Mycamine

micafungin sodium

Mycamine

Pharmacologic class: Semisynthetic lipopeptide (echinocandin)

Therapeutic class: Antifungal

Pregnancy risk category C

Action

Inhibits synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls

Availability

Powder for reconstitution for infusion (lyophilized): 50-mg and 100-mg single-use vials

Indications and dosages

Candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses

Adults: 100 mg daily by I.V. infusion over 1 hour for 15 days (range, 10 to 47 days)

Esophageal candidiasis

Adults: 150 mg daily by I.V. infusion over 1 hour for 15 days (range, 10 to 30 days)

Prophylaxis of Candida infections in patients undergoing hematopoietic stem-cell transplantation

Adults: 50 mg daily by I.V. infusion over 1 hour for 19 days (range, 6 to 51 days)

Contraindications

• Hypersensitivity to drug, its components, or other echinocandins

Precautions

Use cautiously in:
• renal or hepatic disease
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Administer by I.V. infusion only.
• Reconstitute with 5 ml normal saline solution injection (without bacteriostatic agent) or dextrose 5% injection added to 50-mg or 100-mg vial to yield approximately 10 mg/ml or 20 mg/ml, respectively.
• To minimize excessive foaming, gently dissolve powder by swirling vial. Don't shake vigorously.
• Protect diluted solution from light.
• Add reconstituted solution to 100 ml normal saline solution or 100 ml dextrose 5% before infusing.
• Flush existing I.V. line with normal saline solution before infusing drug.
• Infuse over 1 hour. Be aware that more rapid infusion increases risk of histamine-mediated reactions (rash, pruritus, facial swelling, vasodilation).

If serious hypersensitivity (anaphylaxis or anaphylactoid) reaction occurs, immediately discontinue infusion and provide appropriate interventions.

Adverse reactions

CNS: headache, insomnia, fatigue, rigors, dizziness, anxiety

CV: vasodilation, hypotension, hypertension, bradycardia, tachycardia, phlebitis, flushing, atrial fibrillation

EENT: epistaxis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia, decreased appetite

Hematologic: anemia, thrombocytopenia, aggravated anemia, neutropenia, febrile neutropenia

Metabolic: fluid retention, fluid overload

Musculoskeletal: back pain

Respiratory: pneumonia, cough, dyspnea

Skin: rash, pruritus, decubitus ulcers, erythema

Other: facial swelling, injection-site reaction, infection, bacteremia, fever, mucosal inflammation, peripheral edema, sepsis, septic shock, hypersensitivity reaction (including anaphylaxis, anaphylactoid reactions, and shock)

Interactions

Drug-drug.Itraconazole, nifedipine, sirolimus: increased risk of toxicity

Drug-diagnostic tests.ALP, ALT, AST, sodium: increased levels

Calcium, glucose, magnesium, potassium: decreased levels

Liver function tests: abnormal

Patient monitoring

• If patient develops clinical or laboratory evidence of hematologic abnormalities, abnormal liver function tests, or electrolyte disorders, monitor closely for signs or symptoms that these conditions are getting worse. Risks against benefits of continuing therapy should be considered.

Patient teaching

• Instruct patient to contact prescriber if unusual symptoms develop or if preexisting symptoms persist or get worse.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

micafungin

(my-ka-fun-gin) ,

Mycamine

(trade name)

Classification

Therapeutic: antifungals
Pharmacologic: echinocandins
Pregnancy Category: C

Indications

Esophageal candidiasis.Candidemia/acute disseminated candidiasis/Candidal peritonitis and abscesses.Prophylaxis of Candida infections during hematopoetic stem cell transplantation.

Action

Inhibits synthesis of glucan required for the formation of fungal cell wall.

Therapeutic effects

Death of susceptible fungi.
Active against the following Candida spp.: C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Protein Binding: >99 %.
Metabolism and Excretion: Mostly metabolized; 71% fecal elimination.
Half-life: 15 hr.

Time/action profile

ROUTEONSETPEAKDURATION
IVrapidend of infusion24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Severe hepatic impairment; Obstetric: Use only if clearly needed; Lactation / Pediatric: Children <4 mo (safety not established).

Adverse Reactions/Side Effects

Gastrointestinal

  • worsening hepatic function/hepatitis

Genitourinary

  • renal impairment

Hematologic

  • hemolysis/hemolytic anemia

Local

  • injection site reactions

Miscellaneous

  • allergic reactions including anaphylaxis (rare) (life-threatening)

Interactions

Drug-Drug interaction

↑ blood levels and risk of toxicity with sirolimus and nifedipine (dose adjustments may be necessary).

Route/Dosage

Intravenous (Adults) Esophageal candidiasis–150 mg daily for 15 days (range 10–30 days); Candidemia/acute disseminated candidiasis/Candida peritonitis and abscesses—100 mg daily for 15 days (range 10–47 days); Prevention of Candida infections in stem cell transplantation—50 mg daily (duration range 6–51 days).
Intravenous (Children ≥4 mo and >30 k g) Esophageal candidiasis–2.5 mg/kg daily (maximum daily dose = 150 mg); Candidemia/acute disseminated candidiasis/Candida peritonitis and abscesses—2 mg/kg daily (maximum daily dose = 100 mg); Prevention of Candida infections in stem cell transplantation—1 mg/kg daily (maximum daily dose = 50 mg)
Intravenous (Children ≥4 mo and ≤30 kg) Esophageal candidiasis–3 mg/kg daily; Candidemia/acute disseminated candidiasis/Candida peritonitis and abscesses—2 mg/kg daily; Prevention of Candida infections in stem cell transplantation—1 mg/kg daily
Intravenous (Neonates) 7–10 mg/kg daily. Higher dose should be used in neonates <27 weeks gestation and those with meningitis.

Availability

Lyophilized powder for injection: 50 mg/vial, 100 mg/vial

Nursing implications

Nursing assessment

  • Assess symptoms of esophageal candidiasis (dysphagia, odynophagia, retrosternal pain) prior to and during therapy.
  • Monitor for signs of anaphylaxis (rash, pruritus, wheezing, laryngeal edema, abdominal pain). Discontinue micafungin and notify health care professional immediately if these occur.
  • Assess for injection site reactions (phlebitis, thrombophlebitis) during therapy. These occur more frequently in patients receiving micafungin via peripheral IV infusion.
  • Lab Test Considerations: May cause ↑ serum alkaline phosphatase, bilirubin, ALT, AST, and LDH levels. If elevations occur, monitor for worsening liver function; may require discontinuation of therapy.
    • May cause ↑ BUN and serum creatinine.
    • May cause leukopenia, neutropenia, thrombocytopenia, and anemia. Monitor for worsening levels; may require discontinuation of therapy.
    • May cause hypokalemia, hypocalcemia, and hypomagnesemia.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Intravenous Administration
  • Intermittent Infusion: Diluent: For Adults: Reconstitute each 50-mg vial with 5 mL of 0.9% NaCl or D5W to achieve concentration of 10 mg/mL. Reconstitute each 100-mg vial with 5 mL of 0.9% NaCl or D5W to achieve concentration of 20 mg/mL. Dissolve by gently swirling vial; do not shake vigorously. Directions for further dilution based on indication for use. For prophylaxis of Candida infections, add 50 mg of micafungin to 100 mL of 0.9% NaCl or D5W. For treatment of esophageal candidiasis, add 150 mg of micafungin to 100 mL of 0.9% NaCl or D5W. Reconstituted vials and infusion are stable for 24 hr at room temperature. Protect diluted solution from light.Concentration: 0.5–1.5 mg/mL.
  • For Children: Determine dose and divide by final concentration (10 or 20 mg/mL). Add withdrawn volume to 0.9% NaCl or D5W in IV bag or syringe. Concentration: 0.5 mg/mL–4 mg/mL. Concentrations >1.5 m g/mL should be administered via central venous catheter to minimize infusion reactions. Discard unused vials.
  • Rate: Flush line with 0.9% NaCl prior to administration. Infuse over 1 hr. More rapid infusions may result in more frequent histamine mediated reactions.
  • Y-Site Compatibility: aminophylline, bumetanide, calcium chloride, calcium gluconate, carboplatin, cyclosporine, dopamine, doripenem, eptifibatide, esmolol, rtoposide, fenoldopam, furosemide, heparin, hydromorphone, lidocaine, lorazepam, magnesium sulfate, mesna, milrinone, nitroglycerin, nitroprusside, norepinephrine, phenylephrine, potassium chloride, potassium phosphates, sodium phosphates, tacrolimus, theophylline, vasopressin
  • Y-Site Incompatibility: amiodarone, cisatracurium, diltiazem, dobutamine, epinephrine, insulin, labetalol, levofloxacin, meperidine, midazolam, morphine, mycophenolate mofetil, nesiritide, nicardipine, octreotide, ondansetron, phenytoin, rocuronium, telavancin, vecuronium

Patient/Family Teaching

  • Inform patient of the purpose of micafungin.
  • Advise patient to notify health care professional immediately if signs of anaphylaxis occur.

Evaluation/Desired Outcomes

  • Resolution of signs and symptoms of esophageal candidiasis, candidemia, acute disseminated candidiasis, candidal peritonitis and abscesses.
  • Prevention of Candida infections during hematopoetic stem cell transplantation.

Mycamine

a trademark for micafungin.
References in periodicals archive ?
Drug delivery Mycamine 50 mg and 100 mg injections (Micafungin active principle).
3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use.
Decision Resources (Waltham, MA), one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, said that, because of their improvements in safety and efficacy, physicians are increasingly prescribing next-generation antifungals such as Pfizer's Vfend, Schering-Plough's Noxafil, Merck's Cancidas, Astellas' Mycamine and Pfizer's Eraxis.
The addition of this vial size will increase the convenience of use when administering MYCAMINE while decreasing waste in the hospital setting.
Funguard for Infusion (micafungin sodium), which was initially launched in December 2002, is available in the US under the trade name of Mycamine and currently waiting approval from the European Medicines Agency.
Deerfield, IL, announced the launch and availability of their newest systemic anti-fungal agent Mycamine (micafungin sodium) for injection to hospitals nationwide.
Building contracts are ongoing and repeated delivery of parenteral echinocandin antifungal agents contain substances with sodium Macafundiginum from ATC groups J02AX05 - Mycamine 100 mg Inf.
The Department of Justice had investigated Astellas for alleged off-label promotion of MYCAMINE for pediatric use, a claim the company has consistently denied.
Deerfield, IL, and Roche Pharmaceuticals, Basel, Switzerland announced they have formed a partnership for the US promotion of Fujisawa's recently approved product Mycamine (micafungin sodium) injection for the treatment of patients with esophageal candidiasis and for the prophylaxis of Candida infections in patients undergoing hemotopoietic stem cell transplantation.
Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) for the use of MYCAMINE (micafungin sodium) for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT).
The newly approval agent will be marketed in the US under the name Mycamine (micafungin sodium for injection).
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