Optune was safely used together with TMZ
No significant increase in serious AEs compared with TMZ alone1,2
- The most common (≥10%) AEs involving Optune together with TMZ were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsion, and depression3
- A slightly higher incidence of grade 1 to 2 AEs was seen in some of the systems in the Optune + TMZ arm of the study. This is most likely a reflection of the longer duration of TMZ treatment due to the increase in PFS seen in the treatment group1
- The rate of grade 1 to 2 medical device site reaction was 52% for Optune + TMZ compared with 0% for TMZ alone, and severe (grade 3) skin involvement occurred in 2% of patients treated with Optune + TMZ2
- Grade 3 to 4 AEs were well balanced between arms. None of the systemic grade 3 to 4 AEs were considered related to Optune by any of the investigators1
- Mild-to-moderate skin irritation, the most common device-related side effect with Optune, was typically manageable, reversible, and did not result in treatment discontinuation2,3
AEs, adverse events; GBM, glioblastoma; TMZ, temozolomide.
- Optune. Instructions for Use for Glioblastoma Multiforme. Novocure; 2019.
- 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.
- Novocure Data on File OPT-103.
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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.