ISTODAX is indicated for treatment of Cutaneous T-Cell Lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

INN:

Subtype:

Lymphoma, T-Cell, Cutaneous (CTCL)

License:

FDA

Class:

Histone deacetylase inhibitor

R/R

PIhttp://www.celgene.com/content/uploads/istodax-pi.pdf 

1. Approved Labelling

ISTODAX is indicated for treatment of Cutaneous T-Cell Lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

2. Treatment Regimen 

The recommended dose of romidepsin is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the drug.

3. AE/Warnings

Please see section 5 of the PI.

 

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