Rezafungin

What is Rezafungin?

• Rezafungin (Rezzayo ), is a semisynthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Rezzayois an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.

Rezafungin

Rezafungin acetate

What are the uses of this medicine?

• Rezafungin (Rezzayo ) is used in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.

Limitations of use:

• Rezzayo has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

How does this medicine work?

• Rezafungin is an echinocandin antifungal drug.
• 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.

Rezafungin has been shown to be active against most isolates of the following microorganisms:

• Candida albicans
• Candida glabrata
• Candida parapsilosis
• Candida tropicalis

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to rezafungin or other echinocandins.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking rezafungin.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Is this medicine FDA approved?

• Rezafungin was approved by the Food and Drug Administration in March 2023 for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.

How should this medicine be used?

Recommended dosage:

• Administer the recommended dosage of Rezzayoonce weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter.
• If you miss a scheduled appointment to receive rezafungin, call to reschedule immediately.
• If you are able to get the missed dose within 3 days of schedule date, then you can resume your usual schedule.
• However, if more than 3 days have passed, then your dosing schedule will need to be revised.

Administration:

• Rezafungin comes as a solution (liquid) to be injected intravenously (into the vein) by a doctor or a nurse at a healthcare facility.
• It is usually given once a week.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 200 mg as a solid (cake or powder) in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Rezzayo

What side effects can this medication cause?

The most common side effects of this medicine include:

• hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia.

Less common, but serious side effects may include:

• Infusion-related Reactions
• Hepatic Adverse Reactions

What special precautions should I follow?

• Infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, and chest tightness have been observed in clinical trials with Rezzayo .
• Rezzayo may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during Rezzayotreatment.
• Abnormalities in liver tests have been seen in clinical trial patients treated with Rezzayo . Monitor patients who develop abnormal liver tests during Rezzayotherapy and evaluate patients for their risk/benefit of continuing Rezzayotherapy.
• Rezafungin could lead to decreased sperm motility, decreased sperm numbers, and increased incidence of sperm with abnormal morphology. The effect of Rezzayoon human fertility is unknown.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No cases of overdose were reported during the clinical studies.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Rezafungin is highly protein bound and not anticipated to be dialyzable.

Can this medicine be used in pregnancy?

• There are no data on the use of Rezzayoduring pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Rezzayohave not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• rezafungin acetate

Inactive ingredients:

• histidine, mannitol, polysorbate 80,hydrochloric acid and/or sodium hydroxide for pH adjustment.

Who manufactures and distributes this medicine?

Distributed by:

• Melinta Therapeutics LLC
• Lincolnshire, IL
• USA

Manufactured by:

• Patheon Italia S.p.A., a Thermo Fisher Scientific company
• Viale Gian Battista Stucchi 110
• Monza (MB)
• Italy

What should I know about storage and disposal of this medication?

Rezzayo Vials:

• Rezzayo vials should be stored at 20°C to 25°C (68°F to 77°F).
• Brief 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.

• Dailymed label info on Rezafungin
• FDA Rezafungin

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