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Irinotecan hydrochloide

IRINOTECAN HYDROCHLOIDE

Manufacturer: BluePoint Laboratories

Score: 148.0

Quick Summary

Irinotecan hydrochloride is an antineoplastic agent used in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for the treatment of metastatic carcinoma of the colon or rectum. It is also used as a single agent for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. The drug works by inhibiting topoisomerase I, an enzyme involved in DNA replication. Common adverse reactions include diarrhea, nausea, vomiting, abdominal pain, and neutropenia. The recommended dosage is 125 mg/m2 to 350 mg/m2, depending on the regimen and patient population. Special considerations are needed for patients with reduced UGT1A1 activity, pregnant or nursing women, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Metastatic carcinoma of the colon or rectum
  • Recurrent or progressive disease following initial fluorouracil-based therapy

Important Safety Information

Warning

Diarrhea and myelosuppression can be life-threatening

Contraindications

  • Hypersensitivity to irinotecan hydrochloride or its excipients

Adverse Reactions

  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain
  • Neutropenia

Dosing Recommendations

General Guidance

Reduce dose by one level for patients with prior pelvic/abdominal radiotherapy, performance status of 2, or increased bilirubin levels

Metastatic carcinoma of the colon or rectum

Adult Dose

125 mg/m2 to 350 mg/m2

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Can cause fetal harm
  • Use effective contraception during treatment and for 6 months after the final dose

Nursing Mothers

  • May impair female fertility
  • Use effective contraception during treatment and for 6 months after the final dose

Pediatric Use

  • Not established
  • Pharmacokinetic parameters similar to those in adults

Geriatric Use

  • Closely monitor for diarrhea and myelosuppression
  • Starting dose for patients 70 years and older: 300 mg/m2