Rydapt (Midostaurin)
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Fact Table
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| Formula | C35H30N4O4 |
| License | Prescription only (Rx-only, oncology agent) |
| Bioavailability | Moderate, variable; increased exposure with food (AUC ? ~22% standard meal, ~59% high-fat meal); C??? reduced and delayed with food |
| Legal status | Rx-only (US, EU, Canada, others) |
| Chemical Name | N-[(2S,3R,4R,6R)-3-Methoxy-2-methyl-…-N-methylbenzamide (midostaurin, multikinase inhibitor) |
| Elimination half-life | Time-dependent; trough levels peak ~8 days, decline by half by ~28 days; active metabolite CGP52421 continues to accumulate |
| Dosage (Strength) | 25?mg soft capsule. AML: 50?mg orally twice daily with food. ASM/SM-AHN/MCL: 100?mg orally twice daily with food. |
| Pregnancy | Contraindicated—potential fetal harm; pregnancy test and contraception required during and for 4 months after treatment |
| Brands | Rydapt |
| Protein binding | Not specified |
| PubChem CID | 9829523 |
| MedlinePlus | Not assigned |
| ChEBI | Not assigned |
| ATC code | L01EX10 |
| DrugBank | DB06595 |
| KEGG | D05029 |
| Routes of administration | Oral (soft capsules) |
Rydapt (Midostaurin) is a prescription oral kinase inhibitor used in the treatment of specific types of cancers. It is primarily indicated for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive, as determined by an FDA-approved test. Rydapt is used in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy. Additionally, it is approved as a monotherapy for adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
Midostaurin works by inhibiting multiple receptor tyrosine kinases, including FLT3, which play a key role in the proliferation and survival of cancer cells. Its targeted mechanism provides a treatment option for malignancies driven by genetic mutations in kinase signaling pathways.
Directions
Rydapt should be taken orally with food. For FLT3-mutated AML, the recommended dosage is 50 mg twice daily on days 8 to 21 of each cycle of induction and consolidation chemotherapy. Treatment should be administered under the supervision of a qualified healthcare professional and in accordance with specific treatment protocols.
For ASM, SM-AHN, or MCL, the recommended dose is 100 mg twice daily, continuously until disease progression or unacceptable toxicity occurs.
Patients should swallow capsules whole without opening or crushing them. Dosing adjustments may be necessary in cases of adverse reactions or hepatic impairment. Detailed treatment schedules and supportive care should be determined by the prescribing physician.
Ingredients
The active ingredient in Rydapt is midostaurin.
Cautions
Caution is advised when administering Rydapt in patients with hepatic impairment, as midostaurin is primarily metabolized in the liver. Regular monitoring of liver function tests is recommended. Use in combination with strong CYP3A4 inhibitors or inducers should be approached with caution due to potential alterations in drug exposure.
Patients should be closely monitored for signs of pulmonary toxicity, such as interstitial lung disease or pneumonitis, and therapy should be discontinued if such adverse effects are suspected.
Rydapt may also prolong QT interval; therefore, baseline and periodic ECG monitoring is advised, especially in patients with predisposing conditions.
Contraindications
Rydapt is contraindicated in patients with known hypersensitivity to midostaurin or any of its excipients. It should not be used during pregnancy due to its potential to cause fetal harm. Use is also contraindicated in breastfeeding women, as midostaurin may be excreted in human milk and pose a risk to the nursing infant.
Side Effects
Common and serious side effects associated with Rydapt may include:
- Nausea and vomiting
- Diarrhea
- Febrile neutropenia
- Mucositis
- Headache
- Epistaxis (nosebleeds)
- Upper respiratory tract infections
- Rash
- Elevated liver enzymes
- Pulmonary toxicity (e.g., pneumonitis)
- QT prolongation
- Edema
- Anemia
- Fatigue
Patients should report any persistent or severe adverse effects to their healthcare provider promptly.
Frequently Asked Questions about Rydapt (Midostaurin)
What is Rydapt used for?
Rydapt (midostaurin) is a prescription medication used to treat certain types of cancer, including newly diagnosed acute myeloid leukemia (AML) with a FLT3 mutation, and advanced systemic mastocytosis (including aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia).
How does Rydapt work?
Rydapt is a kinase inhibitor that targets specific enzymes involved in cancer cell growth and survival. In AML with FLT3 mutations, it blocks abnormal FLT3 signaling. In systemic mastocytosis, it inhibits multiple kinases, including KIT, to help reduce the number and activity of abnormal mast cells.
How is Rydapt taken?
Rydapt is taken orally as a capsule, usually twice daily with food. For AML, it is used in combination with chemotherapy. For systemic mastocytosis, it is used as monotherapy. Always follow your healthcare provider’s dosing instructions carefully.
What are the common side effects of Rydapt?
Common side effects include nausea, vomiting, diarrhea, upper respiratory tract infections, fever, headache, and fatigue. In AML patients, it may also cause low blood cell counts. Regular monitoring is important during treatment.
Can Rydapt cause serious side effects?
Yes, Rydapt may cause serious side effects, including lung problems (such as interstitial lung disease or pneumonitis), heart rhythm issues, and severe infections. Report symptoms like shortness of breath, chest pain, or irregular heartbeat to your doctor immediately.
Who should not take Rydapt?
Rydapt should not be used in patients who are allergic to midostaurin or any of its ingredients. It may not be suitable for individuals with severe liver problems. Your doctor will determine if Rydapt is appropriate based on your medical history and condition.
Is Rydapt safe during pregnancy or breastfeeding?
Rydapt can cause harm to an unborn baby and should not be used during pregnancy. Women of childbearing potential should use effective contraception during treatment and for at least 4 months after the last dose. Breastfeeding is not recommended while using Rydapt.
Can Rydapt interact with other medications?
Yes, Rydapt can interact with other medications, particularly those that affect liver enzymes (CYP3A4 inhibitors or inducers). Tell your healthcare provider about all medications and supplements you are taking to avoid interactions.
What monitoring is needed while taking Rydapt?
Regular monitoring includes blood counts, liver function tests, and heart monitoring (such as ECG) to detect potential side effects. Your doctor may also monitor for signs of infection or lung toxicity during treatment.
What should I do if I miss a dose of Rydapt?
If you miss a dose of Rydapt, take it as soon as you remember, unless it is close to the time of your next dose. Do not take two doses at once. If you vomit after taking a dose, do not take an additional dose; take your next dose at the scheduled time.
