tretinoin
Retin-A · Atralin · Renova
1 INDICATIONS AND USAGE Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.
Mechanism. 12.1 Mechanism of Action Tretinoin induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo . In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR). The exact mechanism of action of tretinoin in APL is unknown.
FDA requires a boxed warning on this label. See full prescribing information.
What stands out in the reports.
ROR = reporting odds ratio (log-schaal). Een waarde boven 1 betekent dat het symptoom vaker wordt gemeld voor dit product dan voor alle andere producten samen. Dit meet hoeveel het opvalt in meldingen — geen causaliteit, geen risico.
Tretinoin zeigt überproportional häufig gemeldete Nebenwirkungen wie „Maternale Exposition während der Schwangerschaft" (ROR 8.9), „Blasenbildung" (ROR 8.8) und „Hautschälung" (ROR 7.9). Dies ist logisch, da Tretinoin ein Retinoid ist, das die Zellproliferation und -differenzierung beeinflusst, was zu Hautreizungen und Teratogenität führen kann. „Häufig gemeldet" bedeutet nicht „häufig verursacht". Dies ersetzt keinen medizinischen Rat.
Dit vervangt geen medisch advies.
No signals currently mapped to the label.
Report volume per quarter.
No recalls on record.