john a. mcgreal jr., o.d. new horizon in ocular...
TRANSCRIPT
John A. McGreal Jr., O.D.Missouri Eye AssociatesMcGreal Educational Institute11710 Old Ballas RdSuite 102St. Louis, MO 63141Phone: 314.569.2020Fax: 314.569.1596email: [email protected] Horizon in Ocular Anesthesia Lidocaine gel 3.5% (Akorn)Viscous topical ocular anesthetic gel Preservative freeOnset action 20-60 sec persisting for 30 minutesPhysiologic pH – 5.5 tp 7.5SE – hyperemia and HAAvailable as AktenAlcaftadine 0.25% Indicated in treatment of allergic conjunctivitisMechanism: H1 histamine receptor agonistDose: once dailySE: irritation, burning, stinging, redness
– Non-ocular SE include nasopharygitits, HA, influenzaAge >2yoAllergan TherapeuticsAvailable as LastacaftOcular Allergies - Topical TherapyMast Cell Inhibitors
– Cromolyn (Crolom, Opticrom)– Lodoxamide (Alomide)– Nedocromil (Alocril)– Pemirolast (Alamast)
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) – Flurbiprofen (Ocufen)– Profenal (Suprofen)– Diclofenac (Voltaren)– Ketorolac (Acular, Acular-LS, Acuvail)– Bromfenac (Xibrom, Bromday)
Ocular Allergies - Topical TherapyCorticosteroids
– Medrysone (HMS)– Fluorometholone (FML, Flarex, Eflone)– Prednisolone (Pred forte, Inflamase forte, Econopred, Omnipred)– Dexamethasone (Decadron)– Difluprednate (Durezol)– Loteprednol 0.5% (Lotemax)Combination with tobramycin 0.3% (Zylet)
– Loteprednol 0.2% (Alrex)–
Tobramycin/Dexamethasone 0.3%/0.05%
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Tobramycin/Dexamethasone 0.3%/0.05%Antibiotic steroid combination drug
– Tobramycin 0.3% (Alcon)– Dexamethasone 0.1% full strength, 0.05% weaker suspensionIndication – treatment of bacterial conjunctivitis and blepharitis, synergistic with Systane Balance AFTs–Age 6 and older
Dose: as neededSupplied: 5 ml white bottle
Available as TobraDex, TobraDexSTLoteprednol etabonate 0.5% Ointment Indicated in treatment of inflammation & PAIN associated with ocular surgeryContraindications: same as other topical steroidsSecond steroid proven to reduce painFirst & only preservative-free steroid ointmentB&LAvailable as Lotemax OintmentDifluprednate emulsion 0.05% Indicated in treatment of inflammation & PAIN associated with ocular surgeryDose: qidContraindications: same as other topical steroidsFirst & only steroid proven to reduce painEmulsion formulation requires no shakingBAK-freeSirion TherapeuticsAvailable as DurezolClassification of Dry EyeTear Deficient Dry Eye
– Sjogren Syndrome Dry EyePrimary-Sjogren, Congenital AlacrimaSecondary-RA, SLE, Scleroderma, Wegener’s Granulomatosis, Polyarteritis, Primary Bilary Cirrhosis, MCTD
– Non-Sjogren Dry EyeLacrimal Disease-Sarcoid, HIV, GVHD, Congenital, DacryoadenitisLacrimal Destruction-Pemphigoid, Burns, Erythema Multiforme, Trachoma, TraumaReflex-Neurotrophic Keratitis, Contact lens, Bell’s Palsy
Classification of Dry EyeEvaporative
– Oil GlandAnterior BlepharitisPosterior Blepharitis-Obstructive, Meibomian Gland Disease
– Lid RelatedBlink DisordersDisorders of Lid ApertureDisorders of Lid /Globe Congruity
– Contact Lens– Ocular Surface Disorder-Xerophthalmia
Treatment Modalities
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Treatment ModalitiesArtificial Tears/Ointments
– Tears Naturale P.M. preservative free & TearsNatural Forte (Alcon),Tears Again (Cynacon) & Genteal Gel (Ciba), TheraTears Liquid Gel (Advanced Vision Research), Refresh Endura (Allergan), Systane (Alcon), Systane Free Liquid gel (Alcon), Soothe Emollient (Alimera)
Punctal Occlusions - Shuttle (Odyssey)– Tears Naturale PORT (Alcon/Landec Corp)– Smart Plug (Medennium)
Cholinergics - Oral Pilocarpine HCL/Salagen 5mg qidCyclosporin (Restasis/Allergan)Tacrolimus (FK-506/Sucampo Pharmaceuticals – phase II for KCSDiquafosol (Inspire-phase III for KCS)Advanced TechnologyManufacturer: Alcon, Inc. SYSTANE® ULTRA Lubricant Eye DropsActive Ingredients: Polyethylene Glycol 400, Propylene Glycol Inactive Ingredients: boric acid, HP-Guar, potassium chloride, aminomethylpropanol,
purified water, sodium chloride, and sorbitolPreservative: POLYQUAD®Mechanism of ActionHP-Guar, Sorbitol and Borate interact to provide an “Intelligent” Delivery System to
the eye.The critical mechanism of action elements of SYSTANE® ULTRA Lubricant Eye Drops
include:– HP-Guar and borate interaction– pH– Sorbitol– Divalent ions in the tears
Multiphasic MOA WithDynamic StructureUpon instillation
– Shearing action reduces viscosity of drop from bottle– pH adjusts to the natural pH of eye reducing viscosity of solution and increasing
elasticity – Thin coating forms after first blink for immediate comfort– As sorbitol is diluted, stronger cross-linking occurs, creating a structured elastic
matrixMultiphasic MOA WithDynamic StructureRebuilding tear film
– Enhanced cross-linking forms a tightly structured matrix– Visco-elastic matrix works with tear film chemistry and eyelid mechanics to form a
protective coating– Retention of the demulcents and HP-Guar to provide for extended protection and
lubrication
SYSTANE® ULTRAProvides viscoelastic properties that enhances the function of human tearsProvides low viscosity at instillation without causing vision impairing blurDelivers extended protection via dynamic rebuilding of the tear film
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Delivers extended protection via dynamic rebuilding of the tear filmSYSTANE® BalanceProvides viscoelastic properties that enhances the function of human tears and
enhances lipid layerProvides low viscosity at instillation without causing vision impairing blurDelivers extended protection via dynamic rebuilding of the tear filmWorks synergistically with TobradexST in blepharaitisSYSTANE® Healthy Eye EssentialsContains Systane Ultra lubricant eye dropsContains Systane Vitamin softgels
– Vitamin E - 5IU– Omega-3 FAs (as ethyl esters) – 500mgEPA – 264mgDHA - 139mg
Dose – 2 per dayTreatment ModalitiesDietary Supplements
– TheraLife Eye & TheraLife Enhancer (TheraLife)Beta carotene, bilberry, chrysanthemum, copper, fructus lycii, Vitamin E & C, riboflavin (B2), selenium, semen cassiae, zinc
– Hydrate Essential (Cynacon/Ocusoft)Essential fatty acids - Flaxseed oil and bilberry extract encapsulated in hydroxylated lecithin
– HydroEye (Science Based Health)Blend of omega fatty acids and nutrients
– TheraTears Nutrition (Advanced Vision Research)EPA enriched flaxseed oil & Omega-3s
–EyePromise EZ Tears (ZeaVision)Vitamin A (retinyl palmitate) – 1000IUVitamin D3 – 2000IUVitamin E – 60IU Mixed tocopherols / 20mg tocotrienolsEvening primrose oil – 100mg (gamma-linoleic acid)
– Stops conversion of O-6 into inflammatory mediatorsTumeric Extract – 50mg
– Potent inhibitor of interlukins, MMP-9, TNF-a, COX-2 conversion of O-6Green Tea Extract – 50mg
– Potent antioxidant & anti-inflammatory Omega-3 FA – 1000mg DHA/EPA
– Purified & enriched Enteric coated / Available only through doctors
NutritionalsEyePromise Vizual Edge (ZeaVision)
– Zeaxanthin 26mg – Lutein 8mg– Vitamin C – 240mg– Vitamin D3 – 2000 IU– Vitamin E – 120 IU– Zinc – 30mg
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– Zinc – 30mg– Fish oil (omega-3) – 380mg, total fish oil 500mg– Alpha Lipoic acid – 20mg
New NSF certified product to enhance & improve visual performance (glare recovery, contrast, temporal processing speed, light sensitivity)
–Tozal Complete Eye Health FormulaTaurine 400mgZeaxanthin 2mg Lutein 10mgBeta carotene – 18,640 IU, Vitamin A – 10,000 IUVitamin C – 452mgVitamin E – 200 IUVitamin D3 – 800mgZinc – 69mgOmega-3 (DHA/EPA) – 600mg
–Tozal Complete Eye Health Formula
Indications: AMD, dry eye syndromes, MGDCaution: in smokers (beta carotene)Dosage: 3 softgels per day taken with foodSupply: 90 countPrescription only: “Medical food”
– Direct buy from Focus or prescription to pharmacyNutritionals ICaps Lutein & Omega-3 (Alcon Labs)
– Taurine 400mg– Zeaxanthin 2mg – Lutein 10mg– Vitamin A Palmitate 0.6mg– Vitamin C 45mg– Vitamin E 10mg– Vitamin B-12 2.4mg, Vitamin B61.3mg, Folic acid 240mg– Niacin 16mg, Riboflavin 1.3mg, Thiamine 1.2mg– Zinc – 7mg– Fish oil (DHA-EPA omega-3) – 280mg– Calcium 1mg– Copper 0.9mg, Selenium 34mcg, Manganese 2.3mg–
FreshKote (Focus Laboratories)Moderate-severe dry eyePrescription onlyTreats all three layersOncotic pressure mechanism – large colloids induce osmotic flow, similar to
hypertonics without adding hypertonicity– Evidence of epithelial layer becoming “waterlogged” in DES, with loss of permiability
and influx of fluids– Indicated in EBMD and RCE
FreshKote (Focus Laboratories)
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FreshKote (Focus Laboratories)AmisolClear – dispersive agent
– Combination of phospholipids, polysorbate-80, glycerin, ethanolDemulcents – enhance wettability
– Unique combination of polyvinyl alcohol and polyvinyl pyrrolindonePreservative – Polixetonium
– Non-irritating, antimicrobial and antifungal action– Enhances wettability
Price $30 per bottle average
Patented Technology 3 Layers of Tear Film Complete Wettability Unique Lipid High Oncotic Pressure Patented Preservative Rx Advantage Build a Dry Eye Practice
With this oncotic pressure, FreshKote normalizes the inward osmotic flow of water, slowing the absorption of tears.
Ability to monitor patients Dry Eye therapyMaintain patient … not create a consumerDevelop Dry Eye Treatment Program
Insurance coverageState Medicaid and Medicare coverageBuild your Dry Eye practice
Rx artificial TearsOmega 3 oral supplementsHot compress gogglesTear assays
Antimicrobial - Topical TherapyAntibiotics
– Sulfacetamide (Bleph)– Erythromycin (Ilotycin)– Bacitracin (Bacitracin)– Bacitracin/Polymixin B (Polysporin)– Gentamycin (Garamycin)– Tobramycin (Tobrex)
Antibiotic/Steroid Combinations Antimicrobial - Topical TherapyTrimethoprin/Polymixin B (Polytrim)Fluoroquinolones
– Ciprofloxacin (Ciloxan) * generics from B&L, NovexPharma– Ofloxacin (Ocuflox)– Norfloxacin (Chibroxin) – Levofloxacin (Quixin, IQUIX)– Besifloxacin (Besivance)
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– Besifloxacin (Besivance)Fluoroquinolone combinations
– Ciprofloxacin/Dexamethasone– Ofloxacin/ Prednisolone acetate
New 4th generation fluoroquinolones
Ophthalmic Azithromycin: AzaSiteAzaSite™ pairs DuraSite® drug delivery technology with azithromycin (1.0%)Azithromycin has not been previously
– used in ophthalmology– A stable aqueous formulation is difficult
AzaSite™: A stable, easily delivered formulation of azithromycin– All the advantages of topical ophthalmic delivery
CDC & FDA recommendation 7/09 to use azithromycin instead of topical erythromycinBesifloxacin 0.6%Expanded spectrum fluoroquinolones
– Besifloxacin 0.5% (B&L)Besifloxacin
–Dual mechanism of action–Excellent solubility / penetration into cornea–Activity against MRSA
Indication – treatment of bacterial conjunctivitis–Age 1and older
Dose: TIDSupplied: 5 ml white bottle
Available as BesivanceMoxifloxacin 0.5%Expanded spectrum fluoroquinolones
– Moxifloxacin 0.5% (Alcon)–Dual mechanism of action–Excellent solubility / penetration into cornea–Activity against MRSA
Indication – treatment of bacterial conjunctivitis–Age 4 months and older
Dose: BID X 7 DSupplied: 4 ml white bottle
Available as MoxezaBacterial Keratitis Treatment ProtocolCulture directed/Fortified antibiotics
– Tobramycin 15mg/ml & Cephazolin 50mg/mlEmpiric - no culture
– Moxifloxacin (Vigamox) monotherapy– Gatifloxacin (Zymar) monotherapy– Levofloxacin 1.5% (IQUIX) monotherapy– Non-severe, small, peripheral
Combination - culture– 4th generation & Cephazolin – Severe, large, central– Alternative choices include vancomycin, neosporin
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– Alternative choices include vancomycin, neosporinAdjunctive Tetracycline Inhibits collagenase (in vivo/vitro) Inhibits PMNs
– reduces ascorbate levels– decreases phagocytosis & chemotaxis
Current recommendation– TCN 250mg PO qid– Doxycycline 100mg bid
Same rationale helpful in EBMD and RCEs– FreshKote prescription AFTs
Moxifloxacin 0.5%Expanded spectrum fluoroquinolones
– Moxifloxacin 0.5% (Alcon)Moxifloxacin
–Dual mechanism of action–Excellent solubility / penetration into cornea
Indication – treatment of bacterial conjunctivitis–Age 1and older
Supplied: 3 ml white bottle with 2.5ml solutionDurasite vehicle allows increased residence time on surface, increased penetration
Available as Vigamox, VigazeraGatifloxacin 0.3% & 0.5%Expanded spectrum fluoroquinolones
– Gatifloxacin 0.03%, 0.5% (Allergan)Gatifloxacin
–Dual mechanism of action–Excellent solubility / penetration into cornea
Indication – treatment of bacterial conjunctivitis–Age 1and older
Side effects are worsening conjunctivitis, irritationDosage Day 1: q2h WADosage Day 2-7: bid to qidSupplied: 5ml white bottle with 2.5ml solution
Available as Zymar, ZymaxidAntimicrobial Therapy – 2008Expanded spectrum fluoroquinolones
– Levofloxacin 1.5% (IQUIX / Santen/Vistakon)Levofloxacin (L-stereoisomer of ofloxacin)
–Dual mechanism of action–Excellent solubility / penetration into cornea
Indication – treatment of bacterial corneal ulcerSide effects are headache & taste disturbance 8-10%Dosage Day 1-3: q30m to 2 hrs while awake and every 4-6 hrs after retiringDosage Day 4 through completion: q1-4hSupplied: 5ml white bottle with tan top
Antimicrobial Therapy – 2008Expanded spectrum fluoroquinolones
– Besifloxacin 0.6% (Becivance/B&L)Besifloxacin
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Besifloxacin–Dual mechanism of action–Excellent solubility / penetration into cornea / residence time
Indication – treatment of bacterial conjunctivitisSide effects are headache & taste disturbance 8-10%Dosage: Tid x 7 daysSupplied: 5ml white bottle with tan top
Ganciclovir ophthalmic gel 0.15%Anti-viral Indications
– HSV keratitisAction – inhibits DNA replicationSide effects – blurred vision, irritation, SPK Dose – one drop 5 times per day until dendrite resolved, then TID for one weekAvailable as
– Zirgan/Sirion–
Antiviral - Topical TherapyVidarabine (Vira - A)Trifluorodine (Viroptic)Gancyclovir (Zirgan)Treatment Considerations
– Monotherapy– Debridment– Resistance– Adjunctive measures
Acyclovir (Zovirax/Cream 5%) 5X/D x 4DPencyclovir (Denavir/Cream 1%) 9X/D x 4DNSAID / Analgesics - TopicalDiclofenac (Voltaren qid)Suprofen (Profenal q2h)Flubiprofen (Ocufen q 1/2h)Ketorolac (Acular qid, Acular PF, Acular LS, Acuvail 0.45%)
– FDA approval for pain and inflammation after cataract surgery– No more than one day prior to surgery or 14 days after for corneal adverse efects,
common SEs are increased IOP, hyperemia, edemaBromfenac (Bromday) - Ista Pharm/inflammation following cataract surgery: 1st qd
drug– Superb at reaching the retinal tissues!
Nepafenac (Nevanac tid)Bromfenac 0.09%Topical non-steroidal anti-inflammatory agent
– Inhibits COX-1 & 2 reducing prostaglandin synthesis Indications: reduction of pain and inflammation after cataract surgery in age 18 and
upSide effects – contains sodium sulfite that may cause allergic reactions, burning,
redness, corneal SPK & other adverse eventsDosage: bidBottle size: 2.5ml, 5mlAdvantages: bid dose, substantially better posterior penetration
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Advantages: bid dose, substantially better posterior penetration– Post-op CME, DME, BRVO
Available as Bromday
Glaucoma Considerations Glaucoma Diagnosis Has Changed!
– Central corneal pachymetry (CCT – OHTS)– Short Wavelength Autoperimetry / Frequency Doubling– Confocal Scanning Laser Tomography– Ocular Blood Flow Modulation– Neuroprotection of RGC/Stem cells neuroregenerationPrimary injury - mechanical, genetic, vascular, metabolicSecondary injury - glutamate, nitric oxide, free radicals
Glaucoma Treatment Strategies Have Changed!– IOP Reduction / Safety / Optic Nerve Health– Medications / LTP / Trabeculectomy
Latanoprost 0.005%Topical prostaglandin Indications: open angle glaucoma or ocular hypertensionSide effects – hyperemia of conjunctiva, iris pigmentation/color change, lid erythema,
eyelash growthDosage: once daily at bedtimeAdvantages: monotherapy/compliance, favorable SE profile, longest track record,
generic March 2011Available as Xalatan
Bimatoprost 0.03% & 0.01%**Topical prostaglandin Indications: open angle glaucoma or ocular hypertensionSide effects – hyperemia of conjunctiva, iris pigmentation/color change, lid erythema,
eyelash growthDosage: once daily at bedtimeAdvantages: monotherapy/compliance, favorable SE profile with lower concentration
but equal IOP lowering– Switch when having SE with other PGs or as first line PG
Available as Lumigan, Lumigan 0.01%
TafluprostTopical prostaglandin, first preservative-free preparation Indications: open angle glaucoma or ocular hypertensionSupplied: 10 PF ampules per pouch, 3 pouches/boxSide effects – same as other PGADosage: once daily at bedtimeStorage: refrigeration necessary until pouch is opened, then once opened room
temperature is fineAvailable as Zioptan
Anti-Glaucoma Therapy Adrenergic Agonists
– Dipivefrin (Propine 0.1%)– Epinephrine (Epinal,Eppy-N, Epifrin, Glaucon)
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– Epinephrine (Epinal,Eppy-N, Epifrin, Glaucon)– Apraclonidine (Iopidine 0.5%, 1.0%)– Brimonidine (Alphagan 0.2%, Alphagan P-0.1%, 0.15%) / Timolol (Combigan)41% less ocular allergy with Alphagan P vs Alphagan over 12 monthsOnly ophthalmic glaucoma drug without BAK
Cholinergic – Pilocarpine (Pilocar 0.50% - 8.0%, Pilogel 4%)– Carbachol (Carbachol 0.75%, 1.5%, 2.25%, 3%)– Echothiophate Iodide (0.03%, 0.06%, 0.125%, 0.25%)
Antiglaucoma - CAI Topical
– Dorzolamide (Trusopt)– Dorzolamide-Timolol (Cosopt)– Brinzolamide (Azopt)
Oral– Acetazolamide (Diamox)– Methazolamide (Neptazane, MZM)– Dichlorphenamide (Darinide)–
Ocriplasmin / ThromboGenetics, IncNon surgical treatment for vitreomacular adhesions
– Increased macular thickness– CME Diagnosed 8% at slit lamp 30% with OCT
Vitrectomy vs Vitreolysis? – Invasive – Anesthesia– Face down – Retinal breaks – Cataract
Ocriplasmin / ThromboGenetics, IncTruncated form of human plasmin produced by bacteria Indications: developed for dissolving blood clots in vascular disease Single Intravitreal injection Results – resolution 30% at 28 days, closure of hole 40% at 28 days
– better than all other agents tried Spin offs – DME, AMD, adjunct to vitrectomy
Ranibizumab / Lucentis for injectionDose – 0.5mg/monthlyAdministration – 27g needle intravitreal injection Indication – neovascular “wet’ macular degenerationContraindications – ocular infectionWarnings – risk of endophthalmitis, increased IOPDose – may decrease to q3m after 4 monthly injections
– Less effectiveStudies – ANCHOR, SAILOR, PIER, MARINA, FOCUSBevacizumab / Avastin for injection, twice the half life of Lucentis, fraction cost for AMDEffect – Anti VEGF for CA of lung and colorectal CADose – 0.5mg/monthly
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Dose – 0.5mg/monthlyAdministration – 27g needle intravitreal injection Indication – neovascular “wet’ macular degenerationContraindications – ocular infectionWarnings – risk of endophthalmitis, increased IOPDose – may decrease to q3m after 4 monthly injections
– Less effectiveAvastin for EVERYTHING ocularAMDPDRPDR with vitreous hemorrhageDMEVein occlusionsROPChoroidal melanomaNVGThe future is topical eyedrops, oral formulationsAflibercept / Eylea for injection, Effect – Anti VEGF Dose – monthly for 3 months, then every other monthAdministration – 27g needle intravitreal injection Indication – neovascular “wet’ macular degenerationContraindications – ocular infectionWarnings – risk of endophthalmitis, increased IOPBenefit – less injections, less costPradaxa (dabigatran)Anticoagulant – 150mgReduces risk of stroke in A-fib
– 35% MORE REDUCTION IN STROKE THAN WARFARIN– No need for regular blood tests– No dietary restrictions (green leafy vegetsables)
SE – GI 35%, heartburn, GERD, ulcersCost - $7.90/day compared to generic warfarin
– Monthly testing, co-pays, dose adjustments can be $50-$500 per monthGabapentin (Horizant)Anti-seizure drug Neurontin1st non-dopaminergic treatment Indicated – moderate to severe primary restless leg syndromeEmtricitabine / Rilpivirine / TenofirAnti-HIV1st complete regimen for HIV infection Indicated – HIV infection in treatment naïve patientsContraindicated – in HIV with co-infection wth HBVAvailable as - CompleraVilazodone Indicated – Major depressive disorderContraindicated – in MAOI patients, watch for suicidationAvailable as - ViibrydVemurafenib
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Vemurafenib Indicated – in unresectable or metastatic melanoma
– With the BRAF mutation56% reduction in risk of death from any causeRequires BRAF testing result positiveAvailable as - ZelborafRoflumilast Indicated – treatment to reduce risk of COPD exacerbations in severe COPD
associated with chronic bronchitis and history of exacerbationsSide effects – psychiatric, usually suicide thoughts or depressionAvailable as - DalirespIbuprofen & Famotidine Indicated – treatment of osteoarthritis and rheumatoid arthritis to reduce risks of GI
ulcersDose forms – 800mg/26.6mgCombination of #1 NSAID with gastroprotective therapyAvailable as - DuexisBelimumab / Human Genome Sciences Indicated – treatment of adult lupus
– 1st new treatment in 50 years!– ASA in 1948– Plaquenil & steroids in 1955– Humanized IG G1y monoclonal antibody– Inhibits human B lymphocyte stimulator
Dose forms – 800mg/26.6mgDosed – IV infusion, in conjunction with standard therapies (steroids, NSAIDs, anti-
malarials, immune drugs)Available as - BenlystaSaxagliptin Indicated – treatment of adults to improve control of Type 2 DMDose – one daily (weight neutral)Significant reductions in HA1c partnered with oral anti-diabetic agentsAvailable as - OnglyzaSaxagliptin / Metformin Indicated – treatment of adults to improve control of Type 2 DMFirst and only daily metformin & DPP-4 inhibitor combinationDose – one daily (weight neutral)Significant reductions in HA1c partnered with oral anti-diabetic agentsAvailable as - CombiglyzeXRLiraglutide Indicated – treatment of adults to improve glycemic control in type 2 DMGut – slows gastric emptying Liver - lowers glucose outputPancreas – improves insulin secretionSignificant reductions in HA1c partnered with oral anti-diabetic agentsAvailable as - VictozaLinagliptin Indicated – treatment of adults to improve glycemic control in type 2 DMOnly DPP-4 inhibitor at one dose for adultsSignificant reductions in HA1c partnered with oral anti-diabetic agentsNot for use with insulin
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Not for use with insulinAvailable as - TradjentaLorcaserin (Arena Pharm) Indicated – treatment of obesity & overweight patients with one related health
problem (HTN, DM, cholesterol)– Obesity >30 BMI, Overweight >27 BMI
Approved 2012Prescribed with reduced calorie diet & exercise programSE: “serotonin syndrome”-produce excess serotonin, agitation, diarrhea, sweating,
fever, spasms, mental changes– Antidepressants and migraine medications additive to these SE– No heart valve problems
Available as – BelviqPhentermine / Topiramate (Vivus, Inc) Indicated – treatment of obesity & overweight patients with one related health
problem (HTN, DM, cholesterol)– Obesity >30 BMI, Overweight >27 BMI
Approved 7/18/12Prescribed with reduced calorie diet & exercise programSE – tingling of hands/feet, constipation, insomnia, taste perversion, dry mouthContraindications – glaucoma, hyperthyroidism, recent heart disease, strokeAvailable as – Qsymia (3.75/23, 7.5/46, 11.25/69, 15/92)Phentermine / Topiramate (Vivus, Inc)2 clinical studies confirmed benefitOne year results = 7-9% weight loss62-69% = 5% weight lossSafety concerns?
– Phentermine was half of fenfluramine (Fen-Phen) linked to heart valve damage and taken off market 1997
– 13 billion settlement
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