Version May 2024
Candidemia and invasive candidiasis (patients with and without neutropenia) (alternative agent):
Note: Reserve for patients with limited or no alternative options.
IV: 400 mg once on day 1, then 200 mg once weekly beginning on day 8 for up to 4 doses (Ref). Total duration (including oral step-down therapy) is ≥14 days after first negative blood culture and continues until signs/symptoms of candidemia and neutropenia, if present, have resolved; metastatic complications warrant a longer duration (Ref).
Missed dose:
Delay from scheduled dose:
≤3 days from the assigned day: Administer the missed dose as soon as possible, then administer the next weekly dosing on schedule.
>3 days and <2 weeks after the assigned day: Administer the missed dose as soon as possible and revise the dosing schedule to ensure there are at least 4 days before the next dose.
≥2 weeks of missed dosing: Re-initiate dosing with 400 mg loading dose followed by 200 mg once weekly.
There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically relevant effect on the pharmacokinetics of rezafungin were observed based on kidney impairment (CrCl 9.3 mL/minute to >120 mL/minute) and no effect is expected in patients undergoing hemodialysis.
There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically relevant effect on the pharmacokinetics of rezafungin were observed based on hepatic impairment (Child-Pugh class B or C).
Refer to adult dosing.
Infusion-related reactions have been reported during and following rezafungin administration. Symptoms may include flushing, urticaria, and chest tightness. Most reactions resolved without therapy interruption or discontinuation (Ref). Slower infusion rates may be considered in patients who experience an infusion-related reaction.
Onset: Rapid; may occur during or within minutes following infusion (Ref).
Abnormal hepatic function tests, including increased gamma-glutamyl transferase and increase serum transaminases, have been reported with rezafungin.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Endocrine & metabolic: Hypokalemia (15%)
Gastrointestinal: Diarrhea (11%)
Miscellaneous: Fever (12%)
1% to 10%:
Dermatologic: Erythema of skin (<5%)
Endocrine & metabolic: Hypervolemia (<5%), hypomagnesemia (8%), hypophosphatemia (5%)
Gastrointestinal: Abdominal pain (7%), constipation (5%), dysphagia (<5%), gastrointestinal hemorrhage (<5%), nausea (9%), vomiting (9%)
Hematologic & oncologic: Anemia (10%), disseminated intravascular coagulation (<5%)
Hepatic: Abnormal hepatic function tests (<5%), increased gamma-glutamyl transferase (<5%), increased serum transaminases (<5%)
Hypersensitivity: Infusion-related reaction (<5%)
Nervous system: Dizziness (<5%), headache (<5%), insomnia (<5%), peripheral neuropathy (<5%; includes peripheral neuropathy, peroneal nerve palsy, and polyneuropathy), tremor (3%)
Renal: Acute kidney injury (<5%)
Hypersensitivity to rezafungin, other echinocandins, or any component of the formulation.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous, as acetate [preservative free]:
Rezzayo: 200 mg (1 ea) [contains polysorbate 80]
No
Solution (reconstituted) (Rezzayo Intravenous)
200 mg (per each): $2,340.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Infuse over 1 hour. May reduce infusion rate for infusion reaction (eg, flushing, sensation of warmth, urticaria, nausea, chest tightness).
Candidemia and invasive candidiasis: Treatment of candidemia and invasive candidiasis in patients ≥18 years of age.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination
Adverse events were not observed in animal reproduction studies following administration of rezafungin IV to rats or rabbits in doses equivalent to ~5 or ~3 times the recommended human dose, respectively (based on AUC).
It is not known if rezafungin is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Periodic LFTs; infusion reactions including flushing, urticaria, nausea, and chest tightness.
Concentration-dependent inhibition of 1,3-beta-D-glucan synthase resulting in reduced formation of 1,3-beta-D-glucan, an essential polysaccharide of fungal (including Candida species) cell walls (absent in mammalian cells); decreased glucan content leads to osmotic instability and cellular lysis.
Distribution: Vd: 67 ± 28 L.
Protein binding:
Healthy adults: 95.6% to >98.6%.
Patients with candidemia or invasive candidiasis: 87.5% to 93.6%.
Half-life elimination: 152 ± 29 hours.
Time to peak: Immediately after completion of the infusion.
Excretion: Feces: 74.3% as unchanged drug; Urine: 25.7% as inactive metabolites.
Clearance: 0.35 ± 0.13 L/hour.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
