VESANOID CAPSULE 10 MG [SIN08057P]

Product Info

VESANOID CAPSULE 10 MG

[SIN08057P]

4. INDICATIONS AND USAGE
Vesanoid is indicated for induction of remission in acute promyelocytic leukemia (APL; FAB classification AML-M3). 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 any chemotherapy may be treated with all-trans retinoic acid. The association of chemotherapy to all-trans retinoic acid increases the duration of survival, reduces the risk of relapse compared to chemotherapy alone. Maintenance therapy is still under investigation, however a loss of responsiveness to all-trans retinoic acid has been reported among patients maintained on all-trans retinoic acid alone.

5. DOSAGE AND ADMINISTRATION
A total daily dose of 45 mg/m² body surface divided in two equal doses is recommended for oral administration to APL patients. This is approximately 8 capsules per adult dose. It is recommended that pediatric patients 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 for 30 to 90 days until complete remission has been achieved.

Due to the lack of extensive information in case of renal and/or hepatic insufficiency, the dose should be decreased to 25 mg/m² as a precautionary measure.

After completion of remission, a consolidation chemotherapy including anthracycline and cytosine arabinoside should be initiated immediately; for example, three courses in 5 to 6 week intervals.

If there has been a remission with all-trans retinoic acid alone, it is not necessary to modify doses of all-trans retinoic acid if all-trans retinoic acid is used with chemotherapy.

The effect of food on the bioavailability of all-trans retinoic acid has not been characterized. Since the bioavailability of retinoids, as a class, is known to increase in the presence of food, it is recommended that all-trans retinoic acid be administered with a meal or shortly thereafter.

6. CONTRAINDICATIONS
Vesanoid is contraindicated for use in patients with known hypersensitivity to all-trans retinoic acid or any of its components.

All-trans retinoic acid is teratogenic. It is therefore contraindicated in pregnancy and nursing mothers (see section 8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The use of all-trans retinoic acid in combination with vitamin A is contraindicated (see section 10 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).