Administer only to patients with acute promyelocytic leukemia (APL) under the strict supervision of a qualified clinician experienced in the management of patients with acute leukemia.
Appropriate diagnostic and treatment facilities must be readily available in case the patient develops severe toxicity, including respiratory compromise.
Use only when the potential benefits are thought to outweigh the possible risks of therapy.
Retinoic Acid-APL (RA-APL) Syndrome
Clinical manifestations of the syndrome (fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multiorgan failure), with or without leukocytosis, have occurred in about 25% of patients.
Occasionally accompanied by impaired myocardial contractility and episodic hypotension.
Progressive hypoxemia has required endotracheal intubation and mechanical ventilation and may be fatal (due to multiorgan failure).
High-dose corticosteroid therapy administered at first suspicion of the syndrome may reduce morbidity or mortality. (See RA-APL Syndrome under Cautions.)
Leukocytosis
Rapidly evolving leukocytosis occurs in approximately 40% of patients and is associated with an increased risk of life-threatening complications.
High leukocyte count (i.e., >5000/mm3) at diagnosis increases risk of further rapid increase of leukocyte count.
Initiate high-dose corticosteroid treatment immediately if leukocytosis and signs or symptoms of RA-APL syndrome are present together.
Consider adding full-dose chemotherapy (including an anthracycline) to tretinoin. (See Leukocytosis under Cautions.)
Teratogenic Effects
Known teratogen; special precautions and instruction are necessary in women of childbearing potential or pregnant women receiving the drug. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Inform patients of the risks of fetal harm and contraceptive failure.
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