Brand Name
Adstiladrin
Generic Name
Nadofaragene Firadenovec-Vncg
View Brand Information FDA approval date: September 05, 2023
Form: Suspension
What is Adstiladrin (Nadofaragene Firadenovec-Vncg)?
ADSTILADRIN ® is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin -unresponsive non-Muscle Invasive Bladder Cancer with carcinoma in situ with or without papillary tumors. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin -unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
Approved To Treat
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ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
Summary: Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting
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Brand Information
1INDICATIONS AND USAGE
ADSTILADRIN
2DOSAGE AND ADMINISTRATION
Important Administration Instructions
ADSTILADRIN is for intravesical instillation only.
ADSTILADRIN is
2.1Dose
The recommended dose of ADSTILADRIN is 75 mL at a concentration of 3 x 10
Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN.
2.2Preparation and Handling
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling.
Individuals who are immunosuppressed or immune-deficient, should not prepare, administer, or come into contact with ADSTILADRIN [
ADSTILADRIN is provided as a sterile frozen suspension.
All four vials of ADSTILADRIN must be thawed and brought to room temperature (20°C to 25°C [68°F to 77°F]) prior to use.
WHEN THAWING AT ROOM TEMPERATURE
Frozen
WHEN THAWING IN REFRIGERATOR
Frozen
Do not expose the vials to higher temperatures. Protect from light. DO NOT refreeze.
The vials may be moved between refrigerator and room temperature if the total storage time at each condition is not exceeded (24 hours at room temperature and 7 days refrigerated including thawing time).
2.3Bladder instillation of ADSTILADRIN
- Premedication with an anticholinergic before each instillation of ADSTILADRIN is recommended.
- ADSTILADRIN must be brought to room temperature before administration [
- Before administering ADSTILADRIN to the patient, insert one straight, or intermittent, urinary catheter with a proximal funnel opening that will accommodate the Luer lock adapter.
- Use only catheters made of vinyl/PVC (uncoated or coated with hydrogel), red rubber latex or silicone to instill ADSTILADRIN. Do not use catheters coated or embedded with silver or antibiotics.
- Use the catheter to completely empty the patient's bladder before instillation of ADSTILADRIN. Do not remove the catheter.
- Attach the Luer lock end of the same catheter adaptor to the syringe containing ADSTILADRIN and insert the tapered end of the catheter adaptor into the funnel opening of the catheter.
- Slowly instill 75 mL of ADSTILADRIN into the bladder through the catheter, ensuring that the complete volume is administered.
- After the instillation, ADSTILADRIN should be retained in the bladder for 1 hour. During the 1 hour dwell time, the patient should reposition approximately every 15 minutes from left to right, back and abdomen to maximize bladder surface exposure. If, during the dwell time, the patient exhibits bladder cramping or premature voiding, repositioning of the patient may be adjusted or discontinued.
- Evacuate ADSTILADRIN from the bladder as part of routine emptying of the bladder, or the patient may void and completely empty the bladder after 1 hour has elapsed.
- Voided urine should be disinfected for 15 minutes with an equal volume of virucidal agent before flushing of the toilet. [
3DOSAGE FORMS AND STRENGTHS
ADSTILADRIN is a sterile, clear to opalescent suspension for intravesical instillation, supplied as single-use vials.
ADSTILADRIN is provided in a carton containing four (4) vials. All vials have a nominal concentration of 3 × 10
4CONTRAINDICATIONS
ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product [
5DESCRIPTION
ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation.
It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b).
ADSTILADRIN has a nominal concentration of 3 x 10
A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL).
ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative.
6CLINICAL STUDIES
The efficacy of ADSTILADRIN was evaluated in CS-003 (
Patients received ADSTILADRIN 75 mL intravesical instillation (3 x 10
The major efficacy outcome measures were complete response (CR) at any time (as defined by negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response. Low-grade (Ta) papillary disease was not considered a recurrence for the purposes of evaluating CR. CR was assessed at 3, 6, 9, and 12 months by cystoscopy and cytology. Random bladder biopsy of five sites was conducted in patients remaining in CR at Month 12. Assessment of durability of CR subsequent to these evaluations was performed per local standards of care.
The evaluable CIS study population characteristics were median age of 70 (range 44-89) with 32% >75 years of age; 88% male, 92% White. Tumor pattern at study entry was CIS with T1 (5%), CIS with high-grade Ta (19%), and CIS (76%). The median number of instillations of prior BCG was 12 (range 8 to 18).
Efficacy results are summarized in Table 3.
7HOW SUPPLIED/STORAGE AND HANDLING
ADSTILADRIN is shipped frozen at ≤ -60°C (≤ -76°F) in an insulated shipping box that will maintain the required temperature for a minimum of 72 hours after being sealed. Each carton (NDC 55566-1050-1) contains a removable cardboard nest of four (4) clear glass vials of ADSTILADRIN. Each vial (NDC 55566-1050-0) contains a sterile frozen suspension with an extractable volume of 20 mL and is sealed with a bromobutyl rubber stopper and a tamper-evident aluminum crimp.
Upon receipt, cartons of ADSTILADRIN can be stored as indicated below:
- In a freezer ≤ -60°C (≤ -76°F) until expiry date printed on the carton.
- In a freezer between -25°C to -15°C (-13°F to 5°F) up to 3 months, without exceeding the original expiry date printed on the vial and outer carton.
When thawed, ADSTILADRIN is a clear to opalescent suspension, with nominal concentration of 3 × 10
Prior to use, ADSTILADRIN must be brought to room temperature (20°C to 25°C [68°F to 77°F]). Once it is taken out of the freezer, the vials may be stored for up to 24 hours at room temperature and a total of up to 7 days refrigerated at 2°C to 8°C (36°F to 46°F), including thawing time.
After withdrawing the suspension into syringes, the syringes may be stored for up to 6 hours at room temperature (20°C to 25°C [68°F to 77°F]).
• Protect the vials from light. [see Dosage and Administration ()].
• DO NOT REFREEZE
• ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling [
• Dispose of unused product and disposable materials that may have come in contact with ADSTILADRIN in accordance with local biosafety guidelines applicable for handling and disposal of the biohazard waste.
8PATIENT COUNSELING INFORMATION
Risk of Metastatic Bladder Cancer with Delayed Cystectomy
- Inform patients that delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle-invasive or metastatic bladder cancer. Discuss the risk of muscle-invasive or metastatic bladder cancer and that the risk increases the longer cystectomy is delayed in the presence of persisting CIS [
Risk of Disseminated Adenovirus Infection
- Inform patients and their caregivers that treatment or contact with ADSTILADRIN in those who are immunocompromised, including those receiving immunosuppressive therapy, may increase the risk for disseminated adenovirus infection [
Shedding of ADSTILADRIN
Inform patients and their caregivers that transient and low‑level shedding of ADSTILADRIN may occur in urine. Instruct patients and their caregivers that for 2 days following treatment, voided urine should be disinfected for 15 minutes with an equal volume of bleach before flushing [
Manufactured for:
Ferring Pharmaceuticals
U.S. License No. 2222
ADSTILADRIN®, Ferring and the Ferring Pharmaceuticals logo are trademarks of Ferring.
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9PRINCIPAL DISPLAY PANEL - Outer Carton
NDC 55566-1050-1
nadofaragene firadenovec-vncg
ADSTILADRIN
75 mL Intravesical Suspension
75 mL Intravesical Suspension
Each carton contains 4 x 20 mL vials
Each vial contains 3 x 10
Each vial contains 3 x 10
No U.S. standard of potency
For Intravesical Instillation Only
Sterile suspension
U.S. Licence No. 2222
Manufactured for Ferring Pharmaceuticals A/S,
2770 Kastrup, Denmark
by FinVector Oy, Kuopio, Finland
2770 Kastrup, Denmark
by FinVector Oy, Kuopio, Finland
