Optune (NovoTTF-100A System)

Optune is a treatment for adult patients (22 years of age or older). It is used after surgery, radiation, and chemotherapy for newly diagnosed brain cancer (glioblastoma multiforme, or “GBM”) in the higher parts of the brain, together with temozolomide (a type of cancer drug).

It is also used for GBM that reappears after chemotherapy. When used in such cases, it is used alone instead of standard medical therapy for GBM.

Optune is a portable device that produces electric fields, called tumor treatment fields (“TTFields”), to destroy brain cancer cells. The device and battery are carried in a shoulder bag and should be used all the time.

Side Effects of Optune

In case of skin irritation, which appears as redness under the transducer arrays, use high potency topical steroids to relieve the irritation. If the irritation worsens, stop using the cream and contact your doctor. Your doctor will provide an antibiotic cream for replacing the transducer arrays. Continuing without treatment may prolong symptoms and require a break from treatment.

Warning

Qualified and trained personnel should perform all servicing procedures to avoid damage and electric shock from the device.

By using Optune instead of cancer drugs, patients can avoid many side effects like infections, nausea, vomiting, loss of appetite, and tiredness. Patients who used cancer drugs experienced these side effects three times more than those who used Optune.

Administering Optune Therapy

Optune is a portable medical device that delivers electric fields called “TTFields” to the brain using transducer arrays to kill cancer cells. Your doctor will provide instructions on how to use and maintain the device. With proper training, you can use the device independently, replacing transducer arrays, recharging and replacing batteries, and troubleshooting.

The device should be used as many hours per day as possible, with only short breaks for personal needs. The device should be used for at least four weeks.

The Optune Treatment Kit includes four rechargeable batteries, each lasting two to three hours. For longer periods, the device can be plugged into a standard wall outlet. Optune does not require regular maintenance or adjustment of settings. The device will alert you if it is not functioning properly.

Transducer arrays should be changed every 4 to 7 days, and treatment breaks should be minimized. To shower, unplug the transducer arrays from the device and cover your head with a shower cap. The device should not be blocked or obstructed.

Interactions with Other Drugs or Treatments

Optune should not be used with active implanted electronic devices, skull defects, or bullet fragments, as these interactions have not been tested and may cause malfunctioning or tissue damage.

Optune should not be used if you are sensitive to conductive hydrogels used with the device, as it may cause skin irritation or severe allergic reactions.

Use During Pregnancy or Breastfeeding

Optune should not be used if you are pregnant, think you might be pregnant, or are trying to get pregnant. Birth control should be used while using the device. The effects of Optune on pregnancy are unknown.

Other Important Information about Optune

Some general guidelines to follow while using Optune include:

• The device and transducer arrays will activate metal detectors.
• Optune should not be used for tumors located near the spinal cord.
• Using Optune for at least 18 hours a day is recommended for optimal results.
• Treatment should not be stopped before completing four weeks to maximize response.
• Carry extra batteries and transducer arrays for uninterrupted treatment.
• Replace batteries and transducer arrays as needed.
• Follow the troubleshooting guide and do not block device vents.
• Check transducer array packages for seals and do not reuse them.

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Summary

Optune is a portable treatment for adult patients with brain cancer. It is used after surgery, radiation, and chemotherapy, either alone or in combination with temozolomide. The device delivers tumor treatment fields to the head to destroy cancer cells. Optune offers a non-invasive alternative to cancer drugs with fewer side effects.