Adstiladrin: FDA approved December 2022; anticipated availability in the second half of 2023.
Bladder cancer: Treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors in adults.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Endocrine & metabolic: Decreased serum phosphate (16%), increased serum glucose (38%), increased serum triglycerides (30%)
Genitourinary: Bladder spasm (20%), dysuria (16%), hematuria (17%), urinary urgency (19%)
Hematologic & oncologic: Decreased hemoglobin (16%; grades 3/4: <1%)
Local: Application-site discharge (33%)
Nervous system: Chills (16%), fatigue (24%)
Renal: Increased serum creatinine (17%)
Miscellaneous: Fever (15%)
1% to 10%:
Cardiovascular: Acute coronary syndrome (1%), atrial fibrillation (1%), coronary artery disease (1%), syncope (1%)
Endocrine & metabolic: Dehydration (1%), hypoglycemia (1%)
<1%:
Cardiovascular: Heart failure, pericarditis
Gastrointestinal: Choledocholithiasis
Infection: Sepsis
Nervous system: Brain edema
Frequency not defined: Genitourinary: Bladder neoplasm (benign)
Hypersensitivity to interferon alfa or any component of the formulation.
