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Quick facts about Optune

What Optune is

Optune is a noninvasive, portable device that is classified as durable medical equipment (DME).

Optune for glioblastoma medical equipment Optune for glioblastoma medical equipment

How Optune works1

Optune provides continuous action against disease progression by delivering electrical fields to disrupt biological processes in dividing cancer cells.

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

How Optune is used4

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

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

Recommended usage goal for Optune is 18+ hours/day, which gives patients flexibility to decide which times of day are best for use4

Patients can benefit most from wearing Optune for the recommended time

  • In the phase 3 pivotal trial, 75% of patients used Optune 18 or more hours a day during the first 3 months of treatment5
    • 50% daily use was the threshold for significant survival benefit over TMZ alone
    • 86% of patients received a survival benefit from Optune, because they used it more than half the time (n=388/450)
More time on Optune predicted increased significant survival benefit

Adjusting to Optune

  • This brief video shows Optune users and caregivers providing their perspectives on starting to use Optune

Simple steps to start patients on Optune

Novocure® has identified a 4-step process that may help your patients with GBM start Optune 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 initiation to review integration and skin care

4

MANAGE

each patient via monthly follow-ups and review of the Optune Usage Report

Get details about practice support available

GBM, glioblastoma; TMZ, temozolomide; TTFields, Tumor Treating Fields.

References:
  1. Optune. Instructions for Use for Glioblastoma. Novocure; 2019.
  2. China NMPA approves Optune® for the treatment of newly diagnosed and recurrent glioblastoma [press release]. St. Helier, Jersey and Shanghai: Business Wire; May 13, 2020. Accessed October 13, 2022. https://www.businesswire.com/news/home/20200513005458/en/China-NMPA-Approves-Optune®-for-the-Treatment-of-Newly-Diagnosed-and-Recurrent-Glioblastoma
  3. Novocure Data on File OPT-115.3.
  4. Optune. Patient Information and Operation Manual. Novocure; 2019.
  5. 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.

Learn more below

Mechanism of action

Indications for Use

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune 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.

Important Safety Information

Contraindications

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

Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune 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

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

If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.

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

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

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

Please click here to see the Optune Instructions for Use (IFU) for complete information regarding the device’s indications, contraindications, warnings and precautions.

Read more

Indications for Use

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune 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.

Important Safety Information

Contraindications

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

Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune 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

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

If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.

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

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

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

Please click here to see the Optune Instructions for Use (IFU) for complete information regarding the device’s indications, contraindications, warnings and precautions.

Leaving Optune.com

Novocure does not review the information contained on this website and/or database for content, accuracy, or completeness. Use of and access to this information is subject to the terms, limitations, and conditions set by the website and/or database producer.

Novocure makes no representation as to the accuracy or any other aspect of the information contained on such website and/or database, nor does Novocure necessarily endorse such website and/or database.

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