Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Intentional dose omission, Intentional product misuse, Off label use, Rheumatoid arthritis
Clinical narrative: had not taking Enbrel on a regular basis; Takes Enbrel every 6-8 weeks for symptoms/only been needing to take 1 injection every 6 to 8 weeks; Symptoms were getting worse/starting to feel symptoms/symptoms are worsening/sometimes really aches in his ankles, knees, and shoulders; Not taking on a regular basis; Takes Enbrel every 6-8 weeks for symptoms/take 1 injection every 6 to 8 weeks/rheumatologist at the time changed his prescription to once every two weeks and at one point to once every eight weeks; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021001188), license party for etanercept (ENBREL).  This serious solicited report (USASL2021001188) was reported to Amgen on 05/JAN/2021 by a consumer from a commercial program (PSP00180b, PSP00180b) and involves an approximately 69 year old male patient whose symptoms were getting worse [PT: rheumatoid arthritis], not taking on a regular basis [PT: intentional dose omission] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel on an unknown date. On an unknown date in NOV/2020, the patient had not taking Enbrel on a regular basis and had not taken his Enbrel in two months. Subsequently, the patient stated his symptoms were getting worse. No treatment information was received. The outcome of the events rheumatoid arthritis, intentional dose omission were reported as unknown. The causal relationship between the events intentional dose omission, rheumatoid arthritis and Enbrel was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.  Amgen Comment: This individual case report does not change the safety profile of the product.   Amgen Causality Assessment Rheumatoid arthritis aggravated is serious and unrelated to etanercept.  Intentionally missed dose is non-serious and unrelated to etanercept.   The reporter's assessment of the causal relationship of the events Rheumatoid arthritis aggravated and intentionally missed dose with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up (05Jan2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021001188), license party for etanercept (ENBREL).   ADDITIONAL INFORMATION RECEIVED ON and 05/JAN/2021 and 06/JAN/2021: This follow up information was reported by a consumer from a commercial program (PSP00046b) and involves an adult patient whose starting to feel symptoms [PT: rheumatoid arthritis], takes Enbrel every 6-8 weeks for symptoms/only been needing to take 1 injection every 6 to 8 weeks [PT: intentional product misuse] while receiving Enbrel with Multiple Dose Vial Kit For Reconstitution. On an unknown date, the patient stopped taking Enbrel with an unknown formulation for an unknown reason. On an unknown date, the patient switched to Enbrel with Multiple Dose Vial Kit For Reconstitution on an unknown date. The patient had been on Enbrel for over 21 years with different formulations and strengths. On an unknown date, the patient stated that his physician once had him taking an Enbrel injection 25 mg (milligram) twice a week and the patient progressed so well that he was instructed to take it less and less. The patient was communicated that his body would let him know when he needed an Enbrel injection. On an unknown date for approximately the last ten years, the patient had been taking one Enbrel injection every six to eight weeks. On an unknown date, the patient stated that he takes Enbrel every six to eight weeks for symptoms. On an unknown date (previously reported as NOV/2020), the patient stated that he was not taking Enbrel on a regular basis and had not taken his Enbrel in two months. The patient started to feel symptoms so the patient started taking Enbrel more frequently again as previously instructed. The patient stated that his physician retired and now his internist was trying to order Enbrel for him but the internist ordered the wrong formulation and strength. The patient stated that he was used to getting a 25mg vial that comes with a syringe and he mixes the medication together. At the time of this report, the symptoms was getting worse and the Enbrel therapy was ongoing. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the events intentional dose omission and intentional product misuse was reported as unknown. Action taken with Enbrel with Multiple Dose Vial Kit For Reconstitution was continued for the event rheumatoid arthritis. The causal relationship between the event intentional product misuse and Enbrel with Multiple Dose Vial Kit For Reconstitution was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. This case USASL2021001501 identified as duplicate of USASL2021001188 . Source documents are being copied from USASL2021001501 appended to USASL2021001188, which will be the case of record, USASL2021001501 is being deleted after one last submission.  Amgen comments: This individual case report does not change the safety profile of the product.   Amgen Causality Assessment Rheumatoid arthritis aggravated is serious and unrelated to etanercept.  Intentional misuse in dosing frequency andIntentionally missed dose are non-serious and unrelated to etanercept.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up (11Oct2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021001188), license party for etanercept (ENBREL).   ADDITIONAL INFORMATION RECEIVED ON 11/OCT/2021: This follow up information involves a patient who involves a patient whose symptoms were worsening/sometimes really aches in his ankles, knees, and shoulders [PT: rheumatoid arthritis] while receiving Enbrel, Multiple Dose Vial Kit For Reconstitution, Single Dose Prefilled Syringe. Previously reported event PT: intentional product misuse was updated to off label use. The patient's concomitant medication included COVID-19 vaccine. The patient began Enbrel on an unknown date in 2001 (20 years ago). On an unknown date, the patient switched from Multiple Dose Vial to Prefilled Syringe and felt like after switching his symptoms were worsening. Just like the Multiple Dose Vial was better, he believed it worked better. The patient was wondering if the pharmacy was handling the medication correctly and maintained product at the correct temperature range. The patient already spoke with them and they assure him they were handling the medication correctly. For many years he had no symptoms at all so his rheumatologist at the time changed his prescription to once every two weeks and at one point to once every eight weeks which was an off label use. The patient was informed since Enbrel worked for him it would work for him forever. In JAN/2021, the patient received both COVID-19 vaccine and that over the past few months when his symptoms really got bad. The patient just aches all over but sometimes really aches in his ankles, knees, and shoulders. The patient had problems with his right foot aching and some swelling which were the same symptoms he had when he was first put on Enbrel. Two months ago in AUG/2021, the symptoms got so bad he went to his physician and was given a corticoid steroid injection which helped him for a month. The patient stated that now two Advil (ibuprofen) worked better than a shot of Enbrel. The patient was now referred to a new rheumatologist. The worsening of symptoms could be related to something else possibly even the COVID-19 vaccine but felt like he did just fine until he was switched to the Prefilled Syringe and was wondering if there was a difference between the two formulations. Action taken with Single Dose Prefilled Syringe was reported as unknown for the event rheumatoid arthritis. The causal relationship between the events intentional dose omission, rheumatoid arthritis, and ingle Dose Prefilled Syringe was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Amgen comments: This individual case report does not change the safety profile of the product.   Amgen's Causality Assessment: The events Intentionally missed dose, Rheumatoid arthritis aggravated, and Off label dosing frequency were assessed as unrelated to etanercept.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 (COVID-19 vaccine) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: The event rheumatoid arthritis aggravated, confounded by the reported inappropriate schedule of product administration and intentional misuse in dosing frequency,  is unrelated to etanercept and likely represents the natural course of underlying disease. This case will be reassessed upon receipt of additional information.