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Myqorzo
aficamten
Black Box Warnings .
Appropriate Use
available only through restricted distribution program (Myqorzo REMS) due to heart failure risk from systolic dysfunction; prescribers, patients, and pharmacies must enroll at 1-844-285-7367 or www.MYQORZOREMS.com
Heart Failure Risk
LVEF decr. may cause heart failure from systolic dysfunction; echocardiogram required before tx initiation and during tx; avoid tx initiation or up-titration in patients w/ LVEF <55%; decr. dose if LVEF is 40-49%; interrupt tx if LVEF <40%, heart failure signs/symptoms, or worsening clinical status
Adult Dosing .
Dosage forms: TAB: 5 mg, 10 mg, 15 mg, 20 mg
Restricted Distribution in US
- [1-844-285-7367 or www.MYQORZOREMS.com for more info]
obstructive hypertrophic cardiomyopathy
- [5-20 mg PO qd]
- Start: 5 mg PO qd, adjust dose by 5 mg/day PO q2-8wk based on Valsalva LVOT gradient and LVEF; Max: 20 mg/day; Info: see pkg insert for dose adjustment, maintenance, and interruption details; restart tx at 5 mg PO qd if LVEF at least 55% after tx interrupted for 7 days or more; consider dose adjustment or interruption if serious illness, new arrhythmia, or other conditions that may impair systolic function
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- LVEF <55% (tx initiation use)
- caution: LVEF <50%
- caution: arrhythmia
- caution: illness, serious
Drug Interactions .
Overview
aficamten
cardiac myosin inhibitor
- CYP2C9 substrate
- CYP2C19 substrate
- CYP2D6 substrate
- CYP3A4 substrate
- P-gp inhibitor, weak
- cardiotoxic effects
Contraindicated
- colchicine
- rifampin
Avoid/Use Alternative
- aficamten
- apixaban
- dabigatran
- ensartinib
- epirubicin
- fluconazole
- idarubicin
- mavacamten
- neratinib
- pralsetinib
- relugolix
- repotrectinib
- rivaroxaban
- sirolimus albumin-bound
- topotecan
- venetoclax
- voriconazole
Monitor/Modify Tx
- acoramidis
- adagrasib
- adalimumab
- ado-trastuzumab emtansine
- afatinib
- aldesleukin
- alogliptin
- amiodarone
- anagrelide
- apalutamide
- armodafinil
- artemether/lumefantrine
- asciminib
- atazanavir
- atorvastatin
- avelumab
- axitinib
- belzutifan
- berberine
- berotralstat
- bevacizumab
- bexarotene
- bezlotoxumab
- binimetinib
- bortezomib
- bosentan
- bosutinib
- brigatinib
- bupropion
- butalbital
- cannabis
- capecitabine
- carbamazepine
- carfilzomib
- cenobamate
- ceritinib
- certolizumab pegol
- chloramphenicol
- cilostazol
- cimetidine
- clarithromycin
- clobazam
- clozapine
- cobicistat
- cobimetinib
- cyclophosphamide
- cyclosporine
- dabrafenib
- dacomitinib
- danshen
- darolutamide
- daunorubicin
- dexamethasone
- dicloxacillin
- digoxin
- diosmin
- disulfiram
- doxorubicin
- dronedarone
- echinacea
- edoxaban
- efavirenz
- elafibranor
- elagolix
- elexacaftor/tezacaftor/ivacaftor
- enasidenib
- encorafenib
- enfortumab vedotin
- entrectinib
- enzalutamide
- erlotinib
- eslicarbazepine acetate
- etanercept
- etravirine
- everolimus
- fam-trastuzumab deruxtecan
- felbamate
- fexinidazole
- fluorouracil
- fluoxetine
- fluvastatin
- fluvoxamine
- fosamprenavir
- fosphenytoin
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- golimumab
- griseofulvin
- hydroxychloroquine
- ibrutinib
- idelalisib
- ifosfamide
- imatinib
- infliximab
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- itraconazole
- ivacaftor
- ivosidenib
- ketoconazole
- lapatinib
- lenvatinib
- levoketoconazole
- linagliptin
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- margetuximab
- mavorixafor
- meropenem
- metronidazole
- mifepristone
- milk thistle
- mirdametinib
- mitapivat
- mitotane
- mitoxantrone
- mobocertinib
- modafinil
- morphine
- nafcillin
- nefazodone
- nelfinavir
- nevirapine
- nitisinone
- odevixibat
- olutasidenib
- omaveloxolone
- oritavancin
- osimertinib
- oxcarbazepine
- pacritinib
- paroxetine
- pazopanib
- peginterferon beta 1a
- pentobarbital
- perampanel
- pertuzumab
- pexidartinib
- phenobarbital
- phenytoin
- pioglitazone
- ponatinib
- posaconazole
- prednisone
- primidone
- propafenone
- quercetin
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- ranolazine
- regorafenib
- ribociclib
- rifabutin
- rifapentine
- ripretinib
- ritonavir
- ropeginterferon alfa-2b
- rosiglitazone
- rucaparib
- rufinamide
- sarilumab
- saxagliptin
- selumetinib
- sirolimus
- sitagliptin
- sorafenib
- sotorasib
- St. John's wort
- stiripentol
- sulfadiazine
- sulfamethoxazole
- sunitinib
- sunvozertinib
- suzetrigine
- tacrolimus
- talazoparib
- tamoxifen
- tazemetostat
- tecovirimat
- telotristat ethyl
- tenofovir alafenamide
- tenofovir disoproxil
- terbinafine
- tezacaftor/ivacaftor
- tipranavir
- tivozanib
- tocilizumab
- topiramate
- toremifene
- torsemide
- tovorafenib
- trabectedin
- trametinib
- trastuzumab
- tucatinib
- ubrogepant
- vaborbactam
- vamorolone
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- vemurafenib
- vinblastine
- vorasidenib
- zafirlukast
- zanidatamab
- zanubrutinib
- zenocutuzumab
- zongertinib
Caution Advised
- glecaprevir
- naldemedine
- pibrentasvir
Safety/Monitoring .
Monitoring Parameters
echocardiogram at baseline, then q2-8wk during dose adjustments or interruptions, then q6mo if LVEF at least 55% or q3mo if LVEF 50-54% during maintenance tx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of fetal malformation, decreased fetal weight, and post-implantation loss based on animal data at 4-5x MRHD
Pregnancy Reporting
report pregnancy during tx or w/in 3wk after D/C to Cytokinetics, Inc at 1-833-633-2986
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for aficamten: liver extensively; CYP450: 2C9 (primary), 2C19, 2D6, 3A4 substrate
Excretion: for aficamten: urine 32% (0.06% unchanged), feces 58% (5.1% unchanged); Half-life: 80h
Subclass: Hypertrophic Cardiomyopathy: Cardiac Myosin Inhibitors
Mechanism of Action
for aficamten: reversibly inhibits cardiac myosin, decreasing dynamic LVOT obstruction and improving cardiac filling pressures
Formulary .
No Formulary Selected
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