Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Carbohydrate antigen 125, Carbohydrate antigen 125 increased, Computerised tomogram, Flushing, Haemoglobin
Clinical narrative: This is a spontaneous report received from a contactable consumer from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-130164.  This spontaneous case was reported by a consumer and describes the occurrence of CARBOHYDRATE ANTIGEN 125 INCREASED (CA 125 value increased from 24 to 60 CA-1 25 went up to 24 / Blood level keeps going up), BLOOD IRON DECREASED, PRURITUS (Very itchy/Not sure if itching has gotten worse since starting Rubraca), FLUSHING and NAUSEA in 71-year-old female patient who received apixaban (Eliquis) for an unknown indication. The occurrence of additional non-serious events is detailed below CO-SUSPECT PRODUCTS included rucaparib camsylate (Rubraca) tablet for Ovarian cancer and Covid-19 Vaccine for COVID-19 immunisation. The patient's past medical history included Biopsy (Biopsy of cloudy area. Biopsy was negative) on 25-Jun-2021, Surgery (2 unspecified), Dry skin and Chemotherapy (for ovarian cancer). Concurrent medical conditions included Pruritus. On an unknown date, the patient started Eliquis (unknown route). On 12-Aug-2019, the patient started Rubraca (Oral), 600 milligram twice a day. In October 2021, the dose was changed to 500 milligram twice a day. On 26-Feb-2021, the patient started Covid-19 Vaccine (unknown route) First dose. On 28-Mar-2021, the dose was changed to Second dose. In May 2021, the patient experienced CARBOHYDRATE ANTIGEN 125 INCREASED (CA 125 value increased from 24 to 60 CA-1 25 went up to 24 / Blood level keeps going up), BLOOD IRON DECREASED, PRURITUS (Very itchy/Not sure if itching has gotten worse since starting Rubraca), FLUSHING, NAUSEA, BODY TEMPERATURE INCREASED (Hot In the head/temperature was 100.8 F.) and HAEMOGLOBIN DECREASED (Blood levels being a little low/hemoglobin was low). The action taken with Eliquis (Unknown) was unknown. At the time of the report, CARBOHYDRATE ANTIGEN 125 INCREASED was resolving, BLOOD IRON DECREASED, FLUSHING and BODY TEMPERATURE INCREASED outcome was unknown, PRURITUS and HAEMOGLOBIN DECREASED did not resolve and NAUSEA resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Carbohydrate antigen 125: 14. On 28-Mar-2021, Carbohydrate antigen 125: 24. In 2021, Carbohydrate antigen 125: 60, Carbohydrate antigen 125: 125 and Carbohydrate antigen 125: Down to 112. On 07-Sep-2021, Haemoglobin: 7.5 gram per decilitre. In September 2021, Blood iron: Low. On 30-Sep-2021, Haemoglobin: 8.5 gram per decilitre. On 01-Oct-2021, Haemoglobin: 8.3 gram per decilitre. On an unknown date, Body temperature: 100.8 and Computerised tomogram: found something cloudy. On an unspecified date in 2021 patient had blood test done. For Eliquis (Unknown), the reporter did not provide any causality assessments. This case was linked to US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-061727 (Linked Report). Further company follow-up with the Consumer is not possible.  Apixaban (ELIQUIS) is under agreement with agency.  Causality Assessment: apixaban Carbohydrate antigen 125 increased, Pruritus, Flushing, Nausea, Body temperature increased, Hemoglobin low, Blood iron decreased Per Reporter = No Information  Per Company = Related  Follow up (20Dec2021): The following information was received from agency:   The query is: For RUBRACA, Batch number: CCNTX Expiration date: 31-MAR-2023 Batch number: CDKPS Expiration date: 31-AUG-2023 was reported as Additional information on drug in XML. Batch/lot number: CDKPS was reported for dose 600 milligram, bid in XML. Kindly double confirm which dose was matched with Batch number: CCNTX Expiration date: 31-MAR-2023   The response is: Both the batch numbers CDKPS Expiration date: 31-AUG-2023 and CCNTX Expiration date: 31-MAR-2023 belong to the dose of 600 milligrams, bid. Both the batch numbers cannot be captured under the product tab as they have different expiration dates. Hence it was mentioned in the product notes.