- Serious ARs occurred in 11% of patients who received ADSTILADRIN2
safety
ADSTILADRIN Has
a Consistent,
Well-Tolerated
Safety Profile Out to 5 Years
75%
of adverse reactions (ARs)
were mild (grades 1 and 2)
and resolved within 2 days1*
<2 DAYS
was the median duration of
drug-related ARs, which were transient and local in nature1*
2%
of patients discontinued
treatment due to ARs (n=3)2
- ARs that resulted in permanent discontinuation of ADSTILADRIN included bladder spasm, instillation site discharge, and benign neoplasm of the bladder2
- Dosage interruptions of ADSTILADRIN due to an AR occurred in 34% of patients (n=54)2
0 DEATHS
were reported due to
treatment-emergent ARs3
ARs (>10%) in patients with NMIBC in CS-0032
ADVERSE REACTION
ADSTILADRIN (n=157)
Grade 1 or 2 (%)† ADSTILADRIN (n=157)
Grade 3 (%)†
Grade 1 or 2 (%)† ADSTILADRIN (n=157)
Grade 3 (%)†
ADSTILADRIN (n=157)
Grade 1 or 2 (%)†
Grade 3
(%)†
(%)†
General disorders and
administration site conditions
Instillation
site discharge 33 0
site discharge 33 0
Fatigue
24
0
Pyrexia
16
0
Chills
15
0
Renal and urinary disorders
Bladder spasm
20
1
Micturition urgency
19
1
Hematuria
17
1
Dysuria
16
0
No grade 4 or 5 drug-related reactions in both clinical trials and real-world studies2,3
Selected laboratory abnormalities (>15.0%) that worsened
from baseline in patients with NMIBC in CS-0032
LABORATORY ABNORMALITY
ADSTILADRIN‡
All grades (%) ADSTILADRIN‡
Grade 3 or 4 (%)
All grades (%) ADSTILADRIN‡
Grade 3 or 4 (%)
ADSTILADRIN‡
All
grades (%) Grade 3 or 4 (%)
grades (%) Grade 3 or 4 (%)
Chemistry
Glucose increased
38
6
Triglycerides increased
30
1.9
Creatinine increased
17
0
Phosphate decreased
16
1.4
Hematology
Hemoglobin decreased
16
0.6
Contraindications
ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.2
No new safety signals
out to 5 years in clinical trials4
- No deaths due to treatment-emergent ARs
- No new study-related ARs
In both clinical trials and the real-world study1,4
- No grade 4 or 5 drug-related reactions§
| *With the exception of fatigue and pollakiuria (frequent daytime urination).1 |
| †Graded per National Cancer Institute’s Common Terminology Criteria for Adverse Events v4.03.2 |
| ‡The denominator used to calculate the rate varied from 148 to 156 based on the number of patients with a baseline value and at least 1 posttreatment value.2 |
| §In the clinical trial, 3.8% of patients experienced grade 3 reactions out to 60 months.4 |
| Abbreviation: NMIBC, non–muscle-invasive bladder cancer. |
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Form ToggleReferences: 1. Data on file. ADSTILADRIN CSR, Ferring Inc. Parsippany, NJ. 2. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; October 2025. 3. Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol. 2021;22(1):107-117. doi:10.1016/S1470-2045(20)30540-4 4. Narayan VM, Boorjian SA, Alemozaffar M, et al. Efficacy of intravesical nadofaragene firadenovec for patients with Bacillus Calmette-Guérin-unresponsive nonmuscle-invasive bladder cancer: 5-year follow-up from a phase 3 trial. J Urol. 2024;212(1):1-12. doi:10.1097/JU.0000000000004020
Important Safety Information
INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.
WARNINGS AND PRECAUTIONS:
- Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
- Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration.
USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.
ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-10881-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING1-888-FERRING.
Please see full Prescribing Information for ADSTILADRIN.