BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 21957992 · Received May 5, 2025

    Report

    Report Number
    3010457505-2025-00503
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 11, 2025
    Report Date
    May 5, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAYS TO THE ALLERGIC REACTION CANNOT BE RULED OUT. A RISK FACTOR FOR HYPERSENSITIVITY IN THIS PATIENT INCLUDES CONCOMITANT RAMUCIRUMAB (HYPERSENSITIVITY REACTIONS, AND OTHER DERMATOLOGICAL ISSUES SUCH AS RASHES, ERYTHEMA, AND SKIN TOXICITIES ARE LISTED AMONG THE MOST COMMON ADVERSE REACTIONS SOURCE: RAMUCIRUMAB PRESCRIBING INFORMATION). HYPERSENSITIVITY WAS NOT REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC. HYPERSENSITIVITY HAS BEEN REPORTED APPROXIMATELY 395 TIMES IN THE COMMERCIAL PROGRAM TO DATE, 9 IF WHICH WERE AND RELATED TO DEVICE USE. ONE CASE WAS REPORTED FOR A NON- SMALL-CELL-LUNG CANCER PATIENT.

    Description of Event or Problem · 0

    A 75-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION, DESCRIBED AS BLISTERS AND BURNS, ATTRIBUTED TO THE USE OF THE ITE ARRAYS. LATER THAT SAME DAY, ADDITIONAL INFORMATION PROVIDED BY THE PATIENT'S DAUGHTER INDICATED THAT THE PATIENT HAD AN ALLERGIC REACTION AND WAS TREATED WITH ORAL DIPHENHYDRAMINE. WET TOWELS WERE ALSO APPLIED TO THE TORSO TO HELP ALLEVIATE THE BURNING SENSATION. IMAGES PROVIDED SHOWED DIFFUSE, ELEVATED HIVES ACCOMPANIED BY MILD TO MODERATE ERYTHEMA ON THE FRONT AND BACK TORSO, RIGHT THIGH, AND LEFT ARM. ON (B)(6) 2025, THE PATIENT'S DAUGHTER REPORTED AN IMPROVEMENT IN THE PATIENT'S CONDITION AND STATED THAT A HEALTHCARE PROVIDER (HCP) HAD PRESCRIBED ORAL STEROIDS. HOWEVER, ON (B)(6) 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT HAD DISCONTINUED OPTUNE LUA THERAPY DUE TO SKIN TOXICITY ISSUES. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN WITH NO REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469208 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention ACETYLSALICYLIC ACID| B COMPLEX VITAMINS| BACITRACIN-POLYMYXIN TOPICAL OINTMENT| BETAMETHASONE DIPROPIONATE TOPICAL OINTMENT| CILOSTAZOL| DEXAMETHASONE| FUROSEMIDE| IBUPROFEN| LISINOPRIL-HYDROCHLOROTHIAZIDE| MUPIROCIN TOPICAL OINTMENT| PROCHLORPERAZINE| RAMUCIRUMAB| SIMVASTATIN| VARENICLINE