Quizartinib (kwiz-AR-ti-nib)

Treats acute myeloid leukemia (AML).

Brand Name(s):

Vanflyta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take this medicine at the same time each day.
• Swallow the tablet whole. Do not cut, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose of this medicine, do not take an additional dose. Take your next dose at your usual time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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 quizartinib works. Tell your doctor if you are using atovaquone, azithromycin, doxycycline, efavirenz, granisetron, ketoconazole, moxifloxacin, ondansetron, pentamidine, prochlorperazine, St John's wort, tacrolimus, or medicine to treat fungus infection.

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. Your doctor will give you a pregnancy test within 7 days before you use this medicine to make sure you are not pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 7 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 4 months after the last dose.
• Do not breastfeed during treatment and for at least 1 month after the last dose.
• Tell your doctor if you have liver disease, heart disease, heart rhythm problems, or had a stem cell transplant.
• This medicine may cause heart rhythm problems (including QT prolongation, torsades de pointes).
• 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.
• 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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps, uneven heartbeat
• Fainting, dizziness, lightheadedness
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Unusual bleeding, bruising, or weakness

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

• Diarrhea
• Headache
• 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