REZAFUNGIN INJ,LYPHL

Clinical Criteria Summary

FDA approved for patients ≥18 years of age with limited or no alternative options for treatment of candidemia and invasive candidiasis (IC).
Designated as a limited use indication.
Appropriate for patients requiring prolonged outpatient treatment who are unable to transition to oral azole stepdown therapy and face challenges with OPAT (e.g., inability to place PICC line).

Administered once weekly via intravenous infusion.
Regimen: 400 mg loading dose followed by 200 mg weekly thereafter.
FDA limits the indication to a maximum of 4 doses; not studied beyond 4 weekly doses.

Met only the 20% non-inferiority margin for 30-day all-cause mortality compared to caspofungin in the ReSTORE trial; did not meet the 10% margin required for unrestricted approval.
Not studied for complicated infections including septic arthritis in a prosthetic joint, osteomyelitis, endocarditis or myocarditis, CNS infection or endophthalmitis, chronic disseminated candidiasis, or urinary tract candidiasis.
Exhibits poor penetration into the CNS, eye, and urine.

Monitor for infusion-related reactions (e.g., flushing, sensation of warmth, urticaria, nausea, chest tightness); slow or pause infusion if reactions occur.
Monitor patients who develop abnormal liver tests; evaluate risk/benefit of continuing therapy.
Advise patients to use protection from sun exposure and other sources of UV radiation due to potential for phototoxicity/photosensitivity.
No dose adjustment required for renal or hepatic insufficiency.

Dilute in 250 mL of 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose injection (total infusion volume of 250 mL for either 400 mg or 200 mg doses).
Store vials at controlled room temperature between 20°C and 25°C.
Intravenous infusion solution is stable for 48 hours when stored between 5°C and 25°C.

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