Why is this medication prescribed?

Midostaurin is a medication that is prescribed for the treatment of certain types of cancer, specifically acute myeloid leukemia (AML) and a rare type of aggressive systemic mastocytosis (ASM). It is typically used in combination with other chemotherapy drugs as part of a treatment regimen.

• Acute Myeloid Leukemia (AML): Midostaurin is indicated for adults with newly diagnosed AML who have a specific genetic mutation called FLT3-ITD (internal tandem duplication) or a FLT3 tyrosine kinase domain (TKD) mutation. These mutations are associated with a poorer prognosis in AML, and Midostaurin can help improve the chances of remission and survival when used in combination with standard chemotherapy.
• Systemic Mastocytosis: Midostaurin is also used to treat a rare condition called aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL), which are characterized by the abnormal growth and accumulation of mast cells in various tissues in the body. Midostaurin can help control the symptoms and progression of these conditions.

How should this medicine be used?

Midostaurin is available in oral capsule form, and the dosing instructions should be provided by a healthcare professional. However, here are some general guidelines for using Midostaurin:

• Dosage: The recommended dosage and treatment schedule may vary depending on the specific cancer being treated and the individual patient’s condition. Follow your doctor’s instructions carefully.
• Timing: Midostaurin is usually taken with food to enhance its absorption. It’s important to take it at the same time each day to help you remember and ensure consistent blood levels.
• Swallow Whole: Swallow the capsules whole; do not crush, chew, or open them.
• Duration: Treatment with Midostaurin is typically given in cycles, and the duration of treatment may vary. It is essential to complete the prescribed course of treatment unless otherwise instructed by your healthcare provider.
• Monitoring: During treatment, your doctor will monitor your progress and may adjust the dosage or treatment plan based on how you respond and any side effects you may experience.
• Adverse Effects: Like all medications, Midostaurin can cause side effects, which can vary from person to person. Common side effects may include nausea, vomiting, diarrhea, rash, and fatigue. Be sure to report any side effects or unusual symptoms to your healthcare provider.

It’s crucial to have regular check-ups and blood tests while taking Midostaurin to monitor its effectiveness and manage any potential side effects. Always follow your healthcare provider’s recommendations regarding the use of Midostaurin, and do not change your dosage or stop taking the medication without consulting them first.

Other uses for this medicine

Midostaurin is primarily approved for the treatment of AML and systemic mastocytosis. However, research may uncover other potential uses for this medication in the future. It’s important to note that the use of midostaurin for conditions other than those for which it is approved is considered off-label, and your healthcare provider will assess the potential benefits and risks in such cases.

What special precautions should I follow?

When using Midostaurin, several special precautions and considerations should be taken into account:

• Pregnancy and Breastfeeding: Midostaurin can harm an unborn baby, so it should not be used during pregnancy unless the potential benefits outweigh the risks. It is also not recommended for breastfeeding, as it may pass into breast milk and harm the infant. Effective contraception should be used during treatment with Midostaurin, and patients should discuss family planning with their healthcare provider.
• Liver Function: Midostaurin may affect liver function. Regular monitoring of liver enzymes is usually recommended during treatment, and dose adjustments may be necessary if liver function is impaired.
• Drug Interactions: Midostaurin can interact with various medications, including strong CYP3A4 inhibitors and inducers. Patients should inform their healthcare provider of all medications, supplements, and herbal products they are taking to avoid potentially harmful interactions.
• Cardiac Monitoring: Midostaurin may prolong the QT interval on an electrocardiogram (ECG), which can increase the risk of arrhythmias. Cardiac monitoring may be necessary in patients with a history of or predisposition to cardiac issues.
• Bleeding Risk: Midostaurin may increase the risk of bleeding, so it should be used cautiously in patients with a history of bleeding disorders or those taking anticoagulants.
• Allergies: Individuals with known allergies or hypersensitivity to Midostaurin or its components should not use the medication.

Always follow your healthcare provider’s instructions and inform them of any preexisting medical conditions or medications you are taking before starting Midostaurin. They can provide personalized guidance and monitor your treatment for safety and effectiveness.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Midostaurin. However, it’s essential to follow a balanced diet and maintain good nutritional status, especially during cancer treatment. Your healthcare provider or a registered dietitian may provide guidance on nutrition based on your individual needs.

What should I do if I forget a dose?

If you miss a dose of Midostaurin, take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Midostaurin, like many medications, can cause side effects. The severity and specific side effects can vary from person to person. It’s important to discuss potential side effects with your healthcare provider before starting Midostaurin, and they will monitor your condition and adjust your treatment as needed. Common side effects of Midostaurin may include:

• Nausea and Vomiting: Gastrointestinal side effects, such as nausea and vomiting, are common with Midostaurin. Taking the medication with food, as directed by your healthcare provider, can help reduce these symptoms.
• Diarrhea: Diarrhea is another common side effect of Midostaurin. It’s essential to stay hydrated and report severe or persistent diarrhea to your healthcare provider.
• Fatigue: Feeling tired or fatigued is a common side effect of Midostaurin. Be sure to get enough rest, and inform your healthcare provider if fatigue becomes severe or affects your daily life.
• Skin Rash: Some people may develop a skin rash while taking Midostaurin. If you experience a rash, notify your healthcare provider. They can recommend ways to manage it or adjust your treatment if necessary.
• Headache: Headaches are a potential side effect of Midostaurin. If you experience severe or persistent headaches, inform your healthcare provider.
• Fever: Fever may occur as a side effect of Midostaurin. If you develop a fever, it’s essential to contact your healthcare provider promptly.
• Decreased Appetite: Some individuals may experience a decreased appetite while taking Midostaurin. Maintaining proper nutrition is important during treatment, so discuss any appetite changes with your healthcare provider.
• Muscle or Joint Pain: Midostaurin can cause muscle or joint pain in some people. If you experience significant discomfort, report it to your healthcare provider.
• Bleeding or Bruising: Midostaurin may increase the risk of bleeding or bruising. Notify your healthcare provider if you notice any unusual bleeding, such as nosebleeds or easy bruising.
• Cardiac Effects: Midostaurin can affect the heart, leading to irregular heart rhythms (arrhythmias). Regular cardiac monitoring may be necessary, especially in individuals with a history of heart problems.
• Liver Enzyme Elevations: Midostaurin may lead to elevated liver enzymes. Regular liver function tests will likely be performed during treatment.
• Other Serious Side Effects: In rare cases, Midostaurin can cause more severe side effects, including severe allergic reactions, lung problems, and pancreatitis. Contact your healthcare provider immediately if you experience difficulty breathing, severe abdominal pain, or other serious symptoms.

It’s crucial to communicate openly with your healthcare provider about any side effects or symptoms you experience during Midostaurin treatment. They can provide guidance on managing side effects and make adjustments to your treatment plan if necessary. Remember that the potential benefits of Midostaurin in treating your specific medical condition will be carefully considered by your healthcare provider in relation to the possible side effects.

What should I know about storage and disposal of this medication?

Here are some important guidelines for storing and disposing of Midostaurin:

• Storage: Store Midostaurin at room temperature, away from direct sunlight, heat, and moisture. Keep the medication in its original container with the lid tightly closed. Do not store it in the bathroom or kitchen, where it may be exposed to humidity.
• Keep Out of Reach of Children and Pets: Store Midostaurin in a location that is out of reach of children and pets to prevent accidental ingestion.
• Do Not Share: Do not share Midostaurin with others, even if they have a similar medical condition. This medication is prescribed specifically for your treatment and may not be suitable for others.
• Disposal: Dispose of unused or expired Midostaurin capsules according to local regulations or guidelines. Do not flush medications down the toilet or drain unless specifically instructed to do so. Contact your healthcare provider, pharmacist, or local waste disposal facility for guidance on safe disposal.

In case of emergency/overdose

If you suspect an overdose or experience severe symptoms while taking Midostaurin, seek immediate medical attention or contact your local poison control center at once. Overdose symptoms may include severe nausea, vomiting, diarrhea, severe dizziness, confusion, irregular heartbeat, or loss of consciousness.

What other information should I know

• Regular Follow-Up: It is crucial to attend all scheduled follow-up appointments with your healthcare provider while taking Midostaurin. They will monitor your condition, assess treatment efficacy, and manage any side effects or complications.
• Medication Interaction: Inform your healthcare provider of all medications (including prescription, over-the-counter, vitamins, and supplements) you are taking, as Midostaurin may interact with other drugs. Do not start or stop any medication without your healthcare provider’s guidance.
• Pregnancy and Contraception: As mentioned earlier, Midostaurin can harm an unborn baby. If you are of childbearing age, discuss effective contraception methods with your healthcare provider during treatment. If you become pregnant while taking Midostaurin, notify your healthcare provider immediately.
• Blood Tests: You will likely need frequent blood tests to monitor your blood cell counts and liver function during Midostaurin treatment. Attend all recommended blood tests as scheduled.
• Patient Assistance Programs: Depending on your location and healthcare coverage, patient assistance programs or financial support may be available to help with the cost of Midostaurin. Discuss these options with your healthcare provider or a social worker if needed.
• Travel Considerations: If you plan to travel, ensure that you have an adequate supply of Midostaurin to last for the duration of your trip. Travel with the medication in its original container, and be prepared for any possible side effects or emergencies while away from home.
• Patient Education: It’s essential to have a good understanding of your specific treatment plan, including the dosage, timing, and potential side effects of Midostaurin. Feel free to ask your healthcare provider or pharmacist any questions you may have to ensure safe and effective use of the medication.

Remember to follow your healthcare provider’s instructions carefully and report any concerns or changes in your health during Midostaurin treatment promptly. They can provide personalized guidance and address any issues that may arise.