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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 patients or tx-experienced patients without darunavir resistance-associated substitutions; give with food
HIV post-exposure prophylaxis, nonoccupational (off-label)
- [800 mg/150 mg PO qd]
- Info: part of multi-drug regimen; give with food; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
- Dosage forms: TAB: 675 mg/150 mg, 800 mg/150 mg
HIV infection
- [3 yo and older, 25-39 kg]
- Dose: 675 mg/150 mg PO qd; Info: for tx-naive patients or tx-experienced patients without darunavir resistance-associated substitutions; give with food
- [3 yo and older, >40 kg]
- Dose: 800 mg/150 mg PO qd; Info: for tx-naive patients or tx-experienced patients without darunavir resistance-associated substitutions; give with food
HIV post-exposure prophylaxis, nonoccupational (off-label)
- [>40 kg]
- Dose: 800 mg/150 mg PO qd; Info: part of multi-drug regimen; give with food; refer to HIV Post-Exposure Prophylaxis, Nonoccupational table
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
- hepatic impairment, Child-Pugh Class C
- avoid: breastfeeding (patients with non-virological suppression throughout 3rd trimester)
- avoid: breastfeeding (patients with non-virological suppression postpartum)
- avoid: breastfeeding (patients with cracked nipple or bleeding nipple)
- avoid: breastfeeding (patients with 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, weak
- 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
- 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
- atorvastatin
- atrasentan
- avanafil
- avapritinib
- axitinib
- bedaquiline
- betamethasone
- betibeglogene autotemcel
- bosutinib
- brigatinib
- brincidofovir
- bromocriptine
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- buspirone
- cabazitaxel
- cabozantinib
- capivasertib
- cariprazine
- cenobamate
- ceritinib
- ciclesonide
- cladribine oral
- clarithromycin
- clopidogrel
- cobimetinib
- codeine
- copanlisib
- crizotinib
- dabigatran
- dabrafenib
- daridorexant
- dasatinib
- defactinib
- desogestrel (contraceptive)
- dexamethasone
- dienogest (contraceptive)
- dihydrocodeine
- disopyramide
- docetaxel
- dordaviprone
- doxorubicin
- duvelisib
- efavirenz
- elacestrant
- elagolix
- eletriptan
- elinzanetant
- elivaldogene autotemcel
- elvitegravir
- encorafenib
- ensartinib
- entrectinib
- enzalutamide
- erdafitinib
- erlotinib
- erythromycin
- eslicarbazepine acetate
- estazolam
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- etoposide
- etrasimod
- etravirine
- everolimus
- fedratinib
- fentanyl
- fesoterodine
- fexinidazole
- fluticasone propionate
- fosamprenavir
- fosaprepitant
- futibatinib
- gepotidacin
- gilteritinib
- glasdegib
- glecaprevir
- hydrocodone
- ibrutinib
- idelalisib
- imlunestrant
- irinotecan
- ivacaftor
- ivosidenib
- ixabepilone
- lapatinib
- larotrectinib
- lefamulin
- lemborexant
- lenacapavir
- leniolisib
- levoketoconazole
- levonorgestrel (contraceptive)
- lopinavir/ritonavir
- lorlatinib
- lovotibeglogene autotemcel
- lumacaftor/ivacaftor
- lurbinectedin
- macitentan
- maraviroc
- mavacamten
- 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
- orforglipron
- orlistat
- oxcarbazepine
- oxycodone
- palbociclib
- palovarotene
- pazopanib
- pemigatinib
- pexidartinib
- pibrentasvir
- pirtobrutinib
- ponatinib
- pralsetinib
- propafenone
- quetiapine
- quizartinib
- red yeast rice
- regorafenib
- relugolix
- remibrutinib
- repotrectinib
- retapamulin topical
- ribociclib
- rifapentine
- rilpivirine
- rilzabrutinib
- rimegepant
- ritonavir
- rivaroxaban
- ruxolitinib
- ruxolitinib topical
- salmeterol inhaled
- sebetralstat
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sevabertinib
- siponimod
- sirolimus
- sirolimus albumin-bound
- sonidegib
- sotorasib
- sparsentan
- sufentanil
- sunitinib
- sunvozertinib
- suvorexant
- tadalafil
- taletrectinib
- tamsulosin
- tazemetostat
- temsirolimus
- tenofovir alafenamide
- tenofovir disoproxil
- thiotepa
- ticagrelor
- tipranavir
- topotecan
- toremifene
- trabectedin
- tramadol
- trazodone
- tretinoin
- triamcinolone
- vardenafil
- vemurafenib
- vinblastine
- vincristine
- vinorelbine
- vorapaxar
- voriconazole
- zavegepant
Monitor/Modify Tx
- abemaciclib
- acarbose
- afatinib
- aficamten
- alogliptin
- aminophylline
- amitriptyline
- amlodipine
- aripiprazole oral
- artemether/lumefantrine
- asciminib
- atogepant
- avacopan
- avatrombopag
- bexagliflozin
- bortezomib
- bosentan
- brentuximab vedotin
- brexpiprazole
- buprenorphine
- bupropion
- butorphanol
- canagliflozin
- 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
- etuvetidigene autotemcel
- 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
- lixisenatide
- loperamide
- lumateperone
- mavorixafor
- metformin
- methadone
- methotrexate
- metoprolol
- mexiletine
- miglitol
- milsaperidone
- mirtazapine
- mitoxantrone
- momelotinib
- morphine
- nateglinide
- nerandomilast
- nicardipine
- nifedipine
- nintedanib
- nortriptyline
- omeprazole
- osilodrostat
- paclitaxel
- 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
- theophylline
- timolol
- tirzepatide
- tofacitinib
- tolterodine
- upadacitinib
- valbenazine
- vamorolone
- vanzacaftor/tezacaftor/deutivacaftor
- verapamil
- vilanterol inhaled
- vilazodone
- warfarin
- zanubrutinib
- ziftomenib
- 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
- garlic
- gefitinib
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- hydrocortisone topical
- ifosfamide
- isradipine
- lamivudine
- memantine
- meropenem
- mirvetuximab soravtansine
- mometasone implant
- mometasone topical
- naldemedine
- nefazodone
- odevixibat
- olutasidenib
- ospemifene
- oxybutynin
- paroxetine
- perampanel
- pimecrolimus topical
- pramipexole
- prednisolone
- prednisone
- ramelteon
- rifaximin
- ripretinib
- roflumilast
- roflumilast topical
- rufinamide
- sarilumab
- seladelpar
- sirolimus topical
- stiripentol
- sulfasalazine
- tacrolimus topical
- tamoxifen
- tecovirimat
- telisotuzumab vedotin
- telotristat ethyl
- tinidazole
- tisotumab vedotin
- tocilizumab
- topiramate
- tovorafenib
- tradipitant
- triamcinolone topical
- tucatinib
- vaborbactam
- venlafaxine
- vorasidenib
- voxilaprevir
- zaleplon
- zileuton
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- skin reaction, severe
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- acute generalized exanthematous pustulosis
- drug reaction with eosinophilia and systemic symptoms
- immune reconstitution syndrome
- autoimmune disorder
- 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 with cobicistat during pregnancy; inadequate human data available, though risk of virologic failure in pregnant patients with concomitant cobicistat use based on lower systemic exposure during 2nd and 3rd trimesters
cobicistat: avoid use with darunavir during pregnancy; no known risk of fetal harm based on limited human data, though risk of virologic failure in pregnant patients with concomitant darunavir use based on lower systemic exposure during 2nd and 3rd trimesters
Pregnancy Registry
enroll patients 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 with 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 with darunavir, though risk of fetal harm not expected based on limited drug excretion into milk; no human data available with 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
for darunavir: binds to active site of HIV protease, preventing mature virus particle formation; for cobicistat: inhibits CYP3A, boosting darunavir levels
Formulary .
No Formulary Selected
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