Page 1 INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — infigratinib (IN fig RA tih nib) Brand name — Truseltiq™ (troo SEL tik) Approved uses Infigratinib is used to treat people with cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) mutation. Dose and schedule Taking infigratinib 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 infigratinib is 125 milligrams (125 mg) to be taken by mouth at a scheduled time once a day for 21 consecutive days, followed by 7 days off therapy, in 28 day cycles. Infigratinib should be taken on an empty stomach, at least 1 hour before or 2 hours after food, at the same time each day. Infigratinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow infigratinib, talk to your care provider or pharmacist for possible options. If you miss a dose of infigratinib, • Do not take the missed dose if it has been more than 4 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 Infigratinib has many drug interactions. Please inform your care provider of all prescription medications, over the counter medications, vitamins, and herbal products. Medications that decrease stomach acid decrease infigratinib concentrations. Avoid use with proton pump inhibitors (e.g., omeprazole [Prilosec®], esomeprazole [Nexium®]) and histamine 2 receptor antagonists (e.g., famotidine [Pepcid®]), if possible. Grapefruit or grapefruit juice may interact with infigratinib; avoid eating or drinking these during treatment with infigratinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle infigratinib 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 infigratinib at room temperature (68°F–77°F) in a dry location away from light. Keep infigratinib out of reach of children and pets. Leave infigratinib in the provided packaging until it is ready to be taken. INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Whenever possible, you should give infigratinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the infigratinib 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 infigratinib 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. 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. If you have any unused infigratinib, 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 infigratinib. If you are traveling, put your infigratinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Infigratinib Below are common side effects that have been known to happen in about one third or more of patients taking infigratinib 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 Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following. • Decreased amount of urination • Unusual swelling in your legs and feet Changes in electrolytes and other laboratory values • High phosphate levels • Low phosphate levels • High lipase levels • High calcium levels • Low sodium levels • High urate 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 Nail changes Usually, this change starts at the cuticle and may affect the skin around the nail. • Biting, chewing, and picking at your nails can increase the risk of getting an infection. • Talk to your care provider if you notice any changes in your nails. Mouth irritation or sores Practice good mouth care. • Rinse your mouth frequently. • Brush your teeth with a soft toothbrush or cotton swab after meals. • Use a mild non alcohol mouth rinse at least 4 times a day (after eating and at bedtime). One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Continued on the next page INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in liver function Your liver function will 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 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 OK 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 Eye changes This medication may cause blurred vision, dry eyes, or eye pain. Report changes in eyesight to your care provider. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is OK 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. Increased triglyceride levels Changes in triglycerides 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. Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. Continued on the next page INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently, and do not pick your nose. • Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. • When shaving, use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: • A bloody nose that bleeds for more than five minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Pain or discomfort on hands and/or feet Hand foot skin reaction (HFSR) is a skin reaction that appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can do the following: • Keep hands and feet moisturized with a non fragranced moisturizing cream. • Urea 10% or 20% cream may be helpful. • Avoid exposure to hot water on the hands and feet in showers or baths that may dry out the skin, or when doing dishes. • Avoid tight fitting shoes or socks. • Avoid excess rubbing on hands and feet unless putting on lotion. • Wear gloves when working with your hands. 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 OK 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. Continued on the next page INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: • Choose and prepare foods that look and smell good to you. • Use plastic utensils if food tastes like metal. • Flavor foods with spices to change taste. • Suck on mints or chew gum to mask taste. • Brush teeth with a soft bristle toothbrush before and after eating. • Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. 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 (Senakot®) may be helpful. If these do not help within 48 hours, tell your provider. Serious side effects of infigratinib Infigratinib can cause serious birth defects. Do not take infigratinib if you are pregnant or think you might be pregnant. Infigratinib may be harmful to your eyes. Call your care team if you have any issue with your vision, or if you have pain in your eyes. Your blood phosphate levels may be higher while taking infigratinib. Your care provider may have you regularly check blood work for your phosphate level. There are no symptoms of high phosphate levels, so you may not know that your blood phosphate levels are elevated. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since infigratinib 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 infigratinib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Page 7 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 infigratinib 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. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking infigratinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 month after the last dose of infigratinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking infigratinib and for 1 month after the last dose of infigratinib. 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 infigratinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.truseltiq.com Product prescribing information: www.truseltiq.com/pdfs/prescribing information.pdf Product resources: www.truseltiq.com/forging bridges overview Updated – June 7, 2021 INFIGRATINIB ORAL CHEMOTHERAPY EDUCATION Page 8 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions