What is the NovoTTF-100L™ System approved to treat?
The NovoTTF-100L System 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).
What is Optune approved to treat?
Optune is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.
Newly diagnosed GBM
If you have newly diagnosed GBM, Optune is used together with a chemotherapy called temozolomide (TMZ) if:
- Your cancer is confirmed by your healthcare professional AND
- You have had surgery to remove as much of the tumor as possible
Who should not use the NovoTTF-100L System for MPM or Optune for GBM?
The NovoTTF-100L System for MPM and Optune for GBM are not for everyone. Talk to your doctor if you have:
Do not use the NovoTTF-100L System for MPM or Optune for GBM if you are pregnant or are planning to become pregnant. It is not known if the NovoTTF-100L System/Optune is safe or effective during pregnancy.
- MPM and an implanted electronic medical device including a pacemaker, implantable automatic defibrillator, etc. The NovoTTF-100L System has not been tested in people with implanted electronic devices, which may cause the devices not to work properly
- GBM and an implanted medical device (programmable shunt), skull defect (missing bone with no replacement) or bullet fragment. Optune has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune has not been tested in people with skull defects or bullet fragments, which may cause Optune not to work properly
- A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp or upper body like the ones used on EKGs). When the NovoTTF-100L System/Optune comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction
What should I know before using the NovoTTF-100L System for MPM or Optune for GBM?
The NovoTTF-100L System and Optune 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 the NovoTTF-100L System and Optune.
- Do not use any parts that did not come with the NovoTTF-100L System or Optune Treatment Kit 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 the NovoTTF-100L System and Optune have a cord that may cause tripping when connected to an electric socket
- If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with the NovoTTF-100L System or Optune treatment
What are the possible side effects of the NovoTTF-100L System for MPM and Optune for GBM?
The most common side effects of the NovoTTF-100L System when used together with chemotherapy for MPM (pemetrexed and platinum-based 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 the NovoTTF-100L System 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.
The most common side effects of Optune when used together with chemotherapy for GBM (temozolomide or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression.
Talk to your doctor if you have any of these side effects or questions.
Please click here to see the NovoTTF-100L Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.
Please click here to see the Optune IFU for complete information regarding the device's indications, contraindications, warnings, and precautions.