Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rash papular, Sleep disorder, Urinary tract infection
Clinical narrative: Constipation / Occasional constipation; Bloating; mildly elevated blood pressure 144/85 / BP is better; lips slightly swollen; warm flashes; occasional chill; rashes around wrist and thighs / rash; scalp also appears red; appears raised and bumpy; abdominal pain; diarrhea; diverticulitis; mild dizziness occasionally; stomach is rumbling and growling during the day; UTI; sleep disturbance; nausea; dry mouth at beginning, now improved / dry mouth; This case was reported by a consumer and described the occurrence of diverticulitis in a 76-year-old female patient who received niraparib capsule (batch number 2416866, expiry date 30th June 2024) and (batch number 2349954, expiry date 31st July 2024) for ovarian cancer.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included chemotherapy with an associated reaction of no adverse event. Concurrent medical conditions included weight loss (stable now), sleep disturbance (continue, better), anxiety, stress, death of spouse (during her chemotherapy treatment), platelet count low (prior to Zejula, 111K) and ovarian cancer. Concomitant products included levothyroxine, metoprolol succinate (Metoprolol Succinate Er), pravastatin, alprazolam (Xanax), colecalciferol (Vitamin D3), bifidobacterium infantis (Align), dicycloverine hydrochloride (Dicyclomine Hydrochloride), omeprazole and prochlorperazine.   On 25th August 2022, the patient started niraparib 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 September 2022, the patient received Flu vaccine. In August 2022, less than a week after starting niraparib and not applicable after receiving Flu vaccine, the patient experienced dry mouth. On 20th September 2022 03:30, the patient experienced nausea. On an unknown date, the patient experienced diverticulitis (serious criteria GSK medically significant), dizziness, abdominal noises, constipation, bloating, increased blood pressure, lip swelling, hot flashes, chills, rash, scalp redness, raised rash, abdominal pain, diarrhea, urinary tract infection and sleep disturbance. The subject was treated with antiemetics and antinauseants (Anti-Emetic), antibiotics nos (Antibiotics (Brand Names Not Known)), metronidazole and ciprofloxacin (Cipro). Niraparib was continued with no change. On an unknown date, the outcome of the dry mouth, nausea, diverticulitis, dizziness, abdominal noises, constipation, bloating, lip swelling, hot flashes, chills, rash, scalp redness, raised rash, abdominal pain and diarrhea were not recovered/not resolved and the outcome of the increased blood pressure was recovering/resolving and the outcome of the urinary tract infection and sleep disturbance were recovered/resolved.   It was unknown if the reporter considered the diverticulitis, dizziness, abdominal noises, dry mouth, constipation, bloating, increased blood pressure, lip swelling, hot flashes, chills, abdominal pain, diarrhea, urinary tract infection and sleep disturbance to be related to niraparib. The reporter considered the rash, scalp redness and raised rash to be related to niraparib. It was unknown if the reporter considered the diverticulitis and nausea to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 01-Sep-2022 Reporter's Comments: Zejula used by patient as Niraparib. This case reported by Consumer via Pharmacy. Adverse event: New: mild dizziness occasionally; felt like stomach was rumbling and growling during the day; dry mouth at beginning, now improved; pre-existing weight loss, stable now, constipation with bloating; pre-existing sleep disturbance continued with anxiety and stress from loss of spouse in April 2022 during her chemotherapy treatment; mildly elevated blood pressure 144/85. Last lab: 25 Aug 2022 prior to Zejula start, Result low Platelet=111K. Concomitant Medications: Levothyroxine 100 mcg QD, Metoprolol Succinate ER 25 mg QD, Pravastatin 10 mg QD, Xanax 0.5 mg prn, vitamin D3, Align 4 mg, Benefiber daily, Dicyclomine HCl 20 mg prn, Omeprazole 20 mg prn, Prochlorperazine 10 mg prn. Start date 25 Aug 2022 at 200 mg-Dx: (diagnosed) Ovarian 1st line weight 154lbs. Concomitant products included benefiber (nos) (Benefiber).  GSK receipt date 09 Sep 2022, 14 Sep 2022 This follow-up was considered significant. Reporters comment: This information was received from consumer via Pharmacy. Both follow up processed together. Adverse event: Previously reported sleep disturbances better since dosing changed to an earlier time, dry mouth, lips slightly swollen, BP is better, "warm flashes," occasional chill Concomitant Medications: Levothyroxine 100mcg QD, Metoprolol Succinate ER 25mg QD, Pravastatin 10mg QD, Xanax 0.5mg prn, vitamin D3, Align 4mg, Benefiber daily, Dicyclomine HCI 20mg pm, Omeprazole 20mg prn, Prochlorperazine 10mg prn Start Date 25Aug2022 at 200mg - Ovarian 1st line wt 1541bs.Adverse event: Per note, Patient stated that they are aware a side effect from taking meds is rashes. She noticed some rashes around wrist and thighs. They appear raised and bumpy. The rash also hurts. She stated her scalp also appears red. Other than that, she stated that the medication is working fine. Pt will be seeing MD soon and will ask about rash. Pt declined transfer to RN or RPH. Concomitant Medications: Unable to review. Summary of changes: Lab data, Events added.  Follow-up information received on 16-SEP-2022. This follow-up was considered significant.  Reporter's Comments: This information was received Consumer via Pharmacy. Adverse event reported Rash, abdominal pain/diarrhea. Summary of Changes:  Event added.  Follow-up information received on 20-SEP-2022. This follow-up was considered significant.  Reporter's Comments: The reporter reported that patient received flu vaccine and experienced nausea.reported that she received a flu shot today and experienced nausea. She wanted to know usual Zejula dose at 7 pm. She was concerned that the nausea may worsen and lead to vomiting. Patient asked if Zejula has ever caused nausea and she denied. Advised that she would try to take her usual dose within an hour of normal scheduled time Summary of Changes:  New suspect, New event .event outcome, causality and time to onset added and narrative was updated.  Follow-up information received on 14-OCT-2022 Reporter's Comment: The patient experienced occasional constipation which was manageable, urinary tract infection now resolved with antibiotics, sleep disturbances resolved since changing dosing time. The reporter did not consent to follow up.  Summary of Changes: Batch number updated, treatment drug added, new events added and narrative updated.  Follow up information received on 14 Nov 2022 Reporters comment: This information was received from consumer via Pharmacy. Spoke to patient and she is taking metronidazole and cipro for diverticulitis and informed her there were no with zejula but there was a mod with each other for QTc prolongation. She has no hx of heart disease and informed her that she can take it and if there are any symptoms to inform HCP. She had questions about when to take the cipro in relation to dairy and told her to separate them out. If she take the omeprazole, she need to take cipro 2hr before or 6 hours after. Adverse event: She had diverticulitis and hcp started metronidazole and cipro for 10 days. Summary of changes: Dosing regimen,treatment product, Event added; Sender's Comments: Diverticulitis is an unlisted event which is considered unrelated to drug Niraparib.