ADSTILADRIN is now
FULLY AVAILABLE.
For your patients who are Bacillus Calmette-Guérin (BCG) unresponsive
The FIRST and ONLY FDA-approved intravesical gene therapy for high-risk NMIBC
For your patients who are Bacillus Calmette-Guérin (BCG) unresponsive
Learn moreNadofaragene firadenovec-vncg (ADSTILADRIN) is a recommended
treatment option in the NCCN Clinical Practice Guidelines in Oncology
(NCCN Guidelines®)*
Proven and durable complete responses (CRs)1,2
51% of the carcinoma in situ cohort achieved CR by month 3
(after 1 instillation)
Of these patients, 46% remained free of high-grade recurrence at
1 year
In a post hoc analysis, 36% remained free of high-grade recurrence at
2 years
Well-tolerated safety
profile1,3
75% of adverse reactions were mild (grades 1 and 2) and resolved within 2 days
Serious adverse reactions occurred in 11% of patients who received ADSTILADRIN
0 grade 3 or 4 reactions
2% of patients discontinued treatment due to adverse reactions
Convenient dosing
schedule1
Intravesical administration
once every 3 months
For urologists, by urologists:
fits into your existing
management of NMIBC
Hear from a board-certified urologist
“In bladder oncology, I think that this represents a transformative breakthrough.”
Click to play video
Lawrence Karsh,
Lawrence Karsh,
MD, FACS
Treated patients in the ADSTILADRIN clinical trial
*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed August 24, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Abbreviations: NMIBC, non–muscle-invasive bladder cancer.
NCCN, National Comprehensive Cancer Network® (NCCN®).
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References: 1. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; 2023. 2. Schuckman AK, Lotan Y, Boorjian SA, Cilwa KE, Dinney CPN. Efficacy of intravesical nadofaragene firadenovec for patients with carcinoma in situ (CIS), BCG-unresponsive non-muscle invasive bladder cancer (NMIBC): longer-term follow-up from the phase III trial. J Urol. 2021;206(suppl 3):e296. doi:10.1097/JU.0000000000002001.01 3. Data on file. FerGene, Inc. Cambridge, MA.
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.