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Title Layout Antibiotics – an update on recently approved and investigational drugs Jenner Minto, Pharm.D. Disclosures • Nothing to disclose Learning Objectives • Describe the use of new antibacterial agents in clinical practice • Describe the therapeutic potential of antibiotics currently in development Assessment Questions 1. Which of the following statements regarding new antibacterial agents is true? A. Most are FDA approved to treat a broad range of infections B. Recently approved antibiotics are likely to become first-line agents C. Many have a novel mechanism of action D. Most are reserved for infections caused by organisms that are resistant to existing antibiotics 2. The majority of antibiotics currently in development target which pathogen(s)? A. Gram-positive organisms B. Gram-negative ESKAPE pathogens C. Drug-resistant Neisseria gonorrheae D. Drug-resistant Clostridioides difficile Recently Approved Antibiotics 2018 Approvals Plazomicin (Zemdri®) Evracycline (Xerava®) Sarecycline (Seysara®) Omadacycline (Nuzyra®) Rifamycin (Aemcolo®) 2019 Approvals Imipenem, cliastatin, relebactam (Recabrio®) Pretomanid Lefamulin (Xenleta®) Cefiderocol (Fetroja®) Plazomicin (Zemdri®) Approved • June, 2019 Indications • Complicated urinary tract infections (cUTIs), including pyelonephritis, caused by: E. coli, K. pneumoniae, P. mirabilis, Enterobacter cloacae *Reserved for patients ≥ 18 years of age with limited or no alternative treatment options https://zemdri.com/ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf Plazomicin (Zemdri®) Class • Aminoglycoside Mechanism of Action • Inhibits bacterial protein synthesis by binding the bacterial 30S ribosomal subunit Resistance • Aminoglycoside resistance results from production of aminoglycoside modifying enzymes (AMEs), alteration of ribosomal target, up-regulation of efflux pumps, and reduced permeability due to porin loss • Plazomicin is not inhibited by most AMEs that affect other aminoglycosides https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf Plazomicin (Zemdri®) Spectrum of Activity • Broad activity against β-lactamase and AME-producing Enterobacteriaceae Escherichia coli Klebsiella pneumoniae Proteus mirabilis Enterobacter Cloacae • In vitro susceptibility with unknown clinical significance Citrobacter spp. Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf Plazomicin (Zemdri®) Dosing and Administration Dose • 15mg/kg q24h over 30 minutes • Renal dose adjustment required Duration • 4 to 7 days https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf Plazomicin (Zemdri®) Warnings and Precautions • Nephrotoxicity • Ototoxicity • Neuromuscular Blockade • Fetal Harm • Hypersensitivity reactions • Clostridioides difficile-associated diarrhea • Development of Drug-Resistant Bacteria Black Box Warnings • Nephrotoxicity • Ototoxicity Hearing loss, tinnitus, vertigo • Neuromuscular blockade • Fetal harm https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf Plazomicin (Zemdri®) Adverse Reactions • Decreased renal function (11%) • Diarrhea (7%) • Hypertension (7%) • Nausea/Vomiting (4%) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf Plazomicin (Zemdri®) Use in specific populations Pregnancy Use not recommended No available data Lactation Insufficient data in humans Present in lactating rats, systemic exposure ~ 0.04% maternal exposure Geriatric Use Higher rates of adverse reactions in patients ≥ 65 years 40% of patients in clinical trials were ≥ 65 years 17.2 % of patients in clinical trials were ≥ 75 years Pediatric Use Safety and efficacy not established https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303orig1s000lbl.pdf Plazomicin (Zemdri®) Clinical Trial Data Two comparator-controlled clinical trials in patients with cUTI, including pyelonephritis Compared to Meropenem Non-inferior Composite cure at day 5 (88% vs. 91.4%) Higher % of patients had microbiologic eradication at test-of-cure visit (81.7% vs. 70.1%) Small sample size (n=609) Utility in clinical practice Limited by adverse effects and limited safety & efficacy data https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211672s000,211673s000lbl.pdf Eravacycline (Xerava®) Approved • August, 2018 Indications • Complicated intra-abdominal infections (cIAI) *Reserved for patients ≥ 18 years of age with limited or no alternative treatment options https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf. Eravacycline (Xerava®) Class • Synthetic tetracycline (fluorocycline) Mechanism of Action • Inhibits bacterial protein synthesis by binding to the 30S ribosome and preventing the incorporation of amino acids to the elongating peptide chain https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Eravacycline (Xerava®) Resistance • Intrinsic multi-drug-resistant (MDR) efflux and ribosomal modification • C7 and C9 substitution allows activity against some tetracycline-specific resistance mechanisms Efflux mediated by tet(A), tet(B), and tet(K) Ribosomal protection encoded by tet(M) and tet(Q) • In vitro efficacy against Entreobacteriaceae ESBL producing AmpC producing https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Eravacycline (Xerava®) Spectrum of Activity • Gram-positive bacteria Enterococcus faecalis Enterococcus faecium Staphylococcus aureus Streptococcus anginosus • Gram-negative bacteria Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca • Anaerobic Bacteria Clostridium perfringens Bacteroides spp. Parabacteroides distasonis https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Eravacycline (Xerava®) Dosing and Administration Dose • 1mg/kg every 12h over 60 minutes • Renal dose adjustment not required • Hepatic dose adjustment in patients with severe hepatic impairment (Child Pugh C) 1mg/kg q12h on day 1 1mg/kg q24h beginning on day 2 Duration • 4 to 14 days https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Eravacycline (Xerava®) Warnings and Precautions • Hypersensitivity reactions • Tooth discoloration and enamel hypoplasia • Inhibition of bone growth • Clostridioides difficile - Associated Diarrhea • Potential for microbial overgrowth • Development of drug-resistant bacteria Adverse Reactions • Infusion reactions (7.7%) • Nausea (6.5%) • Vomiting (3.7%) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Eravacycline (Xerava®) Drug interactions • Strong CYP3A4 inducers Decrease exposure of eravacycline • Anticoagulants Eravacycline may depress plasma prothrombin activity Decrease dose of anticoagulant recommended https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Eravacycline (Xerava®) Use in specific populations Pregnancy Avoid in 2nd and 3rd trimester Discoloration of teeth Inhibition of bone formation Lactation Avoid during treatment and for 4 days after discontinuation No human data available Geriatric Use No difference in safety and efficacy Pediatric Use No safety or efficacy data available https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Eravacycline (Xerava®) Clinical Trial Data Two comparator-controlled clinical trials in patients with cUTI, including pyelonephritis • Study 1 Non-inferior to ertapenem Clinical cure (86.8% vs. 87.6%) • Study 2 Non-inferior to meropenem Clinical cure (90.8% vs. 91.2%) Utility in clinical practice Marketed as an alternative to minimize carbapenem use https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf Sarecycline (Seysara®) Approved • August, 2018 Indications • Non-nodular moderate to severe acne in patients 9 years of age and older Limitations of use Efficacy beyond 12 weeks not established Safety beyond 12 months not established https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf. Sarecycline (Seysara®) Class • Tetracycline (fluorocycline) Mechanism of Action • Mechanism for treating acne vulgaris is unknown https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf Sarecycline (Seysara®) Dosing and Administration Dose • Dosing based on body weight 33-54 kg 60 mg 55-84 kg 100mg 85-136 kg 150 mg Duration • 12 weeks, then reassess treatment https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf Sarecycline (Seysara®) Warnings and Precautions • Hypersensitivity reactions • Tooth discoloration and enamel hypoplasia • Inhibition of bone growth • Clostridioides difficile - Associated Diarrhea • Central Nervous System Effects • Intracranial Hypertension • Photosensitivity • Potential for microbial overgrowth • Development of drug-resistant bacteria Adverse Reactions • Nausea (3.1%) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf Sarecycline (Seysara®) Drug interactions • P-gp Substrates Sarecycline may increase concentrations of P-gp substrates Dose reduction may be required • Anticoagulants Sarecycline may depress plasma prothrombin activity Decrease dose of anticoagulant recommended https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209521s000lbl.pdf Sarecycline (Seysara®) Use in specific populations Pregnancy Avoid in 2nd and 3rd trimester Discoloration of teeth Inhibition of bone formation
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