Sign Out
General: Since it is a cytotoxic anticancer drug, procedures for proper handling and disposal should be followed. In case of extravasation, monitor infusion site for signs of inflammation.
Irinotecan Injection can induce both early (less than 24 hour onset after dosing) and late forms (24 hours or longer onset after dosing) of diarrhea that appear to be mediated by different mechanisms.
Myelosuppression.
Temporarily discontinue if neutropenic fever occurs or if the ANC drops below 500/mm3. Reduce subsequent dosing if counts fall as follows: Total WBC count (2000/mm3); neutrophil count (1000/mm3); hemoglobin (8 gm/dl); platelet count (100,000/mm3).
Previous cytotoxic or radiation (abdominal or pelvic) therapy.
Elderly (over 65-years).
Renal impairment.
Hepatic impairment (serum bilurubin > 2 mg/dl, transaminase > 3 times upper limit of normal if no liver metastases or > 5 times upper limit of normal if with liver metastases).
History of bleeding disorders.
Carcinogenesis, Mutagenesis and Impairment of Fertility: No long-term animal studies have been performed to evaluate the carcinogenic potential of irinotecan. Rats were however, administered intravenous doses of 2 mg/kg or 25 mg/kg irinotecan once per week for 13 weeks. There was a significant linear trend with dose for the incidence of combined uterine horn endometrial stromal polyps and endometrial stromal sarcomas.
Neither irinotecan nor SN-38 was mutagenic in the in vitro Ames assay.
No significant adverse effects on fertility and general reproductive performance were observed after intravenous administration of irinotecan in doses of up to 6 mg/kg/day to rats and rabbits.
Drug Interactions: The adverse effects of irinotecan injection, such as myelosuppression and diarrhea, would be expected to be exacerbated by other antineoplastic agents having similar adverse effects.
Patients who have previously received pelvic or abdominal irradiation, or both, are at increased risk of severe myelosuppression following the administration.
Lymphocytopenia has been reported. It is possible that the administration of dexamethasone as antiemetic prophylaxis may have enhanced the likelihood of this effect. However, serious opportunistic infections have not been observed.
Hyperglycemia has been observed in patients with a history of diabetes mellitus or evidence of glucose intolerance prior to administration of irinotecan.
The incidence of akathisia in clinical trials was greater in patients (8.5%, 4/47) when prochlorperazine was administration on the same day as irinotecan than when these drugs were given on separate days (1.3%, 1/80).
Patients receiving immunosuppressive chemotherapy should not be vaccinated with live vaccines as there is an increased risk of infection.
Use in Pregnancy & Lactation: Pregnancy: Category D.
Irinotecan hydrochloride injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well controlled studies in pregnant woman. If the drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Woman of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with irinotecan.
As many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that nursing/lactation be discontinued when receiving therapy with irinotecan.
Use in Children: Use of irinotecan in children as well as in pediatric patients is not yet established.
Use in the Elderly: The terminal half-life of irinotecan was 6.0 hrs in patients who were 65 years or older and 5.5 hours in patients younger than 65 years.
