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Vesanoid (Tretinoin Oral) - Indications and Dosage

 
 



INDICATIONS AND USAGE

VESANOID (tretinoin) capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. VESANOID is for the induction of remission only. The optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with VESANOID.

DOSAGE AND ADMINISTRATION

The recommended dose is 45 mg/m2/day administered as two evenly divided doses until complete remission is documented. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first.

If after initiation of treatment of VESANOID the presence of the t(15;17) translocation is not confirmed by cytogenetics and/or by polymerase chain reaction studies and the patient has not responded to VESANOID, alternative therapy appropriate for acute myelogenous leukemia should be considered.

VESANOID is for the induction of remission only. Optimal consolidation or maintenance regimens have not been determined. All patients should, therefore, receive a standard consolidation and/or maintenance chemotherapy regimen for APL after induction therapy with VESANOID, unless otherwise contraindicated.

HOW SUPPLIED

VESANOID is supplied as 10 mg capsules, two-tone (lengthwise), orange-yellow and reddish-brown and imprinted VESANOID 10 ROCHE. Supplied in high-density polyethylene, opaque bottles of 100 capsules with child-resistant closure (NDC 0004-0250-01).

Store at 15° to 30°C (59° to 86°F). Protect from light.

Distributed by:

Roche Laboratories Inc.

340 Kingsland Street

Nutley, NJ 07110–1199

27899522

Rev. July 2008

Copyright © 1998-2008 by Roche Laboratories Inc. All rights reserved.

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