Learning About Optune. Understanding Optune. A guide for patients and their caregivers. Actor portrayals

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1 Learning About Optune Understanding Optune A guide for patients and their caregivers Actor portrayals

2 Indications For Use Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy. For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. Important Safety Information Contraindications Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective. Do not use Optune if you are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure. Warnings and Precautions Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other medical personnel who have completed a training course given by Novocure (the device manufacturer). Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations. The most common ( 10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression. The most common ( 10%) adverse events seen when using Optune alone were scalp irritation from device use and headache. The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer. All servicing procedures must be performed by qualified and trained personnel. Do not use any parts that do not come with the Optune Treatment Kit, or that were not sent to you by the device manufacturer or given to you by your doctor. Do not wet the device or transducer arrays. If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment. Please visit Optune.com/Safety for Optune Instructions For Use (IFU) for complete information regarding the device s indications, contraindications, warnings, and precautions. 2

3 Table of contents About Optune... 4 Optune for newly diagnosed GBM... 6 Optune for recurrent GBM... 7 What to expect with Optune... 8 ncompass complete support...10 Community resources Actor portrayals

after having surgery and radiation with TMZ For patients with recurrent GBM, Optune is used alone once options like surgery and radiation have been exhausted How does Optune work?

4 About Optune What is Optune? Optune is a wearable and portable, FDA-approved device for the treatment of glioblastoma (GBM) For patients with newly diagnosed GBM, Optune is used together with the chemotherapy temozolomide (TMZ) after having surgery and radiation with TMZ For patients with recurrent GBM, Optune is used alone once options like surgery and radiation have been exhausted How does Optune work? GBM cancer cells divide quickly, creating more and more cancerous cells that form a mass, or tumor Cancer cell begins to divide More and more cancer cells appear When Optune is turned on, it creates low-intensity, wave-like electric fields called Tumor Treating Fields, or TTFields. These TTFields are delivered by transducer arrays to the location of a GBM tumor TTFields may interfere with GBM cancer cell division. This action slows or stops GBM cancer cells from dividing, and may cause them to die Cancer cell begins to divide TTFields interfere with the dividing cancer cell Cancer cell division may slow down or stop. Some cells even die 4

5 How does Optune treat where the tumor is? Optune has been shown in clinical trials to safely deliver TTFields to the location of a GBM tumor Because TTFields do not enter the bloodstream like a drug, they have not been shown to affect cells in other parts of the body The most common ( 10%) adverse events seen when using Optune alone were scalp irritation from device use and headache OPTUNE Optune delivers TTFields to the location of a GBM tumor. SYSTEMIC THERAPY Drugs, like chemotherapy, travel through the bloodstream, affecting cells all over the body. How does Optune deliver therapy? Optune uses 4 adhesive patches, called transducer arrays, to deliver TTFields to the location of a GBM tumor. These transducer arrays are applied to your scalp and are connected to the device and battery Selected Important Safety Information Do not use Optune if you have an active implanted medical device, a skull defect (such as, missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective. 5

6 Optune for newly diagnosed GBM Has Optune + TMZ been shown to extend survival? In a clinical trial, using Optune with the chemotherapy TMZ was shown to delay GBM tumor growth and extend survival compared with TMZ alone Approximately half of the patients who used Optune with TMZ were alive at 2 years or longer, compared with 32% who were on TMZ alone Benefits and selected safety information for Optune + TMZ BENEFITS SAFETY INFORMATION Used with the chemotherapy TMZ When Optune and TMZ are used together, they may offer a more effective approach for slowing or stopping GBM tumor growth compared with TMZ alone. Treats where the tumor is Optune delivers TTFields to the brain, where a GBM tumor is located. Because TTFields do not enter the bloodstream like a drug, they did not significantly increase TMZ-related side effects. Portable therapy Continuous treatment with Optune can be received almost anywhere. After speaking with your doctor, you may be able to use Optune while you go about your daily routine at work, for some travel, and at social functions like family get-togethers. Optune + TMZ The most common side effects that patients with newly diagnosed GBM reported while using Optune with TMZ in a clinical trial were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression. Most common device-related adverse events The most common device-related adverse event (AE) seen in a clinical trial was a mild to moderate skin irritation beneath the device transducer arrays. Warning Do not use Optune if you are pregnant, you think you might be pregnant or are trying to get pregnant. It is not known if Optune is safe or effective in these populations. 6

7 Optune for recurrent GBM How does using Optune alone compare with chemotherapy? For patients with recurrent GBM, a large clinical study has shown that Optune was as effective as chemotherapy, with patients self-reporting better quality of life Benefits and selected safety information for Optune BENEFITS SAFETY INFORMATION Better quality of life Compared with patients who took chemotherapy, patients who used Optune self-reported better quality of life, with improved cognitive and emotional functioning. Most common side effects The most common side effects that patients with recurrent GBM reported while using Optune alone in a clinical trial were scalp irritation from device use and headache. Treats where the tumor is Optune delivers TTFields to the brain, where a GBM tumor is located. Because TTFields do not enter the bloodstream like a drug, they did not cause many of the side effects of chemotherapy, like infections, nausea, vomiting, diarrhea, and lowered blood counts. Portable therapy Continuous treatment with Optune can be received almost anywhere. After speaking with your doctor, you may be able to use Optune while you go about your daily routine at work, for some travel, and at social functions like family get-togethers. Most common device-related adverse events The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer. Precaution If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment. 7

8 What to expect with Optune Why do I have to shave my head while using Optune? Transducer arrays need to be applied directly to your scalp to work properly. Hair growth prevents the arrays from making good contact with your scalp You will need to shave your head and change the arrays 2 to 3 times a week Loose-knit wigs, hats, and head coverings can all be worn over the arrays What will I feel when using Optune? You may experience a warm feeling on your head when using Optune, which is normal How long do I have to wear Optune? Optune is designed to be worn continuously throughout the day and night Optune should be used for at least 18 hours a day to get the best response from treatment What can I do while on therapy? Continuous treatment with Optune can be received almost anywhere. After speaking with your doctor, you may be able to use Optune while you go about your daily routine at work, for some travel, and at social functions like family get-togethers Please ask your doctor before engaging in physical activity, to ensure that it is safe for you Can I shower or bathe while on Optune? No matter where you are, it s important that you keep the device and arrays from getting wet Your Device Support Specialist (DSS) will provide direction on how to protect the transducer arrays and device before bathing 8

9 How will I know if Optune is working? As long as Optune is turned on, therapy is being delivered Your healthcare team will continue to monitor you with regular exams and tests like MRI scans, to see if your tumor is responding Optune records how much time per day therapy is being delivered. A monthly compliance report is provided to your healthcare team, so they can monitor your treatment goals Who should not use Optune? Optune is not right for everyone. Do not use Optune if you have an active implanted medical device, a skull defect, or bullet fragments, or if you are known to be sensitive to conductive hydrogels like the gel used on electrocardiogram stickers or transcutaneous electrical nerve stimulation electrodes Do not use Optune if you are pregnant, you think you might be pregnant, or are trying to get pregnant Do not use Optune if you are 21 years old or younger If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment 9

10 Complete support every step of the way From the moment your doctor prescribes Optune, the ncompass program will be there for you on your Optune treatment journey. When your doctor prescribes Optune, our team will help you navigate insurance coverage and financial assistance When you re ready to get started, a Device Support Specialist (DSS) will come to you, to provide personalized device training in the comfort of your home or your doctor s office Whenever you need us, you can always reach out. Whether that means contacting us for 24/7 tech support, or even requesting help when preparing to travel with Optune One call, complete support Coverage questions? Need tech support? Travel assistance? Extra supplies? Call us toll free, any time of day: (toll free) Or us: support@novocure.com For more information about ncompass support, or if you d like additional resources related to Optune, visit Optune.com. 10

11 Community resources The following organizations are dedicated to helping people with cancer live well. They provide valuable information, support, and resources to help patients and their loved ones cope with the emotional, physical, and financial challenges associated with cancer. Musella Foundation virtualtrials.com/musella.cfm The Chris Elliott Fund endbraincancer.org American Brain Tumor Association ABTA (2282) abta.org American Cancer Society s TLC Web Site tlcdirect.org Look Good, Feel Better Helping Women With Cancer LOOK (5665) lookgoodfeelbetter.org CancerCare HOPE (4673) cancercare.org 11 Actor portrayals

12 More to consider Visit Optune.com to explore additional resources for patients and caregivers considering Optune: Patient journey videos Hear personal stories from Optune patients and their caregivers Optune results Learn more about the results of Optune clinical trials Explore the system Get to know the device and its components Educational resources Browse through printable educational resources ncompass support program Learn more about the support ncompass provides For more information about Optune, please visit or call: Optune.com ncompass support at (toll free) References: 1. Optune Instructions For Use. Novocure National Cancer Institute. What is cancer? /what-is-cancer. Updated February 9, Accessed November 19, Kirson ED, Dbalý V, Tovarys F, et al. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007;104(24): MedlinePlus. Chemotherapy. Updated May 29, Accessed November 19, Optune Patient Information and Operation Manual. Novocure Lacouture ME, Davis ME, Elzinga G, et al. Characterization and management of dermatologic adverse events with the NovoTTF-100A System, a novel anti-mitotic electric field device for the treatment of recurrent glioblastoma. Semin Oncol. 2014;41(3 suppl 4):S1-S Novocure. All rights reserved. Optune, ncompass, and Novocure are trademarks of Novocure. OPT

Understanding Optune. A guide for patients and their caregivers. Inside: 5-year survival results in newly diagnosed GBM

Understanding Optune. A guide for patients and their caregivers. Inside: 5-year survival results in newly diagnosed GBM Understanding Optune Learning About Optune A guide for patients and their caregivers Inside: 5-year survival results in newly diagnosed GBM Marcia is on Optune. BT is her husband. What is Optune approved