Midostaurin capsules

What is this medication?

MIDOSTAURIN (mi doe stor in) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat acute myelogenous leukemia and systemic mastocytosis.

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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Do not take with grapefruit juice. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• fluconazole
• pimozide
• posaconazole
• saquinavir
• thioridazine

This medicine may also interact with the following medications:

• bupropion
• certain medicines for HIV or AIDS like boceprevir, cobicistat, danoprevir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, paritaprevir/ritonavir (and ombitasvir and/or dasabuvir), ritonavir, saquinavir, and tipranavir
• certain medicines for fungal infections like ketoconazole, itraconazole, and voriconazole
• certain medicines for seizures like carbamazepine and phenytoin
• clarithromycin
• conivaptan
• diltiazem
• enzalutamide
• grapefruit juice
• idelalisib
• mitotane
• nefazodone
• other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone
• 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?

You may need blood work done while you are taking this medicine.

This medicine may increase your risk of getting an infection. Call your health care provider 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 medicine may increase your risk to bruise or bleed. Call your doctor or health care provider if you notice any unusual bleeding.

Do not become pregnant while taking this medicine or for 4 months after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 4 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine or for 4 months after stopping it.

This medicine may interfere with the ability to have a child. Talk with your health care provider 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 doctor or health care professional as soon as possible:

• allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• heartbeat rhythm changes (chest pain; dizziness; fast, irregular heartbeat)
• high blood sugar (increased hunger, thirst, or urination; blurry vision)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• swelling of the ankles, feet, hands
• trouble breathing
• unusual bleeding or bruising

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

• bone pain
• constipation
• diarrhea
• headache
• mouth sores
• muscle pain
• nausea
• stomach pain
• 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 medicine in the original container. Protect from moisture. Keep the container tightly closed. Get rid of any unused medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine 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.