Efficacy in treating candidemia and other Candida infections

In a noninferiority trial, MYCAMINE® (micafungin sodium) for injection provided treatment success in adult patients at the end of IV therapy and during neutropenia1

Treatment success at end of IV therapy in adult patients
Treatment success at end of IV therapy in adult patients with MYCAMINE

Treatment success rates in neutropenic adult patients
Treatment success rates in neutropenic adult patients with MYCAMINE

70 mg loading dose on day 1, followed by 50 mg/day thereafter.

Absolute neutrophil count <500 cells/mm³ at baseline.

Results were from a randomized, double-blind study to determine the efficacy and safety versus caspofungin in patients with invasive candidiasis and candidemia. Patients were randomized to receive once-daily intravenous infusions (IV) of MYCAMINE, either 100 mg/day or 150 mg/day or caspofungin (70 mg loading dose followed by 50 mg maintenance dose). Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided they were non-neutropenic, had improvement or resolution of clinical signs and symptoms, had a Candida isolate which was susceptible to fluconazole, and had documentation of 2 negative cultures drawn at least 24 hours apart. Patients were stratified by APACHE II score (20 or less or greater than 20) and by geographic region. Patients with Candida endocarditis were excluded from this analysis. Outcome was assessed by overall treatment success based on clinical (complete resolution or improvement in attributable signs and symptoms and radiographic abnormalities of the Candida infection and no additional antifungal therapy) and mycological (eradication or presumed eradication) response at the end of IV therapy.

Treatment-emergent adverse reactions

Selected treatment-emergent adverse reactions in adult patients with candidemia and other Candida infections for MYCAMINE and caspofungin, respectively, included: diarrhea (8% and 7%); nausea (10% and 10%); vomiting (9% and 8%); hypoglycemia (6% and 5%); hypernatremia (4% and 4%); hyperkalemia (5% and 3%); pyrexia (7% and 8%); blood alkaline phosphatase increased (6% and 4%); and atrial fibrillation (3% and 0%).

MYCAMINE was effective across a range of Candida species1

  • Treatment success in the same study for MYCAMINE and caspofungin, respectively: C. albicans 70.4% (n=57/81) and 61.6% (n=45/73); C. glabrata 69.6% (n=16/23) and 61.3% (n=19/31); C. tropicalis 63% (n=17/27) and 75.9% (n=22/29); C. parapsilosis 75% (n=21/28) and 56.4% (n=22/39); C. krusei 62.5% (n=5/8) and 66.7% (n=2/3)§

A patient may have had >1 baseline infection species.

Results were from a randomized, double-blind study to determine the efficacy and safety versus caspofungin in patients with invasive candidiasis and candidemia. Patients were randomized to receive once-daily intravenous infusions (IV) of MYCAMINE, either 100 mg/day or 150 mg/day or caspofungin (70 mg loading dose followed by 50 mg maintenance dose). Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided they were non-neutropenic, had improvement or resolution of clinical signs and symptoms, had a Candida isolate which was susceptible to fluconazole, and had documentation of 2 negative cultures drawn at least 24 hours apart. Patients were stratified by APACHE II score (20 or less or greater than 20) and by geographic region. Patients with Candida endocarditis were excluded from this analysis. Outcome was assessed by overall treatment success based on clinical (complete resolution or improvement in attributable signs and symptoms and radiographic abnormalities of the Candida infection and no additional antifungal therapy) and mycological (eradication or presumed eradication) response at the end of IV therapy.

Important Safety Information and Indications

Contraindications

MYCAMINE is contraindicated in patients with known hypersensitivity to micafungin, any of its components, or other echinocandins.

Warnings and Precautions

Hypersensitivity Reactions: Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE. If these reactions occur, MYCAMINE should be discontinued and appropriate treatment administered.

Hematological Effects: Isolated cases of significant hemolysis and hemolytic anemia have been reported. Patients developing clinical or laboratory evidence should be monitored closely.

Hepatic Effects: In some patients with serious underlying conditions who were receiving MYCAMINE along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure have been reported. Patients who develop abnormal liver function tests should be monitored for evidence of worsening hepatic function and evaluate for the risk/benefit of continuing MYCAMINE therapy.

Renal Effects: Elevations in BUN and creatinine, and isolated cases of significant renal impairment or acute renal failure have been reported. Patients who develop abnormal renal function tests should be monitored for worsening renal function.

Adverse Reactions

Infusion Reactions: Possible histamine-mediated symptoms have been reported with MYCAMINE including rash, pruritus, facial swelling, and vasodilatation. Injection site reactions, including phlebitis and thrombophlebitis have been reported, and tended to occur more often with peripheral intravenous administration.

The most common adverse reactions include diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, and headache.

Indications and Usage

MYCAMINE is indicated in adult and pediatric patients 4 months and older for:

  • Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses
    • MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida infections
  • Treatment of patients with esophageal candidiasis
  • Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation

NOTE: The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.

Please see full Prescribing Information.