Gemcitabine
Dosing in kidney impairment
Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration ]. [See table below.] 2.5 Dosage Modifications for Non-Hematologic Adverse Reactions Permanently discontinue AVGEMSI for any of the following: Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions ] Unexplained dyspnea or evidence of severe pulmonary toxicity [see Warnings and Precautions ] Hemolytic uremic syndrome (HUS) or severe renal impairment [see Warnings and Precautions ] Severe hepatic toxicity [see Warnings and Precautions ] Capillary leak syndrome (CLS) [see Warnings and Precautions ] Posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions ] Withhold AVGEMSI or reduce dose by 50% for other Grade 3 or 4 non-hematological adverse reactions until resolved.
Preparation and administration
Preparation AVGEMSI is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Exercise caution and wear gloves when preparing AVGEMSI solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if AVGEMSI contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption.
After first use, store the partially used multiple-dose vial in the original carton, refrigerated at 2°C to 8°C (36ºF to 46°F) for up to 14 days. Discard unused portion of the multiple-dose vial after 14 days. Preparation for Intravenous Infusion Administration Withdraw the calculated dose from the vial. Prior to administration, dilute the appropriate amount of drug with 0.9% Sodium Chloride Injection, USP to a minimum final concentration of at least 0.1 mg/mL.
Store diluted AVGEMSI solution for no more than 24 hours at controlled room temperature of 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Discard AVGEMSI solution if not used within 24 hours after dilution. Visually inspect for particulate matter or discoloration prior to administration and discard if particulate matter or discoloration is observed.
No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.