Optune Gio users share insights on how they adjusted to sleeping comfortably at night with Optune Gio.
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Please see full Prescribing information at Optunegio.com
Important Safety Information: GBM - Patient
What is Optune Gio® approved to treat?
Optune Gio 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 Gio 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 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 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 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 EKGs). 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 if you are pregnant or are planning to become pregnant. It is not known if Optune Gio 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
• 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?
Most common side effects of Optune Gio 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 Gio 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 visit Optunegio.com/Safety for the Optune Gio Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.
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