Description
Description
Active ingredient: Tretinoin (all-trans retinoic acid)
1 capsule contains 10 mg of tretinoin (all-trans retinoic acid)
VESANOID is the brand innovator for Tretinoin (all-trans retinoic acid) FDA approved.
Indications:
VESANOID (tretinoin) is indicated for induction of remission in acute promyelocytic leukemia (APL; FAB classification AML-M3).
This treatment is intended for previously untreated patients as well as patients who relapse after standard chemotherapy (anthracycline and cytosine arabinoside or equivalent therapies) or patients who are refractory to chemotherapy.
The association of tretinoin with chemotherapy increases the duration of survival and reduces the risk of relapse compared to chemotherapy alone.
Dosage and route of administration
A total daily dose of 45 mg/m2 body surface divided in two equal doses is recommended for oral administration. This is approximately 8 capsules per adult dose. It is recommended to take the capsules with a meal or shortly thereafter. There is limited safety and efficacy information on the use of tretinoin in children. Pediatric patients can be treated with 45 mg/m2 unless severe toxicity becomes apparent. Dose reduction should be particularly considered for children with intractable headache. Treatment should be continued until complete remission has been achieved or up to a maximum of 90 days. Due to limited information on patients with hepatic and/or renal insufficiency, the dose will be decreased to 25 mg/m2 as a precautionary measure. Full-dose anthracycline-based chemotherapy should be added to the tretinoin regimen as follows :
- When the leukocyte count at start of therapy is greater than 5 x 10 9 /L, chemotherapy should be started together with tretinoin on day one.
- When the leukocyte count at start of therapy is less than 5 x 10 9 /L but rapidly increases during tretinoin therapy, chemotherapy should be immediately added to the tretinoin regimen if the leukocyte count reaches greater than 6 x 10 9 /L by day five, or greater than 10 x 109 /L by day ten, or greater than 15 x 109 /L by day 28.
- All other patients should receive chemotherapy immediately after complete remission is attained. If chemotherapy is added to tretinoin because of hyperleukocytosis, it is not necessary to modify the dose of tretinoin. After completion of tretinoin therapy and the first chemotherapy course, consolidation anthracyclinebased chemotherapy should be given, for example, a further two courses at 4 to 6 week intervals. In some patients the plasma levels of tretinoin may fall significantly in spite of continued administration.
Method of administration
Oral.
