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This document provides crucial safety information regarding the use of the medication Rydapt (midostaurin). It is essential to understand the potential risks and necessary precautions. Please read the information thoroughly and consult your healthcare provider with any questions or concerns.

• Respiratory Issues: Although rare, Rydapt (midostaurin) may lead to serious lung complications, such as inflammation or interstitial lung disease. Should you experience any new or worsening respiratory symptoms, contact your healthcare provider immediately. Discontinuation of the medication may be advised.

• Risks During Pregnancy: Animal studies indicate that Rydapt (midostaurin) can cause harm to an unborn child if used during pregnancy. Therefore, it is not recommended for use by pregnant women. Females capable of becoming pregnant will be required to take a pregnancy test one week prior to starting the medication. It is important to use effective contraception while taking Rydapt (midostaurin) and for at least four months following the final dose. Male patients with partners who can become pregnant should also use contraception during treatment and for four months afterward. Notify your healthcare provider immediately if pregnancy occurs during this period.

Please ensure full understanding and adherence to these guidelines to maintain safety while using Rydapt (midostaurin).

When taking this medication, some common side effects may occur, but they are usually mild and not a cause for concern. You may experience nausea, vomiting, diarrhea, stomach pain, mouth sores, constipation, hemorrhoids, headache, dizziness, tiredness, muscle or joint pain, or trouble sleeping. If these effects persist or worsen, it's advisable to consult your healthcare provider.

There is a possibility of experiencing some other side effects such as fever due to low white blood cell counts, high blood sugar levels, lower blood calcium levels, redness or ulcers in the mouth, abnormal blood cell counts, swelling in the hands and feet, and abnormal liver or pancreatic enzyme levels. Some individuals might also notice red, brown, or purple spots on the skin, joint stiffness, cough, trouble breathing, nosebleeds, rash, infections, sweating, or muscle or bone pain.

In rare instances, severe side effects could occur, demanding prompt medical attention. These include symptoms of lung problems such as cough, chest pain, or trouble breathing, fast or irregular heartbeat, severe dizziness, fainting, bloody vomit, black or tarry stool, increased thirst or urination, signs of kidney issues, or unexplained bruising or bleeding. Additionally, severe allergic reactions are highly uncommon but require immediate care if symptoms like rash, swelling, or breathing difficulties appear.

It's important to be aware of these side effects and seek medical advice if you experience any serious issues. Always communicate with your healthcare provider regarding any concerns you have while taking this medication.