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OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Generic

Axitinib

(AK-sih-TIH-nib)

Brand

Inlyta®

(in-LY-tuh)

Axitinib (Inlyta®) is for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy

 
Our Medication Sheet

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Page 1 CERITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ceritinib seh RIH tih nib Brand name — Zykadia® zy KAY dee uh Approved uses Ceritinib is used to treat metastatic non small cell lung cancer NSCLC that has a genetic mutation of the anaplastic lymphoma kinase ALK gene. Dose and schedule Taking ceritinib 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 ceritinib is 750 milligrams 750 mg to be taken by mouth at a scheduled time once a day. Ceritinib should be taken on an empty stomach at least one hour before or two hours after a meal or snack , but at the same time each day. Ceritinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ceritinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ceritinib: Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then, take the next dose at the regularly scheduled time. Do not take the missed dose if it has been more than 12 hours since you should have taken it. Simply take the next dose at the regularly scheduled time. Do not take two doses at one time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle ceritinib 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 ceritinib at room temperature 68°F–77°F in a dry location away from light. Keep ceritinib out of reach of children and pets. Leave ceritinib in the provided packaging until it is ready to be taken. Whenever possible, give ceritinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give ceritinib 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 ceritinib 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. CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for ceritinib. Do not mix other medications into the box with ceritinib. 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 ceritinib, 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 ceritinib. If you are traveling, put your ceritinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since ceritinib 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 ceritinib, 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 ceritinib 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. Drug and foodPage 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. 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. 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. AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for axitinib. Do not mix other medications into the box with axitinib. 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 in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. 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. 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 provider or pharmacist before taking new medications or supplements or receiving any vaccines. AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Axitinib The common side effects that have been known to happen in more than 30% of patients taking axitinib are listed in 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. 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 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 Continued on the next page AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management 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. 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 Continued on the next page AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management 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. 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 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO AXITINIB 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 © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved. 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. 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. 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 – November 27, 2017 Additional instructions interactions Ceritinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Ceritinib should be taken on an empty stomach at least one hour before or two hours after a meal or snack . Grapefruit or grapefruit juice may interact with ceritinib; avoid eating or drinking these during treatment with ceritinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ceritinib The common side effects that have been known to happen in more than 30% of patients taking ceritinib are listed in 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 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 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, 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 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. 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 CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 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. 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 healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Changes in electrolytes and other laboratory values High glucose levels High amylase levels Low phosphorous levels 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 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 page CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If these side effects occur with nausea and vomiting, you might have inflammation of your pancreas pancreatitis . 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. Drink 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. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant, and men should not get a partner pregnant, while taking ceritinib. Women of reproductive potential should use effective contraception during therapy and for a minimum of six months after the last dose of ceritinib. Men with female partners of reproductive potential should use effective contraception during therapy and for a minimum of three months after the last dose of ceritinib. Do not breastfeed while taking ceritinib and for two weeks after the last dose of ceritinib. Please 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 ceritinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO CERITINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www.us.zykadia.com Product prescribing information: www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ zykadia.pdf Product resources: www.us.zykadia.com/patient support/financial resources Updated – November 6, 2017 Additional instructions 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 © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

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