Help to prevent and manage dermatologic adverse events (dAEs)
The most common adverse event associated with Optune in clinical trials was skin irritation beneath the transducer arrays.1 For this reason, it is important to monitor not only the patient’s clinical status, but also his or her scalp health.
Tips to minimize skin irritation1
Advise patients to:
- Change transducer arrays at least twice a week (every 4 days at most)
- Shift transducer arrays during routine exchanges according to transducer array layout map
- Place new array 0.75 inches away from the last place it was on the skin to avoid irritation
- Remove arrays gently by pulling back on the edge of the array, taking a minute to remove each array
- Avoid placing ceramic discs directly over screws, plates, or scars
- Notify provider of erythema or irritation
- Ensure proper ventilation of transducer arrays
Tips to help prevent skin irritation and potential infection1
Advise patients to avoid putting ceramic discs or adhesive tape over areas affected by a dAE when placing or exchanging arrays
Key risk factors correlated with dAEs1:
- High doses of or recent change in systemic corticosteroids
- Concurrent administration of chemotherapy, biologics, or targeted therapies
- Previous skin exposure to ultraviolet or ionizing radiation
- History of contact dermatitis (eg, from tape adhesive or hydrogel)
- Excessive sweating from hot, humid weather or occlusive wigs
- Placement of transducer arrays (ie, ceramic discs) overlying scars or craniotomy hardware
Treatment options for dAEs are dependent upon the type and severity of the dAE.1
Skin irritations seen as a result of treatment with Optune can usually be managed with proper skin care and the use of medications, such as topical corticosteroids and antibiotics, without discontinuing therapy
- Lacouture ME, Davis ME, Elzinga G, et al. Characterization and management of dermatologic adverse events with the NovoTTF-100A System, a novel anti-mitotic electric field device for the treatment of recurrent glioblastoma. Semin Oncol. 2014;41(3 suppl 4):S1-14.
- Novocure Data on File OPT-147.
- Jennings DL II, Sumrall AL, Haggstrom DE. Classification of dermatologic adverse events and management strategies in patients receiving therapy with Optune™ for high grade gliomas. Poster presented at: 2016 Society for NeuroOncology (SNO) Annual Meeting: November 17-20, 2016; Scottsdale, AZ.
Learn more below
Indications for Use
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.
Important Safety Information
Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically 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 ineffective.
Do not use Optune in patients that are known to be sensitive to conductive hydrogels. 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 and Precautions
The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.
If the patient has an underlying serious skin condition on the scalp (e.g. ulcers, open wound, broken skin) evaluate whether this may prevent or temporarily interfere with Optune treatment.
Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective.
Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.
Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).
Please click here to see the Optune Instructions for Use (IFU) for complete information regarding the device’s indications, contraindications, warnings and precautions.