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safety

ADSTILADRIN is targeted, offering a manageable safety profile

2%

of patients discontinued treatment due to adverse reactions (ARs)1

of patients discontinued treatment due to adverse reactions (ARs)1

Permanent discontinuation of ADSTILADRIN (nadofaragene firadenovec-vncg) 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 bladder.1

  • Dosage interruptions of ADSTILADRIN due to an AR occurred in 34% of patients (n=54)1

The majority of ARs (75%) were mild (grade 1 and 2) and resolved within 2 days2

Serious adverse reactions occurred in 11% of patients who received ADSTILADRIN1

ARs (>10%) in patients with NMIBC in CS-0031

ADVERSE REACTION ADSTILADRIN (n=157)
Grades 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

*Graded per National Cancer Institute’s Common Terminology Criteria for Adverse Events v4.03; there were no grade 3 or 4 reactions. 1

Abbreviation: NMIBC, non–muscle-invasive bladder cancer.

Selected laboratory abnormalities (>15.0%) that worsened from baseline in patients with NMIBC in CS-0031

LABORATORY ABNORMALITY ADSTILADRIN†
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

†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. 1

Contraindications

ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.1

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References: 1. ADSTILADRIN. Package insert. Ferring Pharmaceuticals, Inc; 2023. 2. 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.

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Supply Status

ADSTILADRIN supply information

We remain committed to ensuring widespread availability of ADSTILADRIN as early as possible and are therefore scaling up our manufacturing efforts to increase supply.

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