Drug Notebook

FDA Alerts

    Experience of Supervising Clinician
  • Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy. Adequate diagnostic and treatment facilities should be readily available to manage complications.
    GI Toxicity
  • Early and late forms of diarrhea may occur; both may be severe. (See Diarrhea under Cautions.)
  • Early diarrhea (onset within 24 hours of administration) is cholinergic in nature (possibly preceded by diaphoresis, flushing, rhinitis, increased salivation, miosis, lacrimation, and abdominal cramping) and may be prevented or ameliorated by administration of atropine.
  • Late diarrhea (occurring >24 hours after administration) may be prolonged, life-threatening, and lead to dehydration, electrolyte imbalance, or sepsis. Treat late diarrhea promptly with intensive oral loperamide therapy.
  • Carefully monitor patients with diarrhea; administer fluid and electrolyte replacement for dehydration and anti-infective therapy for ileus, fever, or severe neutropenia. Interrupt therapy and reduce subsequent doses if severe diarrhea occurs. (See Dosage Modification for Toxicity sections under Dosage and Administration.)

    Myelosuppression
  • Severe myelosuppression may occur. (See Hematologic Effects under Cautions.)

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irinotecan
(eye ri noe TEE kan)

Before receiving irinotecan, tell your doctor if you are using any of the following drugs:

  • a diuretic (water pill);

  • atazanavir (Reyataz);

  • ketoconazole (Nizoral);

  • rifabutin (Mycobutin);

  • rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  • St. John's wort; or

  • seizure medicine such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).

If you are using any of these drugs, you may not be able to receive irinotecan or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect irinotecan. 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:

  • pale skin, easy bruising or bleeding, unusual weakness;

  • loose stools, watery diarrhea;

  • bloody or black stools;

  • runny nose, watery eyes, increased sweating, stomach cramps, and warmth, tingling, or redness under your skin;

  • fever, chills, body aches, flu symptoms;

  • white patches or sores inside your mouth or on your lips;

  • sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance;

  • chest pain, pain or swelling in one or both legs;

  • swelling or irritation where the IV needle is placed;

  • nausea or vomiting that keeps you from drinking enough fluids; or

  • signs of dehydration, such as dry mouth, increased thirst, drowsiness, feeling light-headed, or fainting.

Less serious side effects may be more likely to occur, such as:

  • loss of appetite, constipation;

  • dizziness;

  • redness or peeling of the skin on your hands and feet;

  • cough,

  • temporary hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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