Bosulif® (Bosutinib) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).
Bosulif® (Bosutinib) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).
Page 1 BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — bosutinib (bah SOO tih nib) Brand name — Bosulif® (BAH soo lif) Approved uses Bosutinib is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+). Dose and schedule Taking bosutinib 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 adult dose of bosutinib is 400 milligrams (400 mg) to 500 milligrams (500 mg) to be taken by mouth at a scheduled time once a day. Bosutinib should be taken with food at the same time each day. Bosutinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow bosutinib, talk to your care provider or pharmacist for possible options. If you miss a dose of bosutinib: • 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 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. Drug and food interactions Bosutinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Medications that decrease stomach acid decrease bosutinib concentrations. Avoid use with proton pump inhibitors (e.g., omeprazole [Prilosec®], esomeprazole [Nexium®]), if possible. If taken with a histamine blocker (e.g., ranitidine [Zantac®], famotidine [Pepcid®]), separate from bosutinib by more than two hours. Grapefruit or grapefruit juice may interact with bosutinib; avoid eating or drinking these during your treatment with bosutinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines.BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle bosutinib 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 bosutinib at room temperature (68°F–77°F) in a dry location away from light. Keep bosutinib out of reach of children and pets. Leave bosutinib in the provided packaging until it is ready to be taken. Whenever possible, give bosutinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give bosutinib 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 bosutinib 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 bosutinib, 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 bosutinib. If you are traveling, put your bosutinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Bosutinib Below are common side effects that have been known to happen in about one third or more of patients taking bosutinib 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, 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. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently, and do not pick your nose. • Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. • When shaving, use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: • A bloody nose that bleeds for more than 5 minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 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 to help with the nausea or vomiting. Rash or itchy skin • 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 ultraviolet (UV) 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. If your rash or itching continues to worsen, contact your care provider. Abdominal pain Abdominal pain/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). Continued on the next pageBOSUTINIB 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 such as: • 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. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple 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: • Shortness of breath • Dizziness • Palpitations 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 • Bleeding or bruising Continued on the next pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Serious side effects of bosutinib Be aware of changes in the electrical activity of your heart, called QT prolongation. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast, while taking bosutinib o You may have diarrhea, nausea, vomitting, or abdominal pain while you are taking bosutinib. Tell your doctor right away if these side effects continue for more than a day. o You may be at a higher risk of bleeding while taking bosutnib. Be sure to seek medical attention right away if you have any major bleeding. Also be sure to check for any signs of bleeding in your stool. o Bosutinib 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. o Bosutinib may be harmful to your kidneys. Speak to your care provider to know when you need to have laboratory tests done to monitor your kidneys. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since bosutinib 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 bosutinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will 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. Possible Side Effect Management Fever You may feel hot, cold and shivery, achy, or dizzy. This usually starts during the first month of therapy but could happen at any time. • Call your doctor immediately if you have a fever of 100.4°F or greater. Ask your doctor if you can take medicine to help with the fever. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know that it is OK 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. Cough A cough that does not produce any mucous or congestion relief (dry cough) may occur while taking this medication. If you experience any breathing problems or shortness of breath, notify your care provider immediately. This may be a serious side effect of the medication. BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 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 bosutinib 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 bosutinib. 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 bosutinib. o Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking bosutinib and for one month after the last dose of bosutinib. 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 bosutinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your bosutinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.bosulif.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2012/203341lbl.pdf Product resources: https://www.bosulif.com/resources Updated — June 7, 2021BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 8 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
Published: 26 June 2018
Last Updated: 10 June 2021
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