Page 1 LORLATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name lorlatinib (lor LA tih nib) Brand name Lorbrena® (lor BREH nuh) Approved uses Lorlatinib is used to treat metastatic non small cell lung cancer that has a genetic mutation called anaplastic lymphoma kinase. Dose and schedule Taking lorlatinib 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 lorlatinib is 100 milligrams (100 mg) to be taken by mouth at a scheduled time, once daily. Lorlatinib can be taken with or without food, but at the same time each day. Lorlatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow lorlatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of lorlatinib, follow these guidelines: Take the missed dose unless the next dose is due within four hours. 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 lorlatinib 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 lorlatinib at room temperature (68°F–77°F) in a dry location away from light. Keep lorlatinib out of reach of children and pets. Leave lorlatinib in the provided packaging until it is ready to be taken. Whenever possible, you should give lorlatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the lorlatinib 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 lorlatinib 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. LORLATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for lorlatinib. Do not mix other medications into the box with lorlatinib. 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 lorlatinib, 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 lorlatinib. If you are traveling, put your lorlatinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since lorlatinib 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 lorlatinib, 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 lorlatinib 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 Lorlatinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with lorlatinib; avoid eating or drinking this during treatment with lorlatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. LORLATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Lorlatinib The common side effects that have been known to happen in more than 30% of patients taking lorlatinib 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 Changes in electrolytes and other laboratory values High cholesterol levels High triglyceride levels High glucose levels Low albumin Changes in some lab 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. Try not to eat salty foods, which can increase swelling. Avoid tight fitting clothing and shoes. Weigh yourself daily. Contact your provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in one week Continued on the next page LORLATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a 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 health care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Numbness or tingling in hands and feet Report changes in your sense of touch, such as a burning sensation, pain on the skin, or weakness. 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 Serious side effects Lorlatinib may cause changes to your heartbeats or heart rhythm. Your care provider should check your heart rhythm before starting lorlatinib and during treatment. Tell your care provider right away if you feel dizzy or faint, or if you have abnormal heartbeats. Lorlatinib can cause lung and breathing problems. Tell your healthcare provider right away if you have new or worsening cough, shortness of breath, chest pain, fever, difficulty breathing, or wheezing. Lorlatinib can cause brain problems. Report any changes in thinking, mood, speech, seeing, or hearing to 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 lorlatinib. Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective with lorlatinib. Women of reproductive potential should use effective nonhormonal contraception during therapy and for a minimum of six months after the last dose of lorlatinib. LORLATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Do not breastfeed while taking lorlatinib and for seven days after the last dose of lorlatinib. 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 gilteritinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your lorlatinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.lorbrena.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2018/210868s000lbl.pdf Product resources: https://www.lorbrena.com/personalized support Updated – November 21, 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.