ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic Name Ponatinib (poe NA ti nib) Brand Name Iclusig (eye CLUE sig) Uses (Indications for this medication) Ponatinib is used to treat adult patients with chronic myeloid leukemia (CML). Ponatinib is also used to treat Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Dose and schedule Ponatinib is recommended to be dosed at 45 mg by mouth once daily with or without food. Do not crush or dissolve the tablet prior to swallowing; swallow whole. If you miss a dose of ponatinib, take your next dose at the regularly schedule time and do not take two doses at the same time to make up for the missed dose. Available dosage forms and identification Three types of tablets are commercially available. The 15 mg tablet is white, round and has an imprint of “A5” on the tablet. The 30 mg tablet is white, round and has an imprint of “C7” on the tablet. The 45 mg tablet is white, round, and has an imprint of “AP4” on the tablet. Warnings This drug may increase your chance of having a heart attack, stroke, or blood clots. Seek medical help immediately if you experience any chest pain, shortness of breath, weakness on one side of the body, drooping on one side of the face, difficulty speaking, or leg swelling. This drug may cause liver damage. Contact your doctor if you notice any yellowing of the skin or whites of your eyes, dark or brown urine, or pain on the right side of your abdomen. Storage and handling Store ponatinib at room temperature (68 °F to 77 °F) in a dry location away from light. Wash hands with soap and water before and after handling ponatinib. Keep ponatinib in the original packaging until it is ready to be taken, and keep ponatinib out of reach of children and pets. When it is time to take ponatinib, gently transfer the medication into a medicine cup and ingest it immediately. Whenever possible, patients should administer ponatinib to themselves. If the dose needs to be given by a caregiver, the caregiver should wear gloves and avoid touching the medication. Do not use the gloves for anything else and discard used gloves in the household trash. Pill containers can be used if they help to take the drug as prescribed, but can become contaminated with dust from the chemotherapy. If it is needed, use a separate pill container for your chemotherapy. The person filling the pill container should wear gloves. When empty, the container should be washed with soap and water. Do not crush or dissolve ponatinib. If you are unable to swallow the pill, discuss the options with your care provider or pharmacist. ORAL CHEMOTHERAPY EDUCATION If you have unused medication, do not dispose of capsules in trash or flush down the sink. Return any unused or expired medications to your health care provider for proper disposal. If traveling, seal your chemotherapy in a plastic bag. Ask your pharmacist if additional travel precautions are needed. Handling body secretions and waste Chemotherapy remains in the body for several days after it is taken. Your body will get rid of the medicine in urine, stool, and vomit. It is important to wash hands thoroughly with soap and water after using the toilet or touching anything (linens, clothing) that may be soiled with chemotherapy or body fluids. Pregnant women should avoid touching anything that may be soiled with body fluids. You may use the same toilet (septic tank 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 removed. If the toilet or seat becomes soiled with urine, stool or vomit, clean the surface before others use the toilet. For those who lose control of bladder or bowels, use a disposable, plastic backed pad, diaper or sheet to absorb waste. Wash exposed skin with soap and water. If the patient uses a bedpan, caregivers should wear gloves to assist with cleanup, and wash the equipment with soap and water daily. Linens or clothing that is soiled with urine, stool or vomit should be washed separately from other household linens. All other laundry may be washed normally. If you do not have a washer, place soiled items into a plastic bag until they can be washed. 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 doctor or nurse. Drug and food interactions Grapefruit juice may interact with ponatinib; avoid drinking grapefruit juice during treatment with ponatinib. Ponatinib has many drug interactions, please inform health care providers of all prescription medications, over the counter drugs, vitamins, and herbal products. Boxed warnings (this type of warning is commonly referred to as a “Black Box warning” and is issued by the U.S. Food and Drug Administration (FDA). These warnings are designed to call attention to serious adverse events which have been associated with a medication). Blood clots Heart failure Liver failure ORAL CHEMOTHERAPY EDUCATION ORAL CHEMOTHERAPY EDUCATION ORAL CHEMOTHERAPY EDUCATION If you experience ANY uncontrolled side effect, call your physician/health care center immediately: _______________________________________________________________________(INSTITUTIONAL CONTACT INFO) Pregnancy and contraception Do not become pregnant while taking this medication. Males and females of reproductive potential should use effective contraception during therapy and for a minimum of 3 months after the last dose. Do not breastfeed while taking this medication. Please inform your doctor if you might be pregnant. Obtaining medication Our staff will assist you obtaining this medication. If applicable, we will verify your prescription plan and obtain approvals from your insurance company. If you have a large out of pocket expense or have difficulty paying for this medication, please inform our staff. Other types of assistance programs are available if necessary. ___________________________________________________ (PHARMACY/SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website http://www.iclusig.com/ Product prescribing information http://www.iclusig.com/pi Product resources http://www.iclusig.com/support and resources/ Updated September 21 2016 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 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, warning, 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 Sheets (OCS) are provided as a free educational resource for patients with cancer in need of concise, east 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 OCS 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 holders/ Permission requests and licensing inquiries will be made through a link on the website which NCODA will forward to HOPA upon receipt. Copyright © 2016 by Hematology Oncology Pharmacy Association. All rights reserved.