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.
Important Administration Instructions
ADSTILADRIN is for intravesical instillation only.
ADSTILADRIN is not for intravenous use, topical use, or oral administration.
Dose
The recommended dose of ADSTILADRIN 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 [see Dosage and Administration ].
Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN.
Preparation and Handling
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling.
Individuals who are immunosuppressed or immune-deficient, should not prepare, administer, or come into contact with ADSTILADRIN [see Warnings and Precautions ].
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.
Pregnancy
Risk Summary
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.
Lactation
Risk Summary
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.
Females and Males of Reproductive Potential
No nonclinical or clinical studies were performed to evaluate the effect of ADSTILADRIN on fertility.
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating ADSTILADRIN.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with ADSTILADRIN and for 6 months following the last dose.
Males
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.
Pediatric Use
Safety and effectiveness of ADSTILADRIN in pediatric patients have not been established.
Geriatric Use
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.
Gender-specific Use
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 [see Description ].
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, 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
Immunocompromised persons, including those receiving immunosuppressant therapy, may be at risk for disseminated adenovirus infection because of the possible presence of low levels of replication-competent adenovirus in ADSTILADRIN. Individuals who are immunosuppressed or immune-deficient should not come into contact with ADSTILADRIN.