Generic Name and Formulations:
Irinotecan HCl 20mg/mL; soln for IV infusion after dilution.
Indications for CAMPTOSAR:
Metastatic colorectal cancer, as 1st line therapy with 5-FU and leucovorin, or as monotherapy if disease recurs or progresses after fluorouracil-based therapy.
Give by IV infusion over 90 mins. Combination therapy: 125mg/m2 on days 1, 8, 15, 22; or, 180mg/m2 on days 1, 15, 29; both: give every 6 weeks. Monotherapy: 125mg/m2 on days 1, 8, 15, 22, then 2-week rest; or, 350mg/m2 once every 3 weeks. Elderly (≥70yrs), pelvic or abdominal radiotherapy, performance status of 2, increased bilirubin, homozygous UGT1A1*28 allele, or toxicity: reduce initial dose. May pretreat with antiemetics and/or atropine. Dose modifications: see full labeling.
Not for use as part of 5-FU/LV "Mayo Clinic" regimen except in certain circumstances (see full labeling). If late diarrhea occurs, promptly treat with loperamide; suspend until bowel function normalizes. Monitor blood counts; suspend if neutropenic fever or ANC <1000/mm3 occurs. Volume depleted. Renal or hepatic impairment. Dialysis: not recommended. Gilbert's syndrome or abnormal glucuronidation. Discontinue if interstitial pulmonary disease occurs. Avoid extravasation. Elderly. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.
Concomitant irradiation: not recommended. Concomitant CYP3A4 inducers (eg, phenytoin, phenobarbital, carbamazepine, rifampin, St. John's wort), CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole), UGT1A1 inhibitors (eg, atazanavir, gemfibrozil): not recommended. Discontinue strong CYP3A4 inhibitors at least 1 week before initiating irinotecan. Avoid diuretics or laxatives if diarrhea occurs. May affect neuromuscular blocking agents.
Nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia, anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, alopecia, weight decrease; hypersensitivity reactions (discontinue if occurs), pulmonary toxicity.
Testing considerations: UGT1A1 mutation analysis
Single-dose vial (2mL, 5mL, 15mL)—1