Caution: Federal law restricts Optune Lua to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.
Optune Lua is a wearable, portable, FDA-approved device indicated for the treatment of adult patients, with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used together with standard chemotherapy (pemetrexed and platinum-based chemotherapy).
Optune Lua is not for everyone. Talk to your doctor if you have:
- An implanted electronic medical device including a pacemaker, implantable automatic defibrillator, etc. Optune Lua has not been tested in people with implanted electronic devices, which may cause the devices not to work properly
- A known sensitivity to conductive hydrogels (the gel on the arrays placed on the upper body like the ones used on EKGs). When Optune Lua comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction
Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy.
Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure®, the maker of Optune Lua.
- Do not use any parts that did not come with Optune Lua sent to you by Novocure or given to you by your doctor
- Do not get the device or transducer arrays wet
- Please be aware that Optune Lua has a cord that may cause tripping when connected to an electric socket
- If you have an underlying serious skin condition on the upper body, discuss with your doctor whether this may prevent or temporarily interfere with the Optune Lua treatment
Most common side effects of Optune Lua when used together with chemotherapy were low red blood cell count, constipation, nausea, tiredness, chest pain, fatigue, skin irritation from device use, itchy skin, and cough.
Other potential adverse effects associated with the use of Optune Lua include: treatment related skin irritation, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.
Talk to your doctor if you have any of these side effects or questions.
Please to see the Optune Lua Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings and precautions.