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New Drug Approvals 2017-2018: Overview and Clinical Application

This presentation provides an overview of recently approved prescription medications, their indications, mechanism of action, dosing specifications, and clinical applicability. It also discusses important counseling points for each medication.

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New Drug Approvals 2017-2018: Overview and Clinical Application

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  1. New Drug Approvals 2017-2018 Michela Fiori, PharmD, BCACP Ambulatory Care Clinical Pharmacist Specialist EMMC Family Medicine Center & Residency Program Assistant Clinical Professor University of New England College of Pharmacy mfiori@une.edu Maine Pharmacy Association Fall 2018 Convention September 22, 2018 3:30-4:30 pm

  2. Disclosures • I have nothing to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation.

  3. Presentation Overview • BRAND (generic) - indication: • OZEMPIC (semaglutide) – type 2 diabetes • STEGLATRO (ertugliflozin) – type 2 diabetes • RHOPRESSA (netarsudil) – glaucoma/ocular hypertension • BEVYXXA (betrixaban) – VTE prophylaxis • SYMPROIC (naldemedine) – opioid induced constipation • LUCEMYRA(lofexidine) – opioid withdrawal • OLUMIANT (baricitinib) – moderate-severe rheumatoid arthritis • ANNOVERA (segesterone/ethinyl estradiol) – contraception • EPIDIOLEX(cannabidiol) – rare, severe forms of epilepsy

  4. Objectives for Pharmacists • Define the indications for recently approved prescription medications • Explain the mechanism of action and dosing specifications for each medication • Discuss clinical applicability of each new medication • Explain important patient counseling points

  5. Objectives for Technicians • Recall the indications for recently approved prescription medications • Recognize mechanism of action and dosing recommendations for each new medication • State each new medication’s place in therapy • Describe key counseling points

  6. OZEMPIC (semaglutide)

  7. OZEMPIC (semaglutide) • Indication: to improve glycemic control in adults with type 2 diabetes • Approval date: 12/5/2017 • MOA: selective glucagon-like peptide-1 (GLP-1) receptor agonist • Increases glucose-dependent insulin secretion • Decreases inappropriate glucagon secretion • Slows gastric emptying • Dose/Administration: SQ injection in abdomen, thigh, or upper arm • Initial: 0.25 mg once weekly for 4 weeks, then 0.5 mg once weekly for at least 4 weeks • Maintenance: if needed, may titrate to 1 mg once weekly • No dose adjustments necessary • Contraindications: personal/family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN-2) Ozempic[Prescribing Information]. Novo Nordisk. Plainsboro, New Jersey. 2017.

  8. OZEMPIC (semaglutide) • Adverse effects: N/V/D, abdominal pain, constipation • Black Box Warning: thyroid C-cell tumors • Monitoring: renal function, signs/symptoms of pancreatitis or gallbladder disease, triglycerides • Clinical/efficacy trial(s): 7 trials, 4087 patients SUSTAIN 1 – 7 Ozempic [Prescribing Information]. Novo Nordisk. Plainsboro, New Jersey. 2017.

  9. OZEMPIC (semaglutide) Ozempic [Prescribing Information]. Novo Nordisk. Plainsboro, New Jersey. 2017.

  10. American Diabetes Association. Standards of Medical Care in Diabetes 2018.DiabetCare.2018; 41 (Suppl 1): 76.

  11. OZEMPIC (semaglutide) • Clinical applicability: • Data suggests improved A1c reduction and weight loss • Once weekly injectable formulation may improve adherence in some patients • May be appropriate as part of dual or triple therapy regimen • Oral formulation in the pipeline • Cost may be a barrier to access • Availability: • Mainecare: PA required • Cigna, Anthem BCBS: Tier 2 preferred • Aetna: Tier 3 preferred • Savings card available through manufacturer Ozempic [Prescribing Information]. Novo Nordisk. Plainsboro, New Jersey. 2017. American Diabetes Association. Standards of Medical Care in Diabetes 2018. DiabetCare.2018; 41 (Suppl 1): 76.

  12. STEGLATRO (ertugliflozin)

  13. STEGLATRO (ertugliflozin) • Indication: to improve glycemic control in adults with type 2 diabetes • Approval date: 12/19/2017 • MOA: sodium-glucose co-transporter 2 (SGLT2) inhibitor • Reduces renal reabsorption of filtered glucose • Lowers renal threshold for glucose • Increases urinary glucose excretion • Dose/Administration: oral tablet in AM without regard to meals • Initial: 5 mg once daily, may increase to maximum 15 mg • Contraindications: hypersensitivity, severe renal impairment (eGFR <30 ml/min), end-stage renal disease, dialysis Steglatro[Prescribing Information]. Merck. Whitehouse Station, New Jersey. 2017.

  14. STEGLATRO (ertugliflozin)

  15. STEGLATRO (ertugliflozin) • Adverse effects: genital candidiasis, urinary tract infection, hypotension, kidney injury, hypoglycemia • Special Alerts: • August 2018: Fournier’s gangrene • July 2018: acute pancreatitis • Monitoring: renal function, volume status, genital mycotic infections, urinary tract infections, lower limbs and feet, lipids • Clinical/efficacy trial(s): VERTIS SITA2 • Double-blind, placebo-controlled, 463 patients w/DM2 • Background metformin (>1500 mg/day) and sitagliptin (100 mg/day) • Statistically significant decrease in A1c alone or with sitagliptin • Significant decrease in weight, FPG, BP Steglatro [Prescribing Information]. Merck. Whitehouse Station, New Jersey. 2017.

  16. STEGLATRO (ertugliflozin) • Clinical applicability: • Reasonable option for add-on therapy • Modest A1c percentage reduction • ~0.8% (monotherapy vs. placebo) • Not ideal for elderly patients/patients prone to UTI • Availability: • MaineCare: PA required • Cigna, Anthem BCBS, Aetna: not covered • Savings card available through manufacturer

  17. RHOPRESSA (netarsudil)

  18. RHOPRESSA (netarsudil) • Indication: reduction of elevated intraocular pressure (IOP) with open-angle glaucoma or ocular hypertension • Approval date: 12/18/2017 • MOA: rho kinase inhibitor • Increased outflow of aqueous humor via trabecular meshwork • Reduced IOP • Dose/Administration: 0.02% ophthalmic, instill 1 drop into affected eye(s) once daily in the evening (max dose) • Contraindications: none Rhopressa[Prescribing Information]. Aerie Pharmaceuticals Inc. Irvine, Californa. 2017.

  19. RHOPRESSA (netarsudil)

  20. RHOPRESSA (netarsudil) • Warnings/Precautions: • Bacterial keratitis with multiple-dose solution • Remove contact lenses before use • Adverse effects: local application site pain, conjunctival hyperemia, eyelid erythema, blurred vision, increased lacrimation • Monitoring: intraocular pressure Rhopressa [Prescribing Information]. Aerie Pharmaceuticals Inc. Irvine, Californa. 2017.

  21. RHOPRESSA (netarsudil) • Clinical/efficacy trial(s): ROCKET 1-3 • 1,800 participants, compared to timolol • Up to 5 mmHg reductions in IOP • IOP <25 mmHg: reductions in IOP with netarsudil 0.02% similar to timolol 0.5% dosed BID • IOP > 25 mmHg: smaller mean reduction in IOP than with timolol • ~3 mmHg difference, favoring timolol Rhopressa [Prescribing Information]. Aerie Pharmaceuticals Inc. Irvine, Californa. 2017.

  22. RHOPRESSA (netarsudil) • Clinical applicability: • Once daily dosing vs. twice daily dosing with timolol • Well tolerated • Studies did not compare netarsudil with latanoprost • Roclatan (netarsudil/latanoprost 0.02/0.005%) March 2019 • No benefit for patients with >25 mmHg IOP • Availability: • MaineCare: PA required • Cigna: not covered • Anthem BCBS: Tier 3 non-preferred • Aetna: Tier 3 non-preferred • Savings card available through manufacturer Rhopressa [Prescribing Information]. Aerie Pharmaceuticals Inc. Irvine, Californa. 2017.

  23. BEVYXXA (betrixaban)

  24. BEVYXXA (betrixaban) • Indication: venous thromboembolism (VTE) prevention in hospitalized adults with restricted mobility due to acute medical illness • Approval date: 6/23/2017 • MOA: factor Xa inhibitor • Directly inhibits fibrin clot formation through factor Xa inhibition • Dose/Administration: oral capsule, daily with food • Initial: single dose 160 mg • Maintenance: 80 mg once daily • CrCl >15 or <30 ml/min: initial single dose 80 mg, then 40 mg daily • Recommended treatment duration: 35-42 days • Contraindications: active pathological bleeding, hypersensitivity Bevyxxa[Prescribing Information]. Portola Pharmaceuticals, Inc. South San Francisco, Californa. 2017.

  25. BEVYXXA (betrixaban) • Adverse effects: hypertension, headache, hypokalemia, GI distress, epistaxis, hemorrhage, epidural hematoma • Black Box Warning: spinal/epidural hematoma • Monitoring: renal function, signs/symptoms of bleeding • Clinical/efficacy trial(s): APEX trial • 3,716 patients per arm • Betrixaban (median 36 days) vs. enoxaparin (median 9 days) • Primary efficacy outcome: composite of asymptomatic proximal DVT and symptomatic VTE • No significant difference with betrixaban vs. enoxaparin Bevyxxa [Prescribing Information]. Portola Pharmaceuticals, Inc. South San Francisco, Californa. 2017.

  26. BEVYXXA (betrixaban) Bevyxxa [Prescribing Information]. Portola Pharmaceuticals, Inc. South San Francisco, Californa. 2017.

  27. BEVYXXA (betrixaban) • Clinical applicability: • Oral formulation may improve ease of use • May be used in patients with history of HIT • Limited coverage currently • No significant reduction in VTE vs. enoxaparin • Availability: • MaineCare: PA required • Cigna: not covered • Anthem BCBS: tier 3 non-preferred • Savings card available through manufacturer Bevyxxa [Prescribing Information]. Portola Pharmaceuticals, Inc. South San Francisco, Californa. 2017.

  28. SYMPROIC (naldemedine)

  29. SYMPROIC (naldemedine) • Indication: treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain • Approval date: 3/23/2017 • MOA: opioid antagonist at mu-, delta-, kappa- receptors • Peripherally-acting mu agonist in GI tract • Reduces constipating opioid effects • Dose/Administration: oral tablet, 0.2 mg once daily • Discontinue use if opioid pain medication is stopped • Contraindications: hypersensitivity, GI obstruction, increased risk for recurrent obstruction Symproic[Prescribing Information]. Shionogi Inc. Florham Park, New Jersey. 2017.

  30. SYMPROIC (naldemedine) • Warnings/Precautions: GI perforation, opioid withdrawal, severe hepatic impairment • Adverse effects: abdominal pain, N/V/D, gastroenteritis, hypersensitivity • Monitoring: symptoms of GI perforation or withdrawal Symproic [Prescribing Information]. Shionogi Inc. Florham Park, New Jersey. 2017.

  31. SYMPROIC (naldemedine) • Clinical/efficacy trial(s): two replicate, 12-week, randomized, double-blind, placebo-controlled trials • Study 1: 547 patients, Study 2: 553 patients • Symproic 0.2 mg daily or placebo for 12 weeks • Primary endpoint: >3 SBMs per week and change from baseline of >1 SBM per week for 9/12 study weeks and 3 out of the last 4 weeks Symproic [Prescribing Information]. Shionogi Inc. Florham Park, New Jersey. 2017.

  32. SYMPROIC (naldemedine) Symproic [Prescribing Information]. Shionogi Inc. Florham Park, New Jersey. 2017.

  33. SYMPROIC (naldemedine) • Clinical applicability: • Similar to Movantik (naloxegol), Relistor (methylnaltrexone) • Indication – chronic non-cancer pain? • Trial nonpharmacologic/other pharmacologic options first • Availability: • MaineCare: PA required • Cigna: tier 3 non-preferred • Anthem BCBS: tier 3 non-preferred • Aetna: tier 3 non-preferred • Savings card available through manufacturer Symproic [Prescribing Information]. Shionogi Inc. Florham Park, New Jersey. 2017.

  34. LUCEMYRA (lofexidine)

  35. LUCEMYRA (lofexidine) • Indication: mitigation of withdrawal symptoms to facilitate abrupt opioid discontinuation • Approval date: 5/16/2018 • MOA: central alpha-2 adrenergic agonist • Dose/Administration: 0.18 mg oral tablet • Three 0.18 mg tabs four times daily at 5-6 hour intervals for up to 14 days • Discontinue with gradual dose reduction over 2-4 days • Dose adjust in renal impairment (GFR) and hepatic impairment (Child-Pugh Score) • Contraindications: none Lucemyra[Prescribing Information]. US WorldMeds, LLC. Louisville, Kentucky. 2018.

  36. LUCEMYRA (lofexidine) • Warnings/Precautions: risk of hypotension, bradycardia, syncope, QT prolongation, CNS depression, opioid overdose after discontinuation • Adverse effects: orthostatic hypotension, bradycardia, dizziness, somnolence, sedation, dry mouth • Monitoring: BP, HR, electrolytes, ECG Lucemyra [Prescribing Information]. US WorldMeds, LLC. Louisville, Kentucky. 2018.

  37. LUCEMYRA (lofexidine) • Clinical/efficacy trial(s): • 2 randomized, double-blind, placebo-controlled trials • 935 patients using short-acting opioids undergoing abrupt withdrawal • Symptoms evaluated using Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) • Lower SOWS-Gossop scores vs. placebo • Lessens severity of opioid withdrawal symptoms, facilitating abrupt discontinuation Lucemyra [Prescribing Information]. US WorldMeds, LLC. Louisville, Kentucky. 2018.

  38. LUCEMYRA (lofexidine) • Clinical applicability: • May mitigate, but not completely prevent opioid withdrawal • AEs may be less than with clonidine • Will not prevent psychological cravings • Cost information not yet available • Availability: information not available Lucemyra [Prescribing Information]. US WorldMeds, LLC. Louisville, Kentucky. 2018. Gish EC, Miller JL, Honey BL, Johnson PN. Lofexidine, an {alpha}2-receptor agonist for opioid detoxification. Ann Pharmacother. 2010;44(2):343-51. doi: 10.1345/aph.1M347.

  39. OLUMIANT (baracitinib)

  40. OLUMIANT (baracitinib) • Indication: moderate to severely active rheumatoid arthritis • Approval date: 5/31/2018 • MOA: Janus kinase (Jak) inhibitor • Dose/Administration: oral tablet • 2 mg once daily, monotherapy or combined with methotrexate or other DMARDs • Test for latent TB prior to initiation • Contraindications: none Olumiant [Prescribing Information]. Lilly USA. Indianapolis, India. 2018.

  41. OLUMIANT (baracitinib) • Warnings/Precautions: GI perforation, hepatic enzyme elevation • Adverse effects: URI, nausea, increased hepatic enzymes, infection, increased lipids • Black Box Warning: serious infections, malignancies, thrombosis • Monitoring: lymphocytes, neutrophils, platelets, LFTs, screen for viral hepatitis, symptoms of infection Olumiant [Prescribing Information]. Lilly USA. Indianapolis, India. 2018.

  42. OLUMIANT (baracitinib) • Clinical/efficacy trial(s): • RA-BEACON Study • 527 patients, randomized to 2 mg or 4 mg baracitinib, or placebo in addition to DMARDs • American College of Rheumatology (ACR) response criteria, reduction in Disease Activity Score-28, and improvement of physical function • 49% response vs. 27% response with placebo Olumiant [Prescribing Information]. Lilly USA. Indianapolis, India. 2018. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Olumiant NDA 207294 Summary Review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207924Orig1s000SumR.pdf.  Published May 31, 2018. Accessed September 13, 2018.

  43. OLUMIANT (baracitinib) • Clinical applicability: • Useful for patients who have failed conventional therapies • Improvement in physical function • Patient support program to help with cost • Infection risk • Not best suited to patients with history of VTE • Availability: • MaineCare: not available • Cigna: not available • Anthem BCBS: not available • Aetna: tier 5 specialty, non-preferred Olumiant [Prescribing Information]. Lilly USA. Indianapolis, India. 2018.

  44. ANNOVERA (segesterone acetate/ethinyl estradiol)

  45. ANNOVERA (segesterone/ethinyl estradiol) • Indication: contraception system for 1 year • Approval date: 8/10/2018 • MOA: suppression of ovulation • Dose/Administration: vaginal ring • 0.15 mg/0.013 mg per day, 21 days, 7 day dose free interval • Contraindications: high risk for VTE, breast cancer, liver tumors, undiagnosed abnormal uterine bleeding, use w/certain Hep C drugs Annovera [Prescribing Information]. Population Council. New York, NY. 2018.

  46. ANNOVERA (segesterone/ethinyl estradiol) • Warnings/Precautions: thromboembolic disorders, BMI >29, liver disease, hypertension, Adverse effects: headache/migraine, N/V, genital mycotic infection/candidiasis, abdominal pain, bleeding irregularities • Black Box Warning: cigarette smoking/CV events • Clinical/efficacy trial(s): 17 clinical trials, 2 phase III safety/efficacy trials • 2,308 women, 18-40 years of age • 97.3% effective when used as directed Annovera [Prescribing Information]. Population Council. New York, NY. 2018.

  47. ANNOVERA (segesterone/ethinyl estradiol) • Clinical applicability: • May be useful in low-resource settings • Surveys suggest high level of satisfaction • Availability: • Information not available Annovera [Prescribing Information]. Population Council. New York, NY. 2018.

  48. EPIDIOLEX (cannabidiol)

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