An antineoplastic - treats Acute Promyelocytic Leukemia
FDA Alerts
Limit to Qualified Personnel
Administer only under the 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, weight gain, radiographic pulmonary infiltrates, pleural or pericardial effusions), with or without leukocytosis, have occurred in about 25% of patients.
Occasionally accompanied by impaired myocardial contractility and episodic hypotension.
Progessive 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 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.
HIV medicines such as indinavir (Crixivan), saquinavir
(Invirase), ritonavir (Norvir), saquinavir (Invirase), or nelfinavir (Viracept).
This list is not complete and there may be other drugs that can interact
with tretinoin. Tell your doctor about all the prescription and over-the-counter medications you
use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.
Do not start using a new medication without telling your doctor.
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
fever, breathing problems, weight gain, swelling of your hands or
feet;
sudden and severe pain behind your eyes, with nausea,
vomiting, and vision problems;
black, bloody, or tarry stools; or
vomit that looks like blood or coffee grounds.
Less serious side effects may include:
feeling tired or weak;
headache;
fever;
dry skin, mouth, or nose;
bone pain;
nausea and vomiting;
rash or itching;
white patches or sores inside your mouth or on your lips;
increased sweating;
vision problems; or
hair loss or skin changes.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect.
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