Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet count decreased, Unevaluable event
Clinical narrative: occasional nausea; Fatigue; weird dreams; Patient reports " low platelets at 29" / her platelets were low; insomnia / continued issues with insomnia; Abdominal Scan - no blockage and "MD's felt it was constipation; Constipation - "crescent like and flat stool; something on lung; 14mm nodule; External hemorrhoid; diarrhea/crescent like and flat stool; another UTI; severe itching at times; Misuse - patient took, Benadryl, Trazadone, and Melatonin together; missed 1 week of medication; joint pain in both hips; feeling so much pressure in rectal area, like a bulb was blocking it; puked my guts up; it got worse, so went to Emergency Room; her ileostomy takedown surgery that was performed on 14/Jul/2020; This case was reported by a consumer: Zejula Patient Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients patient support programs and described the occurrence of nausea in a 60-year-old female patient who received niraparib (Zejula) capsule (batch number 8720486, expiry date 31st March 2022) for malignant neoplasm of fallopian tube.   On 24th April 2020, the patient started Zejula 300 mg once daily (300 mg daily). On an unknown date, an unknown time after starting Zejula, the patient experienced nausea, fatigue and bizarre dreams. The action taken with Zejula was unknown. On an unknown date, the outcome of the nausea, fatigue and bizarre dreams were unknown.   It was unknown if the reporter considered the nausea, fatigue and bizarre dreams to be related to Zejula.  Additional details: The patient reported ome occasional nausea, fatigue, and weird dreams. The patient reported that she had not been getting labs done weekly and the last time she remembers getting labs was on 06 Mar 2020. A nurse advised the patient of the recommendations for weekly then monthly bloodwork. The patient would call the doctor's office to schedule bloodwork for as soon as possible. The nurse placed a call to the doctor's office and spoke with nurse to remind her of the recommended bloodwork schedule for Zejula.  Follow up information received from consumer on 25 May 2020: Zejula Patient Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients: Patient was currently on hold with Zejula therapy. Last dose a week ago. Patient reported low platelets at 29. On an unknown date, an unknown time after starting Zejula, the patient experienced platelets decreased. Zejula was interrupted (Dechallenge was unknown). On an unknown date, the outcome of the platelets decreased was unknown. It was unknown if the reporter considered the platelets decreased to be related to Zejula. Labs completed today, pending results. Oncologist visit via televisit 21 May 2020. Spoke with patient in depth regarding Zejula manufacturer recommendations for dose reduction and common hematologic side effects of Zejula therapy. No questions or concerns regarding therapy. No emergency room (ER) visits or hospitalizations or specialist visits or scans. Denies new allergies or medications. This case was not associated with a product complaint.  Follow up information received from consumer on 11 Jun 2020: Zejula Patient Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients: Patient reported that her platelets were low and her oncologist held Zejula for 2 weeks. She restarted at 200mg 05 Jun 2020. The action taken for Zejula was Interrupted (Dechallenge unknown).  Follow up information received from consumer on 20 Jul 2020: Zejula Patient Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients: On an unknown date, the dose was changed to 100 mg once daily (100 mg daily) (batch number 8720486, expiry date 31st March 2022). The patient reported that she was directed by her oncologist to reduce her dose to 100mg daily but was not certain of what date she reduced. She says it was shortly before her medication was again placed on hold. Zejula was placed on hold with her last dose taken on 06 Jul 2020. She was placed on hold one week prior to her ileostomy take down surgery that was performed on 14 Jul 2020. On 14th July 2020, an unknown time after starting Zejula, the patient experienced ileostomy. On an unknown date, the outcome of the ileostomy was unknown. It was unknown if the reporter considered the ileostomy to be related to Zejula. She reported that she would remain on hold until her follow up appointment with her oncologist on 03 Aug 2020. She expected to resume Zejula at 100mg daily following this. The patient reported having over 30 Zejula on hand. The patient reported that she had a computed tomography (CAT) scan on 03 Jul 2020 and there was no growth in the three areas that were being monitored.  Follow up information received from consumer: Zejula Patient Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients on 21 Aug 2020: On an unknown date, the dose was changed to 100 mg once daily, oral (100 mg daily) (batch number 9078981, expiry date 30th April 2022) . On an unknown date, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was unknown. It was unknown if the reporter considered the insomnia to be related to Zejula. Adverse event: Patient reported having issues with insomnia.  Follow up information received from consumer: Zejula Patient Brochure on 17 Sep 2020: Patient received niraparib (Zejula) capsule (batch number 9722426, expiry date 31st October 2022) for malignant neoplasm of fallopian tube. On an unknown date, the dose was changed to 100 mg once daily (100 mg daily). Zejula was interrupted (Dechallenge was unknown). On an unknown date, the outcome of the insomnia was not recovered/not resolved. Adverse event Patient reported having continued issues with insomnia (previously reported)    Follow up information received from consumer: Zejula Patient Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients on 28 October 2020: This case was reported by a consumer via patient support programs and described the occurrence of nausea in a 60-year-old female patient who received niraparib (Zejula) capsule (batch number 8720486, expiry date 31st March 2022), (batch number 9078981, expiry date 30th April 2022), (batch number 9722426, expiry date 31st October 2022) and (batch number 9266890, expiry date 30th September 2020) for malignant neoplasm of fallopian tube. Co-suspect products included trazodone for product used for unknown indication and melatonin for product used for unknown indication. On 24th April 2020, the dose was changed to 100 mg once daily (100 mg daily). On an unknown date, the patient started trazodone at an unknown dose and frequency and melatonin at an unknown dose and frequency. On 14th July 2020, 2 months 20 days after starting Zejula, the patient experienced ileostomy. On 11th October 2020, the patient experienced discomfort rectal. In October 2020, the patient experienced vomiting and condition aggravated. On an unknown date, the patient experienced nausea, fatigue, bizarre dreams, platelets decreased, insomnia, constipation, lung nodule, hemorrhoids, diarrhea, urinary tract infection, itching and intentional drug misuse. The patient was treated with macrogol (Miralax) and magnesium citrate. Zejula was interrupted (Dechallenge was unknown). The action taken with trazodone was unknown. The action taken with melatonin was unknown. On an unknown date, the outcome of the nausea, fatigue, bizarre dreams, platelets decreased, ileostomy, discomfort rectal, vomiting, condition aggravated, constipation, lung nodule, hemorrhoids, diarrhea, urinary tract infection, itching and intentional drug misuse were unknown and the outcome of the insomnia was not recovered/not resolved. It was unknown if the reporter considered the nausea, fatigue, bizarre dreams, platelets decreased, ileostomy, insomnia, discomfort rectal, vomiting, condition aggravated, constipation, lung nodule, hemorrhoids, diarrhea, urinary tract infection, itching to be related to Zejula. Feeling so much pressure in rectal area, like a bulb was blocking it. It started on 11October 2020 and puked guts up. Then it got worse, so the patient went to Emergency Room on 15October 2020." Abdominal Scan, No blockage and "MD's felt it was constipation," "something on her lung; 14mm nodule." Constipation - "crescent like and flat stool. External hemorrhoid, Miralax - diarrhea, Magnesium citrate and reported feeling better today and "emptied me out." "another UTI." "severe itching at times, Adverse event: Misuse - patient took, Benadryl, Trazadone, and Melatonin together. Causality for nausea, fatigue, bizarre dreams, platelets decreased, ileostomy, insomnia, discomfort rectal, vomiting, condition aggravated, constipation, lung nodule, hemorrhoids, diarrhea, urinary tract infection, itching and intentional drug misuse was not applicable.  Follow up information received from consumer: Zejula Patient Brochure Fulfillment/Shipment; Zejula Nurse Calls To Patients on 24 Nov 2020: Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Concomitant products included colecalciferol (Vitamin D3), vitamin d, apixaban (Eliquis), gabapentin, magnesium, ascorbic acid + vaccinium macrocarpon (Cranberry Plus Vitamin C), Probiotic and centrum silver. On 16th November 2020, the patient received Shingles vaccine. On an unknown date, the patient experienced missed dose and pain in hip. Zejula was interrupted (Dechallenge was unknown). Rechallenge with Zejula was unknown. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the missed dose and pain in hip were unknown and the outcome of the insomnia and diarrhea were not recovered/not resolved. It was unknown if the reporter considered the pain in hip to be related to Zejula, Shingles vaccine, trazodone and melatonin. Patient stated she had been taking medication since April but missed 1 week of medication due to doctor sending prescription to different pharmacy. Patient was experiencing insomnia while on medication and MD prescribed trazodone, which helped a little. Patient also stated she received shingle vaccination on 16 Nov 2020 and had increased joint pain in both hips. Unsure if it was due to Zejula. Past two days she experienced diarrhea and thought might be it was due to being off Zejula because she was usually more constipated. She was using medication for stage 4 fallopian tube cancer.