Mechanism of Action

Optune Gio™ leverages biophysical principles to disrupt tumor viability

TTFields therapy uses alternating electric fields delivered at a unique frequency that allows it to selectively disrupt GBM cell division1

Because healthy cells have different properties than cancer cells (including division rate, morphology, and electrical properties), they are spared by Optune Gio4-9

See the benefit in newly diagnosed GBM

Learn more

TTFields, Tumor Treating Fields.

References: 1. Optune. Instructions For Use. Novocure; 2023. 2. Kirson ED, Gurvich Z, Schneiderman R, et al. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004;64(9):3288-3295. 3. Giladi M, Schneiderman RS, Voloshin T, etal. Mitotic spindle disruption by alternating electric fields leads to improper chromosome segregation and mitotic catastrophe in cancer cells. Sci Rep. 2015;5(1):18046.doi:10.1038/srep18046. 4. Karanam NK, Story MD. An overview of potential novel mechanisms of action underlying tumor treating fields-induced cancer cell death and their clinical implications. Int J Radiat Biol. 2021;97(8):1044-1054. doi:10.1080/09553002.2020.1837984. 5. Cooper GM. The development and causes of cancer. In: The Cell: A Molecular Approach. 2nd ed. Sinauer Associates; 2000:chap 15. Accessed July 17, 2023. https://www.ncbi.nlm.nih.gov/books/NBK9963/. 6. Baba AI, C.toi C. Tumor cell morphology. In: Comparative Oncology. The Publishing House of the Romanian Academy; 2007:chap 3. Accessed July 17, 2023. https://www.ncbi.nlm.nih.gov/booksNBK9553/ 7. Trainito CI, Sweeney DC, Čemažar J, et al. Characterization of sequentially-staged cancer cells using electrorotation. PLoS One. 2019;14(9):1-18. doi:10.1371/journal.pone.0222289. 8. Haemmerich D, Schutt DJ, Wright AW, Webster JG, Mahvi DM. Electrical conductivity measurement of excised human metastatic liver tumours before and after thermal ablation. Physiol Meas. 2009;30(5):459-466. doi:10.1088/0967-3334/30/5/003. 9. Ahmad MA, (IEEE SM), Al Natour Z, Mustafa
F, Rizvi TA. Electrical characterization of normal and cancer cells. IEEE Access. 2018;6:25979-25986. doi:10.1109/ACCESS.2018.2830883

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.

 




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

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US-OPG-00197 v1.0 November 2023