BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIVOLUMAB, 240 MG PD-I1 IHC NIVOLUMAB PHARMDX

    MDR report key: 7227790 · Received January 29, 2018

    Report

    Report Number
    MW5074945
    Event Type
    Injury
    Date Received
    January 29, 2018
    Date of Event
    January 25, 2018
    Report Date
    January 26, 2018
    Manufacturer
    DAKO NORTH AMERICA
    Product Code
    NQF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 PATIENT PRESENTED FOR HIS FIRST LUTATHERA INFUSION, AND SECOND NIVOLUMAB INFUSION. TOWARDS THE END OF THE LUTATHERA INFUSION, PATIENT DEVELOPED HYPOXIA, OXYGEN SATURATION DROPPED TO 85 PERCENT TO 86 PERCENT, AND HE BEGAN RECEIVING 2L ON NC, WHICH EVENTUALLY HAD TO BE INCREASED TO 4L DUE TO LITTLE IMPROVEMENT, EVEN AT REST. HE ALSO DEVELOPED A DRY, NON-PRODUCTIVE COUGH TOWARDS THE END OF THE LUTATHERA INFUSION BUT THE COUGH IMPROVED AFTER USING 2 PUFFS OF HIS ALBUTEROL INHALER THAT HE BROUGHT FROM HOME, AND RECEIVING COUGH SYRUP. AT AROUND 4PM, DR. (B)(6) CAME TO SEE THE PATIENT AGAIN, AND NOTED INSPIRATORY AND EXPIRATORY WHEEZING AND DECIDED TO EXTEND HIS HOSPITALIZATION FOR FURTHER WORK-UP. AS OF (B)(6) 2018 PATIENT IS STILL UNDER OBSERVATION. EVENT UNLIKELY RELATED TO CLINICAL TRIAL DRUGS AS PER ONCOLOGIST. DOSE OR AMOUNT: 240 MG, FREQUENCY: EVERY 2 WEEKS, ROUTE: INTRAVENOUS (NOT OTHERWISE SPECIFIED). DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: SMALL CELL LUNG CANCER. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68162 NIVOLUMAB, 240 MG PD-I1 IHC NIVOLUMAB PHARMDX IMMUNOHISTOCHEMISTRY ASSAY, ANTIBODY NQF DAKO NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization