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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tretinoin
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(TRET i noin)

What are the possible side effects of tretinoin?

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:

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.

What other drugs will affect tretinoin?

Before taking tretinoin, tell your doctor if you are using any of the following drugs:

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.

Where can I get more information?

Your pharmacist can provide more information about tretinoin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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