Quizartinib (Vanflyta®)

How to Take Quizartinib

Quizartinib comes in tablet form to be taken by mouth once daily. Your dose and the number of tablets you will need depends on the type of cancer you have and where in the treatment phase you are (induction, consolidation). You can take this medication with or without food. Swallow the tablet whole; do not bite, crush, open, or cut the tablet. If you vomit after taking this medication, do not take an extra dose, rather take your next dose as scheduled. If you miss a dose or forget to take it at your usual time, take the dose as soon as possible on the same day, then return to your normal schedule the next day. Never take two doses on the same day.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include: grapefruit, grapefruit juice, voriconazole, posaconazole, clarithromycin, ketoconazole, fluconazole, amiodarone, erythromycin, carbamazepine, phenobarbital, efavirenz, rifampin, dexamethasone, and St. John’s wort. Be sure to tell your healthcare provider about all medications, herbs, and supplements you take.

Quizartinib is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS. Providers have undergone specialized training to certify they may prescribe this medication. The facility where you are receiving this medication is qualified to administer the medication and has the required supportive medications available to treat side effects, should you need them.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.

Where do I get this medication?

Certain cancer medications are only available through specialty pharmacies. If you need to get this medication through a specialty pharmacy, your provider will help you start this process. Where you can fill your prescriptions may also be influenced by your pharmaceutical insurance coverage. Ask your health care provider or pharmacist for assistance in identifying where you can get this medication.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals without prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources, if they are available.

Possible Side Effects of Quizartinib

The following side effects can happen when quizartinib is given with chemotherapy. Ask your provider about what side effects to expect when it is given alone. There are a number of things you can do to manage these side effects. Talk to your care team about these recommendations. They can help you decide what will work best for you.

These are some of the most common or important side effects:

Heart Problems

This medication can cause slow or abnormal heartbeats or an abnormal heart rhythm called QT prolongation. Call your oncology care team right away if you feel abnormal heartbeats or if you feel dizzy or faint.
This medication can cause or worsen pre-existing heart problems, such as abnormal heart rhythm, decreased heart function, and heart attack. Your care team will do ECG’s to monitor your heart, as well as bloodwork to check electrolytes (potassium and magnesium) before and throughout your treatment. Be sure to tell your provider about any heart problems you may have.

Call your provider if you have sudden weight gain or swelling in the ankles or legs. If you develop chest pain or pressure, pain in the left arm, back, or jaw, sweating, shortness of breath, clammy skin, nausea, dizziness, or lightheadedness, call 911 or go to the nearest emergency room right away.

Infection and Low White Blood Cell Count (Including Leukopenia, Neutropenia, and Lymphopenia)

This medication can cause life threatening infections, with or without a decrease in white blood cell counts.
White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with, has any vaccinations.

Electrolyte Abnormalities

This medication can affect the normal levels of electrolytes (potassium, phosphorous, magnesium, calcium, etc.) in your body. Your levels will be monitored using blood tests. If your levels become too low, your care team may prescribe specific electrolytes to be given by IV or taken by mouth. Do not take any supplements without first consulting with your care team.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen (belly), as these can be signs of liver toxicity.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Mouth Sores (Mucositis)

Certain cancer treatments can cause sores or soreness in your mouth and/or throat. Notify your oncology care team if your mouth, tongue, inside of your cheek or throat becomes white, ulcerated or painful. Performing regular mouth care can help prevent or manage mouth sores. If mouth sores become painful, your doctor or nurse can recommend a pain reliever.

• Brush with a soft-bristle toothbrush or cotton swab twice a day.
• Avoid mouthwashes that contain alcohol. A baking soda and/or salt with warm water mouth rinse (2 level teaspoons of baking soda or 1 level teaspoon of salt in an eight-ounce glass of warm water) is recommended 4 times daily.
• If your mouth becomes dry, eat moist foods, drink plenty of fluids (6-8 glasses), and suck on sugarless hard candy.
• Avoid smoking and chewing tobacco, drinking alcoholic beverages and citrus juices.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy /fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines or ginger ale to lesson symptoms.
Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Abdominal (Belly) Pain

This medication can cause pain in your abdomen, with or without constipation/diarrhea. Talk with your care team about ways to manage abdominal pain.

Headaches

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Increased Creatine Phosphokinase (CPK)

CPK is an enzyme found naturally in your body. When CPK levels are high, it could mean there has been injury or stress to your muscles, brain, or heart. Your care team will monitor these levels with blood tests.

Upper Respiratory Infection (URI)

An upper respiratory infection causes swelling or irritation in your upper airways. It can cause a runny nose, cough, and sore throat. Call your provider if you have any of these symptoms and for ways to manage a URI.

Sexual and Reproductive Concerns

This medication may affect your reproductive system, resulting in the menstrual cycle or sperm production becoming irregular or stopping permanently. Women may experience menopausal effects including hot flashes and vaginal dryness. In addition, the desire for sex may decrease during treatment. You may want to consider sperm banking or egg harvesting if you may wish to have a child in the future. Discuss these options with your oncology team.

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. For women, effective birth control is necessary during treatment and for at least 7 months after treatment, even if your menstrual cycle stops. For men, effective birth control is necessary during treatment and for at least 4 months after treatment even if you believe you are not producing sperm. You should not breastfeed while receiving this medication and for at least 1 month after your last dose.