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Tretinoin Generic Name & Formulations
Legal Class
Rx
General Description
Tretinoin 10mg; soft gelatin caps; contain parabens.
Pharmacological Class
Retinoid.
How Supplied
Contact supplier
Manufacturer
Tretinoin Indications
Indications
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.
Tretinoin Dosage and Administration
Adult
Use only for induction of remission. 45mg/m2 per day in two divided doses until complete remission is documented. Discontinue 30 days after complete remission or after 90 days of treatment, whichever occurs first.
Children
See full labeling.
Tretinoin Contraindications
Not Applicable
Tretinoin Boxed Warnings
Boxed Warning
Experienced physician and institution. Retinoic Acid-APl syndrome. Leukocytosis at presentation and rapidly evolving leukocytosis during tretinoin treatment. Teratogenic effects.
Tretinoin Warnings/Precautions
Warnings/Precautions
Confirm APL diagnosis. Monitor for Retinoic Acid-APL (RA-APL) syndrome, leukocytosis, pseudotumor cerebri, or respiratory compromise. Consider temporarily interrupting therapy if moderate to severe RA-APL syndrome develops. Monitor blood counts, coagulation profile, lipids, liver function; consider temporary withdrawal if tests >5XULN. Pregnancy (Cat.D); obtain negative pregnancy test 1 week before starting treatment, counsel patient about need to use 2 effective methods of contraception during, and 1 month after therapy. Nursing mothers: not recommended.
Tretinoin Pharmacokinetics
See Literature
Tretinoin Interactions
Interactions
Do not administer with Vitamin A. May be potentiated or antagonized by CYP450 enzyme inducers or inhibitors. Caution with anti-fibrinolytic agents; and other agents known to cause pseudotumor cerebri/intracranial hypertension.
Tretinoin Adverse Reactions
Adverse Reactions
Headache, fever, skin/mucous membrane dryness, bone pain, GI upset, rash, mucositis, pruritus, increased sweating, visual disturbances, alopecia; RA-APL syndrome, leukocytosis, pseudotumor cerebri, hypercholesterolemia/hypertriglyceridemia, others.
Tretinoin Clinical Trials
See Literature
Tretinoin Note
Notes
Formerly known under the brand name Vesanoid.
Tretinoin Patient Counseling
See Literature
