Page 1 IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ixazomib ik SA zoh mib Brand name — Ninlaro® nin LAR oh Approved uses Ixazomib is used to treat multiple myeloma MM in combination with lenalidomide and dexamethasone. Dose and schedule Taking ixazomib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. While capsules come in different strengths 4 mg, 3 mg, and 2.3 mg , the usual dose of ixazomib is 4 milligrams 4 mg to be taken by mouth at a scheduled time once weekly for 3 weeks, followed by a 1 week break i.e., on days 1, 8, and 15 of a 28 day cycle . Ixazomib should be taken on an empty stomach at least 1 hour before or 2 hours after a meal or snack , but at the same time of day. Ixazomib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ixazomib, talk to your care provider or pharmacist for possible options. If you miss a dose of ixazomib: Only take the missed dose if the next scheduled dose is at least 72 hours 3 days away. Then take the next dose at the regularly scheduled time. Do not take the missed dose if it is within 72 hours 3 days of the next scheduled dose. 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 ixazomib 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 ixazomib at room temperature 68°F to 77°F in a dry location away from light. Keep ixazomib out of reach of children and pets. Leave ixazomib in the provided packaging until it is ready to be taken. Whenever possible, you should give ixazomib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the ixazomib 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 ixazomib from its package to a small medicine or other disposable cup. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 2 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. A daily pill box is not recommended to be used with ixazomib. If you have any unused ixazomib, 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 ixazomib. If you are traveling, ask your pharmacist, nurse, or healthcare provider if any additional travel precautions are needed as capsules are to remain in the packaging. Handling body fluids and waste Since ixazomib 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 ixazomib, 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. 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 that 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 ixazomib 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 Ixazomib has many drug interactions, please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Ixazomib should be taken on an empty stomach at least 1 hour before or 2 hours after a meal or snack . Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ixazomib The common side effects that have been known to happen in more than 30% of patients taking ixazomib 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 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, notice blood in your urine or stool, cough up blood, or have 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. 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. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 4 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 ixazomib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 90 days after the last dose of ixazomib. Women using hormonal contraceptives should also use a barrier method of contraception. Do not breastfeed while taking ixazomib and for 90 days after the last dose of ixazomib. 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 either of the following occurs: 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. Constipation 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. Stay active and exercise, if possible. Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in 3 or more days. A daily stool softener, such as docusate Colace® , and/or laxative, such as senna Senakot® , may be helpful. If these do not help within 48 hours, tell your provider. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 5 Page 5 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 © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved. 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 ixazomib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.ninlaro.com Product prescribing information: https://www.ninlaro.com/prescribing information.pdf Product resources: https://www.ninlaro.com/financial resources Updated – March 14, 2018 Additional instructions