Page 1 ELACESTRANT ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — elacestrant (EH-lah-KES-trant) Brand name — Orserdu™ (or-SER-doo) Common uses Elacestrant is used to treat adult patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer that has a genetic variant called estrogen receptor 1 (ESR1). Elacestrant may also be used for other treatments. Dose and schedule Taking elacestrant as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o Your dose may vary, but the usual dose of elacestrant is 345 milligram (345 mg) to be taken by mouth at a scheduled time once a day. o Elacestrant should be taken with food, at the same time each day. o Elacestrant should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow elacestrant, talk to your care provider or pharmacist for possible options. o If you miss a dose of elacestrant: • Do not take the missed dose if you have vomiting or if it has been more than 6 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. Drug and food interactions o Elacestrant has many drug interactions, please inform your care providers of all prescription medications, over-the counter medications, vitamins, and herbal products. o Grapefruit or grapefruit juice may interact with elacestrant; avoid eating or drinking these during treatment with elacestrant. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Page 2 ELACESTRANT ORAL CHEMOTHERAPY EDUCATION Storage and handling Handle elacestrant 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. o Store elacestrant at room temperature (68 to 77 F) in a dry location away from light. o Keep elacestrant out of reach of children and pets. o Leave elacestrant in the provided packaging until it is ready to be taken. o Whenever possible, you should give elacestrant to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the elacestrant 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 elacestrant 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. o 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. Page 3 ELACESTRANT ORAL CHEMOTHERAPY EDUCATION Side Effects of Elacestrant Common side effects that have been known to happen in about one third or more of patients taking elacestrant 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 Muscle or joint pain or weakness • Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is okay to rest as needed, too. • Tell your care provider if pain, interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Take only pain medication that has been prescribed or recommended by your care provider. Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water/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 lay 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. Increased cholesterol levels Changes in cholesterol may occur and will be monitored by a simple blood test. You may not feel any symptoms if changes occur. Your care team will monitor for this. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Page 4 ELACESTRANT ORAL CHEMOTHERAPY EDUCATION Handling body fluids and waste Since elacestrant 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 elacestrant, 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. o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. o 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. o 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. o 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. o Wash any skin that has been exposed to body waste or elacestrant with soap and water. o 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. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking elacestrant. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of elacestrant. o Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. o Do not breastfeed while taking elacestrant and for 1 week after the last dose of elacestrant. o Please inform your care provider if you become pregnant. o 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 team for assistance. Obtaining medication o Talk with your care provider about the process for obtaining your elacestrant. Page 5 ELACESTRANT ORAL CHEMOTHERAPY EDUCATION Additional resources Product website: https://www.orserdu.com Product prescribing information: pi.orserdu.com Product resources: https://www.orserdu.com Updated – April 3, 2023 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 © 2023 by Hematology/Oncology Pharmacy Association. All rights reserved.