For: Urinary Tract Infection
Zemdri (plazomicin) is an aminoglycoside antibacterial for the treatment of complicated urinary tract infections. How Supplied
ZEMDRI injection 500 mg/10 mL (50 mg/mL) is supplied in single-dose, 10-mL vials fitted with flip-off seals with royal blue polypropylene buttons as a clear, colorless to yellow, sterile solution. Each vial contains plazomicin sulfate equivalent to 500 mg plazomicin freebase at a concentration of 50 mg/mL plazomicin in Water for Injection. Each vial contains sodium hydroxide for pH adjustment to 6.5. The solution may become yellow in color; this does not indicate a decrease in potency.
NDC number Package/Volume Units per carton Plazomicin content
71045-010-02 Single use, fliptop vial, 10-mL 10 500 mg in 10 mL (50 mg/mL)
16.2 Storage and Handling
Store ZEMDRI injection 500 mg/10 mL (50 mg/mL) refrigerated at 2�C to 8�C (36�F to 46�F). These highlights do not include all the information needed to use ZEMDRI� safely and effectively. See full prescribing information for ZEMDRI.
ZEMDRI (plazomicin) injection, for intravenous use
Initial U.S. Approval: 2018
WARNING: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE and FETAL HARM
See full prescribing information for complete boxed warning.
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. (5.1)
Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with ZEMDRI. Symptoms of aminoglycoside associated ototoxicity may be irreversible and may not become evident until after completion of therapy. (5.2)
Aminoglycosides have been associated with neuromuscular blockade. During therapy with ZEMDRI, monitor for adverse reactions associated with neuromuscular blockade particularly in high-risk patients. (5.3)
Aminoglycosides, including ZEMDRI can cause fetal harm when administered to a pregnant woman. (5.6, 8.1)
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. (1.1)
As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. (1.1)
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. (1.2)
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. (2.1)
Recommended duration of treatment is 4 to 7 days for cUTI, including pyelonephritis. (2.1)
Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. (2.2)
Recommended initial dosage regimen for patients with renal impairment is shown in the table below. (2.3)
Estimated CLcr * (mL/min) Recommended Dosage for ZEMDRI � Dosing Interval
*
CLcr estimated by the Cockcroft-Gault formula. (2.3)
�
Calculate dosage using Total Body Weight (TBW). For patients with TBW greater than IBW by 25% or more, use adjusted body weight. (2.3)
Greater than or equal to 60 to less than 90 15 mg/kg Every 24 hours
Greater than or equal to 30
to less than 60 10 mg/kg Every 24 hours
Greater than or equal to 15
to less than 30 10 mg/kg Every 48 hours
See Full Prescribing Information for subsequent dosage adjustment based on changes in renal function or Therapeutic Drug Monitoring (TDM). (2.3, 2.4).
See Full Prescribing Information for instructions on preparation of the solution, stability in intravenous fluids and drug compatibilities. (2.5, 2.6, 2.7)
DOSAGE FORMS AND STRENGTHS
ZEMDRI injection 500 mg/10 mL (50 mg/mL) is a single-dose vial containing plazomicin sulfate equivalent to 500 mg plazomicin free base. (3)
CONTRAINDICATIONS
ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside (4, 5.4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions, including anaphylaxis: Reported for aminoglycosides. If an allergic reaction occurs, discontinue ZEMDRI. (5.4)
Clostridium difficile-Associated Diarrhea: Reported for nearly all systemic antibacterial drugs. Evaluate if diarrhea occurs. (5.5)
ADVERSE REACTIONS
Most common adverse reactions (? 1% of patients treated with ZEMDRI) are decreased renal function, diarrhea, hypertension, headache, nausea, vomiting and hypotension. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Achaogen at 1-833-252-6402 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2018
