INTRAVENOUS CANCER TREATMENT EDUCATION FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Name of the regimen and cancer drugs Your care team may refer to your treatment as “FOLFOX” plus trastuzumab and pembrolizumab. FOLFOX plus trastuzumab and pembrolizumab consists of 5 different anti-cancer therapies. • FOL: Leucovorin (LOO koh VOR in); Folinic acid • F: 5-FU or fluorouracil (floor oh YOOR uh sil); Adrucil® • OX: Oxaliplatin (ok SA lih pla tin); Eloxatin® • Trastuzumab (tras TOO zoo mab); Herceptin®, Herzuma®, Kanjinti®, Ogivri®, Ontruzant®, Trazimera® • Pembrolizumab (pem bro LIH zoo mab); Keytruda® Common uses This regimen is most commonly used for the treatment of stomach cancer and esophageal cancer, but may be used for other diagnoses. Treatment schedule Your treatment will be given into your vein through an intravenous (IV) line called a central venous catheter. A central venous catheter, or central line is a long, flexible IV tube that empties into a very large vein next to the heart. Talk with your care team to see which type of central line will be best for you and your treatment. Each FOLFOX + trastuzumab + pembrolizumab treatment is repeated every 42 days (6 weeks). This is known as one cycle. Your treatment may be given for a set number of cycles, or it will keep going until the drug, or drugs, stop working or you have side effects which stop you from continuing treatment. Leucovorin IV on days 1, 15, and 29 Fluorouracil (5-FU) IV push on days 1, 15, and 29 Fluorouracil (5-FU) continuous IV infusion over 48 hours beginning on days 1 (ending on day 3), 15 (ending on day 17), and 29 (ending on day 31) Oxaliplatin IV on day 1, 15, and 29 Trastuzumab IV on days 1, 15, and 29 Pembrolizumab IV on days 1 and 22 Drug Cycle 1 Leucovorin Fluorouracil IV push Fluorouracil IV infusion Oxaliplatin Trastuzumab Pembrolizumab 1 2 3 ... 15 16 17 ... 22 ... 29 30 31 ... 42 Cycle 2 Day 1 Page 1 FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Page 2 INTRAVENOUS CANCER TREATMENT EDUCATION Other medications Other medications may be ordered for you to prevent or treat certain side effects. These include: Instructions: Anti-nausea medications You will receive medications to prevent nausea just before your cancer treatment. You may also get prescriptions for other medications to take at home, as below: Medications to prevent side effects You will receive medications to prevent side effects just before your cancer treatment. You may also get prescriptions for other medications to take at home, as below: Possible drug interactions FOLFOX + trastuzumab + pembrolizumab may interact with other drugs you are taking. Please inform your care providers of all prescription medicine, over-the-counter medications, vitamins, and herbal products that you take. Talk with your care provider or pharmacist before taking new medications, supplements, or receiving any vaccines. FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Page 3 INTRAVENOUS CANCER TREATMENT EDUCATION Common Side Effects Common side effects that have been known to happen in patients receiving FOLFOX+ trastuzumab + pembrolizumab are listed in the left side of this table. In some instances, the side effects may be reported less often but are still important to discuss. This table does not list all the known side effects for this therapy, only the ones that are experienced most often. Not every patient experiences every known side effect of a drug; even if you are taking the same drug as another patient, you may experience different 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 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 often for good personal hygiene. Contact your care team 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 when peeing • Tiredness that is worse than normal • A sore that becomes red, is draining, or does not heal. Check with your care team before taking any medicine for a fever or chills. 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 electric razor instead of razor blades • Use a nail file instead of nail clippers Call your care team if you have bleeding that won’t stop. Examples include: • A bloody nose that bleeds for more than 5 minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed a lot when you floss or brush Continued on the next page FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Page 4 INTRAVENOUS CANCER TREATMENT EDUCATION Possible Side Effect Management Decreased platelet count and increased risk of bleeding (continued) Seek medical help right away if you have any severe headaches, blood in your urine or stool, coughing up blood, or bleeding that you cannot stop or lasts a long time. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care team or dentist before any scheduled procedures. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be checked 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 to 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, too • You might notice that you are more pale than usual Let your care team know right away if you have: • Shortness of breath • Dizziness • Fast or abnormal heartbeat • Headache Nausea or vomiting • Take all medications as prescribed to help prevent and lessen symptoms of nausea and vomiting. • Eat and drink slowly. • Drink 8-10 (8-ounce) glasses of water and/or fluid (soup or broth) each day unless your care team has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid intense exercise immediately after eating. • Don’t lay down right away after eating. • Wear loose-fitting clothing for comfort. • Avoid strong odors. Consider getting fresh air and try deep breathing. Let your care team know if you have nausea or vomiting. Your care team may prescribe medication to help with the symptoms. Continued on the next page FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Page 5 INTRAVENOUS CANCER TREATMENT EDUCATION Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8-10 (8-ounce) glasses of water or fluid each day unless your care team has asked you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low-fiber foods (such as bananas, applesauce, potatoes, chicken, rice, and toast). • Avoid high fiber foods, such as raw vegetables and fruits and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid foods with lactose, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your care team if: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care team may recommend an over-the-counter medication or prescribe something to help manage your symptoms. 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 type of moderate activity every day • Conserve your energy. Plan your activities and do them at a time of day when you feel a bit more energetic • Follow a healthy diet and stay hydrated • Accept help from family and friends • Find healthy ways to manage stress, such as meditation, journaling, yoga, and guided imagery • Develop good sleeping habits, limit napping during the day to help you sleep better at night • Avoid operating heavy machinery if you feel too tired • Contact your care team if you experience extreme fatigue that prevents you from doing your normal daily activities Pain or discomfort on hands and/or feet Hand-and-foot syndrome (HFS) is a skin reaction that appears on the palms of the hands and soles of the feet. It can appear as a rash, peeling skin, or feel like “pins and needles”. Let your care team know right away if you experience this side effect. To prevent HFS, you can: • 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, baths or doing dishes. • Avoid tight shoes or socks. • Avoid excess rubbing on hands and feet unless putting on lotion. • Wear gloves when working with your hands. Continued on the next page FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Page 6 INTRAVENOUS CANCER TREATMENT EDUCATION Possible Side Effect Management Mouth irritation or sores • Practice good mouth care. • Rinse your mouth after meals and at bedtime, and more frequently if you develop sores in your mouth. • 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. • Avoid acidic, hot or spicy foods and beverages, and rough foods that might irritate the mouth. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care team if you experience pain or sores in your mouth or throat. Numbness or tingling in hands and feet Report changes in your sense of touch, such as a burning feeling, pain on the skin or weakness. Sensitivity to cold Oxaliplatin can cause you to be VERY sensitive to cold for 3-7 days after treatment. • Avoid exposure to cold temperatures or touching cold objects • Avoid cold drinks, ice, and cold food. Use a straw when drinking cool liquids • Wear gloves when reaching into the freezer or handling cold objects • Wear gloves and cover mouth with a scarf during cold weather Muscle or joint pain or weakness • Keep a diary of your pain, including when and where the pain happens, 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 team if pain limits what you can do • If the pain or weakness (or spasms) bothers you, ask your provider what you may use to help with this discomfort. Only take pain medication that has been prescribed or recommended by your care team. 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 UV (ultra-violet) radiation occurs between the hours of 10am and 4pm. • Wear long-sleeved clothing, with UV protection if possible. • Wear broad-brimmed hats. Continued on the next page INTRAVENOUS CANCER TREATMENT EDUCATION FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Possible Side Effect Rash or itchy skin (continued) Sun sensitivity Management • 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. • Avoid tanning beds. • If your rash or itching continues to worsen, contact your care team. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to UV (ultra-violet) radiation occurs between the hours of 10am and 4pm. • 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. Rare but serious side effects Cardiomyopathy/Cardiotoxicity: Trastuzumab, fluorouracil, and pembrolizumab may affect your heart’s ability to pump blood. Tell your healthcare provider right away if you experience new or worsening shortness of breath, chest pain, irregular heartbeat, or swelling of your ankles or legs. Pneumonitis/Interstitial Lung Disease: Trastuzumab, pembrolizumab and oxaliplatin may be harmful to your lungs. Inform your care team of any new difficulty breathing, cough, or fever. Your provider may stop treatment with trastuzumab if your lungs are affected. Uveitis/Ocular disorders: Oxaliplatin and pembrolizumab may be harmful to your eyes. Be sure to inform your care team of any issue you have with your vision or pain in your eyes. Your provider may stop treatment with oxaliplatin and pembrolizumab if your eyes are affected. Nephritis/Kidney disorders: Pembrolizumab may be harmful to your kidneys. Speak to your care team to know when you need to have laboratory tests done to monitor your kidneys Colitis: Pembrolizumab may cause inflammation in your colon. If symptoms of diarrhea or severe abdominal pain are present, please contact your health care team right away. Your health care team may have to prescribe corticosteroids in order to decrease the inflammation. Endocrinopathies: Pembrolizumab can alter your hormone levels. Symptoms may include weight and mood changes, headaches, fatigue, sweating, elevated blood pressure, or heart racing. Contact your doctor if you are experiencing any of these symptoms. Hepatitis: Pembrolizumab may be harmful to your liver. Be sure to seek medical attention if you are experiencing jaundice (yellowing of the skin or eyes), severe nausea or vomiting, or easy bruising/bleeding. Dependent on liver function tests and severity of symptoms, your provider may have to discontinue the medication. Dermatitis: Pembrolizumab can cause a severe skin reaction resulting in flu-like symptoms and painful rashes that can spread and blister. Your healthcare professional may withhold or permanently discontinue these medications depending on the severity. Page 7 INTRAVENOUS CANCER TREATMENT EDUCATION FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Rare but serious side effects (continued) Hypersensitivity Reactions: Severe allergic reactions are a rare but serious side effect of oxaliplatin, trastuzumab, or pembrolizumab. Seek medical attention right away if you notice difficulty breathing, swelling of the mouth or tongue, or a serious rash. Dihydropyrimidine dehydrogenase (DPD) deficiency is a rare genetic condition where the body cannot break down certain cancer treatments, leading to severe side effects. Talk to your doctor to see if you should be tested. Pembrolizumab can cause severe reactions in people who receive a stem cell transplant before or after treatment. If you have received a stem cell transplant, talk with your care team about these risks before starting treatment. If you experience ANY new, worsening, or uncontrolled side effects, call your care team immediately. Handling body fluids and waste Some of the drugs you receive may be present in urine, stool, sweat, or vomit for many days after treatment. Many cancer drugs are toxic, your bodily waste may also be toxic and can be dangerous to come into contact with. Once you have started FOLFOX + trastuzumab + pembrolizumab, follow the instructions below for at least two days after your treatment. This is to keep you, your 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 that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surface after every use before other people use the toliet. Wash hands with soap and water after using the toilet for at least 20 seconds. 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 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. Page 8 INTRAVENOUS CANCER TREATMENT EDUCATION FOLFOX + TRASTUZUMAB + PEMBROLIZUMAB Intimacy, sexual activity, contraception, and fertility This treatment may cause changes that can affect intimacy and sexuality, including desire and body image. Maintaining physical closeness and/or intimacy with loved ones can be continued during treatment. Holding hands, hugging, and kissing can be done safely. It is recommended that you talk to your care team about any restrictions or questions you may have. Some treatments can influence the ability to have children, also known as fertility. If you’re interested in preserving fertility, talk to your care team before treatment. Ask your healthcare provider to determine when it is safe to become pregnant after your treatment. Patients of reproductive ability should not become pregnant or get their partners pregnant while receiving FOLFOX + trastuzumab + pembrolizumab. Some of the drugs you receive may be present in semen and vaginal secretion for many days after treatment. You should use barrier devices, such as condoms, during sexual activity to limit exposure to body fluids. Talk to your care team about birth control. Not all options may be right for your treatment or cancer. Effective contraception could include one or more of the following: barrier methods (e.g. condoms), hormone methods (e.g. birth control pills), or surgery. Tell your care team if you become pregnant or plan to breastfeed. Additional resources: Pembrolizumab: https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf Trastuzumab: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf Oxaliplatin: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021492s016lbl.pdf Leucovorin: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pd Fluorouracil or 5-FU (Adrucil): https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl. pdf Additional instructions Updated – September 29, 2023 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 therapy 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 therapy 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 therapy 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 receiving therapy. All decisions related to receiving this therapy should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Intravenous Cancer Treatment Education (IVE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about intravenous cancer therapy. 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 © 2023 by NCODA. All rights reserved. Page 9