ADSTILADRIN

Generic Name/API: nadofaragene firadenovec-vncg

Manufacturer: Ferring Pharmaceuticals

Dosage Forms & Strength & Pack Size:
ADSTILADRIN is a 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 viral particles (vp)/mL.
Each vial of ADSTILADRIN contains an extractable volume of not less than 20 mL.

Storage:
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 stored in freezer, the date of placement in freezer should be noted. In addition, the date for when the carton should be discarded if not used, must be written on the outer carton. These dates should be three months apart but should not past the original expiry date. This discard date supersedes the original expiry date.
The vials may be stored for up to 24 hours at room temperature or refrigerated once it is taken out of the freezer.
When thawed, ADSTILADRIN is a clear to opalescent suspension, with nominal concentration of 3 × 10 viral particles (vp)/mL.
• Protect the vials from light. [see Dosage and Administration (2.2)].
• DO NOT REFREEZE
• ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling [see Dosage and Administration (2.2)].
• 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.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
ADSTILADRIN is a treatment for adults who have all the following:

High-risk non–muscle-invasive bladder cancer
Cancer that is no longer responding to Bacillus Calmette-Guérin (BCG) therapy
Cancer that started in the bladder and has not spread (this is called carcinoma in situ or CIS)
Cancer with or without slender, finger-like tumor growths (papillary tumors) growing into the bladder space, away from the bladder wall

IMPORTANT SAFETY INFORMATION
Who should not receive ADSTILADRIN?
Do not receive ADSTILADRIN if you have a sensitivity to interferon alfa or any of its components.

What is the most important information I should know about ADSTILADRIN?
Individuals who are immunosuppressed or immune-deficient should not prepare, administer, receive or come into contact with ADSTILADRIN.

What should I tell my healthcare provider?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of ADSTILADRIN?
The most common side effects of ADSTILADRIN include:
Urinary discharge, fatigue, bladder spasm, urgency to urinate, and blood in your urine.

These are not all the possible side effects of ADSTILADRIN. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

What other information should I know about using ADSTILADRIN?
For 2 days following treatment, voided urine should be disinfected for 15 minutes with an equal volume of bleach before flushing.

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