Page 1 THALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — thalidomide thuh LIH doh mide Brand name — Thalomid® THA loh MID Approved uses Thalidomide is used to treat multiple myeloma MM in combination with dexamethasone. Dose and schedule Taking thalidomide 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 thalidomide is between 50 milligrams 50 mg and 200 milligrams 200 mg to be taken by mouth at bedtime. Thalidomide should be taken at least 1 hour after the evening meal or snack at the same time each day. Thalidomide should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow thalidomide, talk to your care provider or pharmacist for possible options. If you miss a dose of thalidomide: 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 thalidomide 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 thalidomide at room temperature 68°F–77°F in a dry location away from light. Keep thalidomide out of reach of children and pets. Leave thalidomide in the provided packaging until it is ready to be taken. Whenever possible, give thalidomide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give thalidomide to you, they may 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 thalidomide 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. THALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 A daily pill box or pill reminder is not recommended to be used with thalidomide. If you have any unused thalidomide, 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 thalidomide. If you are traveling, put your thalidomide in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since thalidomide 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 thalidomide, 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 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 thalidomide 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 Thalidomide 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. Thalidomide should be taken at least 1 hour after the evening meal or snack. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Thalidomide can cause serious birth defects. Do not take thalidomide if you are pregnant or think you might be pregnant. Thalidomide can increase your risk for a blood clot. THALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Thalidomide The common side effects that have been known to happen in more than 30% of patients taking thalidomide 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 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. 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. Changes in electrolytes and other laboratory values Low calcium levels Changes in some laboratory values may occur and will 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 Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice: Swelling in the hands, feet, or legs Shortness of breath Weight gain of 5 pounds or more in a week Continued on the next page THALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management 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. Your care provider may recommend over the counter medications to help with your constipation. A daily stool softener such as docusate Colace® and/or laxative such as senna Senokot® may be helpful. If these do not help within 48 hours, tell your provider. Numbness or tingling in the hands and feet Report changes in your sense of touch, such as a burning sensation, pain on the skin, and weakness. Shortness of breath 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. Muscle pain or weakness Keep a diary of your pain or weakness, 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 how you may ease this discomfort. Take pain medication that has been prescribed or recommended by your care provider. 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. Continued on the next page THALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management 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. 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 thalidomide, during any treatment breaks, and for at least four weeks after stopping thalidomide. If you think you might be pregnant, notify your healthcare provider right away. Women of childbearing age and potential should use two forms of birth control or go without having sex during treatment with thalidomide and for at least four weeks after stopping treatment. Men who are taking thalidomide must always wear a latex or synthetic condom during sex, during treatment breaks, and for at least four weeks after stopping thalidomide as the drug can be found in sperm. Do not donate sperm while taking thalidomide, during treatment breaks, and for four weeks after stopping this medication. Do not breastfeed while taking thalidomide and for four weeks after the last dose of thalidomide. It is safe to hug and kiss, but the special precautions described above are required before sexual activity. THALIDOMIDE ORAL CHEMOTHERAPY EDUCATION Page 6 Obtaining medication Talk with your care provider about the process for obtaining your thalidomide. Thalidomide is available only through a Risk Evaluation and Mitigation Strategy REMS program, and prescribers, patients, and pharmacies must be certified with the REMS program. Only a 28 day supply of medication can be obtained from the pharmacy at one time, and this medication is not eligible for automatic refills. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.thalomid.com Product prescribing information: www.celgene.com/content/uploads/thalomid pi.pdf Product resources: www.celgenepatientsupport.com Updated — March 13, 2018 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 © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.