Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Fatigue, Flatulence, Gene mutation identification test, Heart rate, Heart rate increased
Clinical narrative: kidney function down / kidney function has "probably always been low; Fatigability/gets tired quicker than usual/ Fatigue / tired from vaccines; heartburn; Energy down / energy up and down/energy improved; burping/mild and much improved / burping mild continue; Gas/mild and much improved / gas mild continue; basal cell left calf removed with skin graft and is still in process of healing; achy from vaccines; basal cell left calf removed/ basal cell left calf removed with skin graft and is still in process of healing; blood glucose was 41; Constipation/ constipation improved and more controlled still on and go / worsened constipation; dehydrated; heart rate has been elevated; This case was reported by a consumer via patient support programs and described the occurrence of basal cell carcinoma skin excision in a 73-year-old female patient who received niraparib (Zejula) capsule (batch number 1844082, expiry date 31st March 2024), (batch number 2054131, expiry date 31st March 2024), (batch number 2057802, expiry date 30th April 2024), (batch number 2057804, expiry date 30th April 2024), (batch number 2057805, expiry date unknown), (batch number 2057806, expiry date 30th April 2024) and (batch number 2057808, expiry date 30th June 2024) for ovarian cancer.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and ELASOMERAN (MODERNA COVID-19 BOOSTER) for covid-19 prophylaxis.   Concomitant products included apixaban (Eliquis), metoprolol tartrate (Lopressor), triamcinolone acetonide (Nasacort Nasal Spray), simvastatin, paracetamol (Tylenol Es), brimonidine tartrate, esomeprazole magnesium (Nexium), latanoprost, loratadine, denosumab (Prolia Injection), simeticone (Gas X), lactobacillus acidophilus (Probiotic Acidophilus) and paracetamol (Tylenol).   On 21st August 2021, the patient started Zejula 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On 20th October 2021, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the dose was changed to 200 mg once daily (200 mg daily). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and MODERNA COVID-19 BOOSTER. In August 2021, an unknown time after starting Zejula and not applicable after receiving Shingrix, the patient experienced constipation aggravated, dehydration and heart rate increased. On 3rd September 2021, the patient experienced blood glucose decreased. In February 2022, the patient experienced basal cell carcinoma skin excision (serious criteria GSK medically significant). On an unknown date, the patient experienced function kidney decreased (serious criteria GSK medically significant), fatigue, heartburn, energy decreased, burping, gas, skin graft and pain. Zejula was continued with no change. On an unknown date, the outcome of the basal cell carcinoma skin excision, dehydration, energy decreased and skin graft were recovering/resolving and the outcome of the function kidney decreased, heart rate increased, blood glucose decreased and heartburn were unknown and the outcome of the constipation aggravated, fatigue, burping, gas and pain were not recovered/not resolved.   It was unknown if the reporter considered the basal cell carcinoma skin excision, function kidney decreased, constipation aggravated, dehydration, heart rate increased, blood glucose decreased, fatigue, heartburn, energy decreased, burping, gas, skin graft and pain to be related to Zejula. The reporter considered the fatigue and pain to be possibly related to Shingrix.     GSK Receipt Date: 09 SEP 2021 Reporter's Comments: Spoke with patient who reported that she developed constipation since starting the Zejula. Patient also reported requiring intravenous (IV) hydration due to being dehydrated and her blood glucose was 41 on 03 Sep 2021 (physician (MD) aware). Patient stated her labs had been ok but her kidney function had been down a tiny bit. Patient stated she had 4 kidneys and that her kidney function had probably always been low. Patient reported her heart rate had been elevated at 100, 102, 105 since starting the Zejula. The reporter did not give consent to be contacted. The patient history and other products were unknown.  Follow up information was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 11 Oct 2021. Reporter's Comments: Patient reported adverse event with Zejula she got tired quicker than usual. Dates for Fatigability were (From unknown to ongoing). Reporter seriousness for Fatigability were unspecified. Other products and patient history was unknown.  Follow up information was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 05 Nov 2021. Reporter's Comments: Adverse event included constipation. Heartburn, burping. Fatigue.   Follow up information was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 09 Dec 2021: Reporter's Comments: Adverse event: energy up and down, constipation on and off, gas/burping improved, CT Scan 01 Dec 2021 was Clear. Last lab 01 Dec 2021 WNL (within normal limits) CA125=17. Next lab 07 Jan 2022 and Doctor visit.  Follow up information was reported from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 10 Jan 2022: Reporter's Comments: Call to patient for nurse assessment and 3 identifiers obtained, and verified current dose 200mg. Patient stated she had energy up and down, constipation on and off, gas/burping improved, computerised tomogram scan 01Dec2021 was clear. Last lab 07Jan2022 within normal limit carbohydrate antigen 125 was 18. Next lab 07 Feb2022 and physician. Patient confirmed about appetite good, hydration good, blood pressure stable/controlled, sleeping well. Patient denied diarrhea/nausea/skin issues concomittant medication list reviewed and current list as follows: eliquis 2.5mg, lopressor 50mg, multivitamin, nasacort nasal spray, simvastatin 5mg, tylenol es, brimonidine tartrate ophth eye drops, Nexium, gas x, latanoprost ophth eye drops loratadine 10mg prolia inj 1 6 mos. Patient stated that she had not undergone electrocardiogram, specialist visit, emergency room visit, hospital admission, no new drug allergies or medications, refill set up, no missed doses Interventions: hydration and continue to work on constipation and was starting to walk on treadmill to see if helps.  Follow up information was reported from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 11 FEB 2022 Reporter's Comments: Adverse event: energy improved, basal cell left calf removed with skin graft last week healing, constipation improved and more controlled, gas/burping mild. Last lab 07 Feb 2022 Within Normal Limit and physician CA125 was 18 stable. Next lab 07 Mar 2022. start date 21Aug2021 at 200mg for Ovarian start date 20 Oct 2021.  Follow up information was reported from consumer via Zejula PAP Together with GSK Oncology Pharmacy on 11 Mar 2022: Reporter's Comments: Last lab on 07 Mar 2022 and MD within normal limit (WNL), cancer antigen 125 (CA125) was 16 down from 18. Next lab on 06 Apr 2022 and MD. Confirmed appetite good, hydration good, blood pressure stable/controlled, sleeping well. Denied diarrhea or nausea or skin issues. NO electrocardiogram (EKG), specialist visit, emergency room (ER) visit, hospital admission, no new drug allergies or medications, refill not needed, no missed doses.  Follow-up information received on 11-MAY-2022. This follow-up was considered significant Reporter's Comments: This case was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy. Got 2nd booster for COVID and 1st vaccines for shingles. Follow-up: constipation improved more controlled, gas/burping mild. Resolved: basal cell left calf removed with skin graft and is still in process of healing. Last lab 03 May 2022 and MD (Physician checkup) WNL (Within Normal Limit) CA125 (Carbohydrate antigen 125) 15. Next lab 07 Jun 2022 , CT (Computerized Tomography) scan 06 Jun 2022 and MD on 07 Jun 2022. Confirmed: appetite good, hydration good, blood pressure stable/controlled, sleeping well. Denied: diarrhea/nausea/skin issues. Had genetics testing done which was negative for mutant genes. No EKG (Electrocardiogram), scan, specialist visit, ER (Emergency room) visit, hospital admission, no new drug allergies, refill not needed, no missed doses. Other concomitant products included Multivitamins and Moderna Covid Vaccine Booster. Summary of Changes: Lab Data Updated, Products detail updated, Events outcome updated.  Follow-up information received on 10 Jun 2022. This follow-up was considered significant Reporter's Comments: This case was received from consumer via Zejula PAP Together with GSK Oncology Pharmacy. Drug: Zejula C8D23 Start date 21 Aug 2021 at 200mg other source for Ovarian, Breast . RXC (prescribed) start date was 20 Oct 2021 at 200mg. Dose: 200mg PM without food. Notes were Call to patient for nurse assessment and 3 identifiers obtained, and verified current dose 200mg. Adverse Events were tired and achy from vaccines; worsened constipation. Follow-up: gas/burping mild continued. Last lab on 07 Jun 2022 and MD (doctor of medicine) WNL (within normal limit) CA125 (carbohydrate antigen 125) was 16 and CT (computerized tomography) scan on 06 Jun 2022 was fine. Next lab on 05 Jul 2022 and next oncologist visit on 06 Sept 2022. Confirmed appetite good, hydration good, blood pressure stable/controlled, sleeping well and denied diarrhea/nausea/skin issues. Concomitant medication list was reviewed. She had genetics testing done which was negative for mutant genes. No EKG (electrocardiography), scan, specialist visit, ER (emergency) visit, hospital admission, no new drug allergies, refill not needed, no missed doses. The reporter considered the basal cell carcinoma skin excision, function kidney decreased, constipation aggravated, dehydration, heart rate increased, blood glucose decreased, heartburn, energy decreased, burping, gas and skin graft to be not applicable to elasomeran (Moderna Covid-19 Booster). The reporter considered the fatigue aggravated and pain to be possibly related to elasomeran (Moderna Covid-19 Booster). Summary of changes: lab data, co-suspect added and event added. event outcome updated