Indication for Use
Optune Pax® is intended for the treatment of adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.
Important Safety Information
Contraindications
Do not use Optune Pax in patients with an electrical implant. Use of Optune Pax together with electrical implants has not been tested and may lead to malfunctioning of the implanted device.
Do not use Optune Pax in patients with a known sensitivity to conductive hydrogels. In patients with this sensitivity, skin contact with the gel used with Optune Pax may commonly cause increased redness and itching. In rare cases, it may lead to severe allergic reactions that can cause a drop in blood pressure and difficulty breathing.
Warnings and Precautions
Optune Pax can only be prescribed by a healthcare provider who has completed the required certification training provided by Novocure® (the device manufacturer).
Do not prescribe Optune Pax for patients who are pregnant, who you think might be pregnant, or who are trying to get pregnant. Women who are able to get pregnant must use birth control when using the device. Safety and effectiveness of Optune Pax in these populations have not been established.
The most common (≥10%) adverse events involving Optune Pax concomitant with gemcitabine and nab-paclitaxel were neutropenia, anemia, thrombocytopenia, leukopenia, diarrhea, nausea, vomiting, abdominal pain, constipation, fatigue, peripheral edema, pyrexia, pain, COVID-19, infection, respiratory tract infection, urinary tract infection, pneumonia, hepatic enzyme increased, anorexia, hypokalemia, hypoalbuminemia, hyperglycemia, musculoskeletal pain, peripheral neuropathy, taste disorder, dizziness, sleep disorder, dyspnea, alopecia, skin-related disorders, and hypotension.
Optune Pax device-related skin adverse events (≥5%) include dermatitis, rash, pruritus, maculo-papular rash, erythema, skin irritation, skin reaction, and skin ulcer. Other device-related adverse effects associated with the use of Optune Pax include overheating of the array, leading to pain and/or local skin burns, allergic reaction to the adhesive or gel from the transducer arrays, and local warmth and tingling sensation beneath the arrays.
If the patient has an underlying skin condition on the abdomen, evaluate whether this may prevent or temporarily interfere with Optune Pax treatment.
Please see the Optune Pax Instructions for Use (IFU) for complete information regarding the device’s indication, contraindications, warnings, and precautions.