ORAL CHEMOTHERAPY EDUCATION QUIZARTINIB Name of your medication Generic Name — quizartinib (kwih-ZAR-tih-nib) Brand Name — VANFLYTA® (van-FLIH-tah) Common uses Quizartinib is used to treat a type of acute myeloid leukemia with a FLT3 variant. Quizartinib may also be used for other treatments. Dose and schedule Taking quizartinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o Your dose may vary, but the usual dose of quizartinib is 35.4 milligrams (35.4 mg) to be taken by mouth at a scheduled time once daily. Depending on when you are receiving this and whether it is in combination with chemotherapy, you may be taking it only on certain days of the treatment cycle. • During induction chemotherapy, the usual dose is 35.4 milligrams (35.4 mg) once daily on days 8 through 21. • During consolidation chemotherapy, the usual dose is 35.4 milligrams (35.4 mg) once daily on days 6 through 19. • During maintenance, the usual and starting dose is 26.5 milligrams (26.5 mg) once daily, but your dose may increase to 53 milligrams (53 mg) once daily. o Quizartinib can be taken with or without food, but at the same time each day. o Quizartinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow quizartinib, talk to your care provider or pharmacist for possible options. o If you miss a dose of quizartinib, take your dose as soon as possible on the same day. Take your next dose at your usual time the next day. Do not take two doses on the same day to make up for a missed dose. Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions o Quizartinib has many drug interactions. Please inform your care providers of all prescription medications, over-the-counter medications, vitamins, and herbal products that you may be taking. o Grapefruit or grapefruit juice may interact with quizartinib; avoid eating or drinking these during treatment with quizartinib. o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. Page 1 ORAL CHEMOTHERAPY EDUCATION QUIZARTINIB Storage and handling Handle quizartinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. o Store quizartinib at room temperature (68°F to 77°F) in a dry location away from light. o Keep quizartinib out of reach of children and pets. o Leave quizartinib in the provided packaging until it is ready to be taken. o Whenever possible, you should give quizartinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the quizartinib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the quizartinib from its package to a small medicine cup or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. o If a daily pill box or pill reminder will be used, contact your care team before using, and follow these guidelines: • The person filling the pill box or pill reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the pill box or pill reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. Page 2 ORAL CHEMOTHERAPY EDUCATION QUIZARTINIB Side Effects of Quizartinib Below are common side effects that have been known to happen in about one-third or more of patients taking quizartinib; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Decreased white blood cells (WBCs) and increased risk for infection Changes in electrolytes and other laboratory values • Low potassium levels • Low albumin levels • Low phosphorus levels • Increase in alkaline phosphatase (liver enzyme) • Low magnesium levels • Low calcium levels Management Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection: • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infections. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any of the following signs or symptoms of an infection: • Fever (temperature more than 100.4°F or 38°C) • Chills • Sore throat • Burning with urination • Unusual tiredness • A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Changes in some laboratory values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you experience any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Continued on the next page Page 3 ORAL CHEMOTHERAPY EDUCATION QUIZARTINIB Possible Side Effect Diarrhea Management Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low-fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high-fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose-containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care provider may recommend an over-the-counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Practice good mouth care using the following habits: • Rinse your mouth frequently. • Brush your teeth with a soft toothbrush or cotton swab after meals. Mouth irritation or sores Nausea or vomiting • Use a mild nonalcohol mouth rinse at least 4 times per day (after eating and at bedtime). One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lay down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with nausea or vomiting. Page 4 ORAL CHEMOTHERAPY EDUCATION QUIZARTINIB Serious side effects o Quizartinib may cause a condition called QT or QTc prolongation, which is a heart rhythm that can cause fast, irregular heartbeats. These fast heartbeats may cause you to faint or have a seizure. In rare cases, this could be life-threatening. Tell your care team right away if you feel faint, lightheaded, dizzy, or if you feel your heart beating irregularly or quickly while taking quizartinib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Handling body fluids and waste Because quizartinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take quizartinib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. o Toilet and septic systems: • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. o If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. o If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. o Wash any skin that has been exposed to body waste or quizartinib with soap and water. o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washing machine, place the soiled linens in a plastic bag until they can be washed. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Page 5 ORAL CHEMOTHERAPY EDUCATION QUIZARTINIB Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking quizartinib. Females of childbearing age and potential should use effective contraception during therapy and for a minimum of 7 months after the last dose of quizartinib. Males with female partners of childbearing age and potential should use effective contraception during therapy and for a minimum of 4 months after the last dose of quizartinib. o Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. o Do not breastfeed while taking quizartinib and for 1 month after the last dose of quizartinib. o Please inform your care provider if you become pregnant. o It is safe to hug and kiss. Special precautions may be needed for sexual activity while taking oral chemotherapy, and you are encouraged to ask your care team for assistance. Obtaining medication o Talk with your care provider about the process for obtaining your quizartinib. Additional resources Product website: https://www.vanflyta.com/en Product prescribing information: https://www.accessdata.fda.gov/drugsatfda_docs/ label/2023/216993s000lbl.pdf Additional instructions Updated – October 23, 2023 Page 6 ORAL CHEMOTHERAPY EDUCATION QUIZARTINIB Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2023 by Hematology/Oncology Pharmacy Association. All rights reserved. Page 7