Rezafungin

Rezafungin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: HAFIZA AMNA QADEER

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Overview

Rezafungin is an echinocandin antifungal that is FDA approved for the treatment of of patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.. Common adverse reactions include diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Administer the recommended dosage of Rezafungin once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter. The safety of Rezafngin has not been established beyond 4 weekly doses. Rezafungin is administered by intravenous infusion over approximately one hour(~250ml/h).

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and effectiveness of Rezfungin have not been established in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Contraindications

Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.

Warnings

• Infusion Related Reactions
• Photosensitivity
• Hepatic Adverse Reactions

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Rezafungin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Rezafungin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Rezafungin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Rezafungin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rezafungin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Rezafungin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Rezafungin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Rezafungin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Rezafungin in geriatric settings.

Gender

There is no FDA guidance on the use of Rezafungin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Rezafungin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Rezafungin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Rezafungin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Rezafungin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Rezafungin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Rezafungin Administration in the drug label.

Monitoring

There is limited information regarding Rezafungin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Rezafungin and IV administrations.

Overdosage

There is limited information regarding Rezafungin 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 Rezafungin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Rezafungin Mechanism of Action in the drug label.

Structure

There is limited information regarding Rezafungin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Rezafungin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Rezafungin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Rezafungin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Rezafungin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Rezafungin How Supplied in the drug label.

Storage

There is limited information regarding Rezafungin 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 Rezafungin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Rezafungin interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Rezafungin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Rezafungin 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.