MIDOSTAURIN - ORAL

MIDOSTAURIN - ORAL

PHONETIC PRONUNCIATION: (MYE-doe-STAW-rin)

COMMON BRAND NAME(S): Rydapt

GENERIC NAME(S): midostaurin

Uses

USES: Midostaurin is used to treat certain types of blood cell cancer (acute myeloid leukemia-AML, mast cell leukemia-MCL) or an immune system disorder (mastocytosis). It works by slowing or stopping the growth of cancer cells and certain immune system cells (mast cells).


How to use MIDOSTAURIN - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking midostaurin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually twice daily (every 12 hours). Swallow the capsules whole. Do not open or crush the capsules. The dosage is based on your medical condition and response to treatment. For certain conditions, you may not need to take this medication every day (for example, some people are directed to take the medication for 2 weeks, then stop for 2 weeks). Follow your doctor's instructions carefully. Your doctor should instruct you to take other medications to prevent nausea and vomiting. Take those medications as directed. If you vomit after taking a dose, do not take another dose at that time. Take your next dose on your usual dosing schedule. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Side Effects

SIDE EFFECTS: Nausea/vomiting, diarrhea, stomach/abdominal pain, mouth sores, constipation, hemorrhoids, headache, dizziness, tiredness, muscle/joint pain, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: increased thirst/urination, signs of kidney problems (such as change in the amount of urine), signs of infection (such as sore throat that doesn't go away, fever), easy bruising/bleeding, unusual tiredness, vomit that is bloody or looks like coffee grounds, black/tarry stool. Get medical help right away if you have any very serious side effects, including: symptoms of lung problems (such as cough, shortness of breath, chest pain), fast/irregular heartbeat, severe dizziness, fainting. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking midostaurin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung/breathing problems. Midostaurin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using midostaurin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using midostaurin safely. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). Tell your doctor if you are pregnant or plan to become pregnant. You should get a pregnancy test within 7 days of starting this medication. You should not become pregnant while using midostaurin. Midostaurin may harm an unborn baby. Both men and women using this medication should ask about reliable forms of birth control during treatment and for 4 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 4 months after stopping this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of midostaurin from your body, which may affect how midostaurin works. Examples include rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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color
pale orange
shape
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PKC NVR

color
pale orange
shape
oblong
imprint
PKC NVR

color
pale orange
shape
oblong
imprint
PKC NVR

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Faq for MIDOSTAURIN - ORAL

Midostaurin is used to treat a certain type of blood cancer called acute myeloid leukemia (AML). It is specifically used in patients with a specific genetic mutation called FLT3.

Midostaurin works by inhibiting certain proteins in cancer cells, including FLT

Midostaurin is taken orally, usually with food, twice a day. It is important to follow your doctor's instructions and take the medicine at the same time each day.

Common side effects of midostaurin include nausea, vomiting, diarrhea, stomach pain, headache, dizziness, fever, and rash. It is important to report any severe or persistent side effects to your doctor.

It is generally recommended to avoid alcohol consumption while taking midostaurin, as it may increase the risk of side effects and interfere with the effectiveness of the medication. It's best to discuss this with your doctor.

Midostaurin may interact with certain medications, including strong CYP3A4 inhibitors and inducers, anticoagulants, and antiplatelet drugs. It's important to inform your doctor about all the medications you are taking to avoid any potential interactions.

The duration of midostaurin treatment is determined by your doctor based on your individual condition. It is usually taken in cycles, with periods of treatment and rest. It's important to follow your doctor's instructions regarding the duration of treatment.

Midostaurin may harm the unborn baby, so it is not recommended for use during pregnancy. It is also not known if the drug passes into breast milk, so breastfeeding while taking midostaurin is discouraged. It's essential to discuss the potential risks and benefits with your doctor.

If you miss a dose of midostaurin, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.