Optune (NovoTTF-100A System) Tumor Treatment Field System

What is Optune, and what is it used for?

Optune is a treatment for adult patients (22 years of age or older). Optune is used after surgery, and radiation with chemotherapy have been used if possible. A doctor may use Optune to treat a patient with newly diagnosed brain cancer (called glioblastoma multiforme, or “GBM”) in the higher parts of the brain, together with temozolomide (a type of cancer drug).

A doctor may also use Optune to treat a patient with GBM that reappears after they have had chemotherapy (cancer drugs). When Optune is used after it reappears it is used alone, instead of standard medical therapy for GBM.

Optune is a portable device. It produces electric fields, called tumor treatment fields (“TTFields”). Transducer arrays connected to the device deliver TTFields to your head. The TTFields are intended to destroy brain cancer cells. The device and battery are carried in a shoulder bag. You should use them all the time.

What are the side effects of Optune?

In case of skin irritation, which appears as redness under the transducer arrays (a mild rash), use high potency topical steroids (your doctor can prescribe this for you) when replacing transducer arrays. This will help relieve your skin irritation. If you do not use this cream, the skin irritation can become more serious and may even lead to:

skin break down,
infections,
pain and
blisters.

If this happens, stop using the topical steroid cream and contact your doctor. Your doctor will supply you with an antibiotic cream to use when replacing transducer arrays.
If you do not use this cream, your symptoms may continue and your doctor may ask you to take a break from treatment until your skin heals. Taking a break from treatment may lower your chance to respond to treatment.

Warning

All servicing procedures must be performed by qualified and trained personnel. If you attempt to open and service the system alone you may cause damage to the system. You could also get an electric shock by touching the inner parts of the device.

By using Optune instead of cancer drugs, patients would avoid many of the side effects due to cancer drugs. These include infections, nausea, vomiting, loss of appetite, and tiredness. Three times as many patients who used cancer drugs had these side effects compared to patients who used Optune.

How is Optune therapy administered?

Optune is a portable medical device. It delivers electric fields called “TTFields” to the brain using transducer arrays. TTFields are intended to kill cancer cells.

Your doctor has prescribed Optune for use at home. You may be able to use Optune on your own, or you may need help from a doctor, family member, or other caregiver. Use Optune as many hours per day as possible. Only take short breaks for personal needs. Use the device for at least four weeks.

When starting treatment at your doctor’s clinic, your doctor will tell you how to use the device, replace transducer arrays, recharge and replace batteries, and plug in the device. Your doctor will also teach you what to do if an alarm beeps and will give you a telephone number to call for technical support. After this short training at the doctor’s office, with the help of a family member or care provider if needed, you will be able to properly work Optune.

You will also be able to change the batteries, charge the batteries and replace the transducer arrays as needed. The device can be carried when you are using a battery. You can continue your normal daily life while carrying the device in a shoulder bag or backpack. The Optune Treatment Kit includes four rechargeable batteries. Each battery will last for two to three hours. For sleeping, or other times when you plan to stay in the same place for a while, plug the device into a standard wall outlet.

Optune does not need regular maintenance. Optune also does not have any settings for you to change. The only things you need to do are check that the device has a power supply (a charged battery, or is plugged into the wall) and turn it on and off. If the device is not working, an alarm will beep. A simple Troubleshooting Guide is provided in this manual. You can also call the 24-hour technical support telephone number at 855-281-9301.

Shave your scalp and change the transducer arrays every 4 to 7 days. Keep treatment breaks to a minimum. Interrupt treatment only for personal needs such as bathing, exercise, or any time where the device may be a distraction. Stop treatment to replace the transducer arrays.

To take a shower, unplug the transducer arrays from the device (leave the transducer arrays on your head) and put a shower cap on your head so it does not get wet. You can take a full shower and wet your head when you are not wearing the transducer arrays (for example, when you have taken them off but before replacing them with a new pair). You can wear a wig or hat over the transducer arrays, if you wish.

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What other drugs or treatments interact with Optune?

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 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 like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. 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.

Is Optune safe to use while pregnant or breastfeeding?

Do not use Optune if you are pregnant, think you might be pregnant, or are trying to get pregnant. If you are a woman who is able to get pregnant, you must use birth control when using the device. Optune was not tested in pregnant women. It is unknown what side effects the device may cause if you are pregnant or if it will be effective.

QUESTION

Which of these is NOT a type of head and neck cancer?
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What else should I know about Optune?

The Optune device and transducer arrays will activate metal detectors.
Do not use Optune if your tumor is located in the lower parts of the brain close to the spinal cord. Ask your doctor if your tumor is located in this part of your brain. Optune has not been tested in patients with tumors in these locations. It is unknown whether these tumors will respond to treatment.
You should use Optune for at least 18 hours a day to get the best response to treatment. Using Optune for less than 18 hours a day lowers the chances that you will respond to treatment.
Do not stop using Optune before you finish at least four full weeks of therapy to get the best response to treatment. Stopping treatment before four weeks lowers the chances that you will respond to treatment. Notice! Do not stop using Optune even if you have used it less than the recommended 18 hours per day. You should stop using the device only if your doctor tells you to. Stopping treatment could lower the chances that you will respond to treatment.
If you plan to be away from home for more than 2 hours, carry an extra battery and/or the power supply with you in case the battery you are using runs out. If you do not take a spare battery and/or the power supply you may have a break in your treatment. Breaks in treatment may lower your chance to respond to treatment.
Make sure you have at least 12 extra transducer arrays at all times. This will last you until the next transducer array shipment arrives. Remember to order more transducer arrays when there are at least 12 extra transducer arrays left. If you do not order transducer arrays in time you may have a break in your treatment. Breaks in treatment may lower your chance to respond to treatment.
Batteries may weaken over time and need to be replaced. You will know this has happened when the amount of time the device can run on a fully charged battery begins to shorten. For example, if the low battery indicator light flashes within only 1.5 hours from the start of treatment, replace the battery. If you do not have replacement batteries when your batteries run out, you may have a break in your treatment. Breaks in treatment may lower your chance to respond to treatment.
You should carry the Troubleshooting Guide at all times. This guide is necessary to ensure Optune works properly. If you do not work the system correctly you may have a break in your treatment. Breaks in treatment may lower your chance to respond to treatment.
Do not block the device vents located on the sides of the Electric Field Generator. Blocking the vents may cause the device to overheat and turn off, leading to a break in treatment. If this happens, unblock the vents, wait 5 minutes and restart the device.
Do not block the battery charger vents located on the front of the battery chargers. Blocking the vents may cause the charger to overheat. This could prevent your batteries from charging.
Before using a transducer array, make sure its package is sealed by gently rubbing the package between thumb and pointer finger on all four sides. The package should be closed on all sides. There should be no openings in the package seal. If the package is not sealed, the transducer array may be damaged. A damaged transducer array will not work properly and may cause the device to turn off.
• The transducer arrays are for single use and should not be taken off your head and put back on again. If you put a used transducer array back on your head again, it may not stick well to your skin and the device could turn off.