Midostaurin (mye-doe-STAW-rin)

Treats leukemia. Also treats a rare disorder called aggressive systemic mastocytosis or mast cell leukemia.

Brand Name(s):

Rydapt

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Filled Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole. Do not crush, break, chew, or open it.
• You may also receive medicines to help prevent nausea and vomiting.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose or vomit after taking your medicine, skip the missed dose and take your next regular dose. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in the original package to protect from moisture.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how midostaurin works. Tell your doctor if you are using boceprevir, bupropion, carbamazepine, clarithromycin, cobicistat, conivaptan, danoprevir/ritonavir, diltiazem, elvitegravir/ritonavir, enzalutamide, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, mitotane, nefazodone, nelfinavir, paritaprevir/ritonavir and (ombitasvir and/or dasabuvir), phenytoin, posaconazole, rifampin, ritonavir, rosuvastatin, saquinavir/ritonavir, St John's wort, tipranavir/ritonavir, troleandomycin, voriconazole, or birth control pills (including ethinyl estradiol, levonorgestrel).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant within 7 days before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 4 months after the last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for 4 months after the last dose.
• Do not breastfeed during treatment and for 4 months after your last dose.
• Tell your doctor if you have kidney disease, liver disease, or lung or breathing problems.
• This medicine may cause lung or breathing problems (including interstitial lung disease, pneumonitis).
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bone, joint, or muscle pain
• Chest pain, trouble breathing
• Dry mouth, fruit-like breath odor, nausea, vomiting, stomach pain, tiredness
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Headache
• Small red or purple spots on skin
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088