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Cresemba
isavuconazonium sulfate
Adult Dosing .
Dosage forms: CAP: 74.5 mg, 186 mg; INJ: various
aspergillosis, invasive
- [372 mg PO/IV q24h]
- Start: 372 mg PO/IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; do not open cap; may mix IV powder in 5 mL water and give PO
mucormycosis, invasive
- [372 mg PO/IV q24h]
- Start: 372 mg PO/IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging; do not open cap; may mix IV powder in 5 mL water and give PO
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment; no supplement; 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: CAP: 74.5 mg, 186 mg; INJ: various
aspergillosis, invasive
- [IV form, 1-2 yo, <18 kg]
- Dose: 15 mg/kg/dose IV q24h; Start: 15 mg/kg/dose IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose
- [IV form, 3 yo and older, <37 kg]
- Dose: 10 mg/kg/dose IV q24h; Start: 10 mg/kg/dose IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose
- [IV form, 3 yo and older, >37 kg]
- Dose: 372 mg IV q24h; Start: 372 mg IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose
- [PO form, 6 yo and older, 16-17 kg]
- Dose: 149 mg PO q24h; Start: 149 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; do not open cap; may mix IV powder in 5 mL water and give PO
- [PO form, 6 yo and older, 18-24 kg]
- Dose: 223.5 mg PO q24h; Start: 223.5 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; do not open cap; may mix IV powder in 5 mL water and give PO
- [PO form, 6 yo and older, 25-31 kg]
- Dose: 298 mg PO q24h; Start: 298 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; do not open cap; may mix IV powder in 5 mL water and give PO
- [PO form, 6 yo and older, >32 kg]
- Dose: 372 mg PO q24h; Start: 372 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; do not open cap; may mix IV powder in 5 mL water and give PO
mucormycosis, invasive
- [IV form, 1-2 yo, <18 kg]
- Dose: 15 mg/kg/dose IV q24h; Start: 15 mg/kg/dose IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging
- [IV form, 3 yo and older, <37 kg]
- Dose: 10 mg/kg/dose IV q24h; Start: 10 mg/kg/dose IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging
- [IV form, 3 yo and older, >37 kg]
- Dose: 372 mg IV q24h; Start: 372 mg IV q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging
- [PO form, 6 yo and older, 16-17 kg]
- Dose: 149 mg PO q24h; Start: 149 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging; do not open cap; may mix IV powder in 5 mL water and give PO
- [PO form, 6 yo and older, 18-24 kg]
- Dose: 223.5 mg PO q24h; Start: 223.5 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging; do not open cap; may mix IV powder in 5 mL water and give PO
- [PO form, 6 yo and older, 25-31 kg]
- Dose: 298 mg PO q24h; Start: 298 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging; do not open cap; may mix IV powder in 5 mL water and give PO
- [PO form, 6 yo and older, >32 kg]
- Dose: 372 mg PO q24h; Start: 372 mg PO q8h x6 doses; Info: begin maintenance dose 12-24h after final loading dose; continue tx until permanent immunosuppression reversal and complete response on imaging; do not open cap; may mix IV powder in 5 mL water and give PO
renal dosing
- [see below]
- renal impairment: no adjustment
- HD: no adjustment; no supplement; PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- short QT syndrome, familial
- pregnancy
- avoid: breastfeeding
- caution: patients of childbearing potential
- caution: hepatic impairment, Child-Pugh Class C
- caution: hematologic malignancy
Drug Interactions .
Overview
isavuconazonium
azole antifungal
- CYP3A4 substrate
- CYP3A4 inhibitor, moderate
- UGT1A9 inhibitor
- MATE1 inhibitor
- OCT2 inhibitor
- P-gp inhibitor, weak
- CYP2B6 inducer, weak
- CYP3A4 inducer, weak
- shortens QT interval
- isavuconazonium (prodrug) converted to isavuconazole
Contraindicated
- adagrasib
- apalutamide
- atazanavir
- butalbital
- carbamazepine
- ceritinib
- chloramphenicol
- cisapride
- clarithromycin
- cobicistat
- colchicine
- dofetilide
- eliglustat
- encorafenib
- enzalutamide
- flibanserin
- fosphenytoin
- idelalisib
- itraconazole
- ivosidenib
- ketoconazole
- lomitapide
- lonafarnib
- lumacaftor/ivacaftor
- mifepristone
- mitotane
- nefazodone
- nelfinavir
- pentobarbital
- phenobarbital
- phenytoin
- posaconazole
- primidone
- rifabutin
- rifampin
- ritonavir
- St. John's wort
- tipranavir
- tucatinib
- voriconazole
Avoid/Use Alternative
- alfentanil
- alprazolam
- amiodarone
- aprepitant
- avapritinib
- bosentan
- bosutinib
- brigatinib
- buspirone
- cariprazine
- cenobamate
- cobimetinib
- codeine
- conivaptan
- dabigatran
- dabrafenib
- defactinib
- dihydrocodeine
- dihydroergotamine
- disopyramide
- domperidone
- dordaviprone
- doxorubicin
- efavirenz
- elacestrant
- ensartinib
- entrectinib
- ergotamine
- etrasimod
- etravirine
- fentanyl
- fexinidazole
- fosaprepitant
- gepotidacin
- hydrocodone
- ivabradine
- ivacaftor
- ixabepilone
- lemborexant
- lopinavir/ritonavir
- lorlatinib
- lovastatin
- lurbinectedin
- macitentan
- mavacamten
- meperidine
- methylergonovine
- midazolam
- mitapivat
- mobocertinib
- modafinil
- nafcillin
- naloxegol
- neratinib
- netupitant
- nirogacestat
- nisoldipine
- norgestimate (contraceptive)
- olaparib
- oliceridine
- omaveloxolone
- oxycodone
- pacritinib
- palovarotene
- pemigatinib
- pexidartinib
- pimozide
- pralsetinib
- propafenone
- relugolix
- remibrutinib
- repotrectinib
- ribociclib
- rifapentine
- rilzabrutinib
- rivaroxaban
- selpercatinib
- selumetinib
- simvastatin
- siponimod
- sirolimus albumin-bound
- sonidegib
- sotorasib
- sufentanil
- taletrectinib
- tazemetostat
- tolvaptan
- topotecan
- tramadol
- vardenafil
- venetoclax
- vincristine
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- afatinib
- alfuzosin
- apixaban
- aripiprazole oral
- artemether/lumefantrine
- atorvastatin
- avanafil
- avatrombopag
- axitinib
- brexpiprazole
- bromocriptine
- budesonide
- butorphanol
- cabozantinib
- capivasertib
- cilostazol
- clonazepam
- clozapine
- copanlisib
- crizotinib
- cyclophosphamide
- cyclosporine
- daridorexant
- dasatinib
- deflazacort
- digoxin
- docetaxel
- dronedarone
- edoxaban
- elexacaftor/tezacaftor/ivacaftor
- elinzanetant
- enfortumab vedotin
- eplerenone
- erdafitinib
- erythromycin
- estazolam
- everolimus
- fedratinib
- felodipine
- finerenone
- futibatinib
- ganaxolone
- gepirone
- gilteritinib
- glasdegib
- guanfacine
- hydrocortisone
- ibrutinib
- ifosfamide
- iloperidone
- irinotecan
- lapatinib
- lefamulin
- lidocaine
- lumateperone
- lurasidone
- mavorixafor
- mefloquine
- metformin
- midostaurin
- milsaperidone
- morphine
- mycophenolate mofetil
- mycophenolic acid
- nifedipine
- nilotinib
- nimodipine
- nortriptyline
- palbociclib
- pazopanib
- pimavanserin
- pindolol
- pirtobrutinib
- ponatinib
- procainamide
- propofol
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- ranolazine
- red yeast rice
- rimegepant
- riociguat
- rufinamide
- ruxolitinib
- ruxolitinib topical
- saxagliptin
- sebetralstat
- sertraline
- sildenafil
- sirolimus
- sparsentan
- sunitinib
- suvorexant
- suzetrigine
- tacrolimus
- tadalafil
- talazoparib
- tamsulosin
- temsirolimus
- tenofovir alafenamide
- tenofovir disoproxil
- tezacaftor/ivacaftor
- tofacitinib
- toremifene
- trabectedin
- trazodone
- triazolam
- ubrogepant
- vanzacaftor/tezacaftor/deutivacaftor
- vemurafenib
- vinblastine
- vinorelbine
- voclosporin
- warfarin
- zanubrutinib
- ziftomenib
Caution Advised
- aliskiren
- armodafinil
- artesunate
- avacopan
- belzutifan
- berotralstat
- bexarotene
- budesonide rectal
- bupropion
- ciprofloxacin
- clobazam
- clofazimine
- dalfampridine
- danazol
- danshen
- darifenacin
- darolutamide
- darunavir
- dexamethasone
- dicloxacillin
- diltiazem
- duvelisib
- echinacea
- elafibranor
- elagolix
- eletriptan
- enasidenib
- entacapone
- erlotinib
- eslicarbazepine acetate
- felbamate
- fluconazole
- fosamprenavir
- garlic
- ginkgo
- ginseng, Asian
- glecaprevir
- glycerol phenylbutyrate
- grapefruit
- grazoprevir
- griseofulvin
- imatinib
- imlunestrant
- istradefylline
- lamivudine
- larotrectinib
- lenacapavir
- letermovir
- maraviroc
- memantine
- meropenem
- methadone
- methylprednisolone
- naldemedine
- nevirapine
- odevixibat
- olutasidenib
- ospemifene
- oxcarbazepine
- perampanel
- pibrentasvir
- pioglitazone
- pramipexole
- prednisone
- roflumilast
- roflumilast topical
- sarilumab
- seladelpar
- sevabertinib
- silodosin
- sirolimus topical
- stiripentol
- sunvozertinib
- tecovirimat
- telotristat ethyl
- ticagrelor
- tocilizumab
- topiramate
- tovorafenib
- tretinoin
- upadacitinib
- vaborbactam
- vamorolone
- velpatasvir
- verapamil
- vilazodone
- vorasidenib
Adverse Reactions .
Serious Reactions
- anaphylaxis
- skin reaction, severe
- Stevens-Johnson syndrome
- infusion reaction, severe
- hepatotoxicity
- cholecystitis
- QT shortening
- adrenal insufficiency
Common Reactions
- nausea
- vomiting
- diarrhea
- hypokalemia
- headache
- LFTs elevated
- dyspnea
- abdominal pain
- edema, peripheral
- constipation
- fatigue
- insomnia
- renal failure
- back pain
- chest pain
- appetite decr.
- delirium
- rash
- pruritus
- hypotension
- anxiety
- respiratory failure
- dyspepsia
- injection site reaction
- hypomagnesemia
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, then periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of embryo-fetal toxicity and death based on animal data at <0.5x therapeutic exposure
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x28 days after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for isavuconazonium: liver primarily; CYP450: 3A substrate; UGT: substrate (enzymes unknown)
Excretion: for isavuconazonium: feces 46.1%, urine 45.5% (<1% unchanged); Half-life: 130h
Subclass: Antifungals
Mechanism of Action
for isavuconazonium: prodrug converted to isavuconazole, which binds to lanosterol 14 alpha-demethylase, inhibiting ergosterol synthesis and disrupting fungal cell membrane integrity
Formulary .
No Formulary Selected
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