Sugammadex

Renal Impairment This drug is known to be substantially excreted by the kidney. Effect of mild or moderate renal impairment (creatinine clearance ≥30 and ≤80 mL/min) on sugammadex PK and PD was obtained from a study in elderly patients [see Use in Specific Populations] . Although clearance of drug decreased in elderly subjects with mild and moderate renal impairment, there was no significant difference in the ability of sugammadex to reverse the pharmacodynamic effect of rocuronium.

Hence, no dosage adjustment is necessary for mild and moderate renal impairment. Sugammadex Injection is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min) due to insufficient safety information combined with the prolonged and increased overall exposure in these patients [see Warnings and Precautions, Clinical Pharmacology] .

Hepatic Impairment Sugammadex Injection is not metabolized nor excreted by the liver; therefore, dedicated trials in patients with hepatic impairment have not been conducted. Exercise caution when administering Sugammadex Injection to patients with hepatic impairment accompanied by coagulopathy or severe edema [see Warnings and Precautions (5.10, 5.14)] .

Important Dosing and Administration Information Sugammadex Injection dosing is based on actual body weight. Sugammadex Injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.

Doses and timing of Sugammadex Injection administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred. Administer Sugammadex Injection intravenously as a single bolus injection. The bolus injection may be given over 10 seconds, into an existing intravenous line.

Sugammadex Injection has only been administered as a single bolus injection in clinical trials. From the time of Sugammadex Injection administration until complete recovery of neuromuscular function, monitor the patient to assure adequate ventilation and maintenance of a patent airway. Satisfactory recovery should be determined through assessment of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.

The recommended dose of Sugammadex Injection does not depend on the anesthetic regimen. Preparation of dilution for pediatric use: Sugammadex Injection 100 mg/mL may be diluted to a concentration of 10 mg/mL, using 0.9% sodium chloride injection, USP, to increase the accuracy of dosing in the pediatric population. To prepare the required dose, aseptically transfer all the contents of the 2 mL vial of Sugammadex Injection 2-mL single-dose vials containing 200 mg sugammadex (100 mg/mL) to a bottle (or intravenous bag) containing 18 mL of 0.9% sodium chloride injection, to achieve a final concentration of 10 mg/mL sugammadex.

The diluted solution should be used immediately. Sugammadex Injection is a single-dose sterile solution without preservatives. Discard any unused portion from the vial.

Drug Compatibility May inject Sugammadex Injection into the intravenous line of a running infusion with the following intravenous solutions: 0.9% sodium chloride 5% dextrose 0.45% sodium chloride and 2.5% dextrose 5% dextrose in 0.9% sodium chloride isolyte P with 5% dextrose Ringer's lactate solution Ringer's solution Ensure the infusion line is adequately flushed (e.g., with 0.9% sodium chloride) between administration of Sugammadex Injection and other drugs.

Do not mix Sugammadex Injection with other products except those listed above. Sugammadex Injection is physically incompatible with verapamil, ondansetron, and ranitidine. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container permit.