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New Drugs – Part Ii Jacqueline King, Pharm.D

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New Drugs – Part Ii Jacqueline King, Pharm.D 7/7/2016 ANTIBIOTICS AND ANTIFUNGALS 2016 ANNUAL MEETING NEW DRUGS – PART II JACQUELINE KING, PHARM.D. TARA MCNULTY, CPHT, RPHT PHARMACY OPERATIONS SUPERVISOR PROJECT MANAGER UFHEALTH CANCER CENTER WELLCARE HEALTH PLANS, INC [email protected] [email protected] http://s3.amazonaws.com/readers/2010/05/28/bacteria_1.jpg 2016 ANNUAL MEETING DISCLOSURE BACTERIA • Jacqueline King, Pharm.D. • I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation • Tara, McNulty, CPhT, RPhT • I do not have a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation http://www.dbriers.com/tutorials/wp- content/uploads/2012/12/GramPositiveNegative21.jpg https://microbewiki.kenyon.edu/images/1/1b/Gram.jpg 2016 ANNUAL MEETING 2016 ANNUAL MEETING OBJECTIVES ANTIBIOTIC RESISTANCE • Explore new medications for the treatment of infectious diseases, including HIV • Antibiotic resistance occurs when an antibiotic has lost and Hepatitis C its ability to control or kill bacterial growth • Analyze the impact of the new agents within clinical practice • Causes of antibiotic resistance: Drugs not appropriately prescribed, not completing courses of antibiotics, • Utilize drug information to prevent medication misadventures human to human contact • First “superbug” in the United States http://www.cdc.gov/drugresistance/about.html 2016 ANNUAL MEETING 2016 ANNUAL MEETING 1 7/7/2016 GENERATING ANTIBIOTICS INCENTIVES NOW DALVANCE Incentives for creating antibiotics and antifungals • Generic Name: Dalbavancin •Extends the exclusivity for new antibiotics • Class: Glycopeptide Antibiotic •Speeds development and review of new antibiotics • Use: Acute bacterial skin and skin structure infections (ABSSSI) •Development of updated clinical trial guidance • Mechanism: Prevents cross-linking and interferes with cell wall synthesis •Requires listing of pathogens that pose a threat to public health • Dosage Form(s): Intravenous 500 mg vial •Products given Qualified Infectious Disease Product (QIDP) designation Dalvance [package insert]. Allergan Pharmaceuticals, Inc. Parsippany, NJ; January 2016. http://www.allergan.com/assets/pdf/dalvance_pi. Accessed May 31, 2016 https://www.congress.gov/bill/112th-congress/house-bill/2182 2016 ANNUAL MEETING 2016 ANNUAL MEETING LIST OF QUALIFIED PATHOGENS DALVANCE • Dose: GRAM POSITIVE GRAM NEGATIVE • Single dose regimen 1,500 mg as a single dose • Clostridium difficile • Acinetobacter species • Two dose regimen: 1,000 mg as an initial dose, then 500 mg as a single dose 1 week • Enterococcus species • Burkholderia cepacia complex later • Staphylococcus aureus • Campylobacter species • Adverse Effects: GI side effects, headache • Streptococcus agalactiae • Enterobacteriaceae • Streptococcus pneumoniae • Helicobacter pylori • Preparation: • Streptococcus pyogenes • Neisseria gonorrhoeae • Reconstitute with 25 mL of SWFI or D5W for each 500 mg vial • Neisseria meningitidis • Swirl gently to mix • Pseudomonas species • Total time from reconstitution to administration should be less than 48 hours • Vibrio cholerae Dalvance [package insert]. Allergan Pharmaceuticals, Inc. Parsippany, NJ; January http://raps.org/regulatory-focus/news/2014/06/19395/FDA-Final-Rule-On-Qualifying-GAIN-Act-Pathogens/ 2016. http://www.allergan.com/assets/pdf/dalvance_pi. Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING LIST OF QUALIFIED PATHOGENS DALVANCE Pearls FUNGUS/MOLD/YEAST MYCOBACTERIA •One time dose • Aspergillus species • Mycobacterium tuberculosis complex •Long half life means medication last in the system for weeks • Candida species • Non-tuberculous mycobacteria species •Renal adjustment necessary • Coccidioides species •Spectrum: • Cryptococcus species • ABSSSI: Staphylococcus aureus (including methicillin-susceptible and methicillin- resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, S. dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus), and Enterococcus faecalis (vancomycin-susceptible strains) Dalvance [package insert]. Allergan Pharmaceuticals, Inc. Parsippany, NJ; January http://raps.org/regulatory-focus/news/2014/06/19395/FDA-Final-Rule-On-Qualifying-GAIN-Act-Pathogens/ 2016. http://www.allergan.com/assets/pdf/dalvance_pi. Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING 2 7/7/2016 SIVEXTRO ORBACTIV • Generic Name: Tedizolid • Dosage Form(s): Intravenous 400 mg vial • Class: Oxazolidinone Antibiotic • Dose: 1,200 mg as a single dose • Use: Acute bacterial skin and skin structure infections • Adverse Effects: GI side effects, Headache • Mechanism: Inhibits protein synthesis by binding to the 50S • Preparation: bacterial ribosomal subunit which prevents the formation of the • Reconstitute each 400 mg vial with 40 mL SWFI and swirl 70S initiation complex that is essential for the bacterial translation process • Withdraw 120 mL from the 1000 mL D5W bag • Add 120 mL from three reconstituted vials Orbactiv [package insert]. The Medicines Company. Parsippany, Sivextro [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; July 2015. NJ; January 2016. http://www.orbactiv.com/pdfs/orbactiv- http://www.merck.com/product/usa/pi_circulars/s/sivextro/sivextro_pi.pdf. Accessed May 31, 2016 prescribing-information.pdf. Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING SIVEXTRO ORBACTIV • Dosage Form(s): Intravenous 200 mg vial and 200 mg tablet Pearls • Dose: IV, Oral 200 mg once daily •One time dose • Adverse Effects: GI Effects, headache •Long half life makes medication last in the system for weeks • Preparation: Reconstitute with 4 mL SWFI. Swirl gently to mix then further dilute •No renal adjustments (not studied) in 250 mL of normal saline. •Spectrum: • ABSSSI: Staphylococcus aureus (including methicillin-susceptible and methicillin- resistant isolates); Streptococcus pyogenes; Streptococcus agalactiae; Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus); and Enterococcus faecalis (vancomycin-susceptible isolates only) Orbactiv [package insert]. The Medicines Company. Parsippany, Sivextro [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; July 2015. NJ; January 2016. http://www.orbactiv.com/pdfs/orbactiv- http://www.merck.com/product/usa/pi_circulars/s/sivextro/sivextro_pi.pdf. Accessed May 31, 2016 prescribing-information.pdf. Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING ORBACTIV ZERBAXA • Generic Name: Oritavancin • Generic Name: Ceftolozane and Tazobactam • Class: Glycopeptide antibiotic • Class: Cephalosporin Antibiotic • Use: Acute bacterial skin and skin structure infection • Use: Complicated Intra-abdominal Infection (cIAI) and Complicated Urinary Tract Infection (cUTI) • Mechanism: Inhibits cell wall synthesis in several ways • Inhibits the polymerization step by binding to peptidoglycan precursors • Mechanism: • Inhbits crosslinking by binding to bridging segments • Ceftolozane: Inhibits bacterial cell wall synthesis by inhibiting the final step of peptidoglycan synthesis • Disrupts bacterial membrane integrity • Tazobactam: Irreversibly inhibits certain beta-lactamases Orbactiv [package insert]. The Medicines Company. Parsippany, NJ; Zerbaxa [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; July January 2016. http://www.orbactiv.com/pdfs/orbactiv-prescribing- 2015. https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf. information.pdf. Accessed May 31, 2016 Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING 3 7/7/2016 ZERBAXA AVYCAZ • Dosage Form(s): Intravenous 1.5 g vial • Dosage Form(s): Intravenous 2.5 g vial • Dose: • Adult Dose: • cIAI: 1.5 g every 8 hours with metronidazole • cIAI: 2.5 g every 8 hours with metronidazole • cUTI: 1.5 g every 8 hours • cUTI: 2.5 g every 8 hours • Adverse Effects: CNS Effects, GI Effects • Adverse Effects: Anxiety (10%), Gastrointestinal, • Preparation: Add 10 mL of manufacturer recommended diluent to the vial which • Preparation: Add 10 mL of manufacturer recommended diluent to the vial which results in a concentration of ceftolozane 88 mg/mL and tazobactam 44 mg/mL results in a concentration of ceftazidime 167 mg/mL and avibactam 42 mg/mL approximately Zerbaxa [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; July Avycaz [package insert]. GlaxoSmithKline Manufacturing, Inc. Cincinnati, 2015. https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf. OH; September 2015. http://www.allergan.com/assets/pdf/avycaz_pi. Accessed May 31, 2016 Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING ZERBAXA AVYCAZ Pearls Pearls: •Zerbaxa 1.5 g: Ceftolozane 1 g and Tazobactam 0.5 g •Avycaz 2.5 g is Ceftazidime 2 g and 0.5 g Avibactam •Requires renal adjustment •Requires renal adjustment •Protect vials from light •Protect vials from light •Stability of 7 days after mixing when refrigerated •Stability of 24 hours after mixing when refrigerated •Spectrum: •Spectrum: • cIAI: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K. pneumoniae, • cIAI - Enterobacter cloacae, Escherichia coli, Klebsiella
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