Safety Profile

Adverse Events

PLUVICTO HAS AN ESTABLISHED SAFETY PROFILE^1,*

ADVERSE REACTIONS OCCURRING AT ≥5% INCIDENCE IN PATIENTS WHO RECEIVED PLUVICTO + BSOC IN VISION^1-3,*

• 12% of patients discontinued PLUVICTO + BSOC due to any treatment-related adverse events vs 8% with BSOC alone

• Clinically relevant adverse reactions in <5% of patients who received PLUVICTO + BSOC included dry eye, vertigo, and pancytopenia (including bicytopenia)

BSOC, best standard of care.

*National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
^a Peripheral edema includes peripheral edema, fluid retention, and fluid overload.
^b Dry mouth includes dry mouth, aptyalism, and dry throat.
^c Vomiting includes vomiting and retching.
^d Abdominal pain includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain lower, abdominal tenderness, and gastrointestinal pain.
^e Urinary tract infection includes urinary tract infection, cystitis, and cystitis bacterial.
^f Acute kidney injury includes blood creatinine increased, acute kidney injury, renal failure, and blood urea increased.
^g Dysgeusia includes dysgeusia and taste disorder.

Laboratory Abnormalities

SELECT LABORATORY ABNORMALITIES (≥10%) THAT WORSENED FROM BASELINE IN PATIENTS WHO RECEIVED PLUVICTO + BSOC (BETWEEN-ARM DIFFERENCE OF ≥5% ALL GRADES) IN VISION¹

^a The denominator used to calculate the rate for each laboratory parameter varied from 506 to 529 based on the number of patients with a baseline value and at least 1 posttreatment value.
^b The denominator used to calculate the rate for each laboratory parameter varied from 194 to 198 based on the number of patients with a baseline value and at least 1 posttreatment value.
^c No grade 4 laboratory abnormalities worsening from baseline were reported.

NO UNEXPECTED LABORATORY ABNORMALITIES WERE REPORTED IN THE VISION TRIAL.^1,2