- Serious ARs occurred in 11% of patients who received ADSTILADRIN (nadofaragene firadenovec-vncg)2
- 0 deaths were reported due to treatment-emergent ARs3
safety
ADSTILADRIN Is Localized, Offering a
Well-Tolerated Safety Profile
75%
of adverse reactions (ARs) were mild (grades 1 and 2) and resolved within 2 days1
of adverse reactions (ARs) were mild (grades 1 and 2) and resolved within 2 days1
2%
of patients discontinued treatment due to ARs (n=3)2
of patients discontinued treatment due to ARs (n=3)2
- Permanent discontinuation of ADSTILADRIN due to an AR occurred in 3 patients (1.9%). 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
ARs (>10%) in patients with NMIBC in CS-0032
ADVERSE REACTION
ADSTILADRIN (n=157)
Grade 1 or 2 (%)*
Grade 1 or 2 (%)*
General disorders and administration site conditions
Instillation site discharge
33
Fatigue
24
Chills
16
Pyrexia
15
Renal and urinary disorders
Bladder spasm
20
Micturition urgency
19
Hematuria
17
Dysuria
16
No grade 3 or 4 reactions2
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 (%)
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 product2
| * | 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 |
| 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; 2023. 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
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.