BlackBoxRX
 
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Irinotecan

Experienced Physician/Equipped Facilities

  • Irinotecan hydrochloride injection should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
  •  Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

 Severe Diarrhea

  • Irinotecan hydrochloride injection can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms. Both forms of diarrhea may be severe.
  • Early diarrhea (occurring during or shortly after infusion of irinotecan hydrochloride injection) may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Early diarrhea and other cholinergic symptoms may be prevented or ameliorated by atropine 
  • Late diarrhea (generally occurring more than 24 hours after administration of irinotecan hydrochloride injection) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide.
  • Patients with diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated or antibiotic therapy if they develop ileus, fever, or severe neutropenia 
  •  Administration of irinotecan hydrochloride injection should be interrupted and subsequent doses reduced if severe diarrhea occurs
  • Severe myelosuppression may occur

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Early diarrhea occurs during or shortly after infusion and is and may be accompanied by other cholinergic symptoms. May be prevented/ameliorated by atropine
  • Late diarrhea occurs 24 hrs after administration and may be life-threatening due to prolonged nature, dehydration, electrolyte imbalance, or sepsis. Should be treated promptly with loperamide
  • Patients with diarrhea should be carefully monitored. Give fluids and electrolyte replacement if dehydration occurs. Administer antibiotics if ileus, fever, or neutropenia develops.
  • If severe diarrhea occurs interrupt therapy and reduce subsequent doses.
  • Black box data revised May 2002

Patient Counseling Information

Package Inserts

Irinotecan

Additional Information

Updated January 2018