ADSTILADRIN 300000000000 {VP}/mL
nadofaragene firadenovec-vncg · SUSPENSION · Ferring Pharmaceuticals Inc.
ADSTILADRIN is a suspension containing nadofaragene firadenovec-vncg at 300000000000 {VP}/mL, taken intravesical. Manufactured by Ferring Pharmaceuticals Inc..
Key Facts
- Brand Name
- ADSTILADRIN
- Generic Name
- nadofaragene firadenovec-vncg
- NDC Code (Product)
55566-1050- Manufacturer
- Ferring Pharmaceuticals Inc.
- Strength
- 300000000000 {VP}/mL
- Dosage Form
- SUSPENSION
- Route
- INTRAVESICAL
- Marketing Status
- Application #
- BLA125700
- Marketing Start
- 09/05/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 non-replicating adenoviral vector-based gene therapy 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Important Administration Instructions ADSTILADRIN is for intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration. Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN. ( 2.1 ) Administer ADSTILADRIN by intravesical instillation only. ( 2.1 ) ADSTILADRIN is not for intravenous use, topical use, or oral administration. ( 2 ) The dose is 75 mL of ADSTILADRIN at a concentration of 3 x 10 11 viral particles (vp)/mL, instilled once every three (3) months. ( 2.1 ) Allow ADSTILADRIN to be left in the bladder for 1 hour following instillation. ( 2.3 ) 2.1 Dose The recommended dose of ADSTILADRIN is 75 mL at a concentration of 3 x 10 11 viral particles (vp)/mL instilled once every three (3) months into the bladder via a urinary catheter [ see Dosage and Administration (2.2) ]. Premedication with an anticholinergic is recommended before each instillation of ADSTILADRIN. 2.2 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-deficien…
Contraindications
4 CONTRAINDICATIONS ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product [ see Description (11) ]. ADSTILADRIN is contraindicated in patients with hypersensitivity to interferon alfa or any component of the product. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ADSTILADRIN was evaluated in Study CS-003, a multicenter, single-arm, open-label study in 157 U.S. patients [ see Clinical Studies (14 ) ] with high-risk BCG‑unresponsive NMIBC, 107 of whom had BCG-unresponsive carcinoma in situ (CIS) with or without papillary tumors. Patients received 75 mL (3 x 10 11 vp/mL) ADSTILADRIN administered intravesically once every 3 months for …
Frequently Asked Questions
What is ADSTILADRIN used for?
ADSTILADRIN contains nadofaragene firadenovec-vncg. It is a suspension taken intravesical. Consult your doctor for specific uses.
Is ADSTILADRIN a controlled substance?
ADSTILADRIN is not classified as a controlled substance by the DEA.
What is the generic name for ADSTILADRIN?
The generic name for ADSTILADRIN is nadofaragene firadenovec-vncg. There are no other listed brand versions of nadofaragene firadenovec-vncg.
What is the NDC code for ADSTILADRIN 300000000000 {VP}/mL?
The NDC (National Drug Code) for ADSTILADRIN 300000000000 {VP}/mL is 55566-1050, listed by Ferring Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)