Patient 4

Adding Optune Gio can help provide long-term clinical outcomes for patients like this one¹

Patient 4

61, female
2-year Optune Gio use

Married

Real patient profile provided by Gautam Prasad, MD, PhD.

CURRENT MEDICAL STATUS

CONTINUED TREATMENT WITH OPTUNE GIO

SIDE EFFECT MANAGEMENT

Case information used with permission from Gautam Prasad, MD, PhD.

Patient’s MRI

Case information used with permission from Gautam Prasad, MD, PhD.

Patient’s usage report¹

Return to patient cases

Case information used with permission from Gautam Prasad, MD, PhD.

MGMT, O-6-methylguanine-DNA methyltransferase; IDH, isocitrate dehydrogenase; ED, emergency department; WHO, World Health Organization; MRI, magnetic resonance imaging.

Reference: 1. Novocure Data on File OPT-05289.

Indications For Use

Optune Gio^®is intended as a treatment for adult patients (22 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 concomitant standard of care 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.

Important Safety Information

Contraindications

Do not use Optune Gio in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune Gio together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune Gio together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune Gio ineffective.

Do not use Optune Gio in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Gio may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.

Warnings and precautions

Optune Gio can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).

Do not prescribe Optune Gio for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Gio in these populations have not been established.

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. The following adverse reactions were considered related to Optune Gio when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall, and skin ulcer.

Use of Optune Gio in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune Gio in these patients could lead to tissue damage or lower the chance of Optune Gio being effective.

If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune Gio treatment.

Please click here to see the Optune Gio^®Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.

Patient 4

Adding Optune Gio can help provide long-term clinical outcomes for patients like this one1

Patient 4

61, female2-year Optune Gio use

Indications For Use

Important Safety Information

Contraindications

Warnings and precautions

Please click here to see the Optune Gio® Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.

Adding Optune Gio can help provide long-term clinical outcomes for patients like this one¹

61, female
2-year Optune Gio use

Please click here to see the Optune Gio^®Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.