Midostaurin capsules

What is this medicine?

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.

How should I use this medicine?

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.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or chest tightness

• cough

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• shortness of breath

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls

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

• tiredness

• vomiting

What may interact with this medicine?

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:

• 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

• St. John's Wort

• troleandomycin

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

What should I watch for while using this medicine?

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

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. 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 professional if you notice any unusual bleeding.

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

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.