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Lumakras
sotorasib
Adult Dosing .
Dosage forms: TAB: 120 mg, 240 mg, 320 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
KRAS G12C-mutated non-small cell lung CA, locally advanced or metastatic
- [960 mg PO qd]
- Info: for patients who have received at least 1 prior tx; do not cut/crush/chew, but may disperse tab in water
KRAS G12C-mutated colorectal CA, metastatic
- [960 mg PO qd]
- Info: for patients who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based tx; use with panitumumab; may continue as monotherapy if panitumumab permanently D/C'd; do not cut/crush/chew, but may disperse tab in water
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
- avoid: breastfeeding during tx and x1wk after D/C
Drug Interactions .
Overview
sotorasib
KRAS inhibitor
- CYP3A4 substrate
- BCRP inhibitor
- P-gp inhibitor, moderate
- CYP3A4 inducer, moderate
- gastric pH sensitive
Contraindicated
- colchicine
- lonafarnib
- mavacamten
- ranolazine
- zoliflodacin
Avoid/Use Alternative
- abemaciclib
- alfentanil
- alpelisib
- aluminum hydroxide
- apalutamide
- aprepitant
- artemether/lumefantrine
- atazanavir
- atogepant
- atrasentan
- avacopan
- avapritinib
- avatrombopag
- axitinib
- bedaquiline
- bictegravir
- bosutinib
- brigatinib
- buprenorphine
- buspirone
- butalbital
- cabozantinib
- calcium carbonate
- capivasertib
- capmatinib
- carbamazepine
- cariprazine
- cimetidine
- cladribine oral
- clarithromycin
- cobicistat
- cobimetinib
- codeine
- crizotinib
- dabigatran
- daridorexant
- darolutamide
- defactinib
- deflazacort
- desogestrel (contraceptive)
- dexlansoprazole
- diazoxide
- dienogest (contraceptive)
- dihydrocodeine
- diltiazem
- dolutegravir
- doravirine
- dordaviprone
- doxorubicin
- dronedarone
- drospirenone (contraceptive)
- duvelisib
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- elinzanetant
- elvitegravir
- encorafenib
- ensartinib
- entrectinib
- enzalutamide
- erdafitinib
- erlotinib
- esomeprazole
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- everolimus
- famotidine
- fedratinib
- felodipine
- fentanyl
- finerenone
- fosamprenavir
- fosaprepitant
- fosphenytoin
- fostamatinib
- fruquintinib
- ganaxolone
- gepotidacin
- gilteritinib
- glasdegib
- glecaprevir
- grazoprevir
- hydrocodone
- ibrexafungerp
- ibrutinib
- idelalisib
- imatinib
- irinotecan
- isavuconazonium
- isradipine
- istradefylline
- itraconazole
- ivacaftor
- ivosidenib
- ketoconazole
- lansoprazole
- larotrectinib
- lazertinib
- lefamulin
- lemborexant
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- lumateperone
- macitentan
- magnesium carbonate
- magnesium hydroxide
- magnesium oxide
- maraviroc
- medroxyprogesterone (contraceptive)
- meperidine
- methadone
- midazolam
- midostaurin
- mifepristone
- mirtazapine
- mitapivat
- mitotane
- mobocertinib
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- nerandomilast
- neratinib
- netupitant
- nevirapine
- nicardipine
- nifedipine
- nilotinib
- nirmatrelvir
- nirogacestat
- nisoldipine
- nizatidine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- olaparib
- oliceridine
- olutasidenib
- omaveloxolone
- omeprazole
- oxycodone
- palbociclib
- palovarotene
- pantoprazole
- pazopanib
- pemigatinib
- pentobarbital
- phenobarbital
- phenytoin
- pimavanserin
- pirtobrutinib
- ponatinib
- pralsetinib
- praziquantel
- pretomanid
- primidone
- quizartinib
- rabeprazole
- relugolix
- remibrutinib
- repotrectinib
- revumenib
- ribociclib
- rifabutin
- rifampin
- rilpivirine
- rilzabrutinib
- rimegepant
- ripretinib
- ritonavir
- rivaroxaban
- roflumilast
- rolapitant
- samidorphan
- sebetralstat
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sevabertinib
- simvastatin
- sirolimus albumin-bound
- sodium bicarbonate
- sodium citrate
- sodium zirconium cyclosilicate
- sonidegib
- St. John's wort
- sufentanil
- sunvozertinib
- suzetrigine
- tadalafil
- taletrectinib
- tamoxifen
- tasimelteon
- tazemetostat
- tezacaftor/ivacaftor
- thiotepa
- ticagrelor
- tipranavir
- tofacitinib
- tolvaptan
- topotecan
- toremifene
- tramadol
- ulipristal (post-coital contraceptive)
- valbenazine
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- venetoclax
- verapamil
- voclosporin
- vonoprazan
- voriconazole
- voxilaprevir
- zanubrutinib
- ziftomenib
- zuranolone
Monitor/Modify Tx
- abiraterone acetate
- acalabrutinib
- afatinib
- aficamten
- aminophylline
- amlodipine
- apixaban
- atorvastatin
- betamethasone
- brexpiprazole
- butorphanol
- calcitriol
- carvedilol
- cholecalciferol (vitamin D3)
- clozapine
- crinecerfont
- cyclophosphamide
- cyclosporine
- digoxin
- disopyramide
- doxercalciferol
- edoxaban
- enfortumab vedotin
- ethosuximide
- fexinidazole
- fludrocortisone
- fluvastatin
- guanfacine
- haloperidol
- hydrocortisone
- ifosfamide
- imipramine
- lapatinib
- lovastatin
- lurasidone
- macimorelin
- mavorixafor
- methotrexate
- mitoxantrone
- morphine
- nimodipine
- nortriptyline
- orforglipron
- paltusotine
- perampanel
- pitavastatin
- pravastatin
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- red yeast rice
- repaglinide
- riociguat
- rosuvastatin
- sildenafil
- sirolimus
- stiripentol
- tacrolimus
- talazoparib
- temsirolimus
- tenofovir alafenamide
- tenofovir disoproxil
- theophylline
- tiagabine
- ubrogepant
- vilazodone
- vortioxetine
- warfarin
- zonisamide
Caution Advised
- adagrasib
- albendazole
- aliskiren
- alprazolam
- amiodarone
- apremilast
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- avanafil
- belumosudil
- bortezomib
- bosentan
- budesonide
- cannabis
- cenobamate
- ceritinib
- clindamycin
- copanlisib
- cortisone
- dabrafenib
- dapsone
- darunavir
- dasatinib
- dexamethasone
- diazepam
- drospirenone (hormone replacement)
- efavirenz
- eliglustat
- erythromycin
- eszopiclone
- ethinyl estradiol (hormone replacement)
- etoposide
- etrasimod
- etravirine
- exemestane
- felbamate
- fenfluramine
- fesoterodine
- finasteride
- flibanserin
- fostemsavir
- futibatinib
- gefitinib
- gepirone
- glyburide
- imlunestrant
- isotretinoin
- ivabradine
- ixabepilone
- ixazomib
- levonorgestrel (hormone replacement)
- levonorgestrel intrauterine device (contraceptive)
- maribavir
- mefloquine
- methylprednisolone
- metoclopramide
- modafinil
- nafcillin
- nintedanib
- norethindrone (hormone replacement)
- ondansetron
- osimertinib
- oxcarbazepine
- paclitaxel
- pacritinib
- pexidartinib
- pibrentasvir
- pitolisant
- polatuzumab vedotin
- prednisolone
- prednisone
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- propafenone
- quinine
- ramelteon
- regorafenib
- relacorilant
- rifapentine
- risperidone
- ritlecitinib
- ruxolitinib
- seladelpar
- silodosin
- siponimod
- sorafenib
- sulfasalazine
- sunitinib
- suvorexant
- telisotuzumab vedotin
- terbinafine
- tivozanib
- trabectedin
- trazodone
- tretinoin
- triamcinolone
- triazolam
- tucatinib
- upadacitinib
- vandetanib
- vemurafenib
- vinblastine
- vincristine
- vinorelbine
- vorapaxar
- zaleplon
- zolpidem
- zongertinib
Adverse Reactions .
Serious Reactions
- hepatotoxicity
- interstitial lung disease
- pneumonitis
- pneumonia
Common Reactions
- diarrhea
- musculoskeletal pain
- nausea
- fatigue
- hepatotoxicity
- cough
- vomiting
- constipation
- dyspnea
- abdominal pain
- edema
- appetite decr.
- arthralgia
- pneumonia
- rash
- lymphocytes decr.
- Hgb decr.
- ALT or AST incr.
- calcium decr.
- alk phos incr.
- proteinuria
- sodium decr.
- aPTT incr.
- albumin decr.
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, q3wk x3mo, then qmo or more frequently if elevated; signs/symptoms of interstitial lung disease
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; no known risk of teratogenicity or embryo-fetal death based on animal data at 2.6-4.6x systemic exposure, though risk of decr. fetal wt and reduced ossification at 2.6x systemic exposure
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: for sotorasib: oxidation, conjugation; CYP450: 3A substrate
Excretion: for sotorasib: feces 74% (53% unchanged), urine 6% (1% unchanged); Half-life: 5h
Subclass: KRAS Inhibitors
Mechanism of Action
for sotorasib: irreversibly binds unique cysteine of KRAS G12C, blocking KRAS signaling, inhibiting cell growth, and promoting apoptosis in KRAS G12C-mutated tumor cells
Formulary .
No Formulary Selected
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