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Camptosar Generic Name & Formulations
Legal Class
Rx
General Description
Irinotecan HCl 20mg/mL; soln for IV infusion after dilution.
Pharmacological Class
Topoisomerase inhibitor.
How Supplied
Single-dose vial (2mL, 5mL, 15mL)—1
Manufacturer
Camptosar Indications
Indications
Metastatic colorectal cancer, as 1st line therapy with 5-FU and leucovorin, or as monotherapy if disease recurs or progresses after fluorouracil-based therapy.
Camptosar Dosage and Administration
Adult
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.
Children
Not established.
Camptosar Contraindications
Not Applicable
Camptosar Boxed Warnings
Boxed Warning
Diarrhea. Myelosuppression.
Camptosar Warnings/Precautions
Warnings/Precautions
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. Risk of myelosuppression. Infections. 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. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose. Advise males with female partners to use condoms during and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 days after the last dose).
Camptosar Pharmacokinetics
See Literature
Camptosar Interactions
Interactions
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. Consider non-enzyme inducing therapies at least 2 weeks prior to irinotecan initiation. Discontinue strong CYP3A4 inhibitors at least 1 week prior to initiating irinotecan. Avoid diuretics or laxatives if diarrhea occurs. May affect neuromuscular blocking agents.
Camptosar Adverse Reactions
Adverse Reactions
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.
Camptosar Clinical Trials
See Literature
Camptosar Note
Notes
Testing considerations: UGT1A1 mutation analysis
Camptosar Patient Counseling
See Literature
