MYCAMINE® (micafungin sodium) for injection provides once-daily dosing

Once-daily dosing1
Once-daily dosing considersations with MYCAMINE

MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida infections.

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

Safety and effectiveness in pediatric patients younger than 4 months of age have not been established.

In adult patients treated successfully for candidemia and other Candida infections, the mean duration of treatment was 15 days (range 10–47 days).

100 mg micafungin is equivalent to 101.73 mg micafungin sodium.

In adult patients treated successfully for esophageal candidiasis, the mean duration of treatment was 15 days (range 10–30 days).

In adult hematopoietic stem cell transplant (HSCT) recipients who experienced success of prophylactic therapy, the mean duration of prophylaxis was 19 days (range 6–51 days).

50 mg micafungin is equivalent to 50.86 micafungin sodium.

  • Do not mix or co-infuse MYCAMINE with other medications
  • MYCAMINE has been shown to precipitate when mixed directly with a number of commonly used medications
  • Infuse over 1 hour. More rapid infusions may result in more frequent histamine-mediated reactions

MYCAMINE requires no loading dose

Micafungin plasma concentrations following a 100 mg MYCAMINE dose in adult patients on day 12
Micafungin concentrations are maintained through 24 hours
Following the first MYCAMINE dose on day 1, micafungin plasma concentrations above the MIC90 for C. albicans are maintained through 24 hours2,3

MIC90=minimum inhibitory concentration to inhibit 90% of isolates.

The correlation between results of susceptibility studies for 1-3-β-D-glucan synthesis inhibitors and clinical outcome has not been established.

  • Micafungin pharmacokinetics in 229 pediatric patients ≥4 months through 16 years of age were characterized using population pharmacokinetics. Micafungin exposure was dose-proportional across the dose and age range studied1

MYCAMINE requires no dose adjustments based on1:

  • Race, gender, or in the elderly
  • Severe renal dysfunction
  • Mild to severe hepatic insufficiency

Offers flexibility in storage and infusion

Flexibility in storage and infusion with MYCAMINE

For the treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses. NS=0.9% Sodium Chloride, D5W=5% Dextrose in Water, NaCl=Sodium Chloride.

  • Please see PI for detailed directions for reconsitution, dilution, and preparation
MYCAMINE can be stored in and delivered through the Pyxis® system. MYCAMINE can be administered through IV Admixture Systems (MINI-BAG™ Plus, VIAL-MATE™, and addEASE®).

Pyxis® is a registered trademark of CareFusion Corporation.

MINI‑BAG™ Plus and VIAL‑MATE™ are trademarks of Baxter International Inc.

addEASE® is a registered trademark of B. Braun Medical Inc.

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.