-
DrugUpdates
EveVanWagoner,PharmD,BCACPPrimaryCareClinicalPharmacistSouthJordanHealthCenter
[email protected]
-
SAFETYALERTS/LABELINGCHANGES
-
Opioidaddictionmedications
•
Shouldnotbewithheldfrompatientstakingbenzodiazepinesorotherdrugsthatdepressthecentralnervoussystem
•
Theharmcausedbyuntreatedopioidaddictioncanoutweightheserisks
-
Eluxadoline (Viberzi®)andPancreatitis
• FDAreview,patientswithoutagallbladder+Viberzi
=increasedriskforpancreatitis
• Recommendation:– AvoidprescribingViberzi
inpatientswhodonothavegallbladder,consideralternativeoptions
• Warningsigns:–
New/worseningstomach-areaorabdomenpainorpaininupperrightsideofstomach
-
RestricteduseofCodeineandTramadol
• FDAapprovedforadultuseonly• NewContraindication:
– Children
-
Invokana andAmputationRisk• Newdatafromtwolargeclinicaltrials•
Blackboxwarningaddedtodruglabel• Recommendation:
–
Considerfactorsthatmaypredisposepatientstotheneedforamputations(prioramputation,PVD,neuropathy,diabeticfootulcers)
• Warningsigns:–
Newpainortenderness,soresorulcers,orinfectionsinlegsorfeet
-
ACEsandNeprilysin Inhibitor
• Contraindicatedtobeusedatsametime•
DoNOTadministerACE/ARBwithin36hoursofswitchingtoorfromneprilysin
inhibitor,suchasEntresto®
-
Amphetamineandserotoninsyndrome
•
Warningaddedtoallamphetamineproductsofincreasedriskofserotoninsyndrome
• AmphetaminesmetabolizedthroughCPY2D6
• Examples• Fluoxetine• Paroxetine• Bupropion• Ritonavir•
Cincalcet• Sertraline• Duloxetine
-
OralcontraceptivesandHep Cdrugcombinations
•
OralcontraceptivescontainingethinylestradiolshouldbediscontinuedbeforestartingHep
Cdrugcombinationcontainingombitasvir/paritaprevir/ritonavir,withorwithoutdasabuvir
•
PotentialforALTelevationsmorethan5timestheupperlimit,upto20timestheupperlimit
-
Orlistat co-administration
•
Somemedicationsmaynotworkaswellwhenco-administeredwithOrlistat,suchas–
Anticoagulants– Diabetesmedications– Thyroidmedications–
Antiretrovirals
-
NSAIDsandheartconditions
•
Warningofincreasedriskofheartattack,strokeandheartfailureaddedorupdatedondrugfactslabelingfor:–
Ibuprofen– Naproxen
• Warningisalreadyaboxedwarningfor:– Celecoxib– Diclofenac–
Indomethacin
-
Rivaroxaban andCyp3A4inhibitors•
AvoidrivaroxabanandcombinedP-gpandCyp3A4inhibitors,especiallyinpatientswithCrCl15-80mL/min
• Manyhealthsystemshaveanticoagulationmonitoringavailable
• Examples– Ketoconazole– Ritonavir– Notclarithromycin
-
Zyban®/Chantix®andDepression
• Mentalhealthriskispresentbutseriousconsequencesareminimal
•
Considerrisksofdepressionexacerbationwithbenefitsofsmokingcessation
•
FDAremovedBoxedWarningforseriousmentalhealthsideeffectsfromChantix
•
Manyhealthsystemshavesmokingcessationprogramsthroughpharmacists
-
TestosteroneandAbuse/dependence
•
Newwarningofpossibleabuseanddependencetoincludenewsafetyinfo
• Seriousadverseoutcomes–
Heartattack,heartfailure,stroke,livertoxicity,aggression,maleinfertility,depression
• Withdrawalsymptoms–
Depression,fatigue,irritability,insomnia,decreasedlibido
-
HomeopathicTeethingProducts
•
FDAfoundinconsistentamountsofbelladonnainhomeopathicteethingtablets
•
Riskofseizures,difficultybreathing,lethargy,excessivesleepiness,skinflushing,constipation,difficultyurinating
-
PioglitazoneandBladderCancer
•
Updatedreviewconcludedpioglitazonemaybelinkedtoincreasedriskofbladdercancer
• Recommendation:– Donotuseinactivebladdercancer–
Considerrisks/benefitsinpatientwithhistoryofbladdercancer
• Warningsigns:– bloodinurine,urgetourinate,painw/urination
-
ChlorhexidineGluconateandAllergicReactions
• Increasednumberofreportsofseriousallergicreactions
• Recommendation:–
Askpatientsaboutallergicreactionstoantisepticspriortorecommending
– Usealternativeswhennecessary• Warningsigns:
–
Wheezing,difficultybreathing,swellingofface,hives,severerash,shock
-
NEWDRUGAPPROVALS
-
Abaloparatide (Tymlos™)
Indication Osteoporosisinpostmenopausalwomenathighrisk
Mechanism Humanparathyroidhormonerelated analog
Placeintherapy
Newtreatmentoption
Dosing 80mcgsubQ oncedaily
-
Abaloparatide (Tymlos™)Contraindications NoneWarnings
Riskofosteosarcoma,
orthostatichypotension,hypercalcemia,hypercalciuriaandurolithiasis
Adverseeffects
Dizziness,nausea,HA,palpitations,increaseduricacid,hypercalcemia
Other Usefor>2yearsnotrecommended
-
Tymlos™vsForteo™• Postmenopausalwomen
only• Subcutaneousinjectioninto
abdomenonly• 30dosesperpen• Roomtemperatureforup
to30daysafterfirstuse• NoREMSprogram• AWP$1950
•
Postmenopausalwomen,osteoporosisinmen,ANDglucocorticoid-inducedosteoporosis
• Subcutaneousinjectionintothighorabdomen
• 28dosesperpen• Mustbestoredinfridgeat
alltimes• REMSprogram• AWP$3597
-
Valbenazine (Ingrezza™)
Indication Tardivedyskinesia
Mechanism VMAT2inhibitor
Placeintherapy
Oncedailyoption
Dosing 40mgoncedailyincreasingto80mgoncedailyafter1
week*Doseadjustforrenal,hepatic,andconcurrentCYP3A4/CYP2D6inhibitors/inducers
-
Valbenazine (Ingrezza™)
Contraindications None.Caution inQTprolongationpatients
Warnings CNSdepression,suicidalideation,QTprolongation
Adverseeffects Drowsiness,fatigue,sedation
-
Deutetrabenazine (Austedo™)Indication
ChoreaassociatedwithHuntington’s
disease(andtardive dyskinesia)Mechanism VMAT2inhibitor
Placeintherapy
Second treatmentoptionwithlessfrequentdosing
Dosing 6mgoncedaily, increasingweeklybasedonresponse.Administer
in2divideddosesiftotaldailydose
>12mg/day.MAX48mg/day.*DoseadjustwithCYP2D6inhibitors
-
Deutetrabenazine (Austedo™)Contraindications Hepatic
impairment,suicidal
oruntreateddepression,doseadjustmentsw/tetrabenazineorw/in14daysofanMAOIor20daysofreserpine
Warnings Depressionandsuicide, NMS,akathisia,QT prolongation
Adverseeffects Drowsiness,drymouth
-
Austedo™vsIngrezza™
• Twicedaily• Followscheduleifswitchingfromtetrabenazine
and/orMAOI
• IndicatedforChoreaaswell
• Blackboxwarningfordepressionandsuicide
• Oncedaily• CautionwithCyp2D6and3A4
• Nocontraindications• Highercost
-
Safinamide(Xadago®)
Indication
Parkinson’sdisease*Adjunctivetreatmenttolevodopa/carbidopa
inpatientsexperiencing“off”episodes
Mechanism InhibitorofMAO-B
Dosing 50mgoncedaily.Increaseto100mgoncedailyafter2weeks.
-
Safinamide(Xadago®)
Contraindications Severehepaticimpairment,usewithMAOIs,
opioids,SNRIs,TCAs,andothers
Warnings
CNSdepression,hypertension,impulsecontroldisorders,serotoninsyndrome
Adverseeffects Dyskinesia
-
Dupilumab (Dupixent®)
Indication
Moderatetosevereatopicdermatitisnotcontrolledwithtopicaltherapy
Mechanism Interleukin-4receptoralphaantagonist
Dosing 2- 300mgsubcutaneousinjectionsthen300mgeveryotherweek
-
Dupilumab (Dupixent®)
Contraindications NoneWarnings Asthma,conjunctivitisand
keratitis,livevaccinesAdverseeffects Injectionsitereactions,
conjunctivitis,keratitis
-
Naldemedine (Symproic®)
Indication
Opioid-inducedconstipationinpatientswithnon-cancerpain
Mechanism Mu opioidreceptorantagonist
Place intherapy
Another option
Dosing 0.2mgoncedaily
-
Naldemedine (Symproic®)
Contraindications
GIobstruction,increasedriskforrecurrentobstruction
Warnings OpioidwithdrawalAdverseeffects
Abdominalpain,diarrhea,
nausea,gastroenteritis
-
Plecanatide (Trulance™)
Indication Chronicidiopathicconstipation
Mechanism Guanylatecyclase-C agonist
Placeintherapy
Another choiceforconstipation
Dosing 3mgoncedailywithorwithoutfood
-
Plecanatide (Trulance™)
Contraindications
-
Lixisenatide/Insulinglargine(Soliqua™)
Indication Type2diabetes
Mechanism GLP-1 andbasalinsulin
Placeintherapy
Narrowuse
Dosing Startat15 units/5mcg or30units/10mcg.
Max60units/20mcg
-
Lixisenatide/Insulinglargine(Soliqua™)
Contraindications HypersensitivityWarnings
Pancreatitis,hypoglycemia,
medicationerror,AKI,immunogenicity,hypokalemia,
Adverseeffects SameaseitherseparatelyAdministration
1hourbeforefirstmeal
-
Insulinaspart (Fiasp™)
Indication Type 1and2diabetesinadults
Mechanism
Bindstoinsulinreceptorsfacilitatingcellularuptakeofglucose
Placeintherapy
Forpatientswhoforgettoinjectpriortomeals
Dosing Unittounitconversion.Injectwithin20minutesofameal.
-
Insulinaspart (Fiasp™)
Contraindications HypoglycemiaWarnings Hypersensitivity,
hypoglycemia,hypokalemiaAdverseeffects
Hypoglycemia,injectionsite
reactions, weightgain
-
Allopurinolandlesinurad(Duzallo™)
Indication Hyperuricemia
associatedwithgoutnotcontrolledonallopurinol
Mechanism URAT1inhibitorandxanthineoxidaseinhibitor
Placeintherapy
Afterallopurinoltrialtoimprovecontinued symptoms
Dosing 300/200 mgoncedailyor200/200mgforCrCl of45-60mL/min
-
Allopurinolandlesinurad(Duzallo™)
Contraindications Severe
renalimpairment,ESRD,tumorlysissyndrome
Warnings Acuterenalfailure,
rash,hepatotoxicity,bonemarrowsuppression
Adverseeffects Headache, flu,reflux,increasedbloodcreatinine
Administration Takewithbreakfast
-
SUPPLYUPDATES
-
Supplyupdates
• Atenolol25- and50-mgtablets• AmoxicillinandClavulanate
ER1000/62.5-mg• Carisoprodol andaspirindiscontinued• Furosemide20-
and40-mgtablets• Indomethacin25- and50-mgtablets• Tanzeum
discontinuedDrugInfoResourceCenter-DrugShortageshttps://pulse.utah.edu/site/dirc/Pages/Drug-Shortages-update.aspx#Current
-
NEWGENERICDRUGAPPROVALS
-
• QuetiapineER(SeroquelXR®)• Dexmethylphenidate ER(FocalinXR®)•
Pitavastatin (Livalo®)• Fluticasone/salmeterol (AdvairDiskus ®)–
notavailable
• Memantine-donepezil(Namzaric®)• Dexlansoprazole
DelayedRelease(Dexilant®)• EzetimibeandSimvastatin(Vytorin®)•
Prasugrel (Effient®)
-
• Sevelamer carbonate(Renvela®)• Scopolaminepatch(Transderm®)•
Atomoxetine (Strattera®)• Mesalamine DelayedRelease(Lialda®)•
Exenatide (Byetta®)– October2017• Sildenafil(Viagra®)–
December2017• Efavirenz (Sustiva®)– December2017
-
QUIZQUESTIONS
-
Quizquestion#1
Whenswitchingfromanangiotensinconvertingenzymeinhibitortoaneprilysininhibitor,howlongshouldthepatientwaittotaketheneprilysin
inhibitor?A. 24hoursB. 12hoursC. 36hoursD. 42hours
-
Quizquestion#2
WhichofthefollowingmedicationsrequireRiskEvaluationandMitigationStrategy(REMS)?A.
Soliqua ®B. Tymlos ®C. Fiasp ®D. Forteo ®
-
Quizquestion#3
Wherewouldyoufindinformationregardingdrugsupplyshortages?A.
CDCwebsiteB. DrugInformationwebsiteC. PoisoncontrolhotlineD.
Manufacturerwebsites
-
Quizquestion#4
IknowhowIwillusethesedrugwarningsandupdatestopositivelyimpactmycurrentpractice.A.
TrueB. False
-
Questions?
EveVanWagoner,PharmD,BCACPPrimaryCareClinicalPharmacistSouthJordanHealthCenter
[email protected]
