FDA-approved indication

Does Optune Lua™ have an FDA-approved indication?

Yes. Optune Lua is FDA-approved for the treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) as of 2019.

Similar to the way Optune Lua works, Optune® has also been FDA approved to treat glioblastoma (GBM)-a certain type of brain cancer.

  • Optune in combination with chemotherapy was approved for newly diagnosed GBM in 2015, and Optune used by itself for recurrent GBM in 2011
  • More than 10,000 people have started Optune for the treatment of GBM since FDA approval
    • Optune Lua for MPM is classified as a Humanitarian Use Device (HUD), approved under the Humanitarian Device Exemption (HDE) pathway
    • Optune was approved under the Premarket Approval (PMA) pathway
Daily activities

How will Optune Lua fit into my daily life?

  • You can get continuous treatment almost anywhere
  • You can go about your daily routine at work, while traveling, and at social functions if your doctor agrees
Showering and bathing with Optune Lua™

How do I shower or bathe while I use Optune Lua?

There are 2 ways to clean your upper body:

A sponge bath with your arrays still on

  • Unplug the arrays from Optune Lua
  • Cover the unplugged arrays and wires that are still attached to you by placing a towel around your upper body to prevent them from getting wet*

A full shower with your arrays completely removed

  • Unplug the arrays from Optune Lua
  • Take a normal shower once your arrays have been unplugged and completely removed from your body*

*Leave Optune Lua outside the bathroom while taking a sponge bath or a full shower.

For more information on taking care of your skin while using Optune Lua, download the Skin Care Guidelines brochure.

How long to use Optune Lua™

How long should I use Optune Lua?

  • It is recommended that Optune Lua be turned on at least 75% of the time (18 hours per day) to get the best response from your treatment
  • You can choose which parts of the day to have your treatment, including at night when you are sleeping
  • After starting Optune Lua, it may take time to see whether it is working
    • Review with your doctor how well Optune Lua is working and discuss the best path forward for fitting Optune Lua into your lifestyle
  • You should not stop treatment with Optune Lua unless you have been instructed to do so by your doctor
Transducer array replacement

How often do I have to replace my transducer arrays?

  • At least twice per week to help minimize the risk of skin irritation
Shaving guidelines

Why do I have to shave my upper body while using Optune Lua?

  • Transducer arrays need to be applied directly to your skin to work properly. Even a small amount of hair growth can prevent the arrays from making good contact with your skin
  • You will need to shave upper body and change the arrays at least 2 times a week (or every 4 days at most)
  • An array applicator will be provided to help place transducer arrays onto your skin

Regular clothes (loose fitting) may be worn over the arrays.

The Optune Lua™ device

How will I know if Optune Lua is working?

  • Make sure the transducer arrays are in position and Optune Lua is turned on
  • Press the TTFields button. You will know that treatment is being delivered when the 3 blue indicators surrounding the button light up
  • As long as the device and TTFields are turned on, therapy is being delivered
  • Optune Lua records the amount of time that therapy is delivered per day
  • Your healthcare team will receive a monthly usage report to monitor your treatment goals
Warm feeling

What will I feel when using Optune Lua?

  • You may experience a warm feeling/sensation, which is normal
Exercise

Can I exercise while using Optune Lua?

  • Please ask your doctor before engaging in physical activity to ensure that it is safe for you and appropriate while using Optune Lua
  • It's important that you keep the device and arrays from getting wet
  • More frequent array changes may be needed if you've performed a physical activity that causes you to sweat more
Water

What should I do if I get my transducer arrays wet?

  • Getting the transducer arrays wet can cause the patches to come loose and interfere with contact to your skin. If this happens, the alarm may sound and the device may turn off. Any time the transducer arrays become wet or loosen, they should be changed
Warning if pregnant

Can I use Optune Lua if I'm pregnant?

  • Optune Lua was not tested in pregnant women. Do not use Optune Lua if you are pregnant, think you might be pregnant, or are trying to get pregnant
  • Women who are able to get pregnant must use birth control when using the device. It is unknown what side effects the device may cause to a pregnant woman or if it will be effective. For more information, please consult your doctor
Mobile phone

Can I talk on my mobile phone or use a microwave while using Optune Lua?

  • Yes. Optune Lua has been designed to not interfere with other electronic devices according to international standards. In testing and in real-world use, there have been no problems reported with the use of mobile devices while on treatment
Car adapter warning

Can Optune Lua be charged in a car charger?

  • Using a car adapter is not recommended. Please only use those items that were provided to you by Novocure®. Optune Lua is portable and battery operated, but it is not designed to be plugged into a car charger
  • Remember, if you plan to be out for more than 1.5 hours, carry an extra battery or the power supply with you, in case the current battery runs out
Use while driving

Can I drive a car while using Optune Lua?

  • While Optune Lua will not interfere with a person's ability to drive, consult with your doctor regarding your ability to drive a car
  • If you've been given permission to drive, it is best not to place your device on the floor of the driver's seat by your feet
Domestic travel

Can I travel domestically while using Optune Lua?

  • Yes. If your doctor tells you it is okay, travel may be possible with Optune Lua
  • To help prevent unecessary stress and treatment disruption, nCompass™ is available to support you before and during your travel
    • Keep in mind that Optune Lua has portable batteries that contain lithium ion material and are restricted from being checked as luggage or carried in the passenger cabin. Please contact nCompass™ Support if you have questions related to travel restrictions
      • Contact nCompass toll-free at 1-855-281-9301 at least 1 week before your flight. They can help you coordinate your travel and ensure that you will have the supplies and any travel documentation related to Optune Lua that you may need
X-ray, CT scan, or MRI guidelines for transducer arrays

Do I need to remove the transducer arrays for an x-ray, CT scan, or MRI?

  • For all x-rays, CT scans, and MRIs, the device should always be turned off and the arrays should be disconnected from the connection cable box just as you would do when taking a shower. The device should then be left outside of the procedure room
  • Whether or not you also need to remove the arrays depends on what type of test is being performed and on what part of your body. You should speak with your doctor if you are uncertain. If your doctor has questions, he or she can call nCompass at 1-855-281-9301
What to do if Optune Lua™ is damaged

What should I do if my Optune Lua gets damaged?

  • Do not attempt to repair the equipment. If you attempt to open the device, you could cause damage or receive an electric shock. All technical service must be performed by qualified, trained personnel. If your device gets damaged or if you need technical support, call nCompass toll free at 1-855-281-9301
Certified Optune Lua™ healthcare providers

Will I continue to work with my own healthcare providers?

  • If your current healthcare provider is not a certified Optune Lua doctor, it is possible to have your care coordinated with another center

References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2019. 2. FDA Approves the Optune Lua System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma [press release]. St. Helier, Jersey: Business Wire; May 23, 2019. 3. Summary of Safety and Effectiveness Data (SSED). US FDA Website. https://www.accessdata.fda.gov/cdrh_docs/pdf10/p100034s013b.pdf. Accessed April 9, 2019. 4. Optune Lua. Patient Information and Operation Manual for Unresectable Malignant Pleural Mesothelioma. Novocure; 2019.

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What is the Optune Lua™ System approved to treat?
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The Optune Lua System is a wearable, portable, FDA-approved device indicated for…