Page 1 Name of your medication Generic name — tivozanib (ty-VOH-zuh-nib) Brand name — – Fotivda (foh-TIV-dah) Approved uses Tivozanib is used to treat renal cell (kidney) cancer (RCC). Dose and schedule. Taking tivozanib 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 tivozanib is 1.34 milligram (1.34 mg) to be taken by mouth at a scheduled time once a day for 21 days, followed by 7 days off treatment for a 28-day cycle. o Tivozanib can be taken with or without food, but at the same time each day. o Tivozanib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow tivozanib, talk to your care provider or pharmacist for possible options. o If you miss a dose of tivozanib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. 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 Tivozanib has many drug interactions, please inform your care providers of all prescription medications, over-the counter medications, vitamins, and herbal products. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle tivozanib 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 tivozanib at room temperature (68 to 77 F) in a dry location away from light. o Keep tivozanib out of reach of children and pets. o Leave tivozanib in the provided packaging until it is ready to be taken. o Whenever possible, you should give tivozanib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the tivozanib 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 tivozanib from its package to a small medicine or other disposable cup. TIVOZANIB ORAL CHEMOTHERAPY EDUCATION TIVOZANIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Tivozanib Common side effects that have been known to happen in about one third or more of patients taking tivozanib 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 Management Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following. • Decreased amount of urination • Unusual swelling in your legs and feet Continued on the next page 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: • The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the box or 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. o If you have any unused tivozanib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of tivozanib. o If you are traveling, put your tivozanib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. TIVOZANIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Changes in electrolytes and other laboratory values • High glucose levels • Low phosphate levels • Low sodium levels • High lipase levels Changes in some lab 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 have 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 Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your health care provider for high blood pressure or if symptoms such as the following occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8-10 glasses of water/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 (such as bananas, applesauce, potatoes, chicken, rice, and 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. Continued on the next page TIVOZANIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try: • Small frequent meals instead of 3 large meals each day • Keep snacks nearby so you can eat when you feel hungry. • Liquid nutritional supplements • Drink 8-10 glasses of water/fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Nausea or vomiting • Eat and drink slowly. • Drink 8-10 glasses of water/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 the nausea or vomiting. Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Serious side effects o Tivozanib can cause heart failure. Contact your care team right away if you are having any swelling or shortness of breath. o Tivozanib may cause narrowing of arteries in your heart. Contact your care team if you have shortness of breath or chest pain. o Tivozanib can increase your risk of having a stroke. It is important to know the signs and symptoms of a stroke. Pay attention to when the signs and symptoms begin and call 911 immediately at the first sign of a stroke. o Tivozanib can increase your risk of having a blood clot. Seek immediate medical attention if you have sudden swelling in an arm or leg, have chest pain, or trouble breathing. o You may be at a higher risk of bleeding while taking tivozanib. Contact your care team if you notice frequent nose bleeds, blood in your stool, bleeding that occurs by itself without injury, or bleeding that will not stop after five minutes of pressure. TIVOZANIB ORAL CHEMOTHERAPY EDUCATION Page 5 o Tivozanib may cause problems with your thyroid. Speak to your care team to know when you need to have blood tests to monitor your thyroid. Your provider may prescribe medication to keep your thyroid working properly. o Tivozanib can cause cuts or wounds to heal more slowly. Tell your care team if you have a wound that doesn’t heal properly. Also tell your care team if you have planned surgery or dental procedure, as tivozanib should be stopped prior to your surgery. Your doctor may restart tivozanib after your surgical wound has healed. o There is a low risk that you may develop a rare condition called posterior reversible leukoencephalopathy syndrome (PRES) while taking tivozanib. Seek care immediately if you have severe headaches, seizures, confusion, or changes in vision. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Because tivozanib 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 tivozanib, it is important to know 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 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 tivozanib 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 washer, 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. Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking tivozanib. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of tivozanib. o Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. TIVOZANIB ORAL CHEMOTHERAPY EDUCATION Page 6 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 © 2022 by Hematology/Oncology Pharmacy Association. All rights reserved. o Do not breastfeed while taking tivozanib and for one month after the last dose of tivozanib. 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 on 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 tivozanib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.fotivda.com Product prescribing information: https://www.fotivdahcp.com/fotivdapi.pdf Product resources: https://www.fotivdahcp.com/access-support Updated – March 15, 2022 Additional instructions