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Ensacove
ensartinib
Adult Dosing .
Dosage forms: CAP: 25 mg, 100 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
ALK-positive non-small cell lung CA, locally advanced or metastatic
- [225 mg PO qd]
- Info: do not open/crush/chew cap
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin 1-1.5x ULN or AST >ULN: no adjustment; bilirubin >1.5x ULN: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient, severe
- hypersensitivity to tartrazine, severe
- avoid: sun exposure during tx and x1wk after D/C
- avoid: artificial UV light exposure during tx and x1wk after D/C
- avoid: breastfeeding during tx and x1wk after D/C
- caution: female pts of reproductive potential
- caution: male pts of reproductive potential
Drug Interactions .
Overview
ensartinib
- CYP3A4 substrate
- P-gp substrate
- bradycardia
- hyperglycemic effects
- hyperuricemic effects
- photosensitivity
Avoid/Use Alternative
- abrocitinib
- adagrasib
- aminolevulinic acid topical
- amiodarone
- apalutamide
- aprepitant
- asciminib
- atazanavir
- avacopan
- azithromycin
- belumosudil
- berotralstat
- bisoprolol
- bosentan
- brigatinib
- butalbital
- canagliflozin
- cannabidiol
- capmatinib
- captopril
- carbamazepine
- carvedilol
- cenobamate
- ceritinib
- chloramphenicol
- cimetidine
- ciprofloxacin
- clarithromycin
- clofazimine
- cobicistat
- conivaptan
- crizotinib
- cyclosporine
- dabrafenib
- danazol
- danicopan
- daridorexant
- darunavir
- diltiazem
- diosmin
- dronedarone
- duvelisib
- efavirenz
- elacestrant
- elagolix
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- enasidenib
- encorafenib
- entrectinib
- enzalutamide
- erdafitinib
- erythromycin
- etrasimod
- etravirine
- fedratinib
- felodipine
- fexinidazole
- fingolimod
- flibanserin
- fluconazole
- fluvoxamine
- fosamprenavir
- fosphenytoin
- fostamatinib
- futibatinib
- gilteritinib
- ginkgo
- glecaprevir
- grapefruit
- ibrutinib
- idelalisib
- imatinib
- indomethacin
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ivosidenib
- ketoconazole
- lapatinib
- lasmiditan
- ledipasvir
- lefamulin
- lenacapavir
- letermovir
- levacetylleucine
- levoketoconazole
- lofexidine
- lomitapide
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- maribavir
- mavacamten
- mavorixafor
- mifepristone
- milk thistle
- mirabegron
- mitapivat
- mitotane
- modafinil
- nafcillin
- naproxen
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nifedipine
- nilotinib
- nirogacestat
- osimertinib
- ozanimod
- pacritinib
- paroxetine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pibrentasvir
- pirtobrutinib
- ponatinib
- ponesimod
- porfimer
- posaconazole
- pretomanid
- primidone
- propafenone
- quercetin
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ranolazine
- repotrectinib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- ritonavir
- rolapitant
- rucaparib
- sarecycline
- selpercatinib
- siponimod
- sorafenib
- sotagliflozin
- sotorasib
- sparsentan
- St. John's wort
- stiripentol
- suvorexant
- tacrolimus
- telmisartan
- temsirolimus
- tepotinib
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tolvaptan
- trazodone
- trimethoprim
- tucatinib
- turmeric
- uridine triacetate
- valbenazine
- vandetanib
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- vemurafenib
- venetoclax
- verapamil
- vimseltinib
- voclosporin
- voriconazole
- voxilaprevir
- xanomeline
- zonisamide
Monitor/Modify Tx
- acarbose
- acebutolol
- adenosine
- alectinib
- alfentanil
- allopurinol
- alogliptin
- apraclonidine ophthalmic
- arsenic trioxide
- articaine
- atenolol
- betaxolol
- betaxolol ophthalmic
- bexagliflozin
- bromocriptine
- bupivacaine
- bupivacaine liposomal
- carteolol ophthalmic
- chloroprocaine
- clonidine
- clozapine
- colesevelam
- dapagliflozin
- dexmedetomidine
- dexmedetomidine injection
- digoxin
- disopyramide
- donepezil
- dulaglutide
- empagliflozin
- ertugliflozin
- esmolol
- exenatide
- febuxostat
- fentanyl
- flecainide
- galantamine
- glimepiride
- glipizide
- glyburide
- guanfacine
- insulin
- ivabradine
- labetalol
- lacosamide
- lamotrigine
- lanreotide
- levobunolol ophthalmic
- lidocaine
- linagliptin
- liraglutide
- mefloquine
- mepivacaine
- metformin
- metoprolol
- midodrine
- miglitol
- nadolol
- nateglinide
- nebivolol
- neostigmine
- octreotide
- pasireotide
- pegloticase
- pindolol
- pioglitazone
- pramlintide
- praziquantel
- probenecid
- procainamide
- propranolol
- pyridostigmine
- rasburicase
- regadenoson
- remifentanil
- remimazolam
- repaglinide
- rivastigmine
- ropivacaine
- rosiglitazone
- saxagliptin
- semaglutide
- sitagliptin
- sotalol
- succinylcholine
- sufentanil
- sugammadex
- thalidomide
- timolol
- timolol ophthalmic
- tirzepatide
Caution Advised
- acitretin
- methoxsalen
- verteporfin
Adverse Reactions .
Serious Reactions
- interstitial lung dz
- pneumonitis
- hepatotoxicity
- drug rxn w/ eosinophilia and systemic sx
- photosensitivity
- bradycardia
- hyperglycemia
- visual disturbance
- CK elevation
- hyperuricemia
- pneumonia
- hemorrhage
Common Reactions
- rash
- musculoskeletal pain
- cough
- constipation
- pruritus
- nausea
- edema
- fever
- fatigue
- vomiting
- appetite decr.
- URI
- dizziness
- alopecia
- xeroderma
- dysgeusia
- hemorrhage
- interstitial lung dz
- pneumonitis
- ALT or AST incr.
- alk phos incr.
- lymphocytes decr.
- glucose incr.
- albumin decr.
- Hgb decr.
- phosphate decr.
- uric acid incr.
- Cr incr.
- calcium decr.
- sodium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; LFTs at baseline, then q2wk x4wk, then qmo and as clinically indicated; fasting glucose, uric acid at baseline, then periodically; HR regularly; CK; opthalmic exam if changes in vision
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity based on animal data at recommended human dose and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x1wk after D/C in female and male pts
Lactation
Clinical Summary
avoid breastfeeding during tx and x1wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver primarily; CYP450: 3A4 substrate
Excretion: feces 91% (38% unchanged), urine 10% (4.4% unchanged); Half-life: 30h
Subclass: Kinase Inhibitors, ALK Inhibitors
Mechanism of Action
inhibits anaplastic lymphoma kinase (ALK), ALK autophosphorylation, and ALK-mediated downstream signaling, leading to inhibition of ALK-dependent tumor cell proliferation
Formulary .
No Formulary Selected
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