Is Optune Lua FDA approved?
Optune Lua was FDA approved in 2019* to treat patients with malignant pleural mesothelioma that cannot be treated with surgery. Optune Lua is used together with chemotherapy.
Similar to the way Optune Lua works, Optune®† has 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 15,000 people have started Optune for the treatment of GBM since FDA approval
*Optune Lua for MPM is FDA approved under the Humanitarian Device Exemption (HDE) pathway, and classified as a Humanitarian Use Device (HUD).
†Optune was approved under the Premarket Approval (PMA) pathway.
How will Optune Lua fit into my daily life?
- You can get non-stop treatment almost anywhere
- You can go about your daily routine at work, while traveling, and at social functions if your doctor agrees
- If you have any questions about specific activities, it's best to ask your doctor
Can I wear my Optune Lua while I’m sleeping?
- Yes. You can set the device on the nightstand next to your bed
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 transducer 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 the arrays from getting wet‡
A full shower with your transducer arrays completely removed
- Unplug the arrays from Optune Lua
- Take a normal shower once your arrays have been 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.
How long should I use Optune Lua?
- You should turn on Optune Lua at least 75% of the time (averaging 18 hours per day), even at night while you are sleeping
- You can plan ahead for important events (like a wedding) where you do not wish to use the device. This can be done by using Optune Lua for more hours prior to the event
- You can decide which times of the day are best for you to use Optune Lua, even at night when you are sleeping
- After starting Optune Lua, it may take time to see whether it is working
- Discuss with your doctor how well Optune Lua is working and 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
How often do I have to replace my transducer arrays?
- At least twice per week (every 4 days at most) to help minimize the risk of skin irritation
Why do I have to shave my upper body while using Optune Lua?
- The 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 your 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 you place the arrays onto your skin
- Regular clothes (loose fitting) may be worn over the arrays once they are attached to your skin
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
What will I feel when using Optune Lua?
- You may experience a warm feeling/sensation, which is normal
Can I exercise while using Optune Lua?
- Please ask your doctor before exercising or doing any physical activity to make sure that it is safe and OK for you to do while using Optune Lua
- It's important that you keep the device and arrays from getting wet
- You may need to change your arrays more often if you have done a physical activity that caused you to sweat more than you normally do
What should I do if I get my transducer arrays wet?
- Getting the transducer arrays wet can cause them to come loose and interfere with contact to your skin. If this happens, the alarm may sound and the device may turn off. If at any time the arrays become wet or loosen, they should be changed
Can I use Optune Lua if I'm pregnant?
- No. Optune Lua has not been 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
Can I talk on my cell phone or use a microwave oven while using Optune Lua?
- Yes. Optune Lua has been tested and shown to not interfere with other electronic devices according to national and international standards. Novocure is not aware of any limitations with the use of microwaves, cell phones, or any mobile devices while on treatment
Can Optune Lua be charged with a car charger?
- No. Using a car adapter is not recommended. Optune Lua is portable and battery operated, but it is not designed to be plugged into a car charger. Please only use those items that were provided to you by Novocure®
- 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
Can I drive a car while using Optune Lua?
- While Optune Lua will not interfere with a person's ability to drive, talk with your doctor about your ability to drive a car
- If your doctor says it’s OK to drive, do NOT place your device on the floor of the driver's seat by your feet
Can I travel domestically while using Optune Lua?
- Yes. If your doctor tells you it is OK, travel may be possible with Optune Lua
- To help prevent unnecessary stress and treatment disruption, nCompass™ is available to support you before and during your travel
- Keep in mind that the Optune Lua system 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 if you have questions related to travel restrictions
- nCompass is here to help. Contact them 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 many need
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 transducer arrays should be disconnected from the connection cable box just as you would do when taking a sponge bath. 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 not sure. If your doctor has questions, he or she can call nCompass at 1-855-281-9301
What should I do if my Optune Lua system gets damaged?
- Do not attempt to repair the device. 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
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 doctor who is certified