Rezafungin: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=HAFIZA AMNA QADEER, MD
|authorTag=HAFIZA AMNA QADEER
|OTC=Yes
|genericName=REZAFUNGIN
|genericName=REZAFUNGIN
|aOrAn=an
|aOrAn=an
|drugClass=ANTIFUNGAL ECHINOCANDIN
|drugClass=echinocandin antifungal
|indicationType=treatment
|indicationType=treatment
|indication=Patients with invasive candidiasis and candidemia who are at least 18 years old and have few or no other options for treatment.
|indication=of patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.
|adverseReactions=Diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|adverseReactions=diarrhea, vomiting, nausea, abdominal pain, constipation, hypokalemia, hypomagnesemia, hypophosphatemia, pyrexia and anemia.
|fdaLIADAdult=The recommended dosage of rezafungin is 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 used for intravenous infusion only. Administer rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
|fdaLIADAdult=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).
|fdaLIADPed=The safety and effectiveness of Rezfungin have not been established in pediatric patients.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|contraindications=Rezafungin is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins.
|warnings=* Infusion related reactions.
|warnings=* Infusion Related Reactions
* Photosensitivity.
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.
* Hepatic Adverse Reactions.
* Photosensitivity
|clinicalTrials=The following adverse reaction can occur after administration of rezafungin:
Rezafungin may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezafungin treatment.
=GASTROINTESTINAL=
* Hepatic Adverse Reactions
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
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.
=METABOLISM AND NUTRITION DISORDER=
|postmarketing=* GASTROINTESTINAL DISORDERS
Anemia, Disseminated Intravascular Coagulation.
Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), Diarrhea, Nausea, Vomiting, Abdominal pain and constipation
=NERVOUS SYSTEM=
* METABOLISM AND NUTRITION DISORDERS
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
Hypokalemia, Hypomagnesemia and hypophosphatemia
=INTEGUMENTARY SYSTEM=
* BLOOD AND LYMPHATIC SYSTEM DISORDER  
Photosensitivity and erythema.
Anemia, Disseminated Intravascular Coagulation
=CARDIOVASCULAR SYSTEM=
* NERVOUS SYSTEM
Fluid overload.
Tremor, headache, Insomnia, Dizziness and peripheral neuropathy (includes neuropathy peripheral, polyneuropathy and peroneal nerve palsy).
|postmarketing=The following adverse reaction can occur after administration of rezafungin:
* CARDIOVASCULAR SYSTEM  
=GASTROINTESTINAL=
Fluid Overload
Diarrhea, Nausea, Vomiting, Dysphagia, Gastrointestinal hemorrhage, abnormal liver tests (including hypertransaminasemia and increased gamma-glutamyltransferase), abdominal pain and constipation.
* INTEGUMENTARY SYSTEM
=METABOLISM AND NUTRITION DISORDER=
Flushing, Erythema, photosensitivity, Sensation of warmth and Urticaria
Anemia, Disseminated Intravascular Coagulation.
* GENITOURINARY SYSTEM
=NERVOUS SYSTEM=
Abnormal renal functions(Acute Kidney Injury)
Tremor, insomnia, headache, dizziness, peripheral neuropathy (includes neuropathy peripheral, polyneuropathy, and peroneal nerve palsy).
=INTEGUMENTARY SYSTEM=
Photosensitivity and erythema.
=CARDIOVASCULAR SYSTEM=
Fluid overload.
|drugInteractions=Rezafungin is not a substrate of CYP enzymes or drug transporter systems. Rezafungin is not an inhibitor or inducer of common drug metabolizing CYP enzymes or transporter systems.
|useInPregnancyFDA=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.
|useInPregnancyFDA=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.
|useInNursing=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.
|useInNursing=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.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInPed=The safety and effectiveness of rezafungin have not been established in pediatric patients.
|useInGeri=Clinical studies of Rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
|useInGeri=No sufficient clinical data available.
|useInGender=Clinical studies of rezafungin did not include sufficient numbers of older adult patients to determine if patients 65 years and older respond differently than younger adult patients.
|useInRenalImpair=No clinically relevant effect on the pharmacokinetics of rezafungin were observed based on renal impairment (creatinine clearance: 9.3 mL/min to above 120 mL/min) and no effect is expected in patients undergoing hemodialysis.
|useInHepaticImpair=No clinically relevant effects on the pharmacokinetics of rezafungin were observed with hepatic impairment (Child Pugh Class B or C).
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|useInReproPotential=The effect of rezafungin on human fertility is unknown.
|administration=Administer Rezafungin by intravenous infusion over approximately one hour (~250 mL/h). If infusion-related reactions occur, the infusion may be slowed, or paused and restarted at a lower rate.
|overdose=Rezafungin is highly protein bound and not anticipated to be dialyzable and no case reported during clinical trials.
|overdose=No cases of overdose were reported during the clinical studies. Rezafungin is highly protein bound and not anticipated to be dialyzable.
|howSupplied=* 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.
|mechAction=Rezafungin is a semi-synthetic echinocandin. Rezafungin inhibits the 1,3-β-D-glucan synthase enzyme complex, which is present in fungal cell walls but not in mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall of many fungi, including Candida species (spp.). Inhibition of 1,3-β-D-glucan synthesis results in concentration-dependent in vitro fungicidal activity against Candida spp., however, the clinical significance of this activity is unknown.
|structure=REZZAYO (rezafungin for injection), for intravenous use is a sterile solid (cake or powder) that contains rezafungin acetate. Rezafungin acetate is a semisynthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. REZZAYO is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. REZZAYO contains 210 mg of rezafungin acetate, equivalent to 200 mg of rezafungin. REZZAYO also contains 47 mg histidine, 500 mg mannitol, 450 mg polysorbate 80, and hydrochloric acid and/or sodium hydroxide for pH adjustment. Rezafungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water, soluble in methanol, and sparingly soluble in ethanol. Rezafungin acetate is chemically designated as Echinocandin B, 1-[(4R,5R)-4-hydroxy-N2-[[4"- (pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-5-[2-(trimethylammonio)ethoxy]-L-ornithine]-4-[(4S)-4- hydroxy-4-(4-hydroxyphenyl)-L-allothreonine]-, acetate (1:1). The empirical formula of Rezafungin acetate is C63H85N8O17 • C2H3O2, and the formula weight is 1285.46 g/mol.
|PD=Rezafungin exposures achieved with the recommended dosage regimen appear to be on the plateau of the observed flat exposure-efficacy response curve in clinical studies. Rezafungin does not prolong the QTc interval to any clinically relevant extent at a dose 3.5 times the maximum approved recommended loading dose.
|PK=Following single and multiple dosing, the Cmax and AUC of rezafungin increase in a dose-proportional manner over a dose range of 50 mg (0.125 times the approved maximum recommended loading dose) to 400 mg.
|nonClinToxic==CARCINOGENESIS=
Carcinogenicity studies with rezafungin have not been conducted.
=MUTAGENESIS=
Rezafungin was negative in a standard battery of assays, including an in vitro bacterial reverse mutation assay, an in vitro mammalian clastogenicity assay, and an in vivo rat bone marrow micronucleus assay.
=IMPAIRMENT OF FERTILITY=
Rezafungin did not affect mating or fertility in male and female rats following IV administration once every 3 days at doses up to 45 mg/kg (6 times the clinical exposure, based on AUC determined in a separate rat study). Decreased sperm motility was noted at ≥30 mg/kg and most males at 45 mg/kg showed mild/moderate hypospermia and had no detectable motile sperm. At rezafungin doses ≥30 mg/kg there was an increased incidence of sperm with abnormal morphology as well as mild to moderate degeneration of the seminiferous tubules. In a 3-month study of every 3 day IV rezafungin in rats, males dosed at 45 mg/kg showed minimal tubular degeneration/atrophy in the testes and cellular debris in the epididymides at the end of 3 months. The incidence of this finding reduced by the end of a 4-week reversibility period. In contrast, sperm concentration, production rate, morphology and motility were unaffected in adult monkeys dosed weekly with rezafungin, up to 30 mg/kg (about 6 times the clinical dose based on AUC comparisons) for 11 or 22 weeks or after a 52-week recovery period.
|clinicalStudies=The safety and efficacy of REZZAYO in the treatment of patients with candidemia and/or invasive candidiasis (IC) were evaluated in a multicenter, randomized, double-blind study (Trial 1; NCT03667690). Patients were randomized in a 1:1 ratio to receive REZZAYO or caspofungin. Randomization was stratified based on diagnosis (candidemia only; IC) and by Acute Physiology and Chronic Health Evaluation II score (APACHE II)/absolute neutrophil count (ANC) at screening. Patients with septic arthritis in a prosthetic joint, osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection, chronic disseminated candidiasis, or urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract were excluded.


Patients in the REZZAYO arm were to receive a single 400 mg loading dose on Day 1 of Week 1, followed by 200 mg once weekly, for a total of two to four doses. Patients in the caspofungin arm were to receive a single 70 mg IV loading dose, followed by caspofungin 50 mg IV once daily treatment for a total of 2 to 4 weeks. After ≥3 days of IV therapy, patients in the caspofungin group could be switched to oral step-down therapy (fluconazole), if the patient met the criteria for cure and was preparing to be discharged.
* REZZAYO is available in the following packaging configuration:


One hundred and ninety-nine patients in the intent-to-treat (ITT) population were randomized. The age range was 19-91 years, the gender distribution was 62% male and 38% female, and the race distribution was 61% White, 5% Black, 29% Asian, and 5% other races or not reported. The median duration of therapy was 14 days in the two treatment arms.
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.
|packLabel=Carton Label - One 200 mg Sterile Single-dose Vial - REZZAYO


The modified ITT (mITT) population included 187 patients with a culture positive for Candida species within 4 days before randomization and who received at least one dose of study drug. The most frequent species isolated at baseline was C. albicans (42%), followed by C. glabrata (26%), C. tropicalis (20%), and C. parapsilosis (13%). The majority (70%) of patients had a diagnosis of candidemia only. The majority (93%) of patients were not neutropenic (ANC ≥500) and 84% had APACHE II scores less than 20. Risk factors for candidemia were: receipt of broad-spectrum antibacterial drugs (71%), presence of a central venous catheter (60%), major surgery (35%), diabetes mellitus (29%), active malignancy (25%), and total parenteral nutrition (20%). Mechanically ventilated patients were 24% (17% and 30% in the REZZAYO and caspofungin group, respectively).
PRINCIPAL DISPLAY PANEL
NDC 70842-240-01


Efficacy was assessed by all-cause mortality at Day 30. The number and percentage of patients in each treatment group who were alive and deceased/unknown survival status at Day 30 was determined in the mITT population. Additional efficacy outcomes were global cure (mycological eradication/presumed eradication, clinical cure, and radiological cure [for patients with documented IC by radiologic or other imaging findings at baseline]), mycological eradication/presumed eradication, and investigator’s assessment of clinical cure.
Rx only
|howSupplied=Rezafungin is supplied as a single-dose vial containing 200 mg of Rezafungin. For the 400 mg dose, aseptically reconstitute two vials each with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL in each vial. For the 200 mg dose, aseptically reconstitute one vial with 9.5 mL of sterile Water for Injection, to provide a concentration of 20 mg/mL
 
|storage=Store Rezafungin infusion solution between 5°C to 25°C (41°F to 77°F). Stability of the infusion solution has been demonstrated for 48 hours at 5°C to 25°C (41°F to 77°F).
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.
|fdaPatientInfo=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.
|brandNames=REZZAYO
|brandNames=REZZAYO
}}
}}

Latest revision as of 20:04, 24 March 2024

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

Disclaimer

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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.

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