Micafungin is an antifungal medication used to treat certain serious fungal infections, including candidemia (a bloodstream infection caused by Candida species) and invasive candidiasis (a severe infection that can affect various organs). It belongs to a class of antifungal drugs called echinocandins, which work by inhibiting the synthesis of a component of the fungal cell wall called beta-D-glucan, ultimately weakening the fungal cell and leading to its death.

Echinocandin, also known as micafungin, is an antifungal drug used to treat invasive candida infections.

Micafungin (Mycamine) Uses:

• Abcesses, Candida peritonitis, candidemia, and acute disseminated candidiasis:
  • It is used to treat abscesses, Candida peritonitis, acute disseminated candidiasis, candidemia, and paediatric patients older than 4 months or younger than 4 months who do not have meningoencephalitis or ocular dissemination.
• Esophageal candidiasis:
  • It can be used to adults and children older than 4 months to treat esophageal candidiasis.It can be used to adults and children older than 4 months to  treat esophageal candidiasis.
• Prophylaxis of Candida infections:
  • It is given to adults and kids older than 4 months who are getting hematopoietic stem cell transplantation as a prophylactic step against Candida  infections.It is given to adults and kids older than 4 months who are getting hematopoietic stem cell transplantation as a prophylactic step against  Candida infections.
• Off Label Use of Micafungin in Adults:
  • Empiric antifungal therapy (neutropenic fever)
  • Candidiasis empiric therapy (non-neutropenic ICU patients)
  • Aspergillosis, invasive (salvage therapy)
  • Candidiasis, osteoarticular infections
  • Candidiasis, chronic disseminated (hepatosplenic)
  • Candidiasis, prophylaxis against invasive candidiasis (high-risk ICU patients)
  • Candidiasis, intravascular infections
  • Candidiasis, oropharyngeal (refractory disease)

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Micafungin Dose in Adult:

Micafungin (Mycamine) Dose in the treatment of Aspergillosis, invasive (salvage therapy) (off-label):

• The typical dose given through an IV is between 100 to 150 milligrams once a day.
• This treatment is often considered when other options haven't worked well (it's called "salvage therapy").
• Doctors usually continue this treatment for at least 6 to 12 weeks, but sometimes longer depending on how severe the infection is, where it's located in the body, and how the patient is responding to the treatment.

Micafungin (Mycamine) Dose for treating Candidemia, abscesses, acute disseminated candidiasis, and Candida peritonitis:

• The usual dose through an IV is 100 milligrams once a day.
• Typically, patients receive this treatment for around 15 days, although the duration can vary depending on how the patient is responding to the treatment.

For candidemia specifically, guidelines suggest continuing antifungal therapy for at least 2 weeks after clearing the Candida from the bloodstream and resolving symptoms. In stable patients without complications, doctors may switch to fluconazole after 5 to 7 days, provided the Candida strain is susceptible to fluconazole and repeat cultures are negative.

Micafungin (Mycamine) Dose for the Off-Label Treatment of Chronic Disseminated Candidiasis (Hepatosplenic):

• The typical dose given through an IV is 100 milligrams once a day for several weeks.
• Following this initial IV treatment, patients may transition to oral fluconazole therapy as recommended by the IDSA guidelines.

Using Micafungin (Mycamine) at an off-label dose to treat suspected invasive candidiasis in non-neutropenic ICU patients

• The typical dose given through an IV is 100 milligrams once a day.
• Doctors usually continue this treatment for 14 days in patients who show improvement in their symptoms.
• However, if there's no clinical response after 4 to 5 days, doctors may consider discontinuing micafungin and exploring other treatment options.

Micafungin (Mycamine) Dose in the treatment of Candidiasis, intravascular infections (native or prosthetic valve endocarditis, infection of implantable cardiac devices, suppurative thrombophlebitis) (off-label):

• The typical dose administered through an IV is 150 milligrams daily.
• For native or prosthetic valve endocarditis, doctors usually continue therapy for at least 6 weeks after valve replacement surgery. In cases involving implantable cardiac devices, therapy typically continues for 4 to 6 weeks after surgery, depending on the extent of the infection.
• For suppurative thrombophlebitis, after removing the catheter, micafungin therapy should continue for at least 2 weeks after candidemia has cleared.
• In clinically stable patients with fluconazole-susceptible isolates and negative repeat cultures, a transition to fluconazole therapy is recommended as a step-down approach, according to IDSA guidelines.

Treatment of Candidiasis and osteoarticular infections (osteomyelitis or septic arthritis) with Micafungin (Mycamine) Dose (alternative therapy):

• The typical dose given through an IV is 100 milligrams daily for at least 14 days.
• Following this initial IV treatment, patients may transition to fluconazole therapy as recommended by the IDSA guidelines.

As an alternate therapy (off-label), the following dosage of micafungin (Mycamine) is used to treat oropharyngeal candidiasis that is refractory:

• The usual dose administered through an IV is 100 milligrams once daily, as per the recommendations from the IDSA guidelines.

Using Micafungin (Mycamine) at an off-label dose to treat empiric antifungal therapy (neutropenic fever)

• The typical dose given through an IV is 100 milligrams once daily, following the recommendations from the IDSA guidelines.

Micafungin (Mycamine) Dose in the treatment of Esophageal candidiasis:

• The typical dose of micafungin administered through an IV is 150 milligrams once daily.
• Typically, treatment lasts for about 15 days, although the duration can vary between 10 to 30 days based on individual response.

According to the IDSA Candidiasis guidelines, when patients can tolerate oral intake, doctors may consider transitioning to oral fluconazole therapy. However, in cases where the disease does not respond to fluconazole (refractory disease), micafungin treatment should continue for 14 to 21 days.

Micafungin (Mycamine) Dose in the Prophylaxis of Candida infections: IV:

In hematopoietic stem cell transplantation:

• The typical dose administered through an IV is 50 milligrams once daily.
• Treatment duration lasts for an average of 19 days, with a range from 6 to 51 days based on clinical trials.

In high-risk ICU patients in units with a high incidence of invasive candidiasis (alternative therapy; off-label use):

• The recommended dose is 100 milligrams daily, as per the IDSA guidelines provided by Pappas in 2016.

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Micafungin Dose in Children:

Micafungin (Mycamine) Dose for Aspergillosis Treatment:

Micafungin dosages vary based on age and HIV status:

• Infants ≥4 months and Children (independent of HIV status):
  • IV: 1.5 to 3 mg/kg/day once daily.
  • Higher doses may be needed for lack of clinical response or persistent positive cultures.
  • Usual maximum dose range reported: 4 to 8.6 mg/kg/day.
  • Initial doses for infants may lean towards the higher end of the range due to pharmacokinetic differences.
• Adolescents:
  • Non-HIV-exposed/-positive:
    • IV: 1.5 mg/kg/day, with the option to increase if clinically indicated.
    • Maximum daily dose: 150 mg/day.
  • HIV-exposed/-positive:
    • IV: 100 to 150 mg once daily.

Micafungin (Mycamine) Dose for Hematopoietic Stem Cell Transplant (HSCT) Prophylaxis: little information available

Infants under four months old, kids, and teenagers:

• IV: 1 to 3 mg/kg daily.
• Maximum dose: 50 mg.

Micafungin (Mycamine) Dose in the treatment of Candidiasis:

Acute Disseminated Infection, Peritonitis, and Abscesses:

• Non-HIV-Exposed/-Positive:
  • Infants <4 months:
    • IV: 2 mg/kg/day once daily.
    • Higher doses (4 to 10 mg/kg/day) may be needed if no improvement or persistent positive cultures.
    • Reported range: 2 to 10 mg/kg/day.
  • Infants ≥4 months, Children, and Adolescents:
    • IV: 2 mg/kg once daily.
    • Maximum dose: 100 mg/dose.
• HIV-Exposed/-Positive (DHHS [Pediatric] 2013):
  • Infants <4 months (Critically Ill):
    • IV: 5 to 7 mg/kg/day once daily.
    • Treatment duration varies; continue for 2 weeks after last positive blood culture.
  • Infants ≥4 months and Weighing <15 kg:
    • IV: 5 to 7 mg/kg once daily.
  • Children 2 to 8 years and ≤40 kg:
    • IV: 3 to 4 mg/kg once daily.
  • Children ≥9 years and Adolescents:
    • ≤40 kg: IV: 2 to 3 mg/kg once daily.
    • 40 kg: IV: 100 mg once daily.

Esophageal Candidiasis:

• Non-HIV-Exposed/-Positive:
  • Infants ≥4 months, Children, and Adolescents:
    • ≤30 kg: IV: 3 mg/kg once daily.
    • 30 kg: IV: 2.5 mg/kg once daily.
    • Maximum dose: 150 mg/dose.
• HIV-Exposed/-Positive (DHHS [Adult/Pediatric] 2013):
  • Infants <4 months:
    • IV: 5 to 7 mg/kg/day once daily.
    • Treatment duration: ≥3 weeks and at least 2 weeks after symptom resolution.
  • Infants ≥4 months and Weighing <15 kg:
    • IV: 5 to 7 mg/kg once daily.
  • Children 2 to 8 years and ≤40 kg:
    • IV: 3 to 4 mg/kg once daily.
  • Children ≥9 years:
    • ≤40 kg: IV: 2 to 3 mg/kg once daily.
    • 40 kg: IV: 100 mg once daily.
  • Adolescents:
    • <40 kg: IV: 2 to 3 mg/kg once daily.
    • ≥40 kg: IV: 150 mg once daily.
    • Treatment duration: 14 to 21 days.

Micafungin (Mycamine) Dose in the Prophylaxis in hematopoietic stem cell transplantation:

• Infants ≥4 months, Children, and Adolescents:
  • IV: 1 mg/kg daily.
  • Maximum dose: 50 mg.
  • Note: Higher doses up to 3 mg/kg/day have been used in trials, as mentioned in studies by Kusuki (2009) and van Burik (2004).

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Micafungin (Mycamine) Pregnancy Category: C

• In animal reproduction studies, adverse events have been noted, suggesting caution with micafungin use during pregnancy.
• As a result, other treatments are preferred for managing candidiasis in pregnant individuals, according to recommendations from the IDSA guidelines provided by Pappas in 2016.

Micafungin use during breastfeeding:

• The presence of micafungin in breast milk is not well understood.
• Therefore, if a mother is considering breastfeeding while undergoing micafungin therapy, she should carefully weigh the potential risks of infant exposure against the benefits of breastfeeding for her baby and the benefits of treatment for herself.

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Micafungin Dose in Kidney Disease:

• No dosage adjustment is necessary for micafungin in patients with poor dialysis clearance.
• This includes patients on intermittent hemodialysis, as no supplemental dose or dosage adjustment is required in these cases.

Micafungin Dose in Liver disease:

• No dosage adjustment is necessary for micafungin in patients with liver disease.
• This means that individuals with liver problems do not need their dosage of micafungin to be changed.

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Candidiasis treatment:

Common Side Effects of Micafungin (Mycamine):

• Hepatic:
  • Abnormal hepatic function tests
  • Hyperbilirubinemia
•  
• Cardiovascular:
  • Phlebitis
• Gastrointestinal:
  • Vomiting
  • Diarrhea
• Hematologic & oncologic:
  • Anemia
• Miscellaneous:
  • Fever
• Renal:
• • Renal failure

Less Common Side Effects of Micafungin (Mycamine):

• Hepatic:
  • Increased serum alkaline phosphatase
• Dermatologic:
  • Skin rash
•  
• Cardiovascular:
  • Atrial fibrillation
  • Tachycardia
• Hematologic & oncologic:
  • Thrombocytopenia
  • Neutropenia
• Endocrine & metabolic:
• • Hypoglycemia
  • Hypernatremia
  • Hyperkalemia
  • Abnormal aspartate transaminase
• Central nervous system:
  • Headache
• Gastrointestinal:
  • Nausea
  • Abdominal distention
  • Abdominal painAbdominal pain

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Candidiasis prophylaxis in hematopoietic stem cell transplantation:

Common Side Effects of Micafungin (Mycamine):

• Cardiovascular:
  • Tachycardia
• Central Nervous System:
  • AnxietyAnxiety
  • Insomnia
  • HeadacheHeadache
• Dermatologic:
  • UrticariaUrticaria
  • Skin Rash
  • Pruritus
• Endocrine & Metabolic:
  • Abnormal Alanine Aminotransferase
• Gastrointestinal:
  • Abdominal Distention
  • Diarrhea
  • Diarrhea
  • Vomiting
  • Abdominal Pain
  • Nausea
• Genitourinary:
  • Hematuria
  • Decreased Urine Output
• Hematologic & Oncologic:
  • Thrombocytopenia
  • Anemia
  • Neutropenia
  • Febrile Neutropenia
• Hepatic:
  • Abnormal Hepatic Function Tests
  • Hyperbilirubinemia
• Renal:
  • Renal Failure
• Miscellaneous:
  • Fever
  • Infusion-Related Reaction

Less Common Side Effects Of Micafungin (Mycamine):

• Cardiovascular:
  • Cardiac Arrest
  • Myocardial Infarction
  • Pericardial Effusion
• Central Nervous System:
  • Brain Disease
  • Delirium
  • Intracranial Hemorrhage
  • Seizure
• Hematologic & Oncologic:
  • Blood Coagulation Disorder
  • Pancytopenia
  • Thrombotic Thrombocytopenic Purpura
• Hepatic:
  • Hepatic Failure
  • Hepatic Injury
  • Hepatomegaly
  • Jaundice
• Hypersensitivity:
  • Anaphylaxis
  • Hypersensitivity Reaction
• Local:
  • Infusion Site Reaction
  • Venous Thrombosis At Injection Site
• Respiratory:
  • Epistaxis

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Contraindications to Micafungin (Mycamine):

• If someone has a known hypersensitivity to micafungin, other echinocandins, or any component of the micafungin formulation, they should avoid its use.
• This precaution is important to prevent allergic reactions or adverse effects.

Warnings and precautions

Hemolytic anemia/hemoglobinuria:

• Hemolytic anemia and hemoglobinuria have been reported as potential side effects of micafungin use.
• These conditions involve the destruction of red blood cells and the presence of hemoglobin in the urine, respectively.

Hepatic impairment

• Micafungin use has been associated with new-onset or worsening hepatic impairment, which includes conditions like hepatitis and hepatic failure.
• It's crucial to closely monitor patients receiving micafungin and to evaluate the appropriateness of continued use if abnormal liver function tests develop during treatment.

Hypersensitivity reactions

• Hypersensitivity reactions to micafungin can range from severe anaphylactic reactions, including shock, to milder infusion reactions such as rash, itching, facial swelling, or vasodilation.
• If a serious hypersensitivity reaction, like anaphylaxis, occurs, the infusion should be stopped immediately.
• For possible histamine-mediated infusion reactions, slowing down the infusion rate may be considered.

Injection-site reactions:

• Injection-site reactions, such as phlebitis and thrombophlebitis, have been reported with the use of micafungin.
• These reactions are more common when micafungin is administered peripherally.
• It's important for healthcare providers to monitor the injection site for any signs of inflammation, pain, or swelling during micafungin administration.
• If such reactions occur, appropriate management strategies, such as changing the infusion site or adjusting the infusion rate, may be necessary to minimize discomfort and prevent complications.

Renal impairment

• Micafungin use has been associated with increased blood urea nitrogen (BUN), serum creatinine levels, renal dysfunction, and even acute renal failure.
• Therefore, caution is advised when using micafungin in patients who develop worsening renal function during treatment.
• Close monitoring is essential in such cases to promptly detect any signs of renal impairment and take appropriate actions as needed.
• This may include adjusting the dosage of micafungin or considering alternative treatment options based on the patient's individual circumstances.

Micafungin: Drug Interaction

Risk Factor C (Monitor therapy)
Sirolimus	Micafungin may raise the level of Sirolimus in the blood.
Risk Factor X (Avoid combination)
Saccharomyces boulardii	Antifungal (Systemic, Oral) Agents may lessen Saccharomyces boulardii's therapeutic impact.

Monitoring parameters:

Liver Function Tests, Serum Creatinine, BUN, and CBC:

• Periodic monitoring of liver function tests, serum creatinine, blood urea nitrogen (BUN), and complete blood count (CBC) is recommended.
• Increase monitoring frequency in patients who develop abnormalities in these tests during micafungin treatment.

Infusion Reactions:

• Possible histamine-mediated infusion reactions may occur, including rash, itching (pruritus), facial swelling, and vasodilation.
• Be alert for these symptoms during micafungin infusion.
• Adjusting the infusion rate may be considered for suspected histamine-mediated reactions.

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How to administer Micafungin (Mycamine)?

• Route of Administration: Micafungin is for intravenous (IV) use only.
• Infusion Time: Administer the medication over a period of 1 hour.
• Infusion Rate Adjustment: If infusion reactions occur, such as rash, itching (pruritus), facial swelling, or vasodilation, consider reducing the infusion rate.
• Line Flush: Prior to administration, flush the IV line with normal saline (NS).

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Mechanism of action of Micafungin (Mycamine):

• Micafungin works by inhibiting an enzyme called 1,3-beta-D-glucan synthase, which is essential for the formation of a polysaccharide called 1,3-beta-D-glucan.
• This polysaccharide makes up a significant portion (30% to 60%) of the cell walls of Candida, a type of fungus that can cause infections.
• Since mammalian cells lack this specific polysaccharide, micafungin's action targets the fungal cells specifically.
• By reducing the formation of 1,3-beta-D-glucan, micafungin causes osmotic instability in the fungal cells, leading to their lysis or destruction.
• This mechanism helps to combat Candida infections by weakening the fungal cell walls and ultimately killing the fungus.

Absorption:

• Oral: Poor absorption.

Distribution:

• Distributes into the lung, liver, and spleen.
• Minimal distribution to the central nervous system (CNS) and eyes.

Preterm Infants:

• Variable data reported, possibly dependent on gestational age (GA), weight, and postnatal age (PNA).
• Neonatal Pharmacokinetics:
  • PNA 0 to 1 day: 0.76 L/kg
  • PNA 4 days: 1.52 L/kg
  • PNA >3 weeks: 0.43 L/kg (range: 0.28 to 0.66 L/kg)
• Children and Adolescents:
  • Children 2 to 8 years: V: 0.35 ± 0.18 L/kg
  • Children and Adolescents 9 to 17 years: V: 0.28 ± 0.09 L/kg
• Adults: V: 0.39 ± 0.11 L/kg

Protein Binding:

• Neonates: 96.7% to albumin.
• Adults: >99% to albumin.

Metabolism:

• Hepatic metabolism to M-1 (catechol form) by arylsulfatase, further metabolized to M-2 (methoxy form) by catechol-O-methyltransferase, and hydroxylation to M-5 by CYP3A.

Half-life Elimination:

• Preterm Infants: PNA <1 week: 6.7 hours; PNA >3 weeks: Mean 8.3 hours.
• Children 4 months to 16 years: ≤30 kg: 12.5 ± 4.6 hours; >30 kg: 13.6 ± 8.8 hours.
• Healthy Adults: 11 to 21 hours.
• Adults receiving bone marrow or peripheral stem-cell transplantation: 10.7 to 13.5 hours.

Excretion:

• Primarily feces (71%); urine (<1%, unchanged).

Clearance:

• Preterm Infants: PNA 0 to 1 day: 1.48 mL/minute/kg; PNA 4 days: 0.58 mL/minute; PNA >3 weeks: 0.64 mL/minute.
• Children 4 months to 16 years: ≤30 kg: 0.328 mL/minute/kg; >30 kg: 0.241 mL/minute/kg.
• Adults: ~0.3 mL/minute/kg.

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International Brand Names of Micafungin:

• Mycamine
• Funguard
• Micamin
• Mycamiine
• Mycamine
• Ying Te

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Micafungin Brand Names in Pakistan:

No Brands Available in Pakistan.