cell Leukemia (MCL).

Sales Unit: Multipack carton containing 112 soft capsules/tablets (4 inner packs of 28 units each). Strength: 25 mg per unit.

⚠️ APPLICATION INSTRUCTIONS:

• Dosage: Strictly individualized by the doctor. For AML, the standard dose is usually 50 mg (2 capsules) twice daily. For Mastocytosis, it is 100 mg (4 capsules) twice daily.
• Administration: Take twice a day at roughly 12-hour intervals. Must be taken with food and swallowed whole with a glass of water. Do not open, crush, or chew the capsules.
• ✋ Missed Dose: If a dose is missed or if vomiting occurs after taking a dose, do not take an extra dose. Take the next scheduled dose at the usual time.

• ⛔ Drug Interactions: Co-administration with strong CYP3A4 inducers (e.g., rifampicin, St. John's wort, carbamazepine) is strictly contraindicated as it significantly decreases the effectiveness of Rydapt.
• Hypersensitivity to midostaurin or any of the excipients.
• Pregnancy and breastfeeding (highly teratogenic; effective contraception is mandatory during and after treatment).
• Children and adolescents under 18 years of age.

Treatment requires rigorous medical supervision, including regular blood tests and ECGs. Potential side effects include:

• 🩸 Blood Counts: Febrile neutropenia (low white blood cells accompanied by fever), petechiae (small red/purple spots on the skin).
• 🤢 Gastrointestinal: Nausea, vomiting (very common; prophylactic anti-nausea medication is often prescribed), diarrhea.
• 🫀 Cardiac: Prolongation of the QT interval (requires routine ECG monitoring).
• 💤 General: Headache, severe fatigue, musculoskeletal pain.
• 🫁 Respiratory: Shortness of breath, increased risk of pulmonary infections.