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. 1 ) Recommended duration of treatment is 4 to 7 days for cUTI, including pyelonephritis.
1 ) Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. 2 ) Recommended initial dosage regimen for patients with renal impairment is shown in the table below. 3 ) Estimated CLcr CLcr estimated by the Cockcroft-Gault formula.
3 ) (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. 3 ) Dosing Interval 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).
4 ). See Full Prescribing Information for instructions on preparation of the solution, stability in intravenous fluids and drug compatibilities. 1 Recommended Dosage The recommended dosage regimen of ZEMDRI is 15 mg/kg administered every 24 hours by intravenous (IV) infusion over 30 minutes in patients 18 years of age or older and with creatinine clearance (CLcr) greater than or equal to 90 mL/min (Table 1).
The duration of therapy should be guided by the severity of infection and the patient's clinical status for up to 7 days. 4) ].
Table 1:
Dosage Regimen of ZEMDRI in Adults With CLcr CLcr estimated by the Cockcroft-Gault formula using total body weight (TBW). For patients with TBW greater than ideal body weight (IBW) by 25% or more, use IBW. Greater Than or Equal to 90 mL/min cUTI Infection Dosage Regimen Calculate dosage using TBW.
4 × [TBW – IBW]. Duration of Treatment Complicated Urinary Tract Infections, including Pyelonephritis 15 mg/kg every 24 hours 4 to 7 days An appropriate oral therapy may be considered after 4 to 7 days of ZEMDRI therapy to complete a total duration of 7 to 10 days (IV plus oral).
The maximum duration of ZEMDRI for cUTI is 7 days. 6) ] . 3 Dosage in Adult Patients With Renal Impairment The recommended initial dosage regimen of ZEMDRI in adult patients with CLcr greater than or equal to 15 and less than 90 mL/min, estimated by the Cockcroft-Gault formula, is described in Table 2.
4) ] .
Table 2:
Dosage Regimen of ZEMDRI in Adults With CLcr Less Than 90 mL/min Estimated CLcr CLcr estimated by the Cockcroft-Gault formula using total body weight (TBW). For patients with TBW greater than ideal body weight (IBW) by 25% or more, use IBW.
(mL/min) Dosage Calculate dosage using TBW. 4 × [TBW – IBW]. Dosing Interval 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 There is insufficient information to recommend a dosage regimen in patients with CLcr less than 15 mL/min or on renal replacement therapy, including hemodialysis or continuous renal replacement therapy.
4 TDM in cUTI Patients With Renal Impairment For cUTI patients with CLcr greater than or equal to 15 mL/min and less than 90 mL/min, TDM is recommended to maintain plasma trough concentrations below 3 mcg/mL. Measure plazomicin plasma trough concentration within approximately 30 minutes before administration of the second dose of ZEMDRI.
2) ] . 5 Preparation of Diluted Solutions of ZEMDRI ZEMDRI is supplied as a single-dose fliptop 10-mL vial that contains plazomicin sulfate equivalent to 500 mg plazomicin freebase in 10 mL Water for Injection (concentration of 50 mg/mL).
9% Sodium Chloride Injection, USP or Lactated Ringer's Injection, USP to achieve a final volume of 50 mL for intravenous infusion. 7) ] . ZEMDRI does not contain preservatives. Aseptic technique must be followed in preparing the infusion solution.
Discard unused portion of the ZEMDRI vial. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 7 Drug Compatibility Compatibility of ZEMDRI for administration with other drugs has not been established.
ZEMDRI should not be mixed with other drugs or physically added to solutions containing other drugs. Other medications should not be infused simultaneously with ZEMDRI through the same IV line.