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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 (tretinoin) 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 (tretinoin) .
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 (tretinoin) 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 (tretinoin) , alternative therapy appropriate for acute myelogenous leukemia should be considered.
VESANOID (tretinoin) 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 (tretinoin) , unless otherwise contraindicated.
VESANOID (tretinoin) is supplied as 10 mg capsules, two-tone (lengthwise), orange-yellow and reddish-brown and imprinted VESANOID (tretinoin) 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: Pharmaceuticals Roche Laboratories Inc. 340 kingsland street, Nutley, New Jersey 07110- 1199. Revised: July 2008. FDA Rev date: 7/1/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/24/2008
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