Isavuconazonium
CRESEMBA
Pronunciation: eye-sa-vyoo-koe-na-ZOE-nee-um (kree-SEM-ba)
What it isProdrug of the triazole isavuconazole; invasive aspergillosis and mucormycosis.
Why this oneIt covers Mucorales with predictable absorption and uniquely shortens rather than prolongs QT among azoles.
What limits itFamilial short-QT syndrome is a contraindication; hepatotoxicity and CYP3A4 interactions still require review.
FDA-approved for
- invasive aspergillosis and mucormycosis (2015)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Invasive aspergillosis | Adults | Loading 372 mg (=200 mg isavuconazole) q8h ×6 doses (48 h) | Maintenance 372 mg QD | |
| Invasive mucormycosis | Adults | Loading 372 mg q8h ×6 doses (48 h) | Maintenance 372 mg QD | |
| Invasive aspergillosis/mucormycosis | Peds ≥1 yr | IV loading 15 mg/kg (<3 yr) or 10 mg/kg (≥3 yr) q8h ×6 doses | Maintenance same dose QD | 372 mg per dose |
Renal No adjustment needed (mild/moderate/severe incl. ESRD)
Hepatic No adjustment for mild-moderate (Child-Pugh A/B); not studied in severe (C) — use only if benefits outweigh risks, with monitoring
Start maintenance dose 12-24 h after the last loading dose
Instructions
- Capsules: swallow whole; do not chew, crush, dissolve, or open; take with or without food
- IV: infuse over ≥1 hour through an in-line filter (0.2-1.2 micron); do not give as a bolus; do not co-infuse other drugs
- Switching between IV and oral is acceptable (bioequivalent); no loading dose needed when switching
Available strengths
- cap 74.5, 186 mg
- inj 40 mg/mL
Contraindications
- Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole, high-dose ritonavir)
- Coadministration with strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's wort, long-acting barbiturates)
- Familial short QT syndrome
Cautions
- Hepatic adverse reactions — evaluate liver tests at baseline and during therapy
- Infusion-related reactions (IV) — discontinue infusion if they occur
- Hypersensitivity — anaphylaxis (fatal reported) and severe skin reactions (e.g., SJS)
- Embryo-fetal toxicity — advise effective contraception
- Drug particulates — administer IV through an in-line filter
Adverse reactions
- Nausea, vomiting, diarrhea
- Headache
- Elevated liver chemistry tests
- Hypokalemia
- Constipation
- Dyspnea, cough
- Peripheral edema
- Back pain
Pregnancy May cause fetal harm based on animal studies (perinatal mortality, skeletal abnormalities); advise of risk and use contraception.
Lactation No human data; discontinue breastfeeding during treatment with CRESEMBA.
Cost
| Strength | #/mo | generic $ | CostPlus | |
|---|---|---|---|---|
| 74.5 mg | cap | 30 qd | not offered | |
| 186 mg | cap | 30 qd | not offered | |
| 40 mg/mL | inj | per unit | not offered |
Other forms: Isavuconazole (CRESEMBA)
Generic entry2031 est.
NO BOXED WARNINGS
Principal riskContraindicated in familial short QT syndrome
Classes and tags
Clinical profile
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityHepatotoxicity and clinically important CYP/QT interactions; organ toxicity varies markedly by agent.