micafungin sodium

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.

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References in periodicals archive ?
Dearborn, IL, announced the FDA has approved micafungin sodium, an antifungal product for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation and the treatment of esophageal candidiasis.