Sex: F
Vaccine: COVID19, FLUX
Symptoms: Red blood cell sedimentation rate increased, Renal function test, Renal impairment, Urine analysis
Clinical narrative: poor kidney function/has stage III kidney disease with elevated creat of 1.34 and GFR=38; fluid around heart; elevated heart rate that normalizes throughout the day; Elevated BP in AM but normalizes throughout the day/stable/controlled; elevated HR; elevated BP now stable/stable/controlled; CA125 down to 56.1; hair loss/worsening hair loss with loss of eyelashes and eyebrows; hot flushes; nausea/rarely has very mild nausea; dry mouth; dry eyes; Blood pressure increased; taking a fall in September; injuring nose; injuring chin; Injuring right knee; Injuring right elbow; feeling awful; overwhelming feeling of global malaise; dry skin; dyspnea; blood in urine small amount; GFR 35 down from 38; Creatinine 1.41 up from 1.34; SED rate elevated; This case was reported by a consumer via (Zejula PAP Together with GSK Oncology Pharmacy) patient support programs and described the occurrence of heart rate irregular in a 79-year-old female patient who received niraparib capsule (batch number 1844082, expiry date 31st March 2024) for ovarian cancer.   On 12th July 2021, the patient started niraparib 200 mg once daily (200 mg daily). On an unknown date, an unknown time after starting niraparib, the patient experienced heart rate irregular and blood pressure fluctuation. Niraparib was continued with no change. On an unknown date, the outcome of the heart rate irregular and blood pressure fluctuation were not recovered/not resolved.   It was unknown if the reporter considered the heart rate irregular and blood pressure fluctuation to be related to niraparib.  Additional details: The patient received niraparib as Zejula. Adverse event: Occasional elevated heart rate (HR) that normalized throughout the day, elevated blood pressure (BP) in morning (AM) but normalized throughout the day. The patient history was unknown. The reporter did not give consent to be contacted.  Follow up information was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 30 Jul 2021. Concurrent medical conditions included lymphedema. On an unknown date, an unknown time after starting niraparib, the patient experienced heart rate increased and increased blood pressure. Niraparib was continued with no change. On an unknown date, the outcome of the heart rate irregular, blood pressure fluctuation, heart rate increased and increased blood pressure were recovered/resolved. It was unknown if the reporter considered the heart rate increased and increased blood pressure to be related to niraparib. Patient reported elevated HR (heart rate) and, elevated BP (blood pressure) was now stable, preexisting lymphedema wears support hose, no change since started therapy. Last Lab was on 30 Jul 2021 today, no results as yet. Next F/U (follow up) on 06 Aug 2021 and MD (physician visit) on 17 Aug 2021 and weekly labs.  Follow up information was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 03 Sep 2021: Patient received niraparib capsule (batch number 2054130, expiry date 31st March 2024) for malignant neoplasm of ovary at dose 200 mg once daily (200 mg daily). On an unknown date, an unknown time after starting niraparib, the patient experienced ca 125 increased. On an unknown date, the outcome of the ca 125 increased was recovering/Resolving. It was unknown if the reporter considered the ca 125 increased to be related to niraparib. Zejula start date 12Jul2021 at 200mg- Ovarian. Dose: 200mg PM (evening) w/food. Adverse Events: preexisting lymphedema wears support hose-no change since start of therapy. Last Lab: 27Aug2021 platelets 196K CA125 down to 56.1. Next F/U (follow up) 24Sep2021 and MD (physician). Confirmed: appetite good, hydration good, blood pressure stable/controlled. Denied: diarrhea/constipation/nausea/skin issues/sleep disturbances. No new scan, EKG (electrocardiogram), specialist visit, ER (emergency room) visit, hospital admission, new medications or medication changes, no new drug allergies, no missed doses, no refill required. Interventions: Continue current management of symptoms. Other products and other conditions were unknown.  Follow up information was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 02 November 2021: Patient received niraparib capsule dose of 200 mg once daily (batch number 2057785, expiry date 31st March 2024). Concurrent medical conditions included fatigue. On an unknown date, an unknown time after started niraparib, the patient experienced kidney dysfunction (serious criteria GSK medically significant), pericardial effusion (serious criteria GSK medically significant), hair loss, hot flush, nausea, malaise, dry mouth, dry skin and dyspnea. On an unknown date, the outcome of the kidney dysfunction, pericardial effusion, malaise, dry skin and dyspnea were unknown and the outcome of the hair loss, hot flush, nausea and dry mouth were not recovered/not resolved. It was unknown if the reporter considered the kidney dysfunction, pericardial effusion, hair loss, hot flush, nausea, malaise, dry mouth, dry skin and dyspnea to be related to niraparib. Drug Zejula Start Date was 12 Jul 2021 at 200 mg for Ovarian, Dose as 200 mg PM with food. Notes Spoke with patient today, 02 Nov 2021. Reported able to perform activities of daily living with pre-existing mild fatigue since started Zejula. Appetite good. Hydrating 6 to 8 glasses of water, fluid daily. Blood pressure was stable. Last lab reported as WDL (Within defined limit). Next lab and Doctor visit scheduled for Nov 2021. No EKG (electrocardiogram), Scan, Specialist visit, ER (emergency room) hospital visit, change in medications or allergy status, no missed doses. New included hair loss, hot flashes, nausea, overwhelming feeling of global malaise, poor kidney function, dry mouth, dry skin, dyspnea due to fluid around heart. Follow up as N/A (Not applicable), Resolved as Not Applicable.  Follow up information was reported from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 03 Dec 2021: On an unknown date, the dose was changed to 200 mg once daily (200 mg daily) (batch number 2057802, expiry date 30th April 2024) for malignant neoplasm of ovary. On an unknown date, an unknown time after starting niraparib, the patient experienced eye dryness, increased blood pressure, fall, nose injury, face injury, knee injury, elbow injury, feeling abnormal. The subject was treated with beta blocker nos (Beta Blocker). On an unknown date, the outcome of the eye dryness, fall, nose injury, face injury, knee injury, elbow injury and feeling abnormal were unknown and the outcome of the increased blood pressure, kidney dysfunction, malaise, dry skin and dyspnea were not recovered/not resolved. It was unknown if the reporter considered the eye dryness, increased blood pressure, fall, nose injury, face injury, knee injury, elbow injury and feeling abnormal to be related to niraparib. Drug: Zejula C5D23 Start Date 12Jul2021 at 200mg - Ovarian Dose: 200mg daily PM with food Notes: Spoke with patient today, 03Dec2021, she was a physician, so home phone was work phone. Patient reported that she was able to perform activities of daily living with increased fatigue since last call. She used to take Zejula at night due to feeling awful, nausea, and dry mouth and dry eyes. She had stage III kidney disease with elevated creat of 1.34 and glomerular filtration rate was 38. She was having her kidney stints replaced on 21Dec2021, done every 6 months. Her appetite was good. She was hydrating with 6-8 glasses of water/fluid daily. Her blood pressure was increased, so taking beta blocker in AM. She mentioned that she was taking a fall in September and injuring nose, chin, right knee and right elbow, but no bruising due to tripping over a brick while running. Last lab reported abnormal as above, but carbohydrate antigen 125 had decreased to 56.8 from 59. Next lab on 10Dec2021 and physician visit scheduled for 20Dec2021. Patient had no electrocardiogram, scan, specialist visit, emergency room/hospital visit, change in allergy status, no missed doses. Medication list reviewed and updated. No drug-drug interaction found. No refill needed. New: worsening hair loss with loss of eyelashes and eyebrows, increased fatigue; taking a fall in September and injuring nose, chin, right knee and right elbow, but no bruising due to tripping over a brick while running; stage III kidney disease with elevated creatinine of 1.34 and glomerular filtration rate was 38; kidney stints due for replacing 21Dec2021; increased blood pressure; carbohydrate antigen 125 had decreased to 56.8 from 59; takes Zejula at night due to feeling awful Follow-up: hot flashes, nausea, overwhelming feeling of global malaise, poor kidney function, dry mouth, dry skin, dyspnea due to fluid around heart Resolved: none.  Follow up information was reported from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 02 Feb 2022: The age at vaccination was not reported. Co-suspect products included covid-19 vaccine for covid-19 prophylaxis. Concomitant products included docusate sodium (Colace), potassium citrate, metoprolol, levothyroxine, rosuvastatin calcium (Crestor) and loratadine (Claritine). On an unknown date, the patient received niraparib 200 mg once daily (200 mg daily) (batch number 2057805, expiry date 30th April 2024). On an unknown date, the patient received a Flu shot and 3rd Covid 19 vaccine and experienced heart rate increased, increased blood pressure, CA 125 increased, kidney dysfunction, pericardial effusion, hair loss, hot flush, nausea, dry mouth, eye dryness, malaise, dry skin, increased blood pressure, fall, nose injury, face injury, knee injury, elbow injury, feeling abnormal and dyspnea. Last lab on 10 Jan 2022 with doctor of medicine (MD), glomerular filtration rate (GFR) was 35 down from 38, creatinine 1.41 up from 1.34, sedimentation (SED) rate elevated after 3rd Covid vaccine and a Flu shot, blood in urine small amount and patient put on oral prednisone. On 10th January 2022, 5 months 29 days after starting niraparib, the patient experienced glomerular filtration rate decreased, blood creatinine increased, and sedimentation rate increased. Less than 2 weeks after receiving 1st dose of Niraparib, the patient experienced heart rate irregular and blood pressure fluctuation, less than 3 weeks after receiving 1st dose of Niraparib, the patient experienced heart rate increased and increased blood pressure, less than 2 months after receiving 1st dose of Niraparib, the patient CA 125 increased, less than 4 months after receiving 1st dose of Niraparib, the patient experienced kidney dysfunction, pericardial effusion, hair loss, hot flush, nausea, dry mouth, eye dryness, malaise and dry skin, less than 4 months after receiving 1st dose of Niraparib, the patient experienced increased blood pressure, fall, nose injury, face injury, knee injury, elbow injury, feeling abnormal, dyspnea and less than 9 months after receiving 1st dose of niraparib, the patient experienced blood in urine. The subject was treated with prednisone (Prednisone (Oral)). On an unknown date, the outcome of the eye dryness, blood creatinine increased and blood in urine were not recovered/not resolved and the outcome of the glomerular filtration rate decreased, and sedimentation rate increased were unknown. It was unknown if the reporter considered the glomerular filtration rate decreased, blood creatinine increased, sedimentation rate increased and blood in urine to be related to niraparib. It was unknown if the reporter considered the heart rate increased, increased blood pressure, CA 125 increased, kidney dysfunction, pericardial effusion, hair loss, hot flush, nausea, dry mouth, eye dryness, malaise, dry skin, increased blood pressure, fall, nose injury, face injury, knee injury, elbow injury, feeling abnormal, dyspnea and blood in urine to be related to Flu vaccine and Covid 19 vaccine. Next lab on 05 Feb 2022 and doctor of medicine (MD) the next week. Confirmed appetite good, hydration good, blood pressure stable/controlled, sleeping well. Denied diarrhea or constipation or nausea or skin issues. No electrocardiogram (EKG), scan, specialist visit, emergency room (ER) visit, hospital admission, no new drug allergies or medications, no missed doses.