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OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Generic

Larotrectinib

(LAYR-oh-TREK-tih-nib)

Brand

Vitrakvi®

(vi-trak-vee)

Larotrectinib (Vitrakvi®) is used to treat adults and children with solid tumors that are caused by a certain abnormal neurotrophic receptor tyrosine kinase (NTRK) gene.

 
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Page 1 LAROTRECTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name larotrectinib (LAYR oh TREK tih nib) Brand name Vitrakvi® (vi trak vee) Approved uses Larotrectinib is used to treat adults and children with solid tumors that are caused by a certain abnormal neurotrophic receptor tyrosine kinase (NTRK) gene. Dose and schedule Taking larotrectinib 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 larotrectinib is 100 milligrams (100 mg) by mouth twice a day. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Larotrectinib can be taken with or without food, but at the same time each day. Larotrectinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow larotrectinib, talk to your care provider or pharmacist for possible options. If you miss a dose of larotrectinib, follow these guidelines: Take it as soon as you remember, unless your next scheduled dose is due within six hours. Take the next dose at your regular 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 larotrectinib 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 larotrectinib capsules at room temperature (68°F–77°F) in a dry location away from light. Store larotrectinib oral solution in the refrigerator (36°F– 46°F). Do not freeze. Keep larotrectinib out of reach of children and pets. Leave larotrectinib in the provided packaging until it is ready to be taken. Whenever possible, you should give larotrectinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the larotrectinib 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 larotrectinib 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. LAROTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for larotrectinib capsules. Do not mix other medications into the box with larotrectinib capsules. 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 larotrectinib, 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 larotrectinib. If you are traveling, put your larotrectinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since larotrectinib 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 larotrectinib, 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 larotrectinib 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 Larotrectinib has many drug interactions. Please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with larotrectinib; avoid eating or drinking this during treatment with larotrectinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. LAROTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Larotrectinib The common side effects that have been known to happen in more than 30% of patients taking larotrectinib 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 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 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 seven to eight 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 any of the following: Shortness of breath Dizziness Palpitations 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. Continued on the next page LAROTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in laboratory values Low albumin levels 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 legs or feet Red or brown colored urine Serious side effects Larotrectinib can cause serious neurologic adverse effects. Do not drive or operate hazardous machinery if experiencing neurologic adverse effects. Neurologic adverse effects may include confusion, slurred or slowed speech, dizziness, tremor, memory impairment, or a tingling sensation. 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 larotrectinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one week after the last dose of larotrectinib. Do not breastfeed while taking larotrectinib and for one week after the last dose of larotrectinib. 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 larotrectinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) LAROTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Additional resources Product website: www.vitrakvi.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2018/210861s000lbl.pdf Product resources: https://www.hcp.vitrakvi us.com/access and reimbursement Updated – December 11, 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.

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