Plazomicin

1. INDICATIONS AND USAGE ZEMDRI is an aminoglycoside antibacterial indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. To reduce the development of drug-resistant bacteria and maintain effectiveness of ZEMDRI and other antibacterial drugs, ZEMDRI should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms.

ZEMDRI is an antibacterial drug.

2. DOSAGE AND ADMINISTRATION Administer ZEMDRI 15 mg/kg every 24 hours by intravenous (IV) infusion over 30 minutes to patients 18 years of age or older with creatinine clearance greater than or equal to 90 mL/min. Recommended duration of treatment is 4 to 7 days for cUTI, including pyelonephritis. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. Recommended initial dosage regimen for patients with renal impairment is shown in the table below. Estimated CLcr CLcr estimated by the Cockcroft-Gault formula. (mL/min) Recommended Dosage for ZEMDRI Calculate dosage using Total Body Weight (TBW). For patients with TBW greater than IBW by 25% or more, use adjusted body weight.

4. CONTRAINDICATIONS ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside. ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside

Boxed warning (nephrotoxicity, ototoxicity, neuromuscular blockade and fetal harm): Nephrotoxicity has been reported with ZEMDRI. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. 5. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions, including anaphylaxis: Reported for aminoglycosides. If an allergic reaction occurs, discontinue ZEMDRI. Clostridium difficile -Associated Diarrhea: Reported for nearly all systemic antibacterial drugs. Evaluate if diarrhea occurs.

6. ADVERSE REACTIONS The following important adverse reactions are discussed in greater detail in the Warnings and Precautions section: Nephrotoxicity Ototoxicity Neuromuscular Blockade Fetal Harm Hypersensitivity Reactions Clostridium difficile -Associated Diarrhea Most common adverse reactions (≥ 1% of patients treated with ZEMDRI) are decreased renal function, diarrhea, hypertension, headache, nausea, vomiting and hypotension.

Store ZEMDRI injection 500 mg/10 mL (50 mg/mL) refrigerated at 2°C to 8°C (36°F to 46°F).