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References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2021. 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. Kirson ED, Dbalý V, Tovaryš F, et al. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007;104(24):10152-10157. 4. Ceresoli GL, Aerts JG, Dziadziuszko R, et al. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019;20(12):1702-1709. 5. Optune Lua. Patient Information and Operation Manual for Unresectable Malignant Pleural Mesothelioma. Novocure; 2021.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

 

Indication For Use

Optune Lua® is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

 

Important Safety Information 

Contraindications

Do not use Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of Optune Lua together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

 

Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

 

Warnings and Precautions

Optune Lua can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure®.

 

The most common (≥10%) adverse events involving Optune Lua in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

 

Other potential adverse effects associated with the use of Optune Lua include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.

 

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

 

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

 

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

Novocure Websites

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

 

On this site, videos and images identified as Optune Lua users, care partners, or healthcare professionals depict actual patients, care partners, 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
Novocure.com
Novocuretrials.com


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US-OPL-00020 v1.0 August 2024