Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Loss of personal independence in daily activities, Nausea, Off label use, Pain in extremity
Clinical narrative: urinary tract infcetion; retinal tear in the right eye/she got a tear in the retina of her right eye; some diarrhea; constipation/ some constipation on & off; joint pain in legs/ some joint pain in her legs on & off; low blood count; low hemoglobin; currently limited to taking care of herself; chills; difficulty breathing; fever; nausea; abdominal pain; detached retina of her left eye/ retinal detachment in the left eye; Heart rate little elevated/increased heart rate; Blood pressure was a little elevated/bp increased/elevated blood pressure; taking 100mg once daily, off label dosing; This serious case was reported by a consumer via patient support programs and described the occurrence of urinary tract infection in a 54-year-old female patient who received niraparib tosylate monohydrate (Zejula) capsule (batch number 2726927, expiry date 31-AUG-2024) for fallopian tube cancer.   Co-suspect products included niraparib tosylate monohydrate (Zejula) tablet for fallopian tube cancer and Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Chemotherapy with an associated reaction of arthralgia.   On 27-JUL-2022, the patient started Zejula 100 mg daily (100 mg daily). In SEP-2022, the dose was changed to 200 mg daily (200 mg daily). On 14-DEC-2022, the dose was changed to 100 mg daily (100 mg daily). The dose was changed to 100 mg daily (100 mg daily). On an unknown date, the patient started Zejula 100 mg daily (100 mg daily) and Shingles vaccine. On 30-JUL-2022, 3 days after starting Zejula, an unknown time after starting Zejula and not applicable after receiving Shingles vaccine, the patient experienced off label dosing (Verbatim: taking 100mg once daily, off label dosing). On 26-SEP-2022, the patient experienced heart rate increased (Verbatim: Heart rate little elevated/increased heart rate) and increased blood pressure (Verbatim: Blood pressure was a little elevated/bp increased/elevated blood pressure). On 05-JAN-2023, the patient experienced retinal detachment (Verbatim: detached retina of her left eye/ retinal detachment in the left eye) (serious criteria GSK medically significant). On an unknown date, the patient experienced urinary tract infection (Verbatim: urinary tract infcetion) (serious criteria hospitalization), retinal tear (Verbatim: retinal tear in the right eye/she got a tear in the retina of her right eye) (serious criteria GSK medically significant), diarrhea (Verbatim: some diarrhea), constipation (Verbatim: constipation/ some constipation on & off), joint pain (Verbatim: joint pain in legs/ some joint pain in her legs on & off), blood test abnormal (Verbatim: low blood count), hemoglobin decreased (Verbatim: low hemoglobin), decreased activity (Verbatim: currently limited to taking care of herself), chills (Verbatim: chills), difficulty breathing (Verbatim: difficulty breathing), fever (Verbatim: fever), nausea (Verbatim: nausea) and abdominal pain (Verbatim: abdominal pain). The patient was treated with medication unknown (Blood Pressure Medication). Zejula was discontinued. The action taken with Zejula was unknown. The outcome of the urinary tract infection, decreased activity, chills, difficulty breathing and fever were unknown and the outcome of the retinal detachment was resolving and the outcome of the retinal tear, blood test abnormal, hemoglobin decreased, nausea and abdominal pain were resolved and the outcome of the diarrhea, constipation, joint pain, heart rate increased, increased blood pressure and off label dosing were not resolved.   It was unknown if the reporter considered the urinary tract infection, retinal detachment, retinal tear, diarrhea, constipation, joint pain, heart rate increased, increased blood pressure, blood test abnormal, hemoglobin decreased, decreased activity, chills, difficulty breathing, fever, nausea and abdominal pain to be related to Zejula, Zejula and Shingles vaccine.     It was unknown if the company considered the urinary tract infection, retinal detachment, retinal tear, diarrhea, constipation, joint pain, heart rate increased, increased blood pressure, blood test abnormal, hemoglobin decreased, decreased activity, chills, difficulty breathing, fever, nausea and abdominal pain to be related to Zejula, Zejula and Shingles vaccine.   GSK Receipt Date: 09 Aug 2022 Reporter's Comments: This information was received from consumer via Zejula Enhanced Nurse Calls. Patient was taking 100mg once daily, off label dosing.  Follow-up information received on 15-AUG-2022. This follow-up was considered significant Reporter's Comments: This information was received from consumer via Zejula Enhanced Nurse Calls. Patient was taking 100mg once daily, off label dosing. Patient reported she had been having some diarrhea and constipation, unknown if physician was aware. Summary of Changes: event added.  Follow-up information received on 25-Aug-2022. This follow-up was considered significant.  Reporter's Comments: This case reported by Consumer via Zejula Enhanced Nurse Calls. Patient was taking 100mg once daily, off label dosing. Patient reported she had been having some constipation on and off and some joint pain in her legs on  and off that started a few days ago but she had the same pain during chemo, doctor of medicine (MD) not aware. Summary of Changes: New events were added, relevant history was added and narrative updated.  Follow-up information received on 26 Sep 2022. This follow-up was considered significant.  Reporter's Comments: This case reported by Consumer via Zejula Enhanced Nurse Calls. Patient was taking 100 mg once daily. Off label dosing. Patient reported her heart rate and blood pressure were a little elevated today at her office visit. Physician aware. Summary of changes: New event details and lab details were updated.  Follow-up information received on 01 Nov 2022.  Reporter's Comments: This case was reported by consumer via Zejula Enhanced Nurse Calls. Patient was now taking 200mg once daily, increase from 100mg daily at the end of September, exact date unknown. Patient reported her blood pressure has increased, was going up on the 100mg/day dose but increased even more on the 200mg/day dose, so MD had started her on blood pressure medication, MD aware. Summary of Changes: Lab data was added, suspect drug details for dosage regimen and action taken were added, treatment drug was added and narrative updated.  Follow-up information received on 01-Dec-2022.  Reporter's Comments: This case was reported by consumer via Zejula Enhanced Nurse Calls. Patient reported therapy was on hold starting today due to low blood count and low hemoglobin, last dose taken yesterday, patient reported she was symptomatic, no further details provided, has an appointment with MD on Monday to discuss plan. Summary of Changes: New events were added, suspect drug details for dosage regimen and action taken were added, treatment drugs were added and narrative updated.  Follow-up information received on 03-JAN-2023.  Reporter's Comments: This information was received from consumer via Zejula Enhanced Nurse Calls. Patient was now taking100mg once daily, decrease from 200mg daily as of 14Dec2022 due to previously reported low blood count & low hemoglobin therapy hold was from 01Dec2022-14Dec2022, physician was aware. Indication: Fallopian tube cancer. Summary of changes: action taken, dosage regimen.  Follow-up information received on 03-Feb-2023.  Reporter's Comments: This information was received from consumer via Zejula Enhanced Nurse Calls. Patient was taking Zejula 100mg once daily, off label dose. Patient reported she was recovering from a detached retina of her left eye, that happened on 05 Jan 2023, she had emergency surgery (unknown if inpatient or outpatient), she reported she was currently limited to taking care of herself but that was due to the detached retina recovery, denied any missed doses or adverse effects from the Zejula, previously reported low blood count and low hemoglobin had resolved, Physician was aware. Summary of changes: New event details, event outcome and lab details updated.  Follow-up information received on 03-Mar-2023.  Reporter's Comments: This information was received from consumer via Zejula Enhanced Nurse Calls. Patient was taking Zejula 100mg once daily, off label dose. Patient reported she was still recovering from a detached retina (of her left eye, this happened on 05 Jan 23, per last call) that was previously reported, she reported she was recovering well, denied any missed doses or adverse effects from the Zejula, unknown if physician was aware. Summary of changes: Narrative updated.  Follow-up received on 04-APR-2023. This information was received from consumer via Zejula Enhanced Nurse Calls. Patient reported she went to the emergency room last week for fever, chills, difficulty breathing and increased heart rate, she was diagnosed with a urinary tract infection and she was hospitalized overnight and missed one dose of Zejula, date unknown, MD was aware, patient stated she was better now.  Summary of changes: Patient tab, Event tab updated.  Follow-up information received on 15-MAY-2023.  This information was received from consumer via Zejula Enhanced Nurse Calls. Patient reported that she was taking 100mg once daily, as written by md (physician), the dosing differs from the manufacturer recommendation. The patient started therapy at 100mg once daily on 30 jul 2022, then took 200mg once daily from  sep 2022 to 1 dec 2022 then restarted 100mg on 14 dec 2022(as per previous report), dose decreased due to previously reported low blood count & low hemoglobin. Dechallenge was unknown for zejula. Summary of Changes: New dose regimen added, narrative updated.  Follow-up information received on 15-AUG-2023.  Reporter was the PA at HCP's office. PA states that the patient started Zejula therapy in July 2022 as a maintenance treatment for Fallopian Tube Cancer. Per PA, patient had retinal detachment in the left eye in January 2023 and had retinal tear in the right eye in August 2023. Per PA, patient had undergone surgery for retinal detachment in January 2023 and the retinal tear in the the right eye was being monitored. Patient was still taking the medication with the last dose taken today. Per PA, patient's dose was 100 mg p.o daily. Consented to follow up. PA could not provide Zejula lot number and Expiration date information. Summary of changes: event added.  Follow-up information received on 22-AUG-2023.  This information was received from consumer via Zejula Enhanced Nurse Calls. indication: fallopian tube cancer. Patient reported she got a tear in the retina of her right eye, within the last month, (also had previously reported tear of retina in left eye, also while taking zejula), physician was aware. Summary of changes: dosage regimen, outcome of event.  The follow-up information received on 28-SEP-2023. This case was received by consumer via Zejula enhanced nurse calls. Reported indication: fallopian tube cancer. Correct formulation the patient was taking was the tablet. Patient reported she had some nausea and abdominal pain that lasted about 2 weeks when she changed from the capsule to the tablet, now resolved, it was unknown if md was aware. Summary of changes: product tab and event tab were updated.  Follow up information received on 01-NOV-2023 This information received from consumer via Zejula Enhanced Nurse Calls. Indication: fallopian tube cancer. Correct formulation the patient was taking was the tablet. Dose at start of therapy was 100mg once daily, then dose was 200mg once daily from end of September2022 to 01December2022, dose had been back to 100mg once daily since 14December2022. Patient reported she had elevated blood pressure after getting a shingles vaccine (unknown date), MD was unsure whether it was from the zejula or the vaccine, they increased the dose of her high blood pressure medication and would continue to monitor, MD (Physician) aware. Patient age was 56 years. Summary of changes: Patient tab, Product tab updated.