Isavuconazonium
Isavuconazonium is an antifungal ingredient used to treat serious invasive fungal infections, including invasive aspergillosis and invasive mucormycosis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Isavuconazonium: Patient Information Guide
A plain-language walkthrough of Isavuconazonium — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Isavuconazonium (as Cresemba) is an antifungal used to treat two serious, invasive fungal infections:
- Invasive aspergillosis — Cresemba for injection is approved for adults and children 1 year of age and older; Cresemba capsules are approved for adults and children 6 years of age and older weighing at least 16 kg
- Invasive mucormycosis — Cresemba for injection is approved for adults and children 1 year of age and older; Cresemba capsules are approved for adults and children 6 years of age and older weighing at least 16 kg
⚙️How it works▾
Isavuconazonium is a prodrug — a form of the medicine that your body rapidly converts into the active drug, isavuconazole, once it enters your bloodstream. Isavuconazole is an azole antifungal: it works by interfering with the production of ergosterol, a key building block of fungal cell membranes. Without a functioning membrane, the fungus cannot survive or spread.
Before starting treatment, fungal cultures and laboratory studies are recommended to confirm which organism is causing the infection, so that therapy can be adjusted based on those results if needed.
💊How it's taken▾
Cresemba is available as oral capsules and as an intravenous (IV) infusion. Treatment in both adults and children begins with a loading phase — doses given every 8 hours for the first 48 hours — followed by once-daily maintenance dosing starting 12 to 24 hours after the last loading dose. Cresemba capsules may be taken with or without food and must be swallowed whole. The IV form is infused slowly over at least one hour through an in-line filter.
- Capsule doses vary by the patient's age and weight in children — follow your prescriber's exact instructions
- Switching between the IV and oral capsule forms of Cresemba is acceptable without repeating the loading dose
- Pediatric dosing for the injection is based on body weight; follow the prescriber's guidance carefully
🤒Side effects — in detail▾
The most common side effects reported with Cresemba include:
- Nausea, vomiting, and diarrhea
- Constipation
- Headache
- Elevated liver enzyme levels (seen on blood tests)
- Low potassium in the blood (hypokalemia)
- Shortness of breath
- Swelling in the legs or feet
- Rash and itching
In children, the most frequently reported reactions were diarrhea, stomach pain, vomiting, elevated liver tests, rash, nausea, itching, and headache. Seek medical help immediately if you develop signs of liver trouble (yellowing skin or eyes, dark urine) or a severe allergic reaction (difficulty breathing, sudden low blood pressure, widespread hives).
⚠️Warnings & precautions▾
- Liver problems: Serious liver reactions — including hepatitis and liver failure — have been reported. Liver blood tests should be checked before and throughout treatment. Tell your doctor right away if you feel unusually fatigued, notice yellowing of your skin or eyes, or have dark-colored urine.
- Severe allergic reactions: Life-threatening anaphylaxis (a sudden, whole-body allergic reaction) has been reported, sometimes shortly after starting Cresemba. Severe skin reactions like Stevens-Johnson syndrome have been seen with related antifungal drugs. Discontinue Cresemba immediately if a severe reaction occurs.
- Infusion reactions: During IV administration, reactions including low blood pressure, chills, dizziness, and shortness of breath have occurred. The infusion should be stopped if these develop.
- Heart rhythm effect: Cresemba shortens the QTc interval (a measure of the heart's electrical cycle) in a dose-related way. It must not be used in patients with familial short QT syndrome.
- Pregnancy risk: Animal studies show fetal harm at doses below the human therapeutic dose. Effective contraception is required during treatment and for 28 days after the last dose. Breastfeeding should be stopped during treatment.
- Drug interactions: Several common medications can dramatically raise or lower isavuconazole blood levels — review your full medication list with your prescriber before starting.
🔀What it interacts with▾
Isavuconazonium has several clinically significant drug interactions that can affect how well it works or increase the risk of side effects from other medications:
- Ketoconazole and high-dose ritonavir (strong CYP3A4 inhibitors): Contraindicated — can raise isavuconazole levels more than 5-fold, increasing toxicity risk
- Rifampin, carbamazepine, St. John's Wort, long-acting barbiturates (strong CYP3A4 inducers): Contraindicated — can reduce isavuconazole levels by up to 97%, making it ineffective
- Lopinavir/ritonavir: Use with caution — significantly raises isavuconazole levels and may reduce lopinavir/ritonavir effectiveness
- Cyclosporine, tacrolimus, sirolimus (transplant medications): Cresemba raises their blood levels — close monitoring and possible dose adjustment needed
- Digoxin (heart medication): Blood levels increase — regular monitoring required
- Atorvastatin (cholesterol medication): Levels may rise — watch for muscle pain or other statin side effects
- Vincristine (cancer medication): Avoid combining — risk of increased vincristine-related toxicity in adults and children
- Bupropion (antidepressant/smoking cessation): Levels may fall — dose adjustment may be needed, but should not exceed the maximum recommended dose
- Mycophenolate mofetil (immune suppressor): Levels increase — monitor for related toxicities
- Midazolam (sedative): Levels increase — dose reduction of midazolam may be needed
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take Cresemba if you have a known allergy to isavuconazole or any component of the product
- Do not take Cresemba if you have familial short QT syndrome — a hereditary heart rhythm condition
- Tell your doctor about all medications, supplements, and herbal products you take — especially antifungals, HIV drugs, anti-seizure medications, transplant drugs, or St. John's Wort
- Tell your doctor if you are pregnant — Cresemba may harm a developing baby based on animal data; use effective birth control during treatment and for 28 days after your last dose
- Do not breastfeed while taking Cresemba — the drug was found in animal milk and may be present in human milk
- Tell your doctor if you have liver disease — those with severe liver impairment (Child-Pugh Class C) should only use Cresemba when benefits clearly outweigh risks, and need close monitoring
- Cresemba capsules are not for children under 6 years of age or weighing less than 16 kg; the IV form can be used in children as young as 1 year
- Older adults (65+) generally do not need dose adjustments, but should still be monitored for side effects
- No dose adjustment is needed for kidney disease, including end-stage renal disease — and note that isavuconazole is not removed by hemodialysis
🚑If you take too much▾
Taking more Cresemba than prescribed has been associated with a higher rate of side effects, including headache, dizziness, tingling, sleepiness, diarrhea, vomiting, rapid heart rate, and anxiety. There is no specific antidote for isavuconazole, and the drug cannot be removed by hemodialysis (kidney dialysis). Treatment in an overdose situation focuses on supportive care with appropriate monitoring.
📡Pharmacodynamics — effects in the body▾
Cresemba shortens the QTc interval — a measure of how long the heart takes to reset between beats — in a dose-related way. This is the opposite effect of many drugs that prolong the QTc, and it means Cresemba must not be used in people with familial short QT syndrome. In clinical trials for invasive aspergillosis, no clear relationship was found between the amount of drug in the blood and how well it worked against the infection.
🔬Pharmacokinetics — how your body processes it▾
After you take Cresemba capsules, the active drug isavuconazole is absorbed quickly and reaches peak blood levels in about 2 to 3 hours. The oral capsules have nearly complete absorption (98% bioavailability) and can be taken with or without food — a high-fat meal has only a minor effect on overall exposure. Once in the body, isavuconazole spreads widely through tissues and is more than 99% protein-bound (mostly to albumin). It is broken down primarily by liver enzymes (CYP3A4 and CYP3A5) and has a very long half-life of about 130 hours, allowing for once-daily dosing after the loading phase. The drug is eliminated roughly equally in the feces and urine, though less than 1% of the active drug itself is excreted unchanged in urine.
📦How to store it▾
CRESEMBA Capsules Store CRESEMBA capsules at 20°C to 25°C (68°F to 77°F) in the original packaging to protect from moisture. Store CRESEMBA for injection unreconstituted vials at 2°C to 8°C (36°F to 46°F) in a refrigerator.
📄 Written from Isavuconazonium’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Isavuconazonium
138 supplements and herbal products have documented interactions with Isavuconazonium in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 94
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Isavuconazonium — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Cresemba used for? ▾
Can I take the capsules with food, or do I need to take them on an empty stomach? ▾
What side effects should I watch out for — and which ones mean I should call someone right away? ▾
I take other medications. Are there any I need to be especially careful about? ▾
Is Cresemba safe to take during pregnancy or while breastfeeding? ▾
My child has been prescribed Cresemba. Is it safe for kids? ▾
Is Isavuconazonium available over the counter? ▾
When was Isavuconazonium first available? ▾
Who makes Isavuconazonium? ▾
💬 Answers drafted from Isavuconazonium’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Isavuconazonium comes
Isavuconazonium is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Cresemba capsules are used to treat invasive aspergillosis in adults and children 6 years of age and older weighing at least 16 kg
- Cresemba capsules are used to treat invasive mucormycosis in adults and children 6 years of age and older weighing at least 16 kg
- Cresemba capsules can be taken with or without food
- Swallow Cresemba capsules whole — do not chew, crush, dissolve, or open them
- Cresemba capsules are taken more frequently during the first 48 hours (loading phase), then switched to once-daily dosing
- Switching between Cresemba capsules and the IV form does not require an additional loading dose
Injection
How this form is used
- Cresemba for injection is used to treat invasive aspergillosis in adults and children 1 year of age and older
- Cresemba for injection is used to treat invasive mucormycosis in adults and children 1 year of age and older
- Cresemba for injection must be given slowly through a vein over at least 1 hour — never as a rapid bolus injection
- Cresemba for injection must be administered through an infusion set with an in-line filter to remove any particles that may form
- Cresemba for injection must not be infused at the same time as other IV medications through the same line
- Cresemba for injection is given more frequently during the first 48 hours (loading phase), then once daily thereafter
📊 Isavuconazonium across the U.S. market
How Isavuconazonium appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Isavuconazonium is used
A general measure of how commonly Isavuconazonium is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Isavuconazonium is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Isavuconazonium prescribed? Of the 1,596 medications we measure, Isavuconazonium ranks #1,024 by Medicaid prescriptions — more than 36% of them.
Utilization by Isavuconazonium product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
isavuconazonium sulfate 186 MG Oral Capsule Most dispensed
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1608327
isavuconazonium sulfate 372 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1608811
isavuconazonium sulfate 74.5 MG Oral Capsule
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2623470
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Isavuconazonium, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 6 listed Isavuconazonium NDCs with Medicaid activity.
🔍 Compare Isavuconazonium products
A representative set of FDA-listed product records for Isavuconazonium — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 40 mg | Oral | Astellas Pharma US, Inc. × 2 listings | NDA | View NDC → |
| 100 mg | Oral | Astellas Pharma US, Inc. × 3 listings | NDA | View NDC → |
| 40 mg | — | SwissCo Services AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg | — | SwissCo Services AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Injection | ||||
| 40 mg/mL | Intravenous | Astellas Pharma US, Inc. × 3 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Alivus Life Sciences Limited | BULK INGREDIENT | View NDC → |
| 0.54 kg/kg | — | Astellas Pharma US, Inc. | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 25 kg/25 kg | — | Biophore India Pharmaceuticals Pvt. Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hovione Farmaciencia Sa | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Metrochem Api Private Limited | BULK INGREDIENT | View NDC → |
| 3 kg/3 kg | — | Metrochem Api Private Limited | BULK INGREDIENT | View NDC → |
| 5 kg/5 kg | — | Metrochem Api Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sichuan D-Innovation Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
Showing 19 of 19 products — FDA National Drug Code Directory. See every product, package size and price: browse all 19 Isavuconazonium NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Isavuconazonium — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Isavuconazonium in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Isavuconazonium went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1608322 2 dose forms · 3 strengths
-
Dose form (SCDF) Injection RxCUI 1650227In current FDA listingsClinical drug / strength (SCD) sulfate 372 MGRxCUI 1608811 -
Dose form (SCDF) Oral Capsule RxCUI 1608326In current FDA listings
Look up RxCUI 1608322 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Isavuconazonium is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Astellas Pharma US, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.