Amphotec® is the commercial brand name of Amphotericin B Cholesteryl Sulfate Complex for Injection, a lipid formulation of amphotericin B. It binds to ergosterol within fungal cell membranes, disrupting membrane integrity and leading to fungal cell death. This lipid complex formulation reduces the renal toxicity seen with conventional amphotericin B deoxycholate.
Main Indications
Treatment of severe invasive fungal infections in adult patients who cannot tolerate conventional amphotericin B, including invasive aspergillosis, candidiasis, cryptococcosis and mucormycosis.
Clinical Research
Global pivotal clinical trials showed that Amphotec retains robust antifungal efficacy while markedly decreasing the risk of nephrotoxicity compared with conventional amphotericin B;
Multiple prospective studies verified its value as salvage therapy for patients with refractory invasive fungal infections or pre-existing renal dysfunction;
Clinical data also characterized infusion-related reactions and supported pre-medication strategies to reduce acute adverse events.
Common Side Effects
Severe but important risks: Infusion-associated anaphylaxis, acute kidney injury, hypokalemia, hypotension;
Common mild adverse reactions: Fever, chills, headache, nausea, vomiting and abdominal discomfort.
Approval Status in China
Amphotec® (Amphotericin B Cholesteryl Sulfate Complex for Injection, specification:50mg per vial) was officially approved for marketing in China in 2021. It is currently a prescription antifungal agent.
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