Page 1 VANDETANIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — vandetanib van DEH tuh nib Brand name — Caprelsa® ka PREL suh Approved uses Vandetanib is used to treat thyroid cancer. Dose and schedule Taking vandetanib 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 vandetanib is 300 milligrams 300 mg to be taken by mouth once daily. The dose may be adjusted by your care provider based on your individual needs. Vandetanib can be taken with or without food, but at the same time each day. Vandetanib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow vandetanib, talk to your care provider or pharmacist for possible options. If you miss a dose of vandetanib, 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 vandetanib 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 vandetanib at room temperature 68°F–77°F in a dry location away from light. Keep vandetanib out of reach of children and pets. Leave vandetanib in the provided packaging until it is ready to be taken. Whenever possible, you should give vandetanib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the vandetanib 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 vandetanib 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. VANDETANIB ORAL CHEMOTHERAPY EDUCATION Page 2 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for vandetanib. Do not mix other medications into the box with vandetanib. 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 vandetanib, 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 vandetanib. If you are traveling, put your vandetanib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Vandetanib remains in your body for several days after it is taken, so some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take vandetanib, it is important to follow the instructions below every day 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 vandetanib 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 Vandetanib has many drug interactions, please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Vandetanib can cause changes in the heart called QT prolongation. This can cause irregular heartbeats. Serious skin reactions have been reported, even up to four months after stopping treatment. Limit sun exposure, and report any serious skin reaction to your care provider. VANDETANIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Vandetanib The common side effects that have been known to happen in more than 30% of patients taking vandetanib 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 because of some other health problem. 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. 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 to help with the nausea or vomiting. Changes in liver function Your liver function should 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 Unusual bleeding or bruising Continued on the next page VANDETANIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal or diary and report this information to your physician. Contact your healthcare 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 Acne like rash or itchy skin A rash that looks like acne may appear on your face, chest, and upper back while taking this medication. Your doctor may prescribe medication to help prevent or manage the rash. If you do get a rash, keep the area around the rash clean and dry. Check with your care provider before using anything to treat it. Do not use over the counter acne treatments, such as benzoyl peroxide and salicylic acid, and soaps containing alcohol. Oatmeal baths and unscented moisturizers may help with itching. Sunlight can make symptoms worse. Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to UV ultraviolet radiation occurs from 10 am–4 pm. Wear long sleeved clothing, with UV protection if possible. Wear broad brimmed hats. Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on the bottle. Use lip balm with at least SPF 30. Rash Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. Avoid using perfumes and cologne as these products may increase rash symptoms. Avoid being in the heat for long periods of time. Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to UV ultraviolet radiation occurs between 10 am–4 pm. Wear long sleeved clothing, with UV protection if possible. Wear broad brimmed hats. Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on the bottle. Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Continued on the next page VANDETANIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Changes in electrolytes and other laboratory values 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 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 vandetanib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of vandetanib. Do not breastfeed while taking vandetanib and for one month after the last dose of vandetanib. 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 how to obtain your vandetanib. Vandetanib is only available through a Risk Evaluation and Mitigation Strategy REMS program, and prescribers and pharmacies must be certified with this REMS program. Only a 30 day supply of medication can be obtained from the pharmacy at one time. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO VANDETANIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www.caprelsa.com Product prescribing information: www.caprelsa.com/files/caprelsa pi.pdf Product resources: www.caprelsa.com/pt resources and support.asp Updated – August 21, 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.