Isavuconazonium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]
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Overview
Isavuconazonium is an azole antifungal that is FDA approved for the treatment of invasive aspergillosis and invasive mucormycosis. Common adverse reactions include nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, constipation, dyspnea, cough, peripheral edema, and back pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
1.1 Invasive Aspergillosis CRESEMBA is an azole antifungal indicated for patients 18 years of age and older for the treatment of invasive aspergillosis.
[see CLINICAL STUDIES (14.1) and CLINICAL PHARMACOLOGY (12.4)].
1.2 Invasive Mucormycosis CRESEMBA is an azole antifungal indicated for patients 18 years of age and older for the treatment of invasive mucormycosis.
[see CLINICAL STUDIES (14.2) and CLINICAL PHARMACOLOGY (12.4)].
1.3 Usage Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Isavuconazonium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Isavuconazonium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Isavuconazonium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Isavuconazonium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Isavuconazonium in pediatric patients.
Contraindications
There is limited information regarding Isavuconazonium Contraindications in the drug label.
Warnings
There is limited information regarding Isavuconazonium Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Isavuconazonium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Isavuconazonium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Isavuconazonium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Isavuconazonium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Isavuconazonium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Isavuconazonium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Isavuconazonium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Isavuconazonium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Isavuconazonium in geriatric settings.
Gender
There is no FDA guidance on the use of Isavuconazonium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Isavuconazonium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Isavuconazonium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Isavuconazonium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Isavuconazonium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Isavuconazonium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Isavuconazonium Administration in the drug label.
Monitoring
There is limited information regarding Isavuconazonium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Isavuconazonium and IV administrations.
Overdosage
There is limited information regarding Isavuconazonium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Isavuconazonium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Isavuconazonium Mechanism of Action in the drug label.
Structure
There is limited information regarding Isavuconazonium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Isavuconazonium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Isavuconazonium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Isavuconazonium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Isavuconazonium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Isavuconazonium How Supplied in the drug label.
Storage
There is limited information regarding Isavuconazonium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Isavuconazonium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Isavuconazonium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Isavuconazonium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Isavuconazonium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.