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New Drug Update 2019

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New Drug Update 2019 2/23/2019 NEW DRUG UPDATE 2019 KATIE BOYD, PHARMD, BCPS ASSISTANT PROFESSOR OF PHARMACY PRACTICE SAMFORD UNIVERSITY 1 DISCLOSURES • The presenter has nothing to disclose 2 LEARNING OBJECTIVES • Name the major new chemical entities approved by the FDA in 2018 • Recognize the major therapeutic aspects of new drugs approved by the FDA in 2018 (eg, indications, adverse reactions, drug interactions). • Evaluate the new drugs' place in possible disease state therapy. • Review new warnings added to medications in 2018 3 1 2/23/2019 RARE DISEASES 4 BUROSUMAB-TWZA (CRYSVITA®) Approved 4/17/18 • Mechanism of Action: Crysvita is a human monoclonal IgG1 antibody that binds to and inhibits FGF23, restoring renal phosphate reabsorption in x-linked hypophosphatemia (XLH). • How Supplied: • 10mg/mL, 20mg/mL, 30mg/mL Solution for Injection • Dosage: 1mg/kg SubQ every 4 weeks; max dose 90mg. • Special Considerations • Contraindications: Concomitant use of oral phosphate and active vitamin D analogs; serum phosphorus within or above normal range; severe renal impairment or ESRD 5 MIGALASTAT (GALAFOLD™) Approved 8/10/18 • Mechanism of Action: Binds to and stabilizes alpha-galactosidase A protein • Indicated for Fabry disease with amenable GLA • How Supplied: • 123 mg oral capsule • Dosage: 123 mg once every other day (do not administer on 2 consecutive days) • Special Considerations • Administer on an empty stomach; do not consume food at least 2 hours before or 2 hours after the migalastat dose, although clear liquids may be consumed. • If more than 12 hours have passed since missed dose, skip and administer at next schedule dosing time 6 2 2/23/2019 AMIFAMPRIDINE (FIRDAPSE®) Approved 11/28/2018 • Mechanism of Action: potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults • How Supplied: • 10 mg tablets, functionally scored • Dosage: starting dosage is 15 mg to 30 mg daily taken orally in divided doses (3 to 4 times daily) • Special Considerations • May induce seizures 7 EMAPALUMAB-LZSG (GAMIFANT®) Approved 11/20/2018 • Mechanism of Action: an interferon gamma (IFNγ) blocking antibody • How Supplied: • 10 mg/2 mL and 50 mg/10 mL single-use glass vials • Dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week , concomitantly with dexamethasone • Special Considerations • adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) • with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. 8 STIRIPENTOL (DIACOMIT®) Approved 8/20/2018 • Mechanism of Action: may enhance GABAergic inhibitory neurotransmission in Dravet syndrome • How Supplied: • 250 mg, 500 mg oral capsule • 250 mg, 500 mg oral powder for suspension • Dosage: Titrate to 50 mg/kg daily divided in 2-3 doses. • Special Considerations • Only for use in conjunction with clobazam and valproate 9 3 2/23/2019 WHICH OF THE FOLLOWING RARE DISEASES HAVE A NEW MEDICATION THAT WAS FDA APPROVED IN 2018? • Select all that apply A. Fabry disease B. Lambert-Eaton myasthenic syndrome C. Dravet syndrome D. Hemophagocytic lymphohistiocytosis E. X-linked hypophosphatemia 10 WHICH OF THE FOLLOWING RARE DISEASES HAVE A NEW MEDICATION THAT WAS FDA APPROVED IN 2018? • Select all that apply A. Fabry disease B. Lambert-Eaton myasthenic syndrome C. Dravet syndrome D. Hemophagocytic lymphohistiocytosis E. X-linked hypophosphatemia 11 INFECTIOUS DISEASES 12 4 2/23/2019 BICTEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE (BIKTARVY®) Approved 2/7/18 • Mechanism of Action: Bictegravir: Integrase Inhibitor Emtricitabine & Tenofovir alafenamide: Nucleoside Reverse Transcriptase Inhibitor (NRTIs) for treatment of HIV-1 infection • How Supplied: • 50mg-200mg-25mg oral tablet • Dosage: 1 tablet daily (50mg-200mg-25mg) • Special Considerations: • Contraindications: Coadministration with dofetilide, rifampin • US Boxed Warning: Severe acute exacerbations of HBV have been reported 13 IBALIZUMAB-UIYK (TROGARZO™) Approved 3/6/18 • Mechanism of Action: post-attachment inhibitor. It blocks HIV-1 from infecting CD4 T cells. • How Supplied: • 200mg/1.33mL Solution for Infusion • Dosage: Initial: 2,000mg IV as a single dose, followed by a maintenance dose of 800mg every 14 days thereafter. • Special Considerations: • Do not administer IV push or bolus 14 PLAZOMICIN (ZEMDRI™) Approved 6/25/18 • Mechanism of Action: aminoglycoside antibiotic • For use in complicated urinary tract infections • How Supplied: • 500 mg/10 mL (10 mL) IV solution • Dosage: 15 mg/kg once daily for 4 to 7 days • Special Considerations • For patients with TBW greater than ideal body weight (IBW) by ≥25%, use adjusted body weight (ABW) for dosing. • Trough <3 mcg/mL 15 5 2/23/2019 RIFAMYCIN (AEMCOLO™) Approved 11/16/2018 • Mechanism of Action: a rifamycin antibacterial indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults • How Supplied: • 194 mg tablets packaged in blister cards of 12 tablets contained in a cardboard carton • Dosage: 388mg(two tablets) orally twice daily for three days • Special Considerations • not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli. 16 TAFENOQUINE (KRINTAFEL ®™) Approved 7/20/18 • Mechanism of Action: aminoquinoloine antimalarial • How Supplied: • 150 mg oral tablet • Dosage: 300mg as a single dose on the first or second day of the appropriate antimalarial therapy • Special Considerations • Radical cure (prevention of relapse) of P. vivax malaria in patients ≥16 years of age who are receiving appropriate antimalarial therapy for acute P. vivax infection 17 OMADACYCLINE (NUZYRA™) Approved 10/3/2018 • Mechanism of Action: • Dosage: • Antibiotic of the tetracycline class • Community acquired pneumonia • Treats community acquired pneumonia • 200 mg IV loading dose followed by 100 and skin/skin structure infections mg IV daily OR 300 mg oral daily • How Supplied: • 7-14 days • Skin and skin structure infections • 100 mg vial IV solution, reconstituted • Loading dose: 200 mg IV once OR • 150 mg oral tablet 450 mg oral for 2 days • Maintenance dose: 100 mg IV daily OR 300 mg oral daily • 7-14 days 18 6 2/23/2019 TECOVIRIMAT (TPOXX®) Approved 7/13/18 • Mechanism of Action: antiviral for smallpox • How Supplied: • Tpoxx will be available initially only through the US government's Strategic National Stockpile. • Dosage: 600 mg twice daily for 14 days • Special Considerations • Developed to address the risk of bioterrorism 19 ERAVACYLCLINE (XERAVA™) Approved 8/27/2018 • Mechanism of Action: antibiotic of the tetracycline class • Complicated intra-abdominal infections • How Supplied: • 50 mg vial IV solution, reconstituted • Dosage: 1 mg/kg IV every 12 hours for 4-14 days • Special Considerations • Must be adjusted with strong inducers or with severe hepatic impairment 20 DORAVIRINE (PIFELTRO™) Approved 8/30/2018 • Mechanism of Action: Pyridinone non-nucleoside reverse transcriptase inhibitor for HIV-1 infection • How Supplied: • 100 mg oral tablet • Dosage: 100 mg orally daily • Special Considerations • Must be given in combination with other antiretroviral agents 21 7 2/23/2019 BALOXAVIR MARBOXIL (XOFLUZA™) Approved 10/24/2018 • Mechanism of Action: an antiviral drug with activity against influenza virus • How Supplied: Patient Body Weight (kg) Recommended Oral Dose 40 kg to less than 80 kg Single Dose of 40 mg At least 80 kg Single Dose of 80 mg • Dosage: within 48 hours of influenza symptom onset. XOFLUZA is taken orally as a single dose and may be taken with or without food. • Special Considerations • Avoid dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) 22 SARECYCLINE (SEYSARA™) Approved 10/1/2018 • Mechanism of Action: Antibiotic of the tetracycline class • Moderate to severe non-nodular acne vulgaris • How Supplied: • 60 mg, 100 mg, 150 mg oral tablet • Dosage: (weight based) • 33-54 kg: 60 mg once daily • 55-84 kg: 100 mg once daily • 84-136 kg: 150 mg once daily • Special Considerations • Administer with fluid to decrease risk of esophageal irritation or ulceration 23 WHICH OF THE FOLLOWING IS TRUE REGARDING XOFLUZA? A. It is active within 72 hours of symptoms of influenza virus B. It is a single oral dose C. Must be taken with milk 24 8 2/23/2019 WHICH OF THE FOLLOWING IS TRUE REGARDING XOFLUZA? A. It is active within 72 hours of symptoms of influenza virus B. It is a single oral dose C. Must be taken with milk 25 NEUROLOGICAL DISORDERS 26 ERENUMAB-AOOE (AIMOVIG™) Approved 5/17/18 • Mechanism of Action: Aimovig is a human IgG2 monoclonal antibody that has high affinity binding to the CGRP receptor and antagonizes the receptor. • Migraine Prophylaxis • How Supplied: • 70mg/mL Autoinjector Solution for Injection • Dosage: 70mg SubQ once a month • Special Considerations: • Keep solution out of direct sunlight. Allow solution to come to room temperature. Do not shake. 27 9 2/23/2019 FREMANEZUMAB-VFRM (AJOVY™) Approved 9/14/2018 • Mechanism of Action: Antagonizes CGRP receptor function • Migraine prophylaxis • How Supplied: • 225 mg/1.5 mL prefilled syringe • Dosage: 225 mg SQ monthly or 675 mg SQ every 3 months • Special Considerations • 675 mg dose should be administered in 3 consecutive 225 mg doses 28 GALCANEZUMAB-GNLM (EMGALITY®) Approved 9/27/2018 • Mechanism of Action: Antagonizes CGRP receptor function
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