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Camzyos
mavacamten
Black Box Warnings .
Appropriate Use
available only through restricted distribution program (Camzyos REMS) due to heart failure risk from systolic dysfunction; prescribers, patients, and pharmacies must enroll at 1-833-628-7367 or www.CAMZYOSREMS.com
Heart Failure Risk
LVEF decr. may cause heart failure from systolic dysfunction; echocardiogram required before tx initiation and during tx; avoid tx initiation in patients with LVEF <55%; interrupt tx if LVEF <50%, heart failure signs/symptoms, or worsening clinical status; contraindicated with strong CYP2C19 inhibitors, moderate-strong CYP2C19 inducers, or moderate-strong CYP3A4 inducers
Adult Dosing .
Dosage forms: CAP: 2.5 mg, 5 mg, 10 mg, 15 mg
Restricted Distribution in US
- [1-833-628-7367 or www.CAMZYOSREMS.com for more info]
obstructive hypertrophic cardiomyopathy, NYHA Class II-III
- [2.5-15 mg PO qd]
- Start: 5 mg PO qd, titrate dose based on Valsalva LVOT gradient and LVEF q4wk x12wk, then q12wk; Max: 15 mg/day; Info: consider delay dose incr. or hold tx if serious illness or arrhythmia; hold tx if LVEF <50% and restart when LVEF 50% or greater; D/C tx if LVEF <50% x2 on 2.5 mg PO qd; see pkg insert for tx initiation, maintenance, and interruption dose adjustment details; do not open cap
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
- pregnancy
- LVEF <55% (tx initiation use)
- caution: CYP2C19 poor metabolizers
- caution: patients of childbearing potential
- caution: LVEF <50%
- caution: arrhythmia
- caution: illness, serious
Drug Interactions .
Overview
mavacamten
cardiac myosin inhibitor
- CYP2C19 substrate
- CYP3A4 substrate
- CYP2C9 inducer, moderate
- CYP2C19 inducer, moderate
- CYP3A4 inducer, moderate
- cardiotoxic effects
Contraindicated
- apalutamide
- bosentan
- butalbital
- carbamazepine
- cenobamate
- dabrafenib
- dicloxacillin
- efavirenz
- encorafenib
- enzalutamide
- etravirine
- fexinidazole
- fluconazole
- fluoxetine
- fluvoxamine
- fosphenytoin
- ivosidenib
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- mitapivat
- mitotane
- modafinil
- nafcillin
- pacritinib
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- primidone
- ranolazine
- repotrectinib
- rifabutin
- rifampin
- rifapentine
- sotorasib
- St. John's wort
- zoliflodacin
Avoid/Use Alternative
- abemaciclib
- aficamten
- alfentanil
- alpelisib
- aprepitant
- armodafinil
- artemether/lumefantrine
- atazanavir
- atogepant
- atrasentan
- avacopan
- avapritinib
- axitinib
- bedaquiline
- belzutifan
- bexarotene
- bictegravir
- bosutinib
- brigatinib
- buprenorphine
- buspirone
- cabozantinib
- capivasertib
- capmatinib
- cariprazine
- ceritinib
- clarithromycin
- clobazam
- cobicistat
- cobimetinib
- codeine
- crizotinib
- danshen
- daridorexant
- darolutamide
- defactinib
- deflazacort
- desogestrel (contraceptive)
- deuruxolitinib
- dexamethasone
- diazoxide
- dienogest (contraceptive)
- dihydrocodeine
- diltiazem
- disopyramide
- dolutegravir
- doravirine
- dordaviprone
- doxorubicin
- dronedarone
- drospirenone (contraceptive)
- duvelisib
- echinacea
- elacestrant
- elafibranor
- elagolix
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- elinzanetant
- elvitegravir
- enasidenib
- ensartinib
- entrectinib
- epirubicin
- erdafitinib
- erlotinib
- eslicarbazepine acetate
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- everolimus
- fedratinib
- felbamate
- felodipine
- fentanyl
- finerenone
- fosamprenavir
- fosaprepitant
- fostamatinib
- fruquintinib
- ganaxolone
- garlic
- gepotidacin
- gilteritinib
- ginkgo
- ginseng, Asian
- glasdegib
- glecaprevir
- glycerol phenylbutyrate
- grapefruit
- grazoprevir
- griseofulvin
- hydrocodone
- ibrexafungerp
- ibrutinib
- idarubicin
- idelalisib
- imatinib
- irinotecan
- isavuconazonium
- isradipine
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- larotrectinib
- lazertinib
- lefamulin
- lemborexant
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lumateperone
- macitentan
- maraviroc
- medroxyprogesterone (contraceptive)
- meperidine
- methadone
- midazolam
- midostaurin
- mifepristone
- mobocertinib
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- nerandomilast
- neratinib
- netupitant
- nevirapine
- nicardipine
- nifedipine
- nilotinib
- nirmatrelvir
- nirogacestat
- nisoldipine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- odevixibat
- olaparib
- oliceridine
- olutasidenib
- omaveloxolone
- oxcarbazepine
- oxycodone
- palbociclib
- palovarotene
- pemigatinib
- perampanel
- pimavanserin
- pioglitazone
- pirtobrutinib
- ponatinib
- pralsetinib
- praziquantel
- prednisone
- pretomanid
- quizartinib
- remibrutinib
- revumenib
- ribociclib
- rilpivirine
- rilzabrutinib
- rimegepant
- ripretinib
- ritonavir
- rivaroxaban
- roflumilast
- rolapitant
- rufinamide
- samidorphan
- sarilumab
- sebetralstat
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sevabertinib
- simvastatin
- sonidegib
- sparsentan
- stiripentol
- sufentanil
- sunvozertinib
- suzetrigine
- tadalafil
- taletrectinib
- tamoxifen
- tasimelteon
- tazemetostat
- tecovirimat
- telotristat ethyl
- tezacaftor/ivacaftor
- thiotepa
- ticagrelor
- tipranavir
- tocilizumab
- tofacitinib
- tolvaptan
- topiramate
- toremifene
- tovorafenib
- tramadol
- ulipristal (post-coital contraceptive)
- valbenazine
- vamorolone
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- venetoclax
- verapamil
- vinblastine
- voclosporin
- vonoprazan
- vorasidenib
- voriconazole
- voxilaprevir
- zanubrutinib
- ziftomenib
- zuranolone
Monitor/Modify Tx
- abiraterone acetate
- acalabrutinib
- acebutolol
- adagrasib
- adalimumab
- ado-trastuzumab emtansine
- aldesleukin
- alogliptin
- alprazolam
- aminophylline
- amiodarone
- amitriptyline
- amlodipine
- anagrelide
- asciminib
- atenolol
- atorvastatin
- avatrombopag
- avelumab
- belumosudil
- berberine
- berotralstat
- betamethasone
- betaxolol
- bevacizumab
- bezlotoxumab
- bicalutamide
- binimetinib
- bisoprolol
- bortezomib
- brexpiprazole
- butorphanol
- calcitriol
- cannabidiol
- cannabis
- capecitabine
- carfilzomib
- carvedilol
- celecoxib
- certolizumab pegol
- chloramphenicol
- chlorzoxazone
- cholecalciferol (vitamin D3)
- cilostazol
- cimetidine
- ciprofloxacin
- clevidipine
- clofazimine
- clopidogrel
- clotrimazole oropharyngeal
- clozapine
- conivaptan
- cranberry
- crinecerfont
- cyclophosphamide
- cyclosporine
- danazol
- darunavir
- daunorubicin
- diclofenac
- diosmin
- dofetilide
- doxercalciferol
- erythromycin
- esmolol
- esomeprazole
- etanercept
- ethosuximide
- fam-trastuzumab deruxtecan
- flecainide
- flibanserin
- fludrocortisone
- fluorouracil
- givinostat
- givosiran
- glimepiride
- goldenseal
- golimumab
- guanfacine
- haloperidol
- hydrocortisone
- hydroxychloroquine
- ibutilide
- ifosfamide
- imipramine
- infliximab
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoniazid
- kratom
- labetalol
- lapatinib
- lenvatinib
- lidocaine
- linagliptin
- lomitapide
- lovastatin
- luliconazole topical
- lurasidone
- macimorelin
- margetuximab
- maribavir
- mavorixafor
- meropenem
- metoprolol
- mexiletine
- mirdametinib
- mirtazapine
- mitoxantrone
- nadolol
- nateglinide
- nebivolol
- nimodipine
- nortriptyline
- omeprazole
- orforglipron
- osilodrostat
- osimertinib
- paltusotine
- pazopanib
- peginterferon beta 1a
- peppermint
- pertuzumab
- pibrentasvir
- pindolol
- posaconazole
- primaquine
- procainamide
- propafenone
- propranolol
- quercetin
- quetiapine
- quinidine (antiarrhythmic)
- remdesivir
- repaglinide
- resveratrol
- ritlecitinib
- ropeginterferon alfa-2b
- rosiglitazone
- rucaparib
- saxagliptin
- sildenafil
- sirolimus
- sitagliptin
- sorafenib
- sotalol
- spironolactone
- sunitinib
- tacrolimus
- temsirolimus
- theophylline
- tiagabine
- timolol
- tivozanib
- torsemide
- trabectedin
- trametinib
- trastuzumab
- treosulfan
- triclabendazole
- trofinetide
- tucatinib
- ubrogepant
- vaborbactam
- vandetanib
- vilazodone
- viloxazine
- vortioxetine
- warfarin
- xanomeline
- zanidatamab
- zenocutuzumab
- zileuton
- zongertinib
- zonisamide
Caution Advised
- abrocitinib
- albendazole
- aliskiren
- apixaban
- apremilast
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- avanafil
- brivaracetam
- budesonide
- carisoprodol
- clindamycin
- colchicine
- copanlisib
- cortisone
- dapsone
- dasatinib
- dexlansoprazole
- diazepam
- dronabinol
- drospirenone (hormone replacement)
- eliglustat
- enfortumab vedotin
- eszopiclone
- ethinyl estradiol (hormone replacement)
- etoposide
- etrasimod
- exemestane
- fenfluramine
- fesoterodine
- finasteride
- fluvastatin
- fostemsavir
- futibatinib
- gefitinib
- gepirone
- glyburide
- imlunestrant
- isotretinoin
- ivabradine
- ixabepilone
- ixazomib
- lansoprazole
- levonorgestrel (hormone replacement)
- levonorgestrel intrauterine device (contraceptive)
- mefloquine
- methylprednisolone
- metoclopramide
- nintedanib
- norethindrone (hormone replacement)
- ondansetron
- paclitaxel
- pitolisant
- polatuzumab vedotin
- prednisolone
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- quinidine (CYP2D6 inhibitor)
- quinine
- ramelteon
- regorafenib
- relugolix
- risperidone
- ruxolitinib
- siponimod
- sirolimus albumin-bound
- suvorexant
- telisotuzumab vedotin
- terbinafine
- trazodone
- tretinoin
- triamcinolone
- triazolam
- upadacitinib
- vincristine
- vinorelbine
- vorapaxar
- zaleplon
- zolpidem
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; echocardiogram at baseline, then q4wk x12wk, then q12wk and as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of fetal harm, including decr. fetal birth weight, decr. bone density, skeletal malformations, and post-implantation loss based on animal data at 1x MRHD
Pregnancy Reporting
report pregnancy during tx or within 4mo after D/C to Bristol-Myers Squibb Co. at 1-800-721-5072 or www.bms.com
Individuals of Reproductive Potential
obtain negative pregnancy test before tx start; avoid pregnancy by using effective contraception (e.g. combined hormonal contraceptive containing ethinyl estradiol and norethindrone, other combined hormonal contraceptive plus non-hormonal method, or contraceptive method not affected by CYP450 induction), during tx and x4mo after D/C in patients of childbearing potential
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 mavacamten: liver; CYP450: 2C9, 2C19 (primary), 3A4 substrate
Excretion: for mavacamten: urine 85% (3% unchanged), feces 7% (1% unchanged); Half-life: 6-9 days, 23 days (CYP2C19 poor metabolizers)
Subclass: Hypertrophic Cardiomyopathy: Cardiac Myosin Inhibitors
Mechanism of Action
for mavacamten: reversibly inhibits cardiac myosin, decreasing dynamic LVOT obstruction and improving cardiac filling pressures
Formulary .
No Formulary Selected
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