Technical
Can I use a car charger?
Using a car adapter is not recommended. Please only use those items that were provided to you by Novocure. Optune is portable and battery operated, but it is not designed to be plugged into a car charger. Remember, if you plan to be out for more than 2 hours, carry an extra battery or the power supply with you, in case the current battery runs out.
Can I carry the device with me while receiving a CT scan, MRI, or x-ray?
For all x-rays, CT scans, and MRIs the Optune device should always be turned off and the arrays should be disconnected from the connection cable box just as you would do when taking a shower. The device should then be left outside of the procedure room.
What published data is available for me to review?
The Patient Information and Operation Manual explains the clinical trials in broad terms, while Sections 5 and 6 discuss the possible risks and benefits of Optune. Published data is also available on Optune.com and in the Instructions for Use. Your healthcare provider can also answer data- related questions.
Is it common for patients to have skin irritation? Could also be asked “How common is skin irritation?”
o In a large clinical study of patients with recurrent GBM who used Optune as instructed, 18 out of 116 (16%) subjects experienced mild scalp redness (rash) and a separate 18 out of 116 (16%) subjects experienced moderate scalp redness (rash with little sores and blisters).
In a larger clinical study of newly diagnosed patients using Optune together with temozolomide, just over half of the patients had some degree of skin irritation. Most of these cases were not severe and were treated with creams applied to the scalp. (OPT-1408)
Can I use a battery during a thunderstorm?
or
Can I use the power supply during a thunderstorm?
Yes, using the battery or wall power supply while on Optune during a thunderstorm is fine.
Can I use an extension cord or power strip?
A three-pronged extension cord may be used if needed. A power strip is not recommended. Please only use those items that were provided to you by Novocure.
I have skin irritation (described as swelling, redness, excessive itching, or other skin-related symptoms). Is there anything I can do?
Mild-to-moderate skin irritation under the transducer arrays can occur and is the most common side effect experienced by Optune users. Please bring this up with your health care provider as soon as possible since it can often be treated using a topical ointment. Often skin irritation may be treated with a prescription cream or an over-the-counter hydrocortisone cream however, only your HCP can decide if this is best and prescribe this for you. It may be helpful to take a photograph of your skin and send to your healthcare team, especially if you live a distance from the office. You can contact your health care provider’s office to see if that’s possible. We also recommend changing the arrays at least every four days, as well as moving the placement of your transducer arrays slightly during changes. You can find information on how to do this on page 38 of the Patient Information and Operation Manual (PIOM) and on page 7 of the “A Guide to Scalp Care and Proper Transducer Array Placement (OPT-273-02)” brochure.
Can this device shrink tumors as well as stop their growth? Could also be asked as “Will this device shrink my tumor?”
Note to DSS: If the patient or caregiver would like more information, refer them to their health care provider.
How can I keep the arrays cool while sleeping?
Choose bedding carefully. If experiencing alarms, avoid electric blankets and heat trapping materials such as flannel or wool pillow cases.
Can my patient continue wearing the transducer arrays during an MRI?
Optune transducer arrays contain metal in the wiring and will interfere with the magnetic field of the MRI unit and image results. Patients need to remove the arrays for all MRI procedures. After the procedure is completed, the patient should apply new transducer arrays, connect Optune, and restart treatment.
Why can’t I throw away the used transducer arrays? Could also be asked as “Do you reuse the transducer arrays?” Could also be asked “How do I dispose of my used transducer arrays?”
Novocure does not re-use any materials from the transducer arrays. (OPT- 1405)
Can I use a CPAP device while receiving treatment from Optune?
Whether the TTFields are on or off, Novocure is not aware of any interference issue when using a CPAP machine as described while using Optune. The CPAP straps should not physically obstruct the transducer array contact on your scalp. Wearing CPAP straps over the transducer arrays may cause discomfort or irritation, so it is best to discuss placement with your healthcare provide. (OPT-1407)
What clinical trials are happening? Is Novocure researching using Optune for other tumor types?
Currently in the United States Novocure has three open clinical trials, METIS, LUNAR, and PANOVA-3. The METIS trial is intended for patients who have recently been diagnosed with brain metastases from non-small cell lung cancer (NSCLC). The LUNAR trial is intended for patients who have recently been diagnosed with progression of non-small cell lung cancer (NSCLC). The PANOVA-3 trial is intended for patients who have recently been diagnosed with locally advanced, pancreatic adenocarcinoma that cannot be treated with a surgery. The best resource for clinical trial information is our clinical trials website, www.novocuretrial.com.
Can you put me in contact with another patient who has been wearing the device?
DSS provides Buddy Program Flyer (OPT-040.6-02)
After I pass, will my family be billed for this therapy because insurance never paid?
That is a good question for the nCompass team. They can be reached at 1- 855-281-9301.
Is it safe to use Optune while using my computer? Is there any interference with other electronic devices such as the microwave, cell phone, television?
When TTFields are on, know that common household appliances and everyday consumer electronics will not interfere with the operation of Optune. This includes refrigerators and microwaves, cell phones, laptop/desktop computers, and televisions.
• Optune uses low-intensity electric fields that may have some effect on very sensitive electronic devices such as a computer mouse, touch lamp, or sensitive measurement systems used in healthcare
• Examples of sensitive measurement systems used in healthcare include:
Electrocardiogram (EKG)
Telemetry- special equipment that tracks heart rate, blood pressure, breathing, and other vital signs and nerve conduction tests
• These sensitive systems are not necessarily designed or tested in the presence of low intensity electric fields, such as those produced by Optune. Because they weren’t designed to work together, you may notice interference with these types of electronics.
Safety
• Optune has been tested for electromagnetic compatibility. The results of this testing show that no significant electric or magnetic fields are found around the device when it is active. Optune meets all applicable United States and International standards for medical devices, include safety standards related to electromagnetic interference (OPT-1407)Do you have a copy of the Optune Patient Information and Operation Manual? It is a good resource for information; Section 30 includes information on Emitted Radiation & Electromagnetic Compatibility.
How many other patients are on treatment, specifically in this area?
As of June 30, 2018 there were >2,000 patients currently using Optune. That is the most recent data I can share.
***I am unable to share details on number of patients in specific locations. You can find information on our website, Novocure.com. Your health care provider and his/her staff may have experience with other patients using Optune.
How does the treatment work? Could also be asked as “How does this therapy work?”
Optune is a wearable and portable device that produces electric fields, called tumor treating field (“TTFields”). Transducer arrays connected to the device deliver TTFields to your head. The TTFields are intended to destroy brain cancer cells. Cancer cells divide quickly, creating more and more cancerous cells that form a mass, or tumor. When Optune is turned on, it creates low-intensity, wave-like electric fields called Tumor Treating Fields, or TTFields. These wave-like fields alternate at a speed that has been found to be the most effective for treating glioblastoma (GBM) cells (if the patient/caregiver asks about the speed, the DSS can respond that TTFields alternate at a speed of 200kHz). Because TTFields do not enter the bloodstream, like a drug, they have not been shown to affect cells in other parts of the body
Can I travel on a plane internationally?
Please contact nCompass at 1-855-281-9301 (toll free) for more information and assistance with traveling internationally with Optune. Please contact nCompass at least 4 weeks in advance of the planned departure. Please be aware that the device and transducer arrays will set off airport screening devices, and there are restrictions for transporting lithium-ion batteries in checked luggage. You can also call the Transportation Security Administration's TSA Cares help line at 1-855-787-2227 (toll free) to ask about procedures. Try to call more than 72 hours in advance to coordinate security checkpoint support at the airport.
BONUS: How would your answer be different if the question was for domestic travel?
What results have you personally seen? You have taken care of a lot of patients. Has this helped any of them?
More than 7,000 people with GBM have chosen to start Optune. Our Buddy Program can connect you with Optune users and/or caregivers who have experience with Optune. They have been where you are and want to share what they have learned, including: tips on using Optune, advice on how to incorporate Optune into daily life, and personal experiences with Optune.
I’ve heard a lot of lithium batteries causing problems. Are yours safe? Do I need to be worried?
[If question specifically includes mention of problems associated with lithium batteries, start with 1st bullet otherwise start with 2nd bullet]
• Lithium batteries in general
Novocure does not investigate batteries manufactured by other companies. However, based on available follow up reports, it appears that the recently reported problems with lithium batteries are often related to use of third party replacement batteries, use of low quality chargers, or a lack of safety mechanisms.
• Safety mechanisms related to the batteries and charger for Optune
Both the batteries and the charger for Optune have safety mechanisms in place to handle and charge the battery cells properly.
• The batteries are compatible only with the charger provided for Optune which prevents the use of unapproved or low-quality chargers.
• Because batteries can only be charged using the charger provided for Optune, this ensures:
o An optimal charging for the Optune battery pack
o Full charge detection to prevent overcharging and battery cell overheating and
o Proper communication with battery monitoring components
• The battery and charger are a specific system designed only for use with Optune. Every battery and charger undergoes extensive quality checks prior to use.
Hazards if misused
• Please do keep in mind that that there are potential hazards if the batteries or charger are misused. Don’t puncture, disassemble, incinerate, crush, immerse in water, or allow metal to touch the recessed + and – terminals on the bottom of the battery. You should also avoid exposing the battery to temperatures above the declared operating temperature range as described in the Optune Patient Information and Operation Manual (Section 25).
I felt a sharp, dull, constant, pulsing, shocking, or buzzing feeling. Why? What causes this?
If shocking feeling or non-array contact sensation:
Answers to if the sensation is in the Arrays area:
While not common, we do have patients who report different types of sensations while using Optune. An increase in static may contribute to these sensations. Static doesn’t damage the device, but may cause treatment to stop. Some sources of static include: dry environments, cars and vehicles, contact with certain surfaces, such as carpet, pets, or synthetic fabrics. If they ask about using an anti-static product (like Static Guard) tell them not
to use it directly on the device, arrays, or head. Some patients have used humidifiers, dryer sheets, and utilized non-synthetic materials.
If associated with sensation on head pulsating/sensation trying to make contact:
Answer:
Some patients report feeling different kinds of sensations when the array contact with the scalp changes. This may occur either when the arrays lift up off the scalp or when the arrays make better contact with the scalp. I would recommend changing the arrays after re-shaving your head and applying 70% isopropyl alcohol. (OPT-1358)
Will I have headaches/nausea/any other side effect related question with Optune? Could also be asked as “What side effects are associated with Optune?”
The Patient Information and Operation Manual shows the risks associated with Optune. Your healthcare provider can provide more
information regarding any side-effects you may experience during treatment.
The most common side effects of Optune when used together with temozolomide were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression.
The most common side effects when using Optune alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers.
Talk to your doctor if you have any of these side effects or questions.
Can I exercise/swim/surf/run while using Optune?
If the patient wants to participate in low intensity sports, high-intensity sports, or aquatic activities:
Daily life activities that result in increased perspiration may be acceptable; however, this will reduce the array adhesive and result in more frequent array changes. We will supply additional arrays if needed.
If the patient wants to participate in high intensity sports:
If the patients wants to participate in aquatic activities:
Do not use Optune if it has been exposed to water; call us right away for a replacement. If you are concerned that damage has occurred, call nCompass Support right away for troubleshooting and replacement equipment. (OPT- 1428)
Will my insurance not pay if my percentage of monthly use drops below 75%? Will I be forced to stop receiving treatment?
If for any reason your insurance has an issue with your percentage of use, Novocure will fight the denial. If this ever arises you will be informed and continuously updated throughout any appeals process.