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Adstiladrin Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Vials (20mL)—4
Manufacturer
Generic Availability
NO
Mechanism of Action
Adstiladrin is a non-replicating adenoviral vector-based gene therapy designed to deliver a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to the bladder urothelium. Intravesical instillation of Adstiladrin results in cell transduction and transient local expression of the IFNα2b protein that is anticipated to have anti-tumor effects.
Adstiladrin Indications
Indications
High-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
Adstiladrin Dosage and Administration
Adult
For intravesical instillation only. Premedicate with an anticholinergic. Slowly instill 75mL at a concentration of 3×1011 vp/mL once every 3 months into the bladder via urinary catheter. Retain in bladder for 1hr; reposition patient every ~15mins.
Children
Not established.
Adstiladrin Contraindications
Contraindications
Prior hypersensitivity to interferon alfa.
Adstiladrin Boxed Warnings
Not Applicable
Adstiladrin Warnings/Precautions
Warnings/Precautions
Risk for muscle invasive or metastatic bladder cancer with delayed cystectomy. Consider cystectomy if patients with CIS has incomplete response after 3 months, or if CIS recurs. Risk for disseminated adenovirus infection if immunocompromised or taking immunosuppressants. Immunosuppressed or immune-deficient: avoid contact with Adstiladrin. Advise to use effective contraception during and for 6 months (females of reproductive potential) and for 3 months (males w. female partners of reproductive potential) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.
Adstiladrin Pharmacokinetics
Elimination
Renal.
Adstiladrin Interactions
Not Applicable
Adstiladrin Adverse Reactions
Adverse Reactions
Increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition urgency, increased creatinine, hematuria, decreased phosphate, chills, pyrexia, dysuria.
Adstiladrin Clinical Trials
See Literature
Adstiladrin Note
Not Applicable
Adstiladrin Patient Counseling
See Literature
