Page 1 AXITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — axitinib (AK sih TIH nib) Brand name — Inlyta® (in LY tuh) Approved uses Axitinib is used to treat patients with advanced kidney cancer (renal cell carcinoma). Dose and schedule Taking axitinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of axitinib is 5 milligrams (5 mg) to be taken by mouth at a scheduled time twice daily (about 12 hours apart). Axitinib can be taken with or without food with a full glass of water, but at the same time each day. Axitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow axitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of axitinib, 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. If you need to have surgery, tell your care provider you are taking axitinib. Axitinib may need to be stopped until your wound heals after some surgeries. Drug and food interactions Axitinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with axitinib. Avoid eating or drinking these during treatment with axitinib. Talk with your care team or pharmacist before taking new medications or supplements or receiving any vaccines. Storage and handling Handle axitinib 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. Store axitinib at room temperature (68°F–77°F) in a dry location away from light. Keep axitinib out of reach of children and pets. Leave axitinib in the provided packaging until it is ready to be taken. Whenever possible, give axitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give axitinib 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.)AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the axitinib from its package to a small medicine 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. 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 If you have any unused axitinib, 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 axitinib. If you are traveling, put your axitinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Axitinib Below are common side effects that have been known to happen in about one third or more of patients taking axitinib 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 Diarrhea (loose and/ or urgent bowel movements) 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 (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, 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 four 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 pageAXITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management 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 Changes in electrolytes and other laboratory values • Low bicarbonate levels • Low calcium levels • High blood glucose • Low alkaline phosphatase Changes in some laboratory values may occur and should 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 care provider for high blood pressure or if the following symptoms occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling 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, too. • 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. Continued on the next pageAXITINIB 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 the following: • Eat small, frequent meals instead of three large meals each day. • Keep snacks nearby so you can eat when you feel hungry. • Take liquid nutritional supplements. • Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Decreased white blood cells (WBCs) and increased risk for infection 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 infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any 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. Continued on the next pageAXITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Nausea or vomiting • 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 lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Voice changes or hoarseness These changes are not permanent and should go away during the time you are not taking the medication. 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 of axitinib Axitinib can increase your risk of having a stroke. Be aware of the signs of a stroke and seek medical attention immediately at the first sign of a stroke. Axitinib can increase your risk of having a heart attack. Be aware of the signs of a heart attack and seek medical attention immediately at the first sign of a heart attack. If you need to have a surgical or dental procedure, tell your doctor that you are taking axitinib. You may need to stop axitinib until your wound heals after some types of surgery. Axitinib may be harmful to your thyroid. Speak to your care provider to know when you need to have laboratory tests done to monitor your thyroid function. Your doctor may prescribe medication to keep your thyroid functioning properly. Axitinib can cause severe diarrhea or perforation (hole) of the intestine. Tell your doctor right away if you develop fever, severe abdominal pain or diarrhea that lasts longer than a day. A condition called reversible posterior leukoencephalopathy syndrome can occur while taking axitinib. Call your healthcare provider immediately if you have headaches, seizures, confusion or changes in vision. You may be at a higher risk of bleeding while taking axitinib. 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. Axitinib can increase your risk of having a blood clot. Seek immediate medical attention if you have sudden swelling in an arm or leg, chest pain, or trouble breathing.AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 6 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Because axitinib 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 axitinib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. 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. 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. 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. Wash any skin that has been exposed to body waste or axitinib with soap and water. 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. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant, and men should not get a partner pregnant, while taking axitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of axitinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking axitinib and for one month after the last dose of axitinib. Inform your care provider if you become pregnant. 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 provider. Obtaining medication Talk with your care provider about the process for obtaining your axitinib.AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 7 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.inlyta.com Product prescribing information: http://labeling.pfizer.com/ShowLabeling.aspx?id=759 Product resources: www.inlyta.com/cancer resources Updated – June 7, 2021 Additional instructions