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Drug overview for ADSTILADRIN (nadofaragene firadenovec-vncg):
Generic name: nadofaragene firadenovec-vncg (NAD-oh-FAR-a-jeen FYE-ra-DEN-oh-vek)
Drug class:
Therapeutic class: Antineoplastics
Nadofaragene firadenovec-vncg is a non-replicating adenoviral vector-based gene therapy.
No enhanced Uses information available for this drug.
Generic name: nadofaragene firadenovec-vncg (NAD-oh-FAR-a-jeen FYE-ra-DEN-oh-vek)
Drug class:
Therapeutic class: Antineoplastics
Nadofaragene firadenovec-vncg is a non-replicating adenoviral vector-based gene therapy.
No enhanced Uses information available for this drug.
DRUG IMAGES
No Image Available
The following indications for ADSTILADRIN (nadofaragene firadenovec-vncg) have been approved by the FDA:
Indications:
Non-muscle invasive bladder cancer with carcinoma in situ
Professional Synonyms:
None.
Indications:
Non-muscle invasive bladder cancer with carcinoma in situ
Professional Synonyms:
None.
The following dosing information is available for 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.
*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.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ADSTILADRIN VIAL | Maintenance | Adults instill 75 milliliters into bladder via catheter by intravesical route every 3 months |
No generic dosing information available.
The following drug interaction information is available for ADSTILADRIN (nadofaragene firadenovec-vncg):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| 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) |
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There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ADSTILADRIN (nadofaragene firadenovec-vncg):
Drug contraindication overview.
Nadofaragene firadenovec-vncg is contraindicated in patients with hypersensitivity to interferon alfa or any component of the product.
Nadofaragene firadenovec-vncg is contraindicated in patients with hypersensitivity to interferon alfa or any component of the product.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Immunosuppression |
The following adverse reaction information is available for ADSTILADRIN (nadofaragene firadenovec-vncg):
Adverse reaction overview.
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).
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).
There are 7 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Acute coronary syndrome Atrial fibrillation Cerebral edema Choledocholithiasis Chronic heart failure Coronary artery disease Sepsis |
| Rare/Very Rare |
|---|
| None. |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anemia Chills Dysuria Fatigue Fever Hematuria Hyperglycemia Hypertriglyceridemia Hypophosphatemia Spasm of bladder Treatment site sequelae Urinary urgency |
Dehydration Disseminated adenovirus infection Hypoglycemic disorder Syncope |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ADSTILADRIN (nadofaragene firadenovec-vncg):
Safety and effectiveness of nadofaragene firadenovec-vncg in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
The following prioritized warning is available for ADSTILADRIN (nadofaragene firadenovec-vncg):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ADSTILADRIN (nadofaragene firadenovec-vncg)'s list of indications:
| Non-muscle invasive bladder cancer and carcinoma in situ | |
| C67 | Malignant neoplasm of bladder |
| C67.0 | Malignant neoplasm of trigone of bladder |
| C67.1 | Malignant neoplasm of dome of bladder |
| C67.5 | Malignant neoplasm of bladder neck |
| C67.8 | Malignant neoplasm of overlapping sites of bladder |
| C67.9 | Malignant neoplasm of bladder, unspecified |
| D09.0 | Carcinoma in situ of bladder |
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