novocure Optune - Contraindications, Warnings and Precautions; Contraindications for Optune Use; General Warnings for Optune

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4 Contraindications, Warnings and Precautions
Contraindications
Do not use Optune
®
if you have an active implanted medical device, a skull defect (such as, missing bone with no
replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord
stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts. Use of Optune together
with implanted electronic devices has not been tested and may 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 ineective.
Do not use Optune if you are known to be sensitive to conductive hydrogels like the gel used on electrocardiogram
(ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. 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
Warning – Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other
medical personnel who have completed a training course given by the device manufacturer (Novocure). Ask to see a
certificate signed by Novocure that says they completed a training course. Your training will include a detailed review
of this manual and practice in the use of the system. In addition, you will be trained in what to do if there are problems
with treatment. Use of Optune without receiving this training can result in breaks in treatment and may rarely cause
increased scalp rash, open sores on your head, allergic reactions or even an electric shock.
Warning – Optune is not intended to be used as a substitute for chemotherapy but rather as an adjunct to treatment
with TMZ for newly diagnosed GBM.
Warning – Do not use Optune if you are 21 years old or younger. It is unknown what side eects the device may cause
in these cases or if it will be eective.
Warning – Do not use Optune if you are pregnant, think you might be pregnant, or are trying to get pregnant. If you
are a woman who is able to get pregnant, you must use birth control when using the device. Optune was not tested
in pregnant women. It is unknown what side eects the device may cause if you are pregnant or if it will be eective.
Warning – In case of skin irritation, which appears as redness under the transducer arrays (a mild rash), use high potency
topical steroids (your doctor can prescribe this for you) when replacing transducer arrays. This will help relieve your
skin irritation. If you do not use this cream, the skin irritation can become more serious and may even lead to skin
break down, infections, pain and blisters. If this happens, stop using the topical steroid cream and contact your doctor.
Your doctor will supply you with an antibiotic cream to use when replacing transducer arrays. If you do not use this
cream, your symptoms may continue and your doctor may ask you to take a break from treatment until your skin heals.
Taking a break from treatment may lower your chance to respond to treatment.
Warning – All servicing procedures must be performed by qualified and trained personnel. If you attempt to open and
service the system alone you may cause damage to the system. You could also get an electric shock by touching the
inner parts of the device.
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