Frequently asked questions

Optune Lua delivers Tumor Treating Fields (TTFields) to selectively disrupt mitosis.1,2

TTFields are a regional, noninvasive antimitotic treatment that selectively disrupts the division of rapidly dividing cells by delivering low-intensity, intermediate-frequency (150 kHz) alternating electric fields via transducer arrays applied to the upper body.1

Preclinical studies found that optimal frequencies differed between cancer cell types and that frequency was inversely related to cell size.3

Higher frequencies are required to inhibit proliferation of cells that are smaller in size, like malignant pleural mesothelioma (MPM). The optimal frequency for MPM is 150 kHz.1

As determined by simulation modeling, using arrays placed on the torso, TTFields can be delivered at therapeutic intensity
(>1 V/cm) to over 99% of the volume of both lungs.1

Optune Lua can be prescribed by radiation oncologists with prescribing privileges only after completing an FDA-mandated certification training course given by the device manufacturer (Novocure®).

Additionally, because Optune Lua was approved through a Humanitarian Device Exemption (HDE) pathway, only prescribers at facilities with an Institutional Review Board (IRB) or appropriate local committee (LC), which have granted approval to use Optune Lua, will be allowed to prescribe Optune Lua.1,4

The device frequency is “tuned” to mesothelioma cell size (150 kHz)—larger or smaller cells within the pleural cavity would not be affected at this frequency. Tumor Treating Fields selectively disrupt mitosis in rapidly dividing cells. Preclinical studies found a correlation between treatment effect and cell doubling time.1-3

Since mesothelioma cells have a much shorter doubling time, these would be affected by Optune Lua, while normal adult cells (with a longer doubling time) in the pleural cavity would not. Only dividing cells (and not quiescent cells) are affected by TTFields.2

Patients should be encouraged to use TTFields continuously, averaging at least 18 hours per day.1,4

Patients can choose which parts of the day to use Optune Lua, including at night when they are sleeping. Remind patients that they should not stop treatment with Optune Lua unless you have instructed them to do so.

No additional chemotherapy-related side effects were related to the use of Optune Lua.1

The only adverse event (AE) attributed to the use of Optune Lua was the known skin irritation seen in a total of 71% of patients in this study (66% mild-to-moderate and 5% severe). No serious adverse events (SAEs) were considered related to device use.1,4

No SAEs were considered related to device use.1

Grade 3 skin reactions considered to be severe were seen in 4 (5%) of the patients in the STELLAR study. Anemia was the most common SAE, leading to hospital admission of 2 (3%) of the patients. None of the SAEs leading to hospital admission were related to Optune Lua treatment. Proper skin care throughout treatment with Optune Lua may help patients avoid skin irritation, which is the only AE attributed to the use of Optune Lua.1,4

Novocure will provide a customized map for transducer array placement based on patient-specific measurements and tumor location (determined via CT scans).

An nCompass Device Support Specialist (DSS) will then arrange for in-person training at the patient’s home, or virtually. The DSS will instruct patients and caregivers on how to use Optune Lua, how to prepare their upper body (shaving and skin care), and how to properly place the transducer arrays.

If a patient complains about a heat or electric sensation, it may be the result of suboptimal contact between the transducer arrays and the skin.

In such instances, the patient should change the arrays. Complaints should be reported to the Novocure Customer Care Team at
1-855-281-9301.

There is no known risk to those exposed to a patient receiving Optune Lua.

Optune Lua has been tested for electromagnetic compatibility (active and passive) according to all required electromagnetic tests, including EN ISO 60601-1. This means that no significant electric or magnetic fields are found in the vicinity of the device when it is active.

Optune Lua has been tested for electromagnetic compatibility (active and passive) according to all required electromagnetic tests, including EN ISO 60601-1. Novocure is not aware of any limitations with the use of cell phones or microwaves while patients are being treated with Optune Lua.

Novocure assists in all aspects of billing and reimbursement for Optune Lua to help achieve the best possible coverage available from your patients' insurance.

Novocure may also offer financial support to patients who qualify. Programs are available for patients who are uninsured, underinsured, or need co-pay assistance and have a household income of ≤$150,000.

With your permission, travel may be possible.

To help prevent unnecessary stress and treatment disruption, nCompass support is available before, during, and after traveling. nCompass can help ensure that your patients will have the supplies and any travel documentation related to Optune Lua that they may need. Encourage patients to contact nCompass for travel support before flying with Optune Lua.

Patients can shower at the time of transducer array changes, before applying the new arrays.5

Sponge baths can be taken on days that arrays are not being changed. It is recommended that the device be left outside of the bathroom and that arrays are protected to avoid getting them wet.

References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2019. 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; 2019.

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Indications For Use
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The Optune Lua System is indicated for the treatment of adult patients with unresect…

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