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Home , Idarucizumab, Sacubitril

7/17/2017

FSHP 2017 ANNUAL MEETING Disclosure #FSHP2017 • I do not have (nor does any immediate family member have) a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or New Drugs any affiliation with an organization whose philosophy could potentially bias my presentation

Innovations in Kati Shell, PharmD, CpH, BCPS

2017 ANNUAL MEETING

Objectives #FSHP2017 #FSHP2017

• Discuss and review drug discovery process • Describe various naming considerations and conventions • Review key points of selected new medications

https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm295487.jpg 2017 ANNUAL MEETING 2017 ANNUAL MEETING

New Drug Approval Process #FSHP2017 Preclinical Work #FSHP2017 • It takes about 12 years to get a new drug to market at a • Drug is developed by a company cost of approximately $350M • Next step is animal testing • A drug is tested in the lab for an average of 3.5 years prior • Multiple types of animals used to approval for testing on humans • Followed by investigational new drug (IND) application • About one in 1000 compounds actually makes it to human • Specifies composition and manufacturing testing • Explains plan for human testing • FDA- Center for Drug Evaluation and Research (CDER) • FDA ensures humans will not be placed at risk for harm guides the pharmaceutical company at each step of the • Informed consent way • Human Subject Protection

https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm295487.jpg https://www.drugs.com/fda-approval-process.html 2017 ANNUAL MEETING 2017 ANNUAL MEETING

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Clinical Trials #FSHP2017 #FSHP2017

Average Number of patients Focus Duration

20-80 healthy Excretion and Phase I Safety 1 year volunteers metabolism

Compare to 100-300 patient Phase 2 Efficacy 2 years placebo, adverse volunteers effects

Compares 1000-3000 closely Safety and doss/populations Phase 3 3 years monitored patients Efficacy combines with other meds

https://www.drugs.com/fda-approval-process.html https://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm295487.jpg 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Final Approval #FSHP2017 Medwatch #FSHP2017 • After completion of the clinical trials, the manufacturer submits a New Drug Application “NDA” to the FDA for approval • If FDA approves, the FDA assigns a team to review studies of safety and efficacy • Labeling and information for patient and healthcare professionals is reviewed • Manufacturing site is inspected • FDA approval, is available • Phase 4- post marketing monitoring stage • Includes monitoring of adverse events in Medwatch

https://www.drugs.com/fda-approval-process.html https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Novel Drug Naming #FSHP2017 Drug Naming Conventions #FSHP2017 • Three names exist • “olol” for beta blockers, “pril” for ACE inhibitors, “nib” for • Chemical Tyrosine Kinase Inhibitors • Generic named by the USAN Council • Monoclonal Antibodies • Brand name used by company that brought to market for 17 • Prefix years while they have exclusivity of the product • Infix representing target or disease • Involves 5 steps • -t- for tumors, -l- immunomodulator, -b- bacterial • New Chemical Entity “NCE” submission and patent application • Infix indicating the source • generic naming- short, easy to pronounce • -zu- humanized, -u- fully humanized, -xi- chimeric • brand naming- easy to remember, distinct from other names • Stem used as a suffix • FDA review • MAB- , antibody fragments, radiolabeled antibodies • final approval • Example: • Infliximab Distinct Prefix– Infli----xi-Chimeric source--- mab-Monoclonal antibody http://www.medscape.com/viewarticle/414871_5 https://www.ama-assn.org/about/monoclonal-antibodies 2017 ANNUAL MEETING 2017 ANNUAL MEETING

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New Drug Approvals #FSHP2017 New Drug Approvals #FSHP2017 • FDA releases a list of new drugs by year • Selected items that may be used in your hospital • On the site, there is a link to the press release and drug • Bridion ® trials snapshot • Praxbind ® Idarucizumab • Tresiba ® degludec injection • Entresto ® Sacubitril/ • Radicava ® Edaravone • Epclusa ® Sofosbuvir and Velpatasvir • Cinqair ® Reslizumab • Tagrisso ® Osimertinib

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Sugammadex #FSHP2017 Sugammadex #FSHP2017 • First drug approved in new class of medications • Rocuronium and vecuronium are neuromuscular blocking drugs that cause temporary paralysis by interfering with nerve impulses to the muscle and are used to paralyze the vocal cords when patients require an artificial airway, during general anesthesia, or to prevent breathing when a patient is on a ventilator • Sugammadex, in the clinical trials, reversed paralysis in most cases within 5 minutes

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477512.htm Picture: http://www.bing.com/images/search?view=detailV2&ccid=46gXMODH&id=1B6537DD18407DF9C80AE32E8875BFC32BE87C30&thid=OIP.46gXMODHSlKsQgvHNv 2017 ANNUAL MEETING chyQCREs&q=Sugammadex+2015&simid=608053283380004215&selectedIndex=1&ajaxhist=0 2017 ANNUAL MEETING

Sugammadex #FSHP2017 Sugammadex #FSHP2017 • Bridion ® • Adverse effects: Bradycardia (5-13%) Nausea (up to 26%), • Approved 12/2015 pain at injection site (50%) • Category: /selective relaxant binding agent • Pricing: AWP 200mg/20ml vial $114 • Indication: reverse effects of rocuronium and vecuronium used during surgery • Dosing: 2-4mg/kg depending on level of sedation • Storage: Protect from light at 25C • Preparation/administration- IV push over 10 seconds undiluted from vial

Sugammadex: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING Sugammadex: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING

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Idarucizumab #FSHP2017 Idarucizumab #FSHP2017 • $6 Billion Market for oral • In 2014, prescriptions are over 2.2M • With 3,592 Medwatch reports of serious side effects to the FDA, it averaged 14.1 for every 1,000 patient years. • Approximately 75% of these reports involved internal bleeding events

https://www.drugnews.net/news/safest-blood-thinners-xarelto-eliquis-pradaxa/ Image:http://www.bing.com/images/search?view=detailV2&ccid=MiYMPJ3z&id=0B6B9EC0C115FA546A01E7461CE5A2259AADB3DB&thid= 2017 ANNUAL MEETING OIP.MiYMPJ3zEAGUpvKjObpYkwDIDq&q=praxbind&simid=607989447270007798&selectedIndex=3&ajaxhist=0 2017 ANNUAL MEETING

Idarucizumab #FSHP2017 Idarucizumab #FSHP2017 • Praxbind ® • Preparation/administration: Undiluted as an IV bolus over • Approved 10/2015 5-10 minutes via 60mL syringe or as an infusion by hanging the vial. • Category: antidote, monoclonal antibody • Adverse effects: Delirium, hypokalemia, constipation (7%) • Indication: For use in patients who are taking the Pradaxa® (dabigatran) during emergency • Look alike-Sound Alike: IDArubicin, inFLIXimab, ipilimumab situations when there is a need to reverse blood-thinning effects • Pricing: AWP 2.5 gm/50 mL: $2100.00 • Dosing: IV: 5 g (administered as 2 separate 2.5 g doses no more than 15 minutes apart), potential for re-dose in specific situations • Storage: Store intact vials at 36ºF to 46ºF. Do not freeze. Do not shake.

Idarucizumab: Lexi-Comp Online, accessed 5/20/17 Idarucizumab: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Insulin Degludec Injection #FSHP2017 Injection #FSHP2017 • According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes • Long acting are a mainstay of treatment due to daily dosing and less injections for patients

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm464321.htm http://www.bing.com/images/search?view=detailV2&ccid=gu%2fu0Clo&id=8A6B269D8E719BB810013AB59570EB6DF7BBE 2017 ANNUAL MEETING D01&thid=OIP.gu_u0CloW6EXa8Bk2vf50QEsDl&q=Insulin+Degludec 2017 ANNUAL MEETING

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Insulin Degludec Injection #FSHP2017 Insulin Degludec Injection #FSHP2017 • Tresiba ® • Adverse effects: Headache (9-12%) severe hypoglycemia • Approved 9/2015 (10-13%) nasopharyngitis (13-24%) • Category: Long acting insulin • Look Alike-Sound Alike: Tarceva® • Indication: Diabetes mellitus type 1 and 2 • High Alert Medication- double check process • Adult Dosing: individualized dosing per patient • Pearls: U-200 FlexTouch pens do not allow odd numbered depending on indication, administered daily dosing of insulin units; patients requiring odd numbered doses should use the U-100 FlexTouch pen. • Storage: Store unopened pens 36°F to 46°F until expiration date, or at room temperature below 86°F for up to 56 • Pricing: AWP days. • 100 units/mL (3 mL): $106.52 • 200 units/mL (3 mL): $213.05 • Preparation/administration: For subq administration into the thigh, upper arm, or abdomen; do not administer IM or IV, or in an insulin infusion pump Insulin Degludec: Lexi-Comp Online, accessed 5/20/17 Insulin Degludec: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Sacubitril/Valsartan #FSHP2017 Sacubitril/Valsartan #FSHP2017 • is a common condition affecting about 5.1 million people in the United States. • Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs. • It is a leading cause of death in the United States and a leading cause for readmissions in the hospital setting

LexiComp online, sacubitril/valsartan, accessed 5/20/17 images

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453845.htm http://www.bing.com/images/search?view=detailV2&ccid=IgPQh6QU&id=C5815BD402A49C9A735BF838EB846220556755E9&thid=OIP.wYTR8uMWEJvG2p3o- 2017 ANNUAL MEETING YIregEyDL&q=entresto&simid=608015272914519339&selectedIndex=1&ajaxhist=0 2017 ANNUAL MEETING

Sacubitril/Valsartan #FSHP2017 Sacubitril/Valsartan #FSHP2017 • Entresto ® • Adverse effects: hypotension (18%) hyperkalemia (12%) • Approved 7/2015 • Black Box Warning: fetal toxicity • Category: Angiotensin II Receptor Blocker/ • Pearls: Concomitant use of an ACE inhibitor is Inhibitor contraindicated; allow a 36 hour washout period when • Indication: Heart Failure switching from or to an ACE inhibitor. • Dosing: Patients not currently taking an ACE inhibitor or an • Pricing: AWP ARB: Initial: Sacubitril 24 mg and valsartan 26 mg twice • 24-26 mg (60): $485.56 daily. Double the dose every 2 to 4 weeks to the target • 49-51 mg (60): $485.56 maintenance dose of sacubitril 97 mg and valsartan 103 • 97-103 mg (60): $485.56 mg twice daily. • Storage: store at 77F, protect from moisture • administration: with or without food Sacubitril/valsartan: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING Sacubitril/Valsartan: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING

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Edaravone #FSHP2017 Edaravone #FSHP2017 • The Centers for Disease Control and Prevention estimates that approximately 12,000-15,000 Americans have amyotrophic lateral sclerosis (ALS.) • ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles. • The nerves lose the ability to activate certain muscles, which causes the muscles to become weak and leads to paralysis. • ALS is a progressive disease and most patients die from respiratory failure, usually within three to five years from when the symptoms first appear.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm http://www.bing.com/images/search?view=detailV2&ccid=tpcyT2h5&id=680725F6B5F8F40B7409B5BE84EA01FE59E25DF4&thid=OIP.tpcyT2h5OcMIfUoz- 2017 ANNUAL MEETING m7odwD6D6&q=radicava+or+edaravone&simid=608042640448491464&selectedIndex=17&ajaxhist=0 2017 ANNUAL MEETING

Edaravone #FSHP2017 Edaravone #FSHP2017 • Radicava ® • Storage: Store at up to 25°C,Protect from light. Store in • Approved 5/2017 overwrapped package to protect from oxygen degradation until time of use. The oxygen indicator will • Orphan Drug Designation turn blue or purple if the oxygen has exceeded • Provides company various incentives acceptable levels. Once the overwrap package is • Not subject to user fee opened, use within 24 hours. • Category: free radical scavenger • Preparation/administration: administer as prepared • Indication: Treatment of amyotrophic lateral sclerosis 30mg/100mL infusion x2, as total 60 minute infusion (ALS) • Dosing: An initial cycle with daily dosing for 14 days, followed by a 14-day drug-free period • Subsequent cycles with daily dosing for 10 days out of 14- Edaravone prescribing informration. https://www.radicava.com/assets/dist/pdfs/radicava- day periods, followed by 14-day drug-free periods. prescribing-information.pdf https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/Howtoappl Modana, Dan, Edaravone Gets FDA Approval For ALS Treatment. yforOrphanProductDesignation/default.htm 2017 ANNUAL MEETING http://reliawire.com/edaravone-fda-approval-als/ May 6, 2017 2017 ANNUAL MEETING

Edaravone #FSHP2017 Sofosbuvir and velpatasvir #FSHP2017 • Adverse effects: bruising, gait disturbance, headache • According to the Centers for Disease Control, • Pearls- this is the first medication approved for ALS in 20 Approximately 3.5 million persons are currently infected years with Hepatitis C Virus (HCV) • Look alike, Sound Alike: Entacapone • Mortality among HCV-infected persons—primarily adults aged 55–64 years—increased during 2006-2010 • Pricing: $1086/treatment, annual cost would be $145,524 according to Mitsubishi Tanabe Pharma • In 2013, HCV associated deaths exceeded the combined number of deaths with 60 other infectious diseases as underlying causes • First drug to treat all six major forms of HCV.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm 2017 ANNUAL MEETING 2017 ANNUAL MEETING

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Sofosbuvir and velpatasvir #FSHP2017 Sofosbuvir and velpatasvir #FSHP2017 • Epclusa ® • Approved 6/16 • Category: Antihepaciviral NS5A Inhibitor • Indication: Chronic Hepatitis C genotypes 1-6 • Dosing: • Without cirrhosis or with compensated cirrhosis (Child-Pugh class A): One tablet once daily for 12 weeks. • With decompensated cirrhosis (Child-Pugh class B or C): One tablet once daily with concomitant ribavirin for 12 weeks.

http://cdn.hepatitisc.uw.edu/doc/364-1/sofosbuvir-velpatasvir-emepclusaem-bottle.jpg Sofosbuvir/Velpatasvir: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING 2017 ANNUAL MEETING http://www.hepatitisc.uw.edu/page/treatment/drugs/epclusa/prescribing-information

Sofosbuvir and velpatasvir #FSHP2017 Reslizumab #FSHP2017 • Storage: Store below 30°C (86°F). Dispense in original • According to the Centers for Disease Control and container. Prevention, as of 2013, more than 22 million people in the • Administration: Administer with or without food U.S. have asthma, • Adverse effects: Headache (22%), fatigue (15%) • Estimated more than 400,000 asthma-related hospitalizations each year • Boxed warning: Reactivation of Hepatitis B • Pricing: AWP • 400-100 mg (28): $29904.00

Sofosbuvir/Velpatasvir: Lexi-Comp Online, accessed 5/20/17 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491980.htm 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Reslizumab #FSHP2017 Reslizumab #FSHP2017 • Cinqair ® • Approved 6/2016 • Category: Interleukin Receptor-5 Antagonist, monoclonal antibody • Indication: add-on maintenance therapy for asthma, eosinophilic phenotype • Dosing: 3mg/kg IV infusion every 4 weeks • Storage: Intact vials in refrigerator 36°F to 46°F. Protect from light. • Preparation: Withdraw dose from vial and add slowly to 50 mL NS PVC or polyolefin infusion bag. Gently invert the bag; do not shake. http://images.medscape.com/pi/features/drugdirectory/octupdate/TEV06100.jpg Reslizumab: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING 2017 ANNUAL MEETING

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Reslizumab #FSHP2017 Osimertinib #FSHP2017 • Administration: Use an infusion set with an in-line, low • Lung cancer is the leading cause of cancer death in the protein-binding filter, infuse over 20 to 50 minutes United States • Adverse effects: increased creatine phosphokinase (20%, • Estimated 221,200 new diagnoses and 158,040 deaths in transient) 2015, according to the National Cancer Institute. The most • Black Box Warning: Anaphylaxis-0.3% of patients common type of lung cancer, • Look alike Sound Alike: Singulair ® montelukast • Non-Small Cell Lung Cancer (NSCLC) occurs when cancer cells form in the tissues of the lung • Pricing: AWP • 100 mg/10 mL : $1002.00 • EGFR is a protein involved in the growth and spread of cancer cells.

Reslizumab: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Osimertinib #FSHP2017 Osimertinib #FSHP2017 • Tagrisso ® • Approved :11/2015 • Category: Antineoplastic Agent, Epidermal Receptor (EGFR) Inhibitor and Tyrosine Kinase Inhibitor • Indication: Non-small cell lung cancer, metastatic (T790M EGFR mutation-positive) • Dosing: Oral: 80 mg once daily until disease progression or unacceptable toxicity • Storage: Store at 25°C • Preparation: Gloves (single) should be worn during receiving, unpacking, and placing in storage. NIOSH

http://img.medscape.com/thumbnail_library/ht_151113_tagrisso_pill_800x600.jpg recommends single gloving for administration of intact tab Osimertinib: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING 2017 ANNUAL MEETING

Osimertinib #FSHP2017 Osimertinib #FSHP2017 • Preparation of Extemporaneous Suspension: NIOSH • Look alike Sound Alike: Osimertinib may be confused with recommends double gloving, a protective gown, and olaparib, ospemifene. Tagrisso® may be confused with preparation in a controlled device; if not prepared in a Targretin, Tasigna ® controlled device, respiratory and eye/face protection as • High Alert- ISMP classified well as ventilated engineering controls are recommended. • Hazardous- while not on NIOSH 2016 list, this meets criteria for hazardous handling • Administration: with or without food • Pricing: AWP: • Adverse effects: Skin rash (41%), xeroderma (31%), nail • 40 mg (30): $17028.90 disease (25%), pruritus (14%) • 80 mg (30): $17028.90

Osimertinib: Lexi-Comp Online, accessed 5/20/17 Osimertinib: Lexi-Comp Online, accessed 5/20/17 2017 ANNUAL MEETING 2017 ANNUAL MEETING

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References #FSHP2017 References #FSHP2017 • New Drug Approval Process, Drugs.com. https://www.drugs.com/fda-approval- • FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during process.html accessed online 5/20/17 surgery. December 15, 2015 • How Drugs are Developed and Approved, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477512.htm. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandA Accessed online 5/20/17. pproved/default.htm. Last updated 8/15, Accessed online 5/20/17 • FDA approves two new drug treatments for diabetes mellitus. September 25, 2015. • http://www.medscape.com/viewarticle/414871_5 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm464321.htm. Accessed online 5/20/17 • Monoclonal Antibodies. American Medical Association. https://www.ama- assn.org/about/monoclonal-antibodies. Accessed online 5/20/17 • FDA approves new drug to treat heart failure. July 7, 2015 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453845.htm. • LexiComp Online, accessed online 5/20/17 Accessed online 5/20/17 • FDA approves new pill to treat certain patients with non-small cell lung cancer. • FDA approves Epclusa for treatment of chronic Hepatitis C virus infection June 28, 2016. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472525.htm, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm508915.htm. released November 13, 2015. Accessed online 5/20/17 Accessed online 5/20/17 • New Report Ranks Xarelto, Eliquis & Pradaxa By Safety Profile. 11/19/2015. • FDA approves new drug for ALS. May 5, 2017. https://www.drugnews.net/news/safest-blood-thinners-xarelto-eliquis-pradaxa/ accessed https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm. online 5/20/17. Accessed online 5/20/17 • FDA approves Cinqair to treat severe asthma. 3/23/2016. • https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491980.htm. Accessed online 5/20/17

2017 ANNUAL MEETING 2017 ANNUAL MEETING

FSHP 2017 ANNUAL MEETING

New Drugs

Innovations in Medications Kati Shell, PharmD, CpH, BCPS

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