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Winrevair (sotatercept-csrk)
sotatercept
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = sotatercept-csrk
pulmonary arterial HTN
- [0.7 mg/kg/dose SC q3wk]
- Start: 0.3 mg/kg/dose SC x1; Info: hold tx for at least 3wk if Hgb incr. >2 g/dL from previous dose and >ULN, if Hgb incr. >4 g/dL from baseline, if Hgb incr. >2 g/dL above ULN, or if Plt <50,000; reinitiate tx at 0.3 mg/kg/dose SC x1 if tx delay >9wk
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- Plt <50,000
- bleeding, severe
- pregnancy
- avoid: breastfeeding during tx and x4mo after D/C
- caution: patients of childbearing potential
Drug Interactions .
Overview
sotatercept
activin signaling inhibitor
- antiplatelet effects
- thrombogenic effects
Avoid/Use Alternative
- enoxaparin
- fondaparinux
- tranexamic acid
Monitor/Modify Tx
- abemaciclib
- abrocitinib
- acalabrutinib
- ado-trastuzumab emtansine
- afatinib
- aflibercept
- alpha-tocopherol (vitamin E)
- alprostadil intracavernous
- alprostadil intravenous
- alteplase
- aminocaproic acid
- anacaulase topical
- anagrelide
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- antithrombin
- apixaban
- argatroban
- asciminib
- asparaginase
- aspirin
- atidarsagene autotemcel
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- avatrombopag
- axitinib
- baricitinib
- bazedoxifene
- bevacizumab
- binimetinib
- bivalirudin
- botulism immune globulin
- brentuximab vedotin
- brolucizumab
- bromelain
- bromfenac ophthalmic
- C1 esterase inhibitor
- cabazitaxel
- cabozantinib
- calaspargase
- cangrelor
- caplacizumab
- carfilzomib
- celecoxib
- chorionic gonadotropin
- cilostazol
- citalopram
- clopidogrel
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- collagenase clostridium histolyticum
- concizumab
- cysteamine
- cytomegalovirus immune globulin
- dabigatran
- dalteparin
- danazol
- danshen
- darbepoetin alfa
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- defibrotide
- deflazacort
- desogestrel (contraceptive)
- desvenlafaxine
- deuruxolitinib
- dexamethasone
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- dimethyl fumarate
- diosmin
- dipyridamole
- diroximel fumarate
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- duloxetine
- edoxaban
- eltrombopag
- encorafenib
- epirubicin
- epoetin alfa
- epoprostenol
- eptifibatide
- erlotinib
- escitalopram
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethanol (alcoholic beverage)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- evening primrose oil
- everolimus
- factor XIII concentrate
- faricimab
- fedratinib
- fenofibrate
- fenofibric acid
- fenoprofen
- fenugreek
- fibrinogen (human)
- fitusiran
- fluoxetine
- flurbiprofen
- flurbiprofen ophthalmic
- fluvoxamine
- follitropin
- fruquintinib
- garlic
- gefitinib
- gemtuzumab ozogamicin
- ginkgo
- heparin
- hepatitis B immune globulin
- hydrocortisone
- ibrutinib
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- imatinib
- immune globulin
- indomethacin
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- lazertinib
- lenalidomide
- lenvatinib
- levomilnacipran
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- lifileucel
- luspatercept
- lusutrombopag
- magnesium salicylate
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- menotropins
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyl salicylate topical
- methyltestosterone
- milnacipran
- mitotane
- momelotinib
- monomethyl fumarate
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- naproxen
- nattokinase
- necitumumab
- nepafenac ophthalmic
- niacin (vitamin B3)
- nilotinib
- nintedanib
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- nusinersen
- obinutuzumab
- olaparib
- omega-3-acid
- ospemifene
- oxaliplatin
- oxaprozin
- pacritinib
- paroxetine
- pazopanib
- pegaspargase
- penicillin G
- pentosan polysulfate sodium
- pentoxifylline
- piperacillin
- piroxicam
- pirtobrutinib
- plasminogen, human
- pomalidomide
- ponatinib
- porfimer
- pralsetinib
- prasugrel
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- prothrombin complex concentrate (human)
- raloxifene
- ramucirumab
- ranibizumab
- regorafenib
- remibrutinib
- resveratrol
- reteplase
- revakinagene taroretcel
- Rho(D) immune globulin
- ritlecitinib
- rivaroxaban
- romiplostim
- ruxolitinib
- ruxolitinib topical
- salsalate
- saw palmetto
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sepiapterin
- sertraline
- sipuleucel-T
- sirolimus albumin-bound
- sodium tetradecyl sulfate
- sorafenib
- sulindac
- sunitinib
- tamoxifen
- temsirolimus
- tenecteplase
- testosterone
- thalidomide
- ticagrelor
- tipranavir
- tirofiban
- tisotumab vedotin
- tivozanib
- tofacitinib
- tolmetin
- toremifene
- tovorafenib
- trametinib
- trazodone
- treprostinil
- tretinoin
- upadacitinib
- vaccinia immune globulin
- vadadustat
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- vandetanib
- varicella zoster immune globulin
- venlafaxine
- vilazodone
- vinpocetine
- von Willebrand factor
- vorapaxar
- vorinostat
- vortioxetine
- warfarin
- willow bark
- zanubrutinib
- ziv-aflibercept
- zopapogene imadenovec
Adverse Reactions .
Serious Reactions
- erythrocytosis
- thrombocytopenia, severe
- bleeding, severe
- impaired fertility (animal studies)
Common Reactions
- Hgb incr.
- Plt decr.
- headache
- epistaxis
- rash
- telangiectasia
- diarrhea
- dizziness
- erythema
- thrombocytopenia, severe
- bleeding, severe
- intrapulmonary right-to-left shunting
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; Hgb, Plt at baseline, before each dose for 1st 5 doses or longer if unstable levels, then periodically and before each tx reinitiation
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of embryo-fetal death, decr. fetal birth weight, and delayed ossification based on animal data at 0.6x and 4x MRHD
Pregnancy Reporting
report any suspected fetal exposure to Merck Sharp & Dohme, LLC adverse event reporting line at 1-877-888-4231
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and for at least 4mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x4mo after D/C; no human data to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for sotatercept: catabolism; CYP450: unknown
Excretion: for sotatercept: unknown; Half-life: 24 days
Subclass: Pulmonary Arterial Hypertension (PAH)
Mechanism of Action
for sotatercept: binds to activin A and other TGF-b superfamily ligands, inhibiting activin signaling and modulating vascular proliferation
Formulary .
No Formulary Selected
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