rezzayo
Rezzayo (Rezafungin Acetate) is a medication used to treat Invasive Candidiasis, Candidemia.
Rezafungin Acetate · by Mundipharma
Key facts
- Active ingredient
- Rezafungin Acetate
- Form
- Injectable
- Strength
- Rezafungin Acetate EQ 200MG BASE/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- invasive candidiasis, candidemia
- Manufacturer
- Mundipharma
- FDA application
- NDA217417
What is Rezzayo?
From the FDA label: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-[(4 R ,5 R )-4-hydroxy- N 2 -[[4"- (pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-5-[2-(trimethylammonio)ethoxy]-L-ornithine]-4-[(4 S )-4- hydroxy-4-(4-hydroxyphenyl)-L-allothreonine]-, acetate (1:1). The empirical formula of rezafungin acetate is C 63 H 85 N 8 O 17 • C 2 H 3 O 2 , and the formula weight is 1285.46 g/mol. The chemical structure of rezafungin acetate is: image of chemicalstructure
How to use
Administer the recommended dosage of REZZAYO 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 REZZAYO has not been established beyond 4 weekly doses. ( 2.1 ) See full prescribing information for reconstitution, dilution, and administration instructions. ( 2.2 , 2.3 , 2.4 ) 2.1 Recommended Dosage Administer the recommended dosage of REZZAYO 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 REZZAYO has not been established beyond 4 weekly doses [see Adverse Reactions ( 6.1 )] . REZZAYO is for intravenous infusion only [see Dosage and Administration ( 2.4 )] . 2.2 Missed Doses If a scheduled dose is missed (not taken on the assigned day), administer the missed dose as soon as possible. If the missed dose is administered within 3 days of the assigned day, the next weekly dose may be given on schedule. If the missed dose is administered more than 3 days after the assigned day, revise the dosing schedule to ensure there are at least 4 days before the next dose. If restarting after at least 2 weeks of missed dosing, the dosing should be started again at the 400 mg loading dose. 2.3 Preparation and Administration of REZZAYO Reconstitution REZZAYO is supplied as a single-dose vial containing 200 mg of…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Infusion-related Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Adverse Reactions [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of REZZAYO cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of REZZAYO was assessed in 76 subjects in phase 1 studies and 232 patients with candidemia and invasive candidiasis in Trials 1 and 2, who received a 400 mg loading dose followed by a 200 mg dose once weekly or higher (please note that after the loading dose of 400 mg, weekly doses higher than 200 mg are not approved). A total of 151 patients received an initial 400 mg loading dose followed by a 200 mg dose once weekly thereafter (400 mg/200 mg dose);…
Warnings
Important safety information
Hypersensitivity Reactions, including Anaphylaxis: Cases of serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving REZZAYO. If these reactions occur, discontinue REZZAYO and administer appropriate treatment ( 5.1 ). Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. ( 5.2 ) Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. ( 5.3 ) Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. ( 5.4 ) 5.1 Hypersensitivity Reactions, including Anaphylaxis Cases of serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving REZZAYO. If these reactions occur, discontinue REZZAYO and administer appropriate treatment [see Adverse Reactions ( 6.2 )] . 5.2 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 [see Dosage and Administration ( 2.4 )] . 5.3 Photosensitivity REZZAYO may cause photosensitivity. Patients should be advised to use protection from sun exposure and other sources of UV radiation during REZZAYO treatment. 5.4 Hepatic Adverse Reactions Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO [see Adverse Reactions ( 6.1 )] . In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with REZZAYO, clinically significant hepatic abnormalities have occurred. Monitor patients who develop abnormal liver tests during REZZAYO therapy and evaluate patients for their risk/benefit of continuing REZZAYO therapy.
Who should not take Rezzayo
REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Known hypersensitivity to rezafungin or other echinocandins. ( 4 )
Overdose — what happens if you take too much
No cases of overdose were reported during the clinical studies. Rezafungin is highly protein bound and not anticipated to be dialyzable.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Rezzayo treat?
- Rezzayo (Rezafungin Acetate) may be used to treat invasive candidiasis, candidemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Rezzayo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Rezzayo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Rezzayo?
- Rezzayo is marketed by Mundipharma. You can see Mundipharma's full profile, rating, and other products on pharmaranks.
- Is Rezzayo a brand-name or generic drug?
- Rezzayo is a brand-name product with the active ingredient Rezafungin Acetate.
- Is Rezzayo available over the counter?
- No. Rezzayo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Rezzayo come in?
- Rezzayo is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Rezzayo FDA-registered?
- Rezzayo is on record with the U.S. FDA under application number NDA217417. You can verify this on its official FDA label.
- Is Rezzayo safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Rezzayo. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Rezzayo?
- Rezzayo's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Infusion-related Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Adverse Reactions [see Warnings and Preca… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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