Drug Notebook

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.

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(TRET i noin)

What is the most important information I should know about tretinoin?

Do not use vitamin A supplements or multivitamins that contain vitamin A while you are taking tretinoin. Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Tretinoin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What is tretinoin?

Tretinoin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Tretinoin is used to treat acute promyelocytic leukemia (a type of blood cancer).

Tretinoin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking tretinoin?

Before using tretinoin, tell your doctor if you have high cholesterol, or if you have ever had a reaction to another retinoid (such as Accutane, Retin-A, Renova).

If you have any of these conditions, you may not be able to use tretinoin, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause birth defects, miscarriage, premature birth, or death of a baby. Do not use tretinoin if you are pregnant. Tell your doctor right away if you miss a period or become pregnant during treatment. Use an effective form of birth control while you are using this medication and for at least 1 month after your treatment ends. You may need to have a pregnancy test every month during your treatment. You must use effective birth control while you are taking tretinoin unless you have had a hysterectomy and no longer have a uterus. Use birth control even if you have been infertile (unable to have children) in the past, or if you have gone through menopause. It is not known whether tretinoin passes into breast milk or if it could harm a nursing baby. Do not take tretinoin without telling your doctor if you are breast-feeding a baby.
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