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Prezcobix
darunavir/ cobicistat
Adult Dosing .
Dosage forms: TAB: 675 mg/150 mg, 800 mg/150 mg
HIV infection
- [800 mg/150 mg PO qd]
- Info: for tx-naive pts or tx-experienced pts w/o darunavir resistance-assoc. substitutions; give w/ food
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 675 mg/150 mg, 800 mg/150 mg
HIV infection
- [25-39 kg]
- Dose: 675 mg/150 mg PO qd; Info: for tx-naive pts or tx-experienced pts w/o darunavir resistance-assoc. substitutions; give w/ food
- [>40 kg]
- Dose: 800 mg/150 mg PO qd; Info: for tx-naive pts or tx-experienced pts w/o darunavir resistance-assoc. substitutions; give w/ food
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- avoid: breastfeeding (pts w/ non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (pts w/ non-virological suppression postpartum)
- avoid: breastfeeding (pts w/ cracked nipple or bleeding nipple)
- avoid: breastfeeding (pts w/ mastitis)
- caution: hypersensitivity to sulfonamides
- caution: hepatic impairment
- caution: HIV infection and HBV infection, concurrent
- caution: HIV infection and HCV infection, concurrent
- caution: diabetes mellitus
- caution: hemophilia
Drug Interactions .
Overview
cobicistat
CYP3A4 booster
- CYP3A4 substrate
- CYP2D6 inhibitor, weak
- CYP3A4 inhibitor, strong
- BCRP inhibitor
- MATE1 inhibitor
- OATP1B1 inhibitor, weak
- OATP1B3 inhibitor, weak
- P-gp inhibitor, strong
- affected by altered fat absorption
- interferes w/ gene therapy
darunavir
HIV protease inhibitor
- CYP3A4 substrate
- CYP2D6 inhibitor, weak
- CYP3A4 inhibitor, moderate
- OATP1B1 inhibitor, weak
- OATP1B3 inhibitor, weak
- P-gp inhibitor, weak
- CYP3A4 inducer, minor
- affected by altered fat absorption
- hyperglycemic effects
- interferes w/ gene therapy
Contraindicated
- alfuzosin
- alprazolam
- butalbital
- carbamazepine
- cisapride
- colchicine
- conivaptan
- dihydroergotamine
- dofetilide
- domperidone
- dronedarone
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- elbasvir
- eliglustat
- eplerenone
- ergotamine
- finerenone
- flibanserin
- fosphenytoin
- gepirone
- grazoprevir
- isavuconazonium
- ivabradine
- lomitapide
- lonafarnib
- lovastatin
- lurasidone
- mavacamten
- methenamine
- methylergonovine
- midazolam
- naloxegol
- pacritinib
- pentobarbital
- phenobarbital
- phenytoin
- pimozide
- primidone
- ranolazine
- rifampin
- sildenafil
- silodosin
- simvastatin
- St. John's wort
- suzetrigine
- thioridazine
- tolvaptan
- triazolam
- ubrogepant
- venetoclax
- voclosporin
Avoid/Use Alternative
- acalabrutinib
- adagrasib
- ado-trastuzumab emtansine
- alfentanil
- almotriptan
- alpelisib
- amiodarone
- apalutamide
- apixaban
- aprepitant
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- atazanavir
- atidarsagene autotemcel
- atogepant
- atorvastatin
- atrasentan
- avanafil
- avapritinib
- axitinib
- bedaquiline
- betamethasone
- betibeglogene autotemcel
- bosutinib
- brigatinib
- brincidofovir
- bromocriptine
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- buspirone
- cabazitaxel
- cabozantinib
- capivasertib
- cenobamate
- ceritinib
- ciclesonide
- cladribine oral
- clarithromycin
- clopidogrel
- cobimetinib
- codeine
- copanlisib
- crizotinib
- dabigatran
- dabrafenib
- daridorexant
- dasatinib
- desogestrel (contraceptive)
- dexamethasone
- dienogest (contraceptive)
- dihydrocodeine
- disopyramide
- docetaxel
- doxorubicin
- duvelisib
- efavirenz
- elacestrant
- elagolix
- eletriptan
- elivaldogene autotemcel
- elvitegravir
- encorafenib
- ensartinib
- entrectinib
- enzalutamide
- erdafitinib
- erlotinib
- erythromycin
- eslicarbazepine acetate
- estazolam
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- etrasimod
- etravirine
- everolimus
- fedratinib
- fentanyl
- fesoterodine
- fexinidazole
- fluticasone propionate
- fosamprenavir
- fosaprepitant
- futibatinib
- gilteritinib
- glasdegib
- glecaprevir
- hydrocodone
- ibrutinib
- idelalisib
- infigratinib
- irinotecan
- ivacaftor
- ivosidenib
- ixabepilone
- lapatinib
- larotrectinib
- lefamulin
- lemborexant
- lenacapavir
- leniolisib
- levoketoconazole
- levonorgestrel (contraceptive)
- lopinavir/ritonavir
- lorlatinib
- lovotibeglogene autotemcel
- lumacaftor/ivacaftor
- lurbinectedin
- macitentan
- maraviroc
- medroxyprogesterone (contraceptive)
- mefloquine
- meperidine
- methylprednisolone
- midostaurin
- mifepristone
- mitapivat
- mitotane
- mobocertinib
- modafinil
- mometasone inhaled
- mometasone nasal
- nafcillin
- nelfinavir
- neratinib
- nevirapine
- nilotinib
- nimodipine
- nirogacestat
- nisoldipine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- olaparib
- oliceridine
- omaveloxolone
- oxcarbazepine
- oxycodone
- palbociclib
- palovarotene
- pazopanib
- pemigatinib
- pexidartinib
- pibrentasvir
- pirtobrutinib
- ponatinib
- pralsetinib
- propafenone
- quetiapine
- quizartinib
- red yeast rice
- regorafenib
- relugolix
- repotrectinib
- resmetirom
- retapamulin topical
- ribociclib
- rifapentine
- rilpivirine
- rimegepant
- ritonavir
- rivaroxaban
- ruxolitinib
- ruxolitinib topical
- salmeterol inhaled
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- siponimod
- sirolimus
- sirolimus albumin-bound
- sonidegib
- sotorasib
- sparsentan
- sufentanil
- sunitinib
- suvorexant
- tadalafil
- tamsulosin
- tazemetostat
- temsirolimus
- tenofovir disoproxil
- theophylline
- thiotepa
- ticagrelor
- tipranavir
- topotecan
- toremifene
- trabectedin
- tramadol
- trazodone
- tretinoin
- triamcinolone
- vardenafil
- vemurafenib
- vinblastine
- vincristine
- vinorelbine
- vorapaxar
- voriconazole
- zavegepant
Monitor/Modify Tx
- abemaciclib
- acarbose
- afatinib
- alogliptin
- aminophylline
- amitriptyline
- amlodipine
- aripiprazole oral
- artemether/lumefantrine
- asciminib
- avacopan
- avatrombopag
- bexagliflozin
- bortezomib
- bosentan
- brentuximab vedotin
- brexpiprazole
- buprenorphine
- bupropion
- butorphanol
- canagliflozin
- cariprazine
- carvedilol
- cilostazol
- cinacalcet
- clonazepam
- clorazepate
- clozapine
- colesevelam
- cyclophosphamide
- cyclosporine
- dapagliflozin
- darifenacin
- daunorubicin
- deflazacort
- desipramine
- diazepam
- diazoxide
- digoxin
- diltiazem
- doxercalciferol
- dulaglutide
- edoxaban
- elexacaftor/tezacaftor/ivacaftor
- eluxadoline
- empagliflozin
- enfortumab vedotin
- ertugliflozin
- esomeprazole
- eszopiclone
- ethosuximide
- etoposide
- exenatide
- felodipine
- flecainide
- flurazepam
- fluvastatin
- fostamatinib
- glimepiride
- glipizide
- glyburide
- guanfacine
- haloperidol
- hydrocortisone
- ibrexafungerp
- iloperidone
- imatinib
- imipramine
- insulin
- istradefylline
- itraconazole
- ketoconazole
- lacosamide
- levomilnacipran
- lidocaine
- linagliptin
- liraglutide
- loperamide
- lumateperone
- mavorixafor
- metformin
- methadone
- methotrexate
- metoprolol
- mexiletine
- miglitol
- mirtazapine
- mitoxantrone
- momelotinib
- morphine
- nateglinide
- nicardipine
- nifedipine
- nintedanib
- nortriptyline
- omeprazole
- orlistat
- osilodrostat
- paclitaxel
- panobinostat
- paricalcitol
- perphenazine
- pimavanserin
- pioglitazone
- pitavastatin
- polatuzumab vedotin
- posaconazole
- pramlintide
- pravastatin
- procainamide
- propranolol
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- repaglinide
- revumenib
- rifabutin
- riociguat
- risperidone
- romidepsin
- rosiglitazone
- rosuvastatin
- saxagliptin
- semaglutide
- sertraline
- sitagliptin
- solifenacin
- tacrolimus
- talazoparib
- tezacaftor/ivacaftor
- timolol
- tirzepatide
- tofacitinib
- tolterodine
- upadacitinib
- valbenazine
- vamorolone
- vanzacaftor/tezacaftor/deutivacaftor
- verapamil
- vilanterol inhaled
- vilazodone
- warfarin
- zanubrutinib
- zolpidem
- zuranolone
Caution Advised
- aliskiren
- alosetron
- armodafinil
- belzutifan
- betamethasone topical
- bexarotene
- cannabis
- capmatinib
- chloramphenicol
- chlordiazepoxide
- clindamycin
- clobazam
- clobetasol topical
- clomipramine
- cortisone
- danshen
- darolutamide
- dicloxacillin
- doravirine
- doxazosin
- dronabinol
- dutasteride
- echinacea
- elafibranor
- enasidenib
- eravacycline
- estradiol (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (hormone replacement)
- felbamate
- fludrocortisone
- fluocinolone topical
- fluticasone furoate
- fluticasone propionate topical
- ganaxolone
- garlic
- gefitinib
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- hydrocortisone topical
- ifosfamide
- isradipine
- lamivudine
- levonorgestrel (hormone replacement)
- medroxyprogesterone (hormone replacement)
- memantine
- meropenem
- mirvetuximab soravtansine
- mometasone implant
- mometasone topical
- naldemedine
- nefazodone
- norethindrone acetate (hormone replacement)
- norgestimate (hormone replacement)
- olutasidenib
- ospemifene
- oxybutynin
- paroxetine
- perampanel
- pimecrolimus topical
- pramipexole
- prednisolone
- prednisone
- ramelteon
- rifaximin
- ripretinib
- roflumilast
- roflumilast topical
- rufinamide
- sarilumab
- seladelpar
- sirolimus topical
- somatropin
- stiripentol
- sulfasalazine
- tacrolimus topical
- tamoxifen
- tecovirimat
- telotristat ethyl
- tinidazole
- tisotumab vedotin
- tocilizumab
- topiramate
- tovorafenib
- triamcinolone topical
- tucatinib
- vaborbactam
- venlafaxine
- vorasidenib
- voxilaprevir
- zaleplon
- zileuton
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- skin rxn, severe
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- acute generalized exanthematous pustulosis
- drug rxn w/ eosinophilia and systemic sx
- immune reconstitution syndrome
- autoimmune disorders
- rhabdomyolysis
- hepatotoxicity
- diabetes mellitus
- diabetic ketoacidosis
- pancreatitis
- osteonecrosis
Common Reactions
- diarrhea
- nausea
- headache
- rash
- hypercholesterolemia
- hypertriglyceridemia
- hyperamylasemia
- hyperlipasemia
- ALT or AST elevated
- hyperbilirubinemia
- jaundice
- ocular icterus
- hyperglycemia
- diabetes mellitus
- vomiting
- abdominal pain
- asthenia
- anorexia
- lipodystrophy
- CK elevated
- glycosuria
- hematuria
- Cr incr.
Safety/Monitoring .
Monitoring Parameters
Cr at baseline, then periodically; LFTs at baseline, 2-8wk after tx start or change, then q3-6mo; lipid profile at baseline, then q6-12mo; fasting glucose at baseline, then q3-6mo if clinically indicated, then q12mo
Pregnancy/Lactation .
Pregnancy
Clinical Summary
darunavir: avoid use w/ cobicistat during pregnancy; inadequate human data available, though risk of maternal virologic failure w/ concomitant cobicistat use based on lower systemic exposure during 2nd and 3rd trimesters
cobicistat: avoid use w/ darunavir during pregnancy; no known risk of fetal harm based on limited human data, though risk of maternal virologic failure w/ concomitant darunavir use based on lower systemic exposure during 2nd and 3rd trimesters
Pregnancy Registry
enroll pts in Antiretroviral Pregnancy Registry at 1-800-258-4263; additional info at www.apregistry.com
Lactation
Clinical Summary
weigh risk/benefit if virologically suppressed throughout 3rd trimester and at delivery, otherwise avoid breastfeeding; avoid breastfeeding if mastitis or nipples cracked or bleeding; give infant antiretroviral prophylaxis w/ zidovudine or nevirapine; risk of postnatal HIV transmission if non-virologically suppressed based on human data; risk of postnatal HIV transmission low if virologically suppressed based on limited human data; inadequate human data available w/ darunavir, though risk of fetal harm not expected based on limited drug excretion into milk; no human data available w/ cobicistat to assess risk of infant harm; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for darunavir: liver 51%; CYP450: 3A substrate; for cobicistat: liver; CYP450: 2D6 (minor), 3A substrate
Excretion: for darunavir: feces 80% (41% unchanged), urine 14% (8% unchanged); Half-life: 15h; for cobicistat: feces 86.2%, urine 8.2%; Half-life: 3-4h
Subclass: HIV: Protease Inhibitors (PIs)
Mechanism of Action
darunavir binds to active site of HIV protease, preventing mature virus particle formation; cobicistat inhibits CYP3A, boosting darunavir levels
Formulary .
No Formulary Selected
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