CAMPTOSAR - NDA 20-571/sNDA 009 Final Package Insert - 4/20/00 3 71 versus time curve (AUC) values for SN-38 are 2% to 8% of irinotecan and SN-38 is 95% bound 72 to plasma proteins compared to approximately 50% bound to plasma proteins for irinotecan (see 73 Pharmacokinetics). >>

CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. Once-Every-3-Week Dosage Schedule: Study ResultsIn the two randomized studies, the EORTC QLQ-C30 instrument was utilized. Measurements of pain, performance status, and weight loss were collected prospectively in the two studies; however, the plan for the analysis of these data was defined retrospectively. Irinotecan hydrochloride injection, USP is available in single-dose amber colored vials in the following package sizes: 2 mL NDC 68001-425-35. • Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.Administer Irinotecan hydrochloride injection as a 90-minute intravenous infusion. [0 /XYZ 42.7199999 16 0 obj 15 0 obj Patients with risk factors should be closely monitored for respiratory symptoms before and during Irinotecan hydrochloride therapy. 0000006469 00000 n Protect from freezing. Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Protect from light. @�b��-�%ḣ59"!w���

The use of gloves is recommended. Irinotecan hydrochloride should be used as recommended in Table 2 In the clinical trials, higher rates of hospitalization, neutropenic fever, thromboembolism, first-cycle treatment discontinuation, and early deaths were observed in patients with a baseline performance status of 2 than in patients with a baseline performance status of 0 or 1.Based on its mechanism of action and findings in animals, Irinotecan hydrochloride can cause fetal harm when administered to a pregnant woman. These symptoms are expected to occur more frequently with higher Irinotecan doses.Late diarrhea (generally occurring more than 24 hours after administration of Irinotecan hydrochloride) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. endobj /CSp /DeviceRGB [0 /XYZ 67.6800000

%PDF-1.5 %���� /ExtGState << The precise contribution of SN-38 to the activity of CAMPTOSAR is thus 74 … ONIVYDE ® (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Administration of Irinotecan to pregnant rabbits at a dose of 6 mg/kg (approximately half of the clinical dose of 125 mg/m2 based on BSA) resulted in similar findings to those in rats, with increased post-implantation loss, decreased live fetuses, and increased external, visceral, and skeletal abnormalities.Irinotecan administered to rat dams for the period following organogenesis through weaning at doses of 6 mg/kg/day caused decreased learning ability and decreased female body weights in the offspring.Irinotecan and its metabolites are present in human milk. >> 876 35 IRINOTECAN HYDROCHLORIDE. [0 /XYZ 54.2399999 The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. In Study 8, second-line Irinotecan therapy was compared with infusional 5-FU-based therapy. Irinotecan hydrochloride injection should be diluted in 5% Dextrose Injection, USP, (preferred) or 0.9% Sodium Chloride Injection, USP, to a final concentration range of 0.12 mg/mL to 2.8 mg/mL.

Several published guidelines for handling and disposal of anticancer agents are available.Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation.