Dermatologic AEs

Maximize time on Optune Gio with proper skin care

Help maximize time on treatment by getting ahead of dermatologic adverse events (dAEs) with the M3 approach: mitigate with care, monitor symptoms, and manage with proper treatment1

 

  • The most common adverse event associated with Optune Gio in clinical trials was skin irritation beneath the arrays. For this reason, it is important to monitor not only the patient’s clinical status but also their scalp health2,3

 

  • dAEs can potentially be prevented, are typically mild to moderate in nature, and are generally managed with topical therapy without resulting in treatment discontinuation2,3

Note: Inform your patients to contact you as soon as they experience itching, redness, or inflammation. Proper identification/management may prevent progression to a more serious grade1

Help mitigate dAEs with preventative measures1,4

Reduce the risk of skin irritation while using Optune Gio by directing patients to properly care for their skin and instruct them to follow prophylactic interventions to properly remove, place, or replace arrays

Advise patients and caregivers to:

Always wash their hands prior to application and removal of transducer arrays

 

Wash their scalp between transducer array exchanges

Clean the electric razor per manufacturer’s guidelines after every shave

Help reduce the risk of skin irritation with proper transducer array placement and shifting

 

Guidance based on clinical trial results and real-world clinical experience in glioblastoma. Novocure cannot give medical advice.1,4

Note: Properly preparing the skin before applying the Optune Gio arrays is important to help prevent irritation, reduce the risk of infection, and ensure the arrays adhere effectively.4

Monitor symptoms and intervene with the necessary action

Help identify the most common dAEs related to Optune Gio use and initiate appropriate management by clicking the (+) next to each dAE

Note: Inform your patients to contact you as soon as they experience itching, redness, or inflammation. Proper identification/management may prevent progression to a more serious grade. Treatment interruption may be required for persistent or severe dAEs that do not improve despite dAE management. If skin conditions continue, consider referral to a dermatologist.1

Manage with the proper treatment

Advise patients on how to apply topical agents and when/if treatment breaks are needed for dAE management

Pharmacologic interventions1

Depending on diagnosis, recommended treatments include topical antibiotics and topical corticosteroids

 

Patient instructions on how to apply topical medications:

  • Remove arrays and clean scalp with mild, fragrance-free soap and water
  • Apply a topical agent (eg, steroid or antibiotic) to affected area(s)

     

    • Apply topical agents only when arrays are exchanged, at least 2 times a week (every 4 days at most) 
    • A thin layer should be applied to the dry scalp
    • Wait at least 15 minutes to allow agent to dry

       

  • Wipe scalp with medical (70%) alcohol after agent has dried
  • Apply new arrays to dry scalp, shifting array placement by 0.75 inches at each array change, ensuring that pairs of arrays are moved together

Treatment interruptions4

Interruption may be required for persistent or severe dAEs that do not improve despite management

 

Instructions on treatment interruptions:

 

  • Interrupting for 2-7 days in addition to topical treatment is often sufficient
  • Skin ulcerations require interruption until AEs are grade 0-1 (up to 14 days)
  • Resume treatment when dAE no longer interferes with placement of array
  • Extended interruption may compromise treatment efficiency

Skin irritations seen as a result of treatment with Optune Gio can usually be managed with proper skin care and the use of medications, without discontinuing therapy1

Common questions about Optune Gio

References: 1. Optune Gio. Patient Information and Operation Manual. Novocure; 2023. 2. Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316. 3. Novocure Data on File OPT-103. 4. Lacouture ME, Anadkat MJ, Ballo MT, et al. Front Oncol. 2020;10:1045. doi:10.3389/fonc.2020.01045

Indications For Use

Optune Gio® is intended as a treatment for adult patients (22 years of age or older) with histologically confirmed glioblastoma multiforme (GBM).

 

Optune Gio 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.

 

For the treatment of recurrent GBM, Optune Gio is indicated following histologically or radiologically confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
 

Important Safety Information

Contraindications

Do not use Optune Gio in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune Gio together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune Gio together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune Gio ineffective.

 

Do not use Optune Gio in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Gio 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

Optune Gio can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).

 

Do not prescribe Optune Gio for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Gio in these populations have not been established.

 

The most common (≥10%) adverse events involving Optune Gio in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

 

The most common (≥10%) adverse events seen with Optune Gio monotherapy were medical device site reaction and headache.
The following adverse reactions were considered related to Optune Gio when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall, and skin ulcer.

 

Use of Optune Gio in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune Gio in these patients could lead to tissue damage or lower the chance of Optune Gio being effective.

 

If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune Gio treatment.

Please click here to see the Optune Gio® Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.

Novocure Websites

This website is intended for people seeking information on Optune Gio.

 

On this site, videos and images identified as Optune Gio users, caregivers, or healthcare professionals depict actual patients, caregivers, and healthcare professionals.

 

Patient images reflect the health status of the patients at the time each photo or video was taken.

 




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US-OPG-00197v1.0 February 2025 

 

US-OPG-00197 v1.0 February 2025