What are the indications and usage?
ISTODAX is a his tone deacetylase (HDAC) inhibitor indicated for:
- Treatment of cutaneous T – cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy
- Treatment of peripheral T – cell lymphoma (PTCL) in patients who have received at least one prior therapy
How supplied/storage and handling ?
ISTODAX is supplied as a kit including a sterile, l yophilized powder in a single – use vial containing 10 mg of romidepsin and 20 mg of the bulking agent, povidone, USP. In addition, each kit include s one sterile d iluent via l containing 2 mL (deliverable volume) of 80% propylene glycol, USP, and 20% dehydrated alcohol, USP
ISTODAX (romidepsin) for injection is supplied as a kit containing 2 vials in a single carton. The carton must be stored at 20° to 25°C, excursions permitt ed between 15° to 30°C. (See USP Controlled Room Temperature.)