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Patient-Management Guidelines

For patients with metastatic colon or rectal cancer recurring or progressing after 5-FU.

Related Topics

There are a number of factors that influence the toxicity of CAMPTOSAR Injection (irinotecan hydrochloride injection) and can assist in successful patient management:

Patient Selection

  1. Ensure patients are performance status 0 to 2 and have normal biliary function.
  2. Ensure patients are motivated to report any complications immediately.
  3. Ensure patients are aware of the importance of compliance with treatment regimen for diarrhea management.
  4. Caution should be exercised when administering CAMPTOSAR to
    1. Patients greater than65 years of age because of increased risk of diarrhea.
    2. Patients who have previously received pelvic or abdominal irradiation because of increased risk of severe myelosuppression.

Patient Education

  1. Inform and educate the patient and his or her family and care givers about the adverse effects of CAMPTOSAR and how to manage them.
  2. Stress the need for prompt recognition and early intervention of adverse effects (eg, loperimide for diarrhea).
  3. Encourage patients and care givers to seek early medical advice.

Patient Monitoring

  1. Monitor patients to determine the presence of toxicities, especially during the first course of therapy.
  2. Adjust dosing to help manage treatment-related toxicities.

Suggested Side-Effect Management During Administration

Nausea and vomiting: It is recommended that patients receive premedication with antiemetic agents. The suggested management of nausea and vomiting during infusion is 10 mg of dexamethasone plus another antiemetic agent, such as 5-HT3 blocker, (given at least 30 minutes before the administration of CAMPTOSAR begins).

Early-onset diarrhea (occurring during or within 24 hours of the administration of CAMPTOSAR ) is cholinergic in nature. It can be severe but is usually transient. Administration of 0.25 mg to 1 mg of intravenous (IV) atropine, unless clinically contraindicated, should be considered for patients who experience early-onset diaphoresis, abdominal cramps, or diarrhea.

Patients receiving CAMPTOSAR should be instructed to notify a physician immediately if they experience any of the following: vomiting, fever above 101°F, diarrhea, or symptoms of dehydration.

Late-Onset Side-Effect Management

Late-onset diarrhea (beginning more than 24 hours after administration) may be severe. The median onset of late diarrhea occurs 11 days after the first injection of CAMPTOSAR. At the first sign of late diarrhea, patients should take 4 mg of loperamide, then 2 mg every 2 hours until free of diarrhea for at least 12 hours. A dose of 4 mg every 4 hours may be taken at night. Note that this dosage regimen exceeds the usual dosage recommendations for loperamide.

If grade 3 or 4 late-onset diarrhea occurs, administration of CAMPTOSAR should be delayed until the patient recovers and subsequent doses should be decreased (see Recommended Dose Modification Table in the full prescribing information).

Late-onset nausea and vomiting may be treated with antiemetics (eg, prochlorperazine).

Neutropenia was typically transient and noncumulative in clinical trials; growth factors were administered to 5.6% of the patients (17/304) after neutropenia had already occurred. Severe myelosuppression may occur.


The recommended starting dose of CAMPTOSAR is 125 mg/m2 administered as a 90-minute IV infusion. The recommended treatment regimen (one treatment course) is 125 mg/m2 administered once weekly for 4 weeks followed by a 2-week rest. The next treatment course may begin when the patient has adequately recovered. (Please see Recommended Dose Modifications Table in the full prescribing information.)

Pharmacia & Upjohn

© 1996 Pharmacia & Upjohn Company

USX 5833.00 August 1996

Manufactured by PHARMACIA & UPJOHN COMPANY, Kalamazoo, Michigan, USA

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