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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]

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2016 ANNUAL MEETING

DISCLOSURE • 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

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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

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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 (ABSSSI) •Development of updated clinical trial guidance • Mechanism: Prevents cross-linking and interferes with cell wall synthesis •Requires listing of 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

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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 • • Streptococcus pneumoniae • • Preparation: • Streptococcus pyogenes • • Reconstitute with 25 mL of SWFI or D5W for each 500 mg vial • • Swirl gently to mix • Pseudomonas species • Total time from reconstitution to administration should be less than 48 hours • 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

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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

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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

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ORBACTIV ZERBAXA

• Generic Name: Oritavancin • Generic Name: Ceftolozane and Tazobactam • Class: Glycopeptide antibiotic • Class: Cephalosporin Antibiotic • Use: Acute bacterial skin and skin structure • 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

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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: , , , K. pneumoniae, • cIAI - Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K. pneumoniae, , , Bacteroides fragilis, Streptococcus Proteus mirabilis, stuartii, and Pseudomonas aeruginosa anginosus, Streptococcus constellatus, and Streptococcus salivarius • cUTI - , C. koseri, Enterobacter aerogenes, E. cloacae, Escherichia • cUTI: Escherichia coli, , Proteus mirabilis, and Pseudomonas coli, Klebsiella pneumoniae, Proteus spp, and Pseudomonas aeruginosa aeruginosa Zerbaxa [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; July Avycaz [package insert]. GlaxoSmithKline Manufacturing, Inc. 2015. https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf. Cincinnati, OH; September 2015. Accessed May 31, 2016 http://www.allergan.com/assets/pdf/avycaz_pi. Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING

AVYCAZ CRESEMBA

• Generic Name: Ceftazidime/Avibactam • Generic Name: Isavuconazonium Sulfate • Class: Cephalosporin Antibiotic • Class: Azole Derivative, Antifungal • Use: Complicated Intra-abdominal Infection (cIAI) and Complicated Urinary Tract • Use: Invasive aspergillosis and Invasive Mucormycosis Infection (cUTI) • Mechanism: Prodrug metabolized for isavunconazole in the blood. • Mechanism: Isavuconazole inhibits the systhesis of ergosterol, a key component in antifungal • Ceftazidime: Inhibits bacterial cell wall synthesis by inhibiting the final step of cell membrane peptidoglycan synthesis • Avibactam: Inactivates beta-lactamases and protects ceftazidime from degradation

Avycaz [package insert]. GlaxoSmithKline Manufacturing, Inc. Cresemba [package insert]. Astellas Pharmaceuticals, Inc. Northbrook, IL; April Cincinnati, OH; September 2015. 2015. http://www.astellas.us/docs/cresemba.pdf. Accessed May 31, 2016 http://www.allergan.com/assets/pdf/avycaz_pi. Accessed May 31, 2016

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CRESEMBA HEPATITIS C

• Dosage Form(s): 186 mg oral capsule or 372 mg intravenous vial • Hepatitis is inflammation of the liver • Dose: • Estimated 2.7-3.9 million people living with chronic hepatitis C • Initial: 372 mg every 8 hours for 6 doses • Of every 100 people infected with hepatitis C • Maintenance: 372 mg once daily • 60-70 will go on to develop chronic liver disease • Adverse Effects: Peripheral edema, headache, hypokalemia, GI side effects • 5-20 will develop cirrhosis over the next 20-30 years • Preparation: Dissolve with 5 mL of SWFI and add to a 250 mL bag of normal • 1-5 will die from the consequences of the disease saline or dextrose 5% in water

Cresemba [package insert]. Astellas Pharmaceuticals, Inc. Northbrook, IL; April 2015. http://www.astellas.us/docs/cresemba.pdf. Accessed May 31, 2016 http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section

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CRESEMBA HEPATITIS C

Pearls •372 mg isavuconavonium sulfate dose is equivalent to 200 mg isavulconazole •Requires no renal adjustment •Stability of 24 hours after mixing when refrigerated •IV Mixture will precipitate •Must administer IV formula with an in-line filter of 0.2-1.2 micron size •Capsules must be swallowed whole

Cresemba [package insert]. Astellas Pharmaceuticals, Inc. Northbrook, IL; April 2015. http://www.astellas.us/docs/cresemba.pdf. Accessed May 31, 2015 http://www.frontiersin.org/files/Articles/12721/fmicb-02-00177-r2/image_m/fmicb-02-00177-g001.jpg

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HEPATITIS C ZEPATIER

• Generic Name: Elbasvir and Grazoprevir • Class: Antihepaciviral NS5A Inhibitor and Protease Inhibitor • Use: Chronic hepatitis C infection, with or without cirrhosis, genotype 1 and 4 • Mechanism: • Elbasvir is an inhibitor of HCV NS5A which is essential for viral replication and virion assembly • Grazoprevir is an inhibitor of HCV NS3/4A protease, necessary for cleavage of protein essential for viral replication

Zepatier [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; January 2016. http://www.emcdda.europa.eu/topics/pods/hepatitis-c-treatment http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf. Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING

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ZEPATIER TECHNIVIE

• Dosage Form(s): Oral tablet • Generic Name: Ombitasvir, Paritaprevir, and Ritonavir • Fixed combination: 50 mg elbasvir and 100 mg grazoprevir • Class: Antihepaciviral NS5A inhibit, Protease inhibitor and • Dose: One tablet daily for 12-16 weeks (with or without concomitant ribavirin) cytochrome P450 inhibitor • Adverse Effects: Fatigue, headache, nausea • Use: Chronic hepatitis C genotype 4 • Pearls • Mechanism: • Can be used in HIV-1 co-infection • Ombitasvir inhibits HCV NS5A and interferes with viral RNA replication and virion assembly • AWP: $10,920/14 tablets= $65,520-87,360 per treatment course • Paritaprevir inhibits HCV NS3/4A protease and interferes with HCV • In clinical trials over 90% of patients reached sustained virological response coded poly protein cleavage necessary for replication • Ritonavir is a CYP3A inhibitor that increases peak and trough plasma Zepatier [package insert]. Merck Pharmaceuticals, drug concentrations and overall drug exposure Inc. Whitehouse Station, NJ; January 2016. Technivie [package insert]. AbbVie Inc. North Chicago, IL; http://www.merck.com/product/usa/pi_circulars/z/zep January 2016. http://www.rxabbvie.com/pdf/technivie_pi.pdf. atier/zepatier_pi.pdf. Accessed May 31, 2016 Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING

DAKLINZA TECHNIVIE

• Generic Name: Declatasvir • Dosage Form(s): Oral Tablet • Class: Antihepaciviral NS5A Inhibitor • Fixed Dose: Ombitasvir 12.5 mg, paritaprevir 75 mg, and ritonavir 50 mg • Use: Chronic hepatitis C infection genotype 1 and 3 • Dose: 2 tablets once daily in the morning with/without ribavirin for 12 weeks • Mechanism: Binds to the N-terminus within Domain 1 of • Adverse Effects: Fatigue, nausea, weakness HCV nonstructural protein 5A and inhibits viral RNA • Pearls: replication and virion assembly • AWP: $1,095.04/2 tablets=$91,983.36 • Sustained virological response: greater than 90%

Daklinza [package insert]. Bristol-Myers Squibb Company. Princeton, Technivie [package insert]. AbbVie Inc. North Chicago, IL; NJ; April 2016. http://packageinserts.bms.com/pi/pi_daklinza.pdf. January 2016. http://www.rxabbvie.com/pdf/technivie_pi.pdf. Accessed May 31, 2016 Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING

DAKLINZA HUMAN IMMUNODEFICIENCY VIRUS

• Dosage Form(s): Oral tablet (30, 60, and 90 mg) • Dose: 60 mg daily with concomitant sofosbuvir for 12-24 weeks • Adverse Effects: Fatigue, headache, nausea, anemia • Pearls • Dose adjustments based on drug interactions • AWP: $25,200/28 tablets=$75,600-151,200 per treatment course • Sustained virologic response in 50-100% of patients

Daklinza [package insert]. Bristol-Myers Squibb Company. Princeton, NJ; April 2016. http://packageinserts.bms.com/pi/pi_daklinza.pdf. Accessed May 31, 2016

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HUMAN IMMUNODEFICIENCY VIRUS ODEFSEY

• In 2011, roughly 1.2 million people living with HIV • Dosage Form(s): Oral Tablet (Emtricitabine 200 mg, Rilpivirine 25 mg, and Tenofovir Alafenamide 25 mg) • 86% of patients are diagnosed • Dose: One tablet daily • Only 4 in 10 people with HIV are adequately treated • Adverse Effects: • Only 3 in 10 people reach viral suppression • Emtricitabine/Tenofovir: CNS Effects, GI Side Effects, Respiratory Effects • Life expectancy of a 20 year old taking anti-retroviral therapy: 71 • Rilpivirine: CNS Effects, Hepatic Effects • Pearls • Life expectancy of a 20 year old not taking anti-retroviral therapy: 32 • AWP Cost: $2815.04/30 tablets • Tenofovir Alafenadmide requires a lower dose to achieve the same clinical outcomes, with reduced side effects because of lower overall drug exposure Odefsey [package insert]. Gilead Sciences, Inc. Foster City, CA; March 2016. http://www.gilead.com/~/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.pdf?l http://www.cdc.gov/hiv/library/infographics.html a=en. Accessed May 31, 2016

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HUMAN IMMUNODEFICIENCY VIRUS EVOTAZ

• Generic Name: Atazanavir and Cobicistat • Class: Antiretroviral • Use: HIV-1 Infection (Treatment naïve or treatment experienced) • Mechanism: • Atazanavir binds to the site of HIV-1 protease activity and prevents protein cleavage • Cobicistat is a mechanism-based inhibitor of cytochrome P450 3A

Evotaz [package insert]. Bristol-Myers Squibb Company. Princeton, NJ; January 2016. http://packageinserts.bms.com/pi/pi_evotaz.pdf. Accessed May 31, 2016

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ODEFSEY EVOTAZ

• Generic Name: Emtricitabine, Rilpivirine, and Tenofovir Alafenamide • Dosage Form(s): Oral tablet (Atazanavir 300 mg and Cobicistat 150 mg) • Class: Antiretroviral • Dose: One tablet daily • Use: HIV-1 Infection • Adverse Effects: Hepatic effects, Ophthalmic effects • Mechanism: • Pearls: • Rilpivirine: Binds to reverse transcriptase • AWP: $1,817.51/30 tablets • Emtricitabine: A cytosine analogue which interferes with HIV viral RNA dependent DNA polymerase activity result inhibition of viral replication • Tenofovir Alafenamide Fumurate: An adenosine 5’-monophosphate which interferes with HIV viral RNA dependent DNA polymerase activity result inhibition of viral replication

Odefsey [package insert]. Gilead Sciences, Inc. Foster City, CA; March 2016. Evotaz [package insert]. Bristol-Myers Squibb Company. Princeton, http://www.gilead.com/~/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.pd NJ; January 2016. http://packageinserts.bms.com/pi/pi_evotaz.pdf. f?la=en. Accessed May 31, 2016 Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING

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GENVOYA PREZCOBIX

• Generic Name: Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir • Dosage Form(s): Oral tablet (Darunavir 800 mg and Cobicistat 150 mg) Alafenamide • Dose: One tablet • Class: Antiretroviral • Use: HIV-1 Infection • Adverse Effects: Dermatologic effects, gastrointestinal effects • Mechanism: • Pearls • Emtricitabine: A cytosine analogue which interferes with HIV viral RNA • AWP Cost: $1,862.12 / 30 tablets dependent DNA polymerase activity result inhibition of viral replication • Can cause fat accumulation in specific areas (“buffalo hump”) • Tenofovir Alafenamide Fumurate: An adenosine 5’-monophosphate which interferes with HIV viral RNA dependent DNA polymerase activity result inhibition of viral replication Genvoya [package insert]. Gilead • Elvitegravir: Inhibits catalytic activity of integrase, preventing integration of Sciences, Inc. Foster City, CA; proviral gene in human DNA March 2016. Prezcobix [package insert]. Janssen Therapeutics. Titusville, NJ; March http://www.gilead.com/~/media/files/ 2016. https://www.prezcobixhcp.com/sites/www.prezcobix.com- • Cobicistat is a mechanism-based inhibitor of cytochrome P450 3A pdfs/medicines/hiv/genvoya/genvoy hcp/files/prescribing-information-prezcobix.pdf. Accessed May 31, 2016 a_pi.pdf. Accessed May 31, 2016 2016 ANNUAL MEETING 2016 ANNUAL MEETING

USING DRUG INFORMATION TO PREVENT GENVOYA MISADVENTURES

• Dosage Form(s): Oral tablet (Elvitegravir 150 mg, Cobicistat 150 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg) • Dose: One tablet daily • Adverse Effects: CNS Effects, GI Side Effects • Pearls • AWP Cost: $3,093.19 / 30 tablets

Genvoya [package insert]. Gilead Sciences, Inc. Foster City, CA; March 2016. http://www.gilead.com/~/media/files/pdfs/me dicines/hiv/genvoya/genvoya_pi.pdf. Accessed May 31, 2016

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NEW DRUGS AND ERRORS PREZCOBIX • A Medication Error is "any preventable event that may cause or lead to • Generic Name: Darunavir and Cobicistat inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer," according to the • Class: Antiretroviral National Coordinating Council for Medication Error Reporting and Prevention. • Use: HIV-1 Infection • The FDA reviews about 1400 reports of medication errors per month and • Mechanism: analyzes them to determine the cause and type of error. • Darunavir binds to the site of HIV-1 protease activity and prevents protein cleavage • Medication errors cause one death everyday and injure approximately 1.3 • Cobicistat is a mechanism-based inhibitor of cytochrome million people every year in the United States P450 3A

Prezcobix [package insert]. Janssen Therapeutics. Titusville, NJ; March 2016. https://www.prezcobixhcp.com/sites/www.prezcobix.com- hcp/files/prescribing-information-prezcobix.pdf. Accessed May 31, 2016

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NEW DRUG ERROR PREVENTION DRUG INFORMATION RESOURCES

To assist with medication error prevention, the FDA has New drug availability information can be found in the following implemented the following: resources: •Drug Name Review •FDA website http://www.centerwatch.com/drug-information/fda-approved- drugs/ •Drug Labeling and Packaging •Drugs.com •Bar Code Label Rule •Online Drug Information Websites ( Facts and Comparisons, Lexi-Comp, •Error Analysis Medi-span) •Guidance for Industry •Education

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PHARMACY TECHNICIANS AND NEW DRUG ERROR PREVENTION DRUG INFORMATION RESOURCES Pharmacy technicians play an important role in avoiding medication misadventures. Technicians can assist with this added layer of safety Referring to the drug’s package insert is an excellent resource to familiarize through the following key safety checks: yourself with the following: Key Safety Checks: •Indications of use •Dosage and Administration • Prescription Drop-off • Obtaining critical patient information •Warnings and Precautions • Establishing patient need of medication through patient profile overview • Order Entry •Adverse Reactions • Knowledge of pharmacy terminology and drug names •Drug Interactions • Knowledge of new drug availability • Adherence to standard operating procedures •Storage and Preparation (no workarounds)

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PHARMACY TECHNICIANS AND NEW DRUG ERROR PREVENTION QUESTIONS? Key Safety Checks

• Filling and Dispensing • Correctly reading a label • Avoid short cuts • Separating locations for look-a-like medications or similarly packaged drugs • Point of Sale Review • Verification of patient demographics

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REFERENCES

• Avycaz [package insert]. GlaxoSmithKline Manufacturing, Inc. Cincinnati, OH; September 2015. http://www.allergan.com/assets/pdf/avycaz_pi. Accessed May 31, 2016 • Cresemba [package insert]. Astellas Pharmaceuticals, Inc. Northbrook, IL; April 2015. http://www.astellas.us/docs/cresemba.pdf. Accessed May 31, 2016 • Dalvance [package insert]. Allergan Pharmaceuticals, Inc. Parsippany, NJ; January 2016. http://www.allergan.com/assets/pdf/dalvance_pi. Accessed May 31, 2016 • Daklinza [package insert]. Bristol-Myers Squibb Company. Princeton, NJ; April 2016. http://packageinserts.bms.com/pi/pi_daklinza.pdf. Accessed May 31, 2016 • Evotaz [package insert]. Bristol-Myers Squibb Company. Princeton, NJ; January 2016. http://packageinserts.bms.com/pi/pi_evotaz.pdf. Accessed May 31, 2016 • Genvoya [package insert]. Gilead Sciences, Inc. Foster City, CA; March 2016. http://www.gilead.com/~/media/files/pdfs/medicines/hiv/genvoya/genvoya_pi.pdf. Accessed May 31, 2016

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REFERENCES

• Odefsey [package insert]. Gilead Sciences, Inc. Foster City, CA; March 2016. http://www.gilead.com/~/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.pdf?la=en. Accessed May 31, 2016 • Orbactiv [package insert]. The Medicines Company. Parsippany, NJ; January 2016. http://www.orbactiv.com/pdfs/orbactiv-prescribing-information.pdf. Accessed May 31, 2016 • Prezcobix [package insert]. Janssen Therapeutics. Titusville, NJ; March 2016. https://www.prezcobixhcp.com/sites/www.prezcobix.com-hcp/files/prescribing-information- prezcobix.pdf. Accessed May 31, 2016 • Sivextro [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; July 2015. http://www.merck.com/product/usa/pi_circulars/s/sivextro/sivextro_pi.pdf. Accessed May 31, 2016 • Technivie [package insert]. AbbVie Inc. North Chicago, IL; January 2016. http://www.rxabbvie.com/pdf/technivie_pi.pdf. Accessed May 31, 2016 • Zepatier [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; January 2016. http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf. Accessed May 31, 2016 • Zerbaxa [package insert]. Merck Pharmaceuticals, Inc. Whitehouse Station, NJ; July 2015. https://www.merck.com/product/usa/pi_circulars/z/zerbaxa/zerbaxa_pi.pdf. Accessed May 31, 2016

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REFERENCES

• "U.S. Food and Drug Administration." Novel Drug Approvals for 2015. U.S Food and Drug Administration, n.d. Web. 05 June 2016. . • "U.S. Food and Drug Administration." New Drug Development and Review Process. U.S Food and Drug Administration, 11 Feb. 2016. Web. 05 June 2016. . • "U.S. Food and Drug Administration." Avoiding Medication Mistakes. U.S Food and Drug Administration, n.d. Web. 05 June 2016. .

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A4 Please include citatio for each package insert and study referenced in the presentation. Although in-slide citation was noted, a full reference should be listed at the end Author, 6/7/2016