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HIGHLIGHTS OF PRESCRIBING INFORMATION - …

HIGHLIGHTS OF PRESCRIBING INFORMATION Recommended initial dosage regimen for patients with renal These HIGHLIGHTS do not include all the INFORMATION needed to use impairment is shown in the table below. ( ). ZEMDRI safely and effectively. See full PRESCRIBING Recommended INFORMATION for ZEMDRI. Estimated CLcr a Dosage for ZEMDRI (plazomicin) injection, for intravenous use (mL/min) ZEMDRI b Dosing Interval Initial Approval: 2018 Greater than or equal to 60 15 mg/kg Every 24 hours WARNING: NEPHROTOXICITY, OTOTOXICITY, to less than 90. NEUROMUSCULAR BLOCKADE and FETAL HARM Greater than or equal to 30 10 mg/kg Every 24 hours See full PRESCRIBING INFORMATION for complete boxed warning. to less than 60. Nephrotoxicity has been reported with ZEMDRI. The risk Greater than or equal to 15 10 mg/kg Every 48 hours of nephrotoxicity is greater in patients with impaired renal to less than 30.

ZEMDRI™ Prescribing Information 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZEMDRI™ safely and effectively.

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