Rezafungin
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)
Rezafungin is indicated for the treatment of candidemia and invasive candidiasis. 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 Rezafungin 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
Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with REZZAYO. If these reactions occur, slow or pause the infusion and restart at a lower rate.
- Photosensitivity
Rezafungin may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezafungin treatment.
- Hepatic Adverse Reactions
In some patients with serious underlying medical conditions who were receiving multiple other medications along with Rezafungin, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during Rezafungin therapy and evaluate patients for their risk/benefit of continuing Rezafungin therapy.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Rezafungin Clinical Trials Experience in the drug label.
Postmarketing Experience
- GASTROINTESTINAL DISORDERS
Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), Diarrhea, Nausea, Vomiting, Abdominal pain and constipation
- METABOLISM AND NUTRITION DISORDERS
Hypokalemia, Hypomagnesemia and hypophosphatemia
- BLOOD AND LYMPHATIC SYSTEM DISORDER
Anemia, Disseminated Intravascular Coagulation
- NERVOUS SYSTEM
Tremor, headache, Insomnia, Dizziness and peripheral neuropathy (includes neuropathy peripheral, polyneuropathy and peroneal nerve palsy).
- CARDIOVASCULAR SYSTEM
Fluid Overload
- INTEGUMENTARY SYSTEM
Flushing, Erythema, photosensitivity, Sensation of warmth and Urticaria
- GENITOURINARY SYSTEM
Abnormal renal functions(Acute Kidney Injury)
Drug Interactions
There is limited information regarding Rezafungin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There are no data on the use of rezafungin during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
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 are no data on the presence of rezafungin or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric Use
The safety and effectiveness of rezafungin have not been established in pediatric patients.
Geriatic Use
No sufficient clinical data available.
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
The effect of rezafungin on human fertility is unknown.
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
Rezafungin is highly protein bound and not anticipated to be dialyzable and no case reported during clinical trials.
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
- REZZAYO (rezafungin for injection) is supplied as sterile white to pale yellow solid (cake or powder) in a single-dose 20 mL Type I glass vial with a stopper, an aluminum seal, and blue polypropylene flip-off cap. The vial stopper is not made with natural rubber latex.
- REZZAYO is available in the following packaging configuration:
One single-dose vial of REZZAYO 200 mg (NDC 70842-240-01)
Storage
- REZZAYO VIALS
Rezafungin vials should be stored at 20°C to 25°C (68°F to 77°F). Short exposure to 15°C to 30°C (59°F to 86°F) permitted.
- RECONSTITUTED SOLUTION
REZZAYO reconstituted solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 24 hours.
- IV INFUSION SOLUTION
REZZAYO infusion solution can be stored between 5°C (41°F) and 25°C (77°F) for up to 48 hours. Do not freeze the solution.
Images
Drug Images
{{#ask: Page Name::Rezafungin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
Carton Label - One 200 mg Sterile Single-dose Vial - REZZAYO
PRINCIPAL DISPLAY PANEL NDC 70842-240-01
Rx only
REZZAYO™ (rezafungin for injection) 200 mg per vial
Vial contains rezafungin:
200 mg (equivalent to 210 mg of rezafungin acetate). For intravenous Infusion Only Must be reconstituted and further diluted. {{#ask: Label Page::Rezafungin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
Patient should be counselled about photosensitivity related to rezafungin and advised to use protection against sun exposure and other sources of UV radiation during treatment.
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
REZZAYO
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.