Dosing & Uses
Dosage Forms & Strengths
intravesical solution
- 3 x 1011 viral particles (vp)/mL per vial
- Each vial contains an extractable volume of 20 mL
Bladder Cancer
Indicated for high-risk Bacillus Calmette Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors
Premedicate with an anticholinergic is recommended before each instillation
Instill 75 mL into bladder at a concentration of 3 x 1011 viral particles (vp)/mL once q3months
Leave in bladder for 1 hr following instillation
Dosing Considerations
Verify pregnancy status in females of reproductive potential before initiating
Premedicate with an anticholinergic is recommended before each instillation
Safety and efficacy not established
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (1)
- ublituximab
ublituximab and nadofaragene firadenovec both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
>10%
Glucose increased, all grades (38%)
Instillation site discharge (33%)
Triglycerides increased, all grades (30%)
Fatigue (24%)
Bladder spasm (20%)
Micturition urgency (19%)
Hematuria (17%)
Creatinine increased, all grades (17%)
Chills (16%)
Dysuria (16%)
Phosphate decreased, all grades (16%)
Hemoglobin decreased (16%)
Pyrexia (15%)
1-10%
Glucose increased, Grade 3 or 4 (6%)
Triglycerides increased, Grade 3 or 4 (1.9%)
Phosphate decreased, Grade 3 or 4 (1.4%)
Coronary artery disease (1.3%)
Acute coronary syndrome (1.3%)
Atrial fibrillation (1.3%)
Dehydration (1.3%)
Hypoglycemia (low blood sugar) (1.3%)
Syncope (fainting) (1.3%)
<1%
Heart failure (0.6%)
Pericarditis, (0.6%)
Brain edema (swelling) (0.6%)
Bile duct stone (0.6%)
Sepsis (0.6%)
Hemoglobin decreased (0.6%)
Warnings
Contraindications
Hypersensitivity reactions to interferon alfa or to any component of the product
Cautions
Risk of muscle invasive or metastatic bladder cancer with delayed cystectomy
- Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer
- Risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS
- Median time from persistence or recurrence of CIS to cystectomy in these patients was 235 days
- If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy
Risk of disseminated adenovirus infection
- Owing to possible presence of low levels of replication-competent adenovirus in drug, immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection
- Avoid exposing immunosuppressed or immune-deficient individuals to nadofaragene firadenovec
Pregnancy & Lactation
Pregnancy
No adequate and well-controlled studies have been conducted in pregnant females
Advise pregnant females of potential risk to a fetus
Verify pregnancy status in females of reproductive potential before initiating
Contraception
- Females of reproductive potential: Use effective contraception during treatment and for 6 months following last dose
- Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months following last dose
Lactation
There is no information regarding drug presence in human milk, effects on breastfed infants, or effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Non-replicating adenoviral vector-based gene therapy delivers a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to bladder urothelium
Intravesical instillation results in cell transduction and transient local expression of IFNα2b protein that is anticipated to have antitumor effects
Absorption
One patient receiving a second dose at dose level of 3 x 1011 vp/mL (2.25 x 1013 vp) had measurable vector DNA in blood; no other patients in either study had measurable vector DNA at 1 hr postdosing in blood
Administration
Intravesicular Bladder Preparation
Drug is a nonreplicating adenoviral vector-based gene therapy
Follow universal biosafety precautions for handling
Immunosuppressed or immune-deficient individuals should not prepare, administer, and avoid exposure to nadofaragene firadenovec
Remove 4 vials from freezer; allow vials to thaw at room temperature (20-25ºC [68-77ºF]) until liquid; do NOT expose vials to higher temperatures; protect from light
Drug must be calibrated to room temperature (20-25ºC [68-77ºF]) before use
Time for thawing and calibrating drug to room temperature: ~8-10 hr (thawing vials in cardboard nest); ~3-5 hr (thawing vials outside cardboard nest); Do NOT refreeze
Visually inspect vials for visible particles and discoloration; suspension is clear to slightly opalescent and may contain opalescent flecks; discard if visible particles or discoloration observed
Mix gently; do not shake
Using aseptic technique, remove cap from vial and attach vented vial adapter according to manufacturer’s instructions
Connect syringe to vial adapter and withdraw contents of vial into syringe; repeat steps for remaining 3 vials until 75 mL has been withdrawn into 1-2 syringes
Note: Volumes in syringes do not have to be equal
Discard any unused product according to universal precautions
Use syringe(s) within 1 hr of drawing up
Intravesicular Bladder Administration
Intravesical instillation only
Not for IV use, topical use, or oral administration
Premedicate with an anticholinergic is recommended before each instillation
Before administering, insert 1 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; do NOT use catheters coated or embedded with silver or antibiotics
Use catheter to completely empty patient’s bladder before instillation; do not remove catheter
Attach Luer lock end of same catheter adaptor to drug-containing syringe and insert tapered end of the catheter adaptor into funnel opening of catheter
Slowly instill 75 mL of nadofaragene firadenovec into bladder through catheter, ensuring that complete volume is administered
After instillation, retain drug in bladder for 1 hr
During 1-hour dwell time, reposition patient approximately every 15 minutes from left to right, back and abdomen to maximize bladder surface exposure
If, during dwell time, bladder cramping or premature voiding occurs, repositioning of patient may be adjusted or discontinued
Evacuate drug from bladder as part of routine emptying of bladder, or may void and completely empty bladder after 1 hr has elapsed
Disinfect voided urine for 30 minutes with an equal volume of virucidal agent before flushing of toilet
Storage
Unopened vials
Ship frozen at ≤ -60ºC (≤ -76ºF) in an insulated shipping box that will maintain required temperature for ≥72 hr after being sealed
Upon receipt, store cartons as indicated below
- In a freezer ≤ -60ºC (≤ -76ºF) until expiration date printed on carton
- In a freezer between -25º to -15ºC (-13°ºF to 5º) up to 3 months, without exceeding original expiration date on vial and outer carton
- When stored in freezer, note date of placement in freezer
- Additionally, write date on outer carton for when to discard carton if not used
- Instillation dates should be 3 months apart, but not past the original expiry date; discard date supersedes original expiration
Thawed vials
- May be stored at room temperature (20-25ºC [68-77ºF]) or refrigerated at 2-8ºC (36-46ºF) for up to 24 hr
- Do NOT refreeze
Drawn up syringes
- Use within 1 hr of drawing up
Decontamination and biohazard handling
- Treat any spills with a virucidal agent (eg, sodium hypochlorite with 0.5% active chlorine or 6% hydrogen peroxide solution) for 30 min
- Place disposable materials that have come into contact in biohazard containers for destruction
- Decontaminate non-disposable equipment according to facility’s standard operating procedures
Images
Formulary
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