Adstiladrin (nadofaragene firadenovec-vncg)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*Premedication with an anticholinergic is recommended before each instillation of nadofaragene firadenovec-vncg.

*Administer nadofaragene firadenovec-vncg by intravesical instillation only. Follow universal biosafety precautions for handling.

*Nadofaragene firadenovec-vncg is not for intravenous use, topical use, or oral administration.

*The recommended dose of nadofaragene firadenovec-vncg is 75 mL at a concentration of 3 x 1011 viral particles (vp)/mL, instilled once every three (3) months into the bladder via a urinary catheter.

*After the instillation, allow nadofaragene firadenovec-vncg to be left in the bladder for 1 hour. During the 1 hour dwell time, the patient should reposition approximately every 15 minutes.

*See Full Prescribing information for additional instructions on preparation and administration of nadofaragene firadenovec-vncg.

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No dosing information is available for this tab.

There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Nadofaragene Firadenovec/Selected Immunosuppressants

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Nadofaragene firadenovec may contain low levels of replication-competent adenovirus.(1)

CLINICAL EFFECTS: Concurrent use of nadofaragene firadenovec in patients receiving immunosuppressive therapy may cause disseminated adenovirus infection.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Individuals who are immunosuppressed or immune-deficient should not receive nadofaragene firadenovec.(1)

DISCUSSION: Nadofaragene firadenovec is a non-replicating adenoviral vector-based gene therapy but may contain low levels of replication-competent adenovirus. Immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Nadofaragene firadenovec-vncg is contraindicated in patients with hypersensitivity to interferon alfa or any component of the product.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Immunosuppression

The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever), and dysuria (painful urination).

Less Frequent

• Acute coronary syndrome
• Atrial fibrillation
• Cerebral edema
• Choledocholithiasis
• Chronic heart failure
• Coronary artery disease
• Sepsis

More Frequent

• Anemia
• Chills
• Dysuria
• Fatigue
• Fever
• Hematuria
• Hyperglycemia
• Hypertriglyceridemia
• Hypophosphatemia
• Spasm of bladder
• Treatment site sequelae
• Urinary urgency

Less Frequent

• Dehydration
• Disseminated adenovirus infection
• Hypoglycemic disorder
• Syncope

No enhanced messaging available.

Safety and effectiveness of nadofaragene firadenovec-vncg in pediatric patients have not been established.

Adequate and well-controlled studies with nadofaragene firadenovec-vncg have not been conducted in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with nadofaragene firadenovec-vncg. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

There is no information regarding the presence of nadofaragene firadenovec-vncg in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for nadofaragene firadenovec-vncg and any potential adverse effects on the breastfed infant from nadofaragene firadenovec-vncg or from the underlying maternal condition.

Clinical studies of nadofaragene firadenovec-vncg in BCG-unresponsive high-risk NMIBC with CIS did not include sufficient numbers of patients younger than 65 years of age to determine whether safety and effectiveness differ from older patients.