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EPIC: Phase 3 study design1,2
cUTI, complicated urinary tract infection; EPIC, Evaluating Plazomicin In cUTI; IV, intravenous; LFU, late follow-up; mMITT, microbiologic modified intent-to-treat; PO, oral; q8h, every 8 hours; q24h, every 24 hours; TOC, test of cure.
aSwitch to an oral antibacterial drug, such as levofloxacin, was allowed after a minimum of 4 and maximum of 7 days of IV therapy for a total of 7 to 10 days of treatment.1
bGiven as a 30-minute infusion.1
cThe mMITT population included all patients who received study medication and had at least 1 baseline uropathogen.1
Co-primary endpoints1
Composite cure definitions1
mMITT population1
CFU, colony-forming unit; cUTI, complicated urinary tract infection; mMITT, microbiologic modified intent-to-treat; TOC, test of cure.
EPIC, Evaluating Plazomicin In cUTI.
References: 1. ZEMDRI® (plazomicin) injection Prescribing Information. Cipla USA, Inc. 2. Wagenlehner FME, Cloutier DJ, Komirenko AS, et. al. Once-Daily Plazomicin for Complicated Urinary Tract Infections. N Engl J Med. 2019 Feb 1;380(8):729-740.
ZEMDRI® (plazomicin) injection is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.
As only limited clinical safety and efficacy data for ZEMDRI are currently available, reserve ZEMDRI for use in cUTI 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.
BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM
ZEMDRI is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Nephrotoxicity
Ototoxicity
Neuromuscular Blockade
Fetal Harm
Hypersensitivity Reactions
Clostridium difficile-Associated Diarrhea
Development of Drug-Resistant Bacteria
The most common adverse reactions (≥1% of patients treated with ZEMDRI) are decreased renal function, diarrhea, hypertension, headache, nausea, vomiting and hypotension.
Please see the full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Cipla Therapeutics, a division of Cipla USA, Inc., at (866) 604-3268 or drugsafety@cipla.com
ZEMDRI (plazomicin) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.
As only limited clinical safety and efficacy data for ZEMDRI are currently available, reserve ZEMDRI for use in cUTI 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 or prevent infections that are proven or strongly suspected to be caused by susceptible microorganisms.
BOXED WARNINGS: NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR BLOCKADE AND FETAL HARM