Nadofaragene Firadenovec Dosage

Medically reviewed by Drugs.com. Last updated on Dec 5, 2023.

Usual Adult Dose for Bladder Cancer

Usual dose: 75 mL at a concentration of 3 x 10(11) viral particles (vp)/mL instilled once every three months into the bladder via a urinary catheter

Comments:

• Administer an anticholinergic as a premedication prior to each instillation of this drug.

Use: 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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: Hypersensitivity to interferon alfa or any component of the product

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug by intravesical instillation only.
• This drug is not for intravenous use, topical use, or oral administration.
• This drug should be left in the bladder for 1 hour following instillation.
• Refer to manufacturer product information for detailed instructions on administration of this drug.

Storage requirements:

• Upon receipt:
• In a freezer at minus 60C (minus 76F or lesser) or lesser until expiry date printed on the product.
• In a freezer between minus 25C to minus 15C (minus 13F to minus 5F) for up to 3 months, without exceeding the original expiry date printed product.
• The vials may be stored for up to 24 hours at room temperate or refrigerated once it is taken out of the freezer.
• Protect the vials from light.
• Do not refreeze.

Reconstitution/preparation techniques:

• Refer to manufacturer product information for detailed instructions on reconstitution of this drug.

Patient advice:

• Risk of Metastatic Bladder Cancer with Delayed Cystectomy: Advise patients that delaying cystectomy in cases of BCG-unresponsive carcinoma in situ (CIS) could result in the emergence of muscle-invasive or metastatic bladder cancer. Discuss the potential for developing muscle-invasive or metastatic bladder cancer, highlighting that this risk becomes more pronounced as the delay in cystectomy continues while persistent CIS is present.
• Risk of Disseminated Adenovirus Infection: Provide patients and their caregivers with information about the possibility of an increased risk for disseminated adenovirus infection as a result of treatment or contact with this drug, particularly for those who have compromised immune systems, including individuals undergoing immunosuppressive therapy.
• Shedding of this drug: Inform patients and their caregivers that there might be a transient and low-level shedding of this drug in urine. Instruct patients and caregivers that, for a period of 2 days after treatment, any voided urine should be disinfected for 30 minutes by adding an equal volume of bleach before flushing.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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