Midostaurin Capsules

What is this medication?

MIDOSTAURIN (mi doe STOR in) treats blood and bone marrow cancers. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Rydapt

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Lung or breathing disease
• An unusual or allergic reaction to midostaurin, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. Swallow the capsules whole. Take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose or vomit after taking it, skip that dose. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Dronedarone
• Fluconazole
• Pimozide
• Posaconazole
• Saquinavir
• Thioridazine

This medication may also interact with the following:

• Bupropion
• Certain medications for HIV or AIDS, such as boceprevir, cobicistat, danoprevir, elvitegravir, indinavir, lopinavir;ritonavir, nelfinavir, paritaprevir;ritonavir (and ombitasvir and/or dasabuvir), ritonavir, saquinavir, tipranavir
• Certain medications for fungal infections, such as ketoconazole, itraconazole, or voriconazole
• Certain medications for seizures, such as carbamazepine, phenytoin
• Clarithromycin
• Conivaptan
• Diltiazem
• Enzalutamide
• Grapefruit juice
• Idelalisib
• Mitotane
• Nefazodone
• Other medications that cause heart rhythm changes
• Rifampin
• Rosuvastatin
• St. John's wort
• Troleandomycin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 4 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 4 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 4 months after the last dose.

This medication may cause infertility. Talk with your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Dry cough, shortness of breath or trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bone, joint, or muscle pain
• Constipation
• Headache
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Swelling of the ankles, hands, or feet
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.