WHAT IS OPTUNE GIO APPROVED TO TREAT?

Optune Gio is intended as a treatment for adult patients (18 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune Gio with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with and after standard of care maintenance chemotherapy.

For the treatment of recurrent GBM, Optune Gio is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Newly diagnosed GBM

If you have newly diagnosed GBM, Optune Gio is used together with a standard of care maintenance chemotherapy if:

• Your cancer is confirmed by your healthcare professional AND
• You have had surgery to remove as much of the tumour as possible and completed radiation therapy

Recurrent GBM

If your tumour has come back, Optune Gio 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 Gio?

Optune Gio for GBM is not for everyone. Talk to your doctor if you have:

• An implanted medical device {programmable shunt), skull defect (such as missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly
• A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on ECGs). When Optune Gio 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 Gio for GBM 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 Gio?

Optune Gio 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 Gio.

• Do not use any parts that did not come with the Optune Gio 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 Optune Gio has a cord that may cause tripping when connected to an electric socket
• If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment

What are the possible side effects of Optune Gio?

Common side effects of Optune Gio when used together with chemotherapy for GBM were low blood platelet count, nausea, vomiting, tiredness, seizure, and depression.

The most common (≥10%) adverse events involving Optune Gio in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression. The most common (≥10%) adverse events seen with Optune Gio monotherapy were medical device site reaction and headache.

Talk to your doctor if you have any of these side effects or questions.

Please click here to see the Optune Gio User Manual 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 labelled as Optune Gio 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.