Select a medication above to begin.
Tryvio
aprocitentan
Black Box Warnings .
Appropriate Use
restricted distribution program (TRYVIO REMS) to minimize fetal exposure; prescribers and pharmacies must enroll at 1-866-429-8964 or www.TRYVIOREMS.com
Embryo-Fetal Toxicity
contraindicated in pregnancy due to risk of major birth defects; counsel pts who can become pregnant about the potential risk to a fetus; exclude pregnancy prior to tx start, then qmo during tx, and 1mo after D/C; avoid pregnancy by using acceptable methods of contraception prior to tx start, during tx, and x1mo after D/C
Adult Dosing .
Dosage forms: TAB: 12.5 mg
Restricted Distribution in US
- [1-866-429-8964 or www.TRYVIOREMS.com for more info]
HTN, adjunct tx
- [12.5 mg PO qd]
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- Child-Pugh Class B or C or baseline AST/ALT >3x ULN: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- anemia, severe
- heart failure, NYHA Class III-IV
- BNP >500
- cardiac impairment
- hepatic impairment, Child-Pugh Class B-C
- ALT or AST >3x ULN
- caution: elderly pts
- caution: female pts of reproductive potential
- caution: renal impairment
Drug Interactions .
Overview
aprocitentan
endothelin antagonist
- antihypertensive agent
Contraindicated
- isocarboxazid
Avoid/Use Alternative
- aldesleukin
- aripiprazole lauroxil
- lofexidine
Monitor/Modify Tx
- abiraterone acetate
- albuterol
- albuterol inhaled
- alfentanil
- alfuzosin
- almotriptan
- amantadine
- amifostine
- amitriptyline
- amoxapine
- amphetamine
- apomorphine
- apraclonidine ophthalmic
- arformoterol inhaled
- aripiprazole
- aripiprazole bimonthly injection
- armodafinil
- articaine
- asciminib
- asenapine
- aspirin
- atomoxetine
- atropine ophthalmic
- avanafil
- axitinib
- benzphetamine
- berberine
- betamethasone
- betaxolol ophthalmic
- bethanechol
- bevacizumab
- bexagliflozin
- bismuth subsalicylate
- bortezomib
- brexpiprazole
- brigatinib
- brimonidine ophthalmic
- brimonidine topical
- bromocriptine
- budesonide
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- bupropion
- butalbital
- butorphanol
- cabergoline
- caffeine
- caffeine citrate
- canagliflozin
- cannabis
- carfilzomib
- cariprazine
- carteolol ophthalmic
- celecoxib
- chloroprocaine
- chlorpromazine
- cilostazol
- clofarabine
- clomipramine
- clonidine
- clozapine
- cocaine
- codeine
- coenzyme Q-10
- corticotropin
- cortisone
- cyclosporine
- danazol
- dapagliflozin
- daprodustat
- darbepoetin alfa
- deflazacort
- desflurane
- desipramine
- desmopressin
- desvenlafaxine
- dexamethasone
- dexmedetomidine
- dexmedetomidine injection
- dexmethylphenidate
- dextroamphetamine
- diazoxide
- diclofenac
- diclofenac topical
- diethylpropion
- diflunisal
- dihydrocodeine
- dihydroergotamine
- dinutuximab
- dipyridamole
- doxapram
- doxazosin
- doxepin
- dronabinol
- droxidopa
- duloxetine
- eletriptan
- empagliflozin
- entacapone
- entrectinib
- enzalutamide
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- epinephrine inhaled
- epoetin alfa
- epoprostenol
- erenumab
- ergotamine
- ertugliflozin
- esketamine
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethanol
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- fenfluramine
- fenoprofen
- fentanyl
- ferumoxytol
- fingolimod
- flaxseed
- flibanserin
- fludrocortisone
- fluphenazine
- flurbiprofen
- formoterol inhaled
- foslevodopa
- fostamatinib
- frovatriptan
- fruquintinib
- garlic
- gilteritinib
- guanfacine
- haloperidol
- hoodia
- hydralazine
- hydrocodone
- hydrocortisone
- hydromorphone
- ibrutinib
- ibuprofen
- iloperidone
- iloprost
- iloprost inhaled
- imipramine
- indomethacin
- iron sucrose
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- ketoprofen
- ketorolac
- lanreotide
- leflunomide
- levalbuterol inhaled
- levobunolol ophthalmic
- levodopa
- levomilnacipran
- levorphanol
- levothyroxine
- licorice
- lidocaine
- liothyronine
- lisdexamfetamine
- loxapine
- lubiprostone
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- luspatercept
- magnesium salicylate
- magnesium sulfate
- maraviroc
- meclofenamate
- mefenamic acid
- meloxicam
- meperidine
- mepivacaine
- methadone
- methamphetamine
- methohexital
- methoxy polyethylene glycol-epoetin beta
- methylene blue injection
- methylergonovine
- methylphenidate
- methylprednisolone
- metoclopramide
- midazolam
- midodrine
- milnacipran
- milrinone
- mirabegron
- mirtazapine
- modafinil
- molindone
- morphine
- nabumetone
- nalbuphine
- naphazoline ophthalmic
- naproxen
- naratriptan
- nattokinase
- naxitamab
- niacin (vitamin B3)
- nilotinib
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- obinutuzumab
- olanzapine
- oliceridine
- olodaterol inhaled
- opicapone
- opium
- osilodrostat
- oxaprozin
- oxazepam
- oxycodone
- oxymetazoline nasal
- oxymetazoline ophthalmic
- oxymetazoline topical
- oxymorphone
- ozanimod
- paliperidone
- palopegteriparatide
- pentamidine
- pentazocine
- pentobarbital
- pentoxifylline
- perphenazine
- pexidartinib
- phendimetrazine
- phenelzine
- phenobarbital
- phentermine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- piroxicam
- ponatinib
- ponesimod
- pralsetinib
- pramipexole
- prazosin
- prednisolone
- prednisone
- procarbazine
- prochlorperazine
- promethazine
- propofol
- protriptyline
- pseudoephedrine
- quetiapine
- ramucirumab
- rasagiline
- regorafenib
- remifentanil
- remimazolam
- riociguat
- ripretinib
- risperidone
- rizatriptan
- ropinirole
- ropivacaine
- rotigotine transdermal
- sacubitril
- safinamide
- salmeterol inhaled
- salsalate
- selegiline
- selegiline transdermal
- selpercatinib
- sevoflurane
- sildenafil
- silodosin
- siponimod
- sodium ferric gluconate complex
- sorafenib
- sotagliflozin
- sotalol
- sparsentan
- sufentanil
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tadalafil
- tagraxofusp
- tamsulosin
- tapentadol
- taurine
- terazosin
- terbutaline
- teriflunomide
- testosterone
- tetrahydrozoline ophthalmic
- thalidomide
- thioridazine
- thiothixene
- thyroid
- timolol ophthalmic
- tivozanib
- tizanidine
- tolcapone
- tolmetin
- tramadol
- trametinib
- tranylcypromine
- trazodone
- treprostinil
- triamcinolone
- trifluoperazine
- trimipramine
- vamorolone
- vandetanib
- vardenafil
- vasopressin
- venlafaxine
- vilanterol inhaled
- viloxazine
- voclosporin
- vosoritide
- yohimbe
- ziprasidone
- ziv-aflibercept
- zolmitriptan
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- hepatotoxicity
- fluid retention, severe
- anemia
Common Reactions
- edema
- anemia
- sperm count decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline, then qmo during tx and 1mo after D/C; Hgb, LFTs at baseline, then as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
contraindicated during pregnancy; inadequate human data available; risk of teratogenicity based on animal data at 2x and 15x MRHD
Pregnancy Reporting
report any suspected fetal exposure to Tryvio pregnancy safety study at 1-866-429-8964
Individuals of Reproductive Potential
obtain negative pregnancy test prior to tx start, then qmo during tx, and 1mo after D/C; avoid pregnancy by using acceptable contraception prior to tx start, during tx, and x1mo after D/C in pts who can become pregnant
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available, though risk of infant harm not expected based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: hydrolysis primarily; CYP450: none; UGT: 1A1, 2B7
Excretion: urine 52% (0.2% unchanged), feces 25% (6.8% unchanged); Half-life: 41h
Subclass: Endothelin Receptor Antagonists
Mechanism of Action
binds to endothelin receptors, blocking vasoconstrictive effects of endothelin-1; reduces endothelial dysfunction, vascular hypertrophy and remodeling, sympathetic activation, and aldosterone synthesis (endothelin receptor antagonist)
Formulary .
No Formulary Selected
Join Now to View Patient Handouts!
Create a FREE epocrates Online account to access patient medication instructions. Your patients and caregivers will appreciate you printing these friendly handouts, available in English and Spanish. Each handout addresses common concerns such as how to take the medication, and possible side effects.
Current Members: Sign In.
Pill Pictures
Join Now to View Pill Pictures!
Create a FREE epocrates Online account to access full-color images of medications within the drug monograph.
Current Members: Sign In.