What is Optune Gio

Quick facts about Optune Gio

Long-term data

5-year

survival results in newly diagnosed GBM1

 

Experience

>25,000

patients with GBM
started Optune Gio2

 

Availability

1,600+

certified medical centers prescribing Optune Gio for GBM3

What is Optune Gio?

Optune Gio is a wearable treatment delivery system that can provide continuous anti-cancer therapy*

 

  • Small and lightweight, at just 2.7 pounds4
  • Designed for convenience, carrying comfort, and usability
  • Wearable and portable for use during most normal daily activities

How Optune Gio works

Optune Gio leverages biophysical principles to disrupt tumor viability

 

  • Watch how Tumor Treating Fields can disrupt cancer cell division. This video shows the mechanism of action of TTFields

Optune Gio can provide consistent, continuous anti-cancer treatment.1,*

Optune Gio uses alternating electric fields to target GBM cells.

Explore the Optune Gio MOA

*Continuous treatment requires patient to be wearing the powered device.

How Optune Gio is used

Transducer arrays are applied to the shaved scalp and must be changed at least 2 times per week (every 4 days, at most)5

  • Arrays should always have good scalp contact
  • Avoid activities that may result in the device or transducer arrays becoming wet. Getting the device wet may cause it damage2

Recommended usage goal for Optune is 18+ hours/day, which gives patients flexibility to decide which times of day are best for use2

Patients can benefit most from wearing Optune Gio for the recommended time6

  • In the phase 3 pivotal trial, 75% of patients used Optune Gio 18 or more hours a day during the first 3 months of treatment
    • 50% daily use was the threshold for significant survival benefit over TMZ alone 
    • 86% of patients received a survival benefit from Optune Gio, because they used it more than half the time (n=388/450)
See how more time on Optune Gio predicted increased survival benefit

Simple steps to start patients on Optune Gio

Novocure® has identified a 4-step process that may help your patients with GBM start Optune Gio and achieve their treatment goals.

  1. Discuss treatment plan with multidisciplinary team, patient, and caregiver
  2. Submit prescription order form and supporting documentation
  3. Follow-up 2 weeks post Optune Gio initiation to review integration and skin care
  4. Manage each patient via monthly follow-ups and review of the Optune Gio Usage Report
Get details about practice support

See the Optune Gio system in detail

Learn more

References: 1. Optune Gio. Instructions For Use. Novocure; 2023. 2. Novocure Data on File US-DOF-0036. 3. Novocure Data on File OPT-115.3. 4. Kinzel A, Ambrogi M, Varshaver M, Kirson ED. Tumor treating fields for glioblastoma treatment: patient satisfaction and compliance with the second-generation Optune® system. Clin Med Insights Oncol. 2019;13:1179554918825449. doi:10.1177/1179554918825449 5. Optune. Patient Information and Operation Manual. Novocure; 2023. 6. Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019;141(2):467-473.

Indications For Use

 

Optune GioTM 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 GioTM Instructions For Use for complete information regarding the device's indications, contraindications, warnings, and precautions.

Novocure Websites

This website is intended for people seeking information on Optune Gio.

On this site, videos and images identified as Optune Gio users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals.

Patient images reflect the health status of the patients at the time each photo or video was taken.

 


External links

Tumortreatingfieldstherapy.com
Optunegio.com
Optunelua.com
Novocuretrials.com


©2023 Novocure GmbH. All Rights Reserved. 

Optune, Optune Gio, MyNovocure, NovoTAL, and Novocure are trademarks of Novocure GmbH. 

All other trademarks, registered or unregistered, are the property of their respective owners. 

US-OPG-00197v1.0 November 2023