Adstiladrin
(Nadofaragene Firadenovec-Vncg)Dosage & Administration
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Adstiladrin Prescribing Information
ADSTILADRIN® is indicated 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.
ADSTILADRIN is a sterile, clear to opalescent 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 × 1011 viral particles (vp)/mL. Each vial of ADSTILADRIN contains an extractable volume of not less than 20 mL.
Immunocompromise/immunodeficiency: Avoid in patients with immunocompromise or immunodeficiency. (
Immunocompromise/immunodeficiency: Avoid in patients with immunocompromise or immunodeficiency.
Adequate and well-controlled studies with ADSTILADRIN have not been conducted in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with ADSTILADRIN. 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 ADSTILADRIN 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 ADSTILADRIN and any potential adverse effects on the breastfed infant from ADSTILADRIN or from the underlying maternal condition.
No nonclinical or clinical studies were performed to evaluate the effect of ADSTILADRIN on fertility.
Verify pregnancy status in females of reproductive potential prior to initiating ADSTILADRIN.
Advise females of reproductive potential to use effective contraception during treatment with ADSTILADRIN and for 6 months following the last dose.
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ADSTILADRIN and for 3 months following the last dose.
Safety and effectiveness of ADSTILADRIN in pediatric patients have not been established.
Clinical studies of ADSTILADRIN 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.
In clinical studies with ADSTILADRIN, no overall differences in safety or efficacy were observed between females and males.
ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product [
ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation.
It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b).
ADSTILADRIN has a nominal concentration of 3 x 1011vp/mL.
A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL).
ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative.
- Delaying cystectomy could lead to the development of metastatic bladder cancer, which can be lethal. ()
5.1 Risk of Muscle Invasive or Metastatic Bladder Cancer with Delayed CystectomyDelaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
Of the patients with CIS treated with ADSTILADRIN on Study CS-003 who underwent subsequent radical cystectomy and for whom pathologic data were available, 14% (n = 6) had muscle-invasive (T2 or greater) disease at cystectomy. Median time from persistence or recurrence of CIS to cystectomy in these patients was 235 days (range 38 to 582 days). Two additional patients who did not undergo cystectomy experienced progression to muscle-invasive disease during the treatment period.
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: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals. (5.2)