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Pharmaceutical Update 20/20Tracy Offerdahl, PharmD, BPharmSalus University8360 Old York RoadElkins Park, PA 19027 HYPERLINK "mailto:tofferdahl@salus.edu" tofferdahl@salus.edu267-241-9146Greg Caldwell, OD, FAAOgrubod@814-931-2030Course DescriptionEvery year the FDA approves numerous pharmaceuticals (AKA “Legend Drugs”) for the management of diseases in many therapeutic categories.This course will review recently approved pharmaceuticals that are pertinent to optometric patient care.This course will review systemic and ocular complications of select pharmaceuticals. Therapeutic Areas to be CoveredOptometryEndocrinologyCardiology/Vascular DiseaseFamily Medicine Hepatology (liver, pancreas, gall bladder)NeurologyDermatologyGastroenterologyMiscellaneousPharmaceutical Resource MatrixCommercial/SalesRepresentativesOn label, educational lunches, samples, discount cards, couponsOrganizes the promotional dinnersMedical Affairs- Medical Science Liaison (MSL)OD, MD, PharmD, PhD,…Education, education, educationOn label or that “reactive” off label questionWhere the granular discussion occursNo salesClinical ResearchCompany sponsored studies MarketingAssists representative on therapeutic usageConsultant, advisory board, promotional speakerMarket AccessFormulary accessCommercial and Federal payersAvaclyr (Acyclovir)Ophthalmic ointment for treatment of herpetic keratitisComparison to Zirgan and ViropticClinical dataADRsVyzulta? (latanoprostene Bunod) Ophthalmic Solution 0.024%Bausch & Lombapproved (previously Vesneo?)Indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertensionOnce daily monotherapy Dual mechanism of actionUveoscleral pathway to increase aqueous humor outflowButanediol mononitrate, which releases NO to increase outflow through the trabecular meshwork and Schlemm's canal. Ocular adverse events Conjunctival hyperemia, eye irritation, eye pain and instillation site painIncreased pigmentation of the iris and periorbital tissue and growth of eyelashes can occurXelpros? (latanoprost ophthalmic solution 0.005%) Sun PharmaceuticalsDosage: QDReduce IOP in open-angle glaucoma and ocular hypertensionXelpros is the first latanoprost product not formulated with the preservative benzalkonium chloride?Potassium sorbate 0.47% - preservativeReduces IOP in patients with open-angle glaucoma and ocular hypertension Up to a mean of 6 mm Hg to 8 mm Hg in randomized clinical trialsRhopressa netarsudil ophthalmic solution)Aerie PharmaceuticalsTreatment of glaucoma or ocular hypertensionRho kinase inhibitorROCK-NET InhibitorOnce daily in the eveningTwice a day dosing is not well tolerated and is not recommendedSide EffectsConjunctival hyperemiaCorneal verticillataInstillation site painConjunctival hemorrhageRhopressa (ROCK-NET Inhibitor) Triple-ActionWang SK, Chang RT. An emerging treatment option for glaucoma: Rho kinase inhibitors. Clin Ophthal 2014;8:883-890.Wang RF, Williamson JE, Kopczynski C, Serle JB. Effect of 0.04% AR-13324, a ROCK, and norepinephrine transporter inhibitor, on aqueous humor dynamics in normotensive monkey eyes. J Glaucoma 2015. 24(1):51-4. Kiel JW, Kopczynski C. Effect of AR-13324 on episcleral venous pressure (EVP) in Dutch Belted rabbits. ARVO 2014. Abstract 29003 Identified IOP-Lowering Mechanisms Netarsudil Causes Expansion of TM in Donor Eyes, Increases TM Outflow Facility in ClinicNetarsudil Is Similarly Effective at Baseline IOPs<25 mmHg and ≥25 mmHgMost Frequently Reported Systemic TEAEsNetarsudil Once Daily Demonstrated Consistent Ocular Safety Profile with Four Phase 3 StudiesOcular AEs Leading to DiscontinuationsPooled Phase 3 StudiesConjunctival Hyperemia Was Sporadic and Severity Did Not Increase with Continued DosingNetarsudil Once-Daily Dosing Biomicroscopy Hyperemia Severity Did Not Increase Over Time Netarsudil QD (N=839)Conjunctival Hemorrhage Was Sporadic and Severity Did Not Increase with Continued DosingCornea Verticillata Observed in Phase 3 StudiesCornea Verticillata Due to PhospholipidosisSummary of the Most Common Netarsudil Ocular TEAEsHow Will I Use Netarsudil to Treat Glaucoma?Rocklatan?(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%Stay tunedAerie pharmaceuticalsOnce-daily eye dropAerie Pharmaceuticals Announces Early Notification of FDA Acceptance of NDA Submission for Roclatan? (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Oxervate? (cenegermin-bkbj)Dompé farmaceutici SpAOphthalmic solution indicated for the treatment of neurotrophic keratitisDosing: Instill 1 drop in affected eye 6 times per day (at 2 hour intervals) for 8 weeksStorage issues: in the freezer at the pharmacy; patient keeps the individual vials in the fridge – once “actively ready” for use, then it is only stable for 12 hoursADRs: eye pain, inflammation, corneal depositsZerviate (cetirizine) ophthalmic solution 0.24%NicOxTreatment of ocular itching associated with allergic conjunctivitisTwice daily (approximately 8 hours apart)Second generation antihistamine (H1 receptor antagonist)Binds competitively to histamine receptor sites to reduce SwellingItchingVasodilationLuxturna (voretigene neparvovec)Spark Therapeutics For the treatment of vision loss due to confirmed biallelic RPE65-mediated inherited retinal diseaseGene therapy for mutations in the RPE65 geneIntraocular suspension for subretinal injectionAdministered to each eye on separate days Within a close interval, no fewer than 6 days apartOnce inside the eye, the new genetic material enables patients to produce the protein that is missing as a result of their genetic mutationRPE65-mediated Inherited Retinal Disease (IRD)Also known as inherited retinal dystrophies Leber’s congenital amaurosis (LCA) Autosomal recessive retinitis pigmentosa (RP). Group of rare blinding conditions caused by one of more than 220 different genesBiallelic?RPE65gene mutations often experience Night blindness (nyctalopia) NystagmusLoss of peripheral visionDevelop tunnel visionEventually, they may lose their central visionlResulting in total blindnessCequa? (cyclosporine ophthalmic solution) 0.09%Dosed BIDSingle-use vials “New Nanomicellar Ophthalmic Solution for Treatment of Keratoconjunctivitis Sicca”Formulation technology uses micellesGelatinous aggregates of amphipathic moleculesHydrophobic and hydrophilic moleculesEase of entry into conjunctiva and corneaHigh delivery of cyclosporine A (CsA)Indication and Important Safety InformationA calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye)Warnings and Precautions:Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces. Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solutionAdverse Reactions:The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%)Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infectionInveltys- loteprednol etabonateKala Pharmaceuticals Nanoparticle-based Mucus Penetrating Particles (MPP)MOD1.0% pain after ocular surgery0.25% temporary relief of the signs and symptoms of dry eye diseaseOcular/Immunology/Rheumatology MedsHumira (adalimumab)Company: AbbvieIndication: uveitisSpecifically indicated for the?treatment of non-infectious intermediate, posterior and panuveitisDosage: subcutaneous injectionRecommended dose is?80 mg initial doseFollowed by 40 mg every other week starting one week after initial doseThe significance of this FDA approval is important! Many insurance companies (ex. Medicare) will not pay for “off-label” uses.Monitoring parameters:Must place PPD before initiating = if PPD+, then initiation of Humira may convert latent TB to ACTIVE tuberculosisOnce Humira is initiated, watch for any signs or symptoms of infection…if the patient has a “cold”, “flu”, or is taking antibiotics, then Humira dose must be HELD until the patient is healthy.Non-infectious intermediate, posterior and panuveitisReason for reduced acuity?Actemra? (tocilizumab)- GenetecFirst innovative therapy for GCA in more than 50 yearsDesign to speed the development for treatments of serious diseases such as GCA and certain cancersPatients were randomized to receive tocilizumab 162 mg weekly injections plus a 6-month and 12-month prednisone-taper compared to controls receiving placebo plus similar steroid taperThe preliminary results indicate that patients receiving high dose tocilizumab had superior disease remission at 1 year compared to the steroid-only taperFurther investigation from this study will attempt to identify the lowest therapeutic dose of prednisone that can be used in patients also using tocilizumab, the amount of tocilizumab needed to induce remission, and how long patients stay in remission on this therapyTocilizumab does not directly treat GCAReduces steroid load after disease has been adequately treated by steroids and enhances disease remissionSteroids are main therapyStudies are ongoing to see:What is the lowest steroid tapering dose that can be used with tocilizumabFuture studies may show tocilizumab as steroid replacementBiosimilarsHadlima (Adalimumab-bwwd)Biologic agent SIMILAR to HumiraWhat is a “biosimilar”agent?Olumiant? (baricitinib); Rinvoq (upadacitinib)Janus Kinase inhibitorIndicated for the treatment of adult patients with moderate/severe active rheumatoid arthritisMust have failed 1 or more TNF-alpha inhibitors (e.g. Remicade, Humira)THE HUB-BUB? It is an orally administered medication, as opposed to MOST of the others that are injectables! Known as “un-jections”EndocrinologyIncretin SystemNew/updated Type 2 diabetes guidelines suggest use of insulin and/or agents that act as agonists on the incretin system!Many, MANY manufacturers are starting to make new combination drugs that contain bothBenefit? Fewer injections per day!Risk? The patient’s wallet, and increased risk of hypoglycemia!Qternmet XR (dapagliflozin/saxagliptin/metformin), Ozempic (semaglutide), bination medicationsType 2 diabetes Soliqua 100/33 (insulin glargine and lixisenatide injection)Long-Acting insulin + GLP-1 Agonist Inadequately controlled type 2 diabetesSynjardy?(empagliflozin and metformin hydrochloride)SGLT-2 inhibitor + biguanide (ORAL)Type 2 diabetesALERT! Watch for even NEWER guideline updates to include the “flozins” (above and Invokana/canagliflozin) due to new data that shows improvement in CV risks in HIGH RISK patients!Cardiology/Vascular DiseaseConsensi? (amlodipine and celecoxib)New combination of a calcium-channel blocker (CCB) and specific COX-2 inhibitiorIndicated for patients with hypertension and osteoarthritisRepatha?(evolocumab)Heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular diseasePraluent? (alirocumab)Heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular diseaseBoth subcutaneous injections…used when “statins” don’t work!Stay tuned for myopathy issues…“statins on steroids” – diplopia, etc.Family Medicine Evenity (Romosozumab-aqqg)A sclerostin inhibitor for treatment of postmenopausal osteoporosis Used in patients at high risk for fractureDosing considerationsLucemyra? (Lofexidine)Central alpha-2 adrenergic agonistIndicated for the mitigation of opioid withdrawal symptoms; helps facilitate abrupt opioid discontinuation in adultsUsually taken PO, 4 times a dayADRsVaccines…Zostavax? – SQ, live vaccine; 60 years and older“the only game in town…”50-ish% effective; 1 doseEfficacy wanes after 4-5 yearsShingrix? – has replaced Zostavax?We are moving in the right direction!Recommended for 50 years and older90+% effective?; 2 doses; IM; recombinant vaccineEfficacy seems solid up to 7-8 yearsRecombinant vaccine with adjuvant for added immunogenicityVERY difficult to get right nowPost-shingles: Wait until acute episode and symptoms are resolvedPost-Zostavax? patient:Wait 8 weeks after Zostavax vaccine before giving ShingrixApadaz ? (benzhydrocodone/acetaminophen)INITITIAL approval = 1982; this is for change in formulation!BLACK BOXED: addiction, abuse, respiratory depression, hepatotoxicity, drug interactionsBenzhydrocodone = prodrug of hydrocodone6.12mg benzhydrocodone = 4.54mg hydrocodone (plain) or 7.5mg hydrocodone bitartrateIndicated for the short-term treatment of acute pain that is severe enough to require an opioidCassipa?(buprenorphine/naloxone)HIGHER strength SL film for maintenance treatment of opioid dependence Other choices: Suboxone, MethadoneHepatology (liver, pancreas, gall bladder)Vemlidy? (tenofovir alafenamide)Chronic hepatitis BEpclusa? (sofosbuvir and velpatasvir)Hepatitis CYou will see many new hepatitis B and C meds, as now these patients can be CURED!NeurologySpravato? (Esketamine)Nasal spray used in treatment-resistant depressionMechanims of efficacy and toxicityADRsEpidiolex? (Cannabidiol oil)Oral solution: twice per day dosingIndicated for the treatment of seizures in people > 2 years old (with Lennox-Gastaut syndrome or Dravet syndrome)ADRsDEA is working on “scheduling” this product!Abilify MyCiteAripiprazole plus sensor: new drug device combinationTablet is embedded with a tracking sensor to verify complianceIEM: ingestible event markerIndicated for adult patients with schizophrenia, certain types of bipolar disorder, adjunctive therapy with major depressive disorderAimovig? (erenumab-aooe)Ajovy ? (fremanezumab-vfrm)Indicated for the PREVENTIVE treatment of migraine in adult patientsCalcitonin gene-related receptor antagonistSQ injectionOnce per month for either productOnce every three months for Ajovy?ADRsWould be used ALONG WITH “triptans”DermatologyDoxycyclineDoryx? (enteric coated hyclate pellet), Adoxa? (monohydrate), Oracea? (monohydrate – 75% immedidate release + 10% delayed release)Approved 2005Good ‘ol doxy…being reborn AGAIN!Did you know?At normal doses, the monohydrate and hyclate salts have equal efficacy?At normal dose, the monohydrate salt MIGHT have a decrease in GI side effects.ALL doxy products can generally be taken with food to decrease GI upset.Don’t get caught in the web of “sexy doxy” formulationsDelafloxacin? (Baxdela)A fluoroquinolone antibiotic for acute bacterial skin and skin structure infectionsAvailable orally and intravenouslyAdverse effects: SO NEW…but in clinical trials, the only ophthalmic side effects that were noted = blurred vision!Only time will tell if retinal detachment is something to worry about with this new FQ!Nuzyra?(omadacycline)Tetracycline antibioticApproved for PO/IV treatment of patients with bacterial skin infections or community-acquired bacterial pneumoniaChelation issues JUST like other tetracyclines!ADRsSeysara? (sarecycline)Tetracycline drugIndicated for the treatment of inflammatory acne in non-nodular, moderate to severe acne vulgarisCan be taken WITH or WITHOUT food!ADRXerava? (eravacycyline)Tetracycline antibioticIndicated for the treatment of intra-abdominal infections in adultsIV ONLYGastroenterologySymproic? (naldemedine)Approved 2017Opioid antagonist in the GUTOpioid-induced constipationThank You!Questions ................
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