Important Safety Information
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
Recurrent GBM
If your tumor has come back, Optune can be used alone as an alternative to standard medical therapy if:
- You have tried surgery and radiation and they did not work or are no longer working AND
- You have tried chemotherapy and your GBM has been confirmed by your healthcare professional
Who should not use Optune?
Optune is not for everyone. Talk to your doctor if you have:
- 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 like the ones used on EKGs). When Optune 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 if you are pregnant or are planning to become pregnant. It is not known if Optune is safe or effective during pregnancy.
What should I know before using Optune?
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 Optune.
- Do not use any parts that did not come with the Optune Treatment Kit sent to you by Novocure or given to you by your doctor
- Do not get the device or transducer arrays wet
- If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune treatment
What are the possible side effects of Optune?
The most common side effects of Optune when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions.
Please click here for the Optune Instructions for Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
On this site, patient and healthcare professional videos as well as all images labeled as Optune users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals. All other depictions of patients and caregivers are actor portrayals. Patient images reflect the health status of the patients at the time each photo was taken.
