Mycamine (Micafungin)
Echinocandin antifungal for invasive candidiasis, esophageal candidiasis, and antifungal prophylaxis
Quick Facts About Mycamine
Key Takeaways About Mycamine
- Echinocandin antifungal: Mycamine inhibits 1,3-beta-D-glucan synthesis in the fungal cell wall, making it fungicidal against most Candida species
- Hospital-administered only: Given exclusively by slow intravenous infusion once daily; not available in oral form
- Three approved indications: Invasive candidiasis, esophageal candidiasis, and prophylaxis of Candida infections in immunocompromised patients
- Suitable for all ages: Approved for adults, adolescents, children, and neonates with age-appropriate dosing
- Liver monitoring required: Animal studies showed liver tumors with long-term use; liver function tests should be monitored during therapy
What Is Mycamine and What Is It Used For?
Mycamine (micafungin) is an echinocandin antifungal medication used to treat invasive candidiasis, esophageal candidiasis, and to prevent Candida infections in immunocompromised patients. It works by inhibiting an essential enzyme required for fungal cell wall synthesis, leading to fungal cell death.
Mycamine contains the active substance micafungin, a semisynthetic lipopeptide belonging to the echinocandin class of antifungal agents. It is indicated for the treatment of infections caused by Candida species, a group of yeast-like fungi that can cause serious systemic infections, particularly in immunocompromised patients. Echinocandins are considered first-line therapy for invasive candidiasis according to the Infectious Diseases Society of America (IDSA) and European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines.
The mechanism of action of micafungin involves the non-competitive inhibition of 1,3-beta-D-glucan synthase, an enzyme complex responsible for producing 1,3-beta-D-glucan. This polysaccharide is a critical structural component of the fungal cell wall that does not exist in mammalian cells, which gives micafungin high selectivity for fungal organisms while sparing human cells. When glucan synthesis is disrupted, the fungal cell wall develops defects that compromise its structural integrity, ultimately leading to osmotic instability and cell death.
Micafungin demonstrates potent fungicidal activity against most clinically relevant Candida species, including Candida albicans, Candida glabrata, Candida tropicalis, Candida krusei, and Candida parapsilosis. It also exhibits fungistatic activity against Aspergillus species, though it is not indicated for the treatment of aspergillosis.
Approved Indications
Your doctor may prescribe Mycamine when other suitable antifungal agents are not available or appropriate, for the following conditions:
- Invasive candidiasis: Treatment of adults, adolescents, and children (including neonates) with a serious systemic Candida infection that has spread beyond localized areas into the bloodstream or internal organs
- Esophageal candidiasis: Treatment of adults and adolescents aged 16 years and older with a Candida infection of the esophagus, when intravenous therapy is appropriate
- Antifungal prophylaxis: Prevention of Candida infections in patients undergoing allogeneic hematopoietic stem cell transplantation (bone marrow transplantation) or patients expected to have neutropenia (low levels of neutrophils, a type of white blood cell) lasting 10 days or more
Invasive candidiasis is a leading cause of healthcare-associated bloodstream infections worldwide, with mortality rates ranging from 20% to 40% depending on the patient population and Candida species involved. Prompt initiation of appropriate antifungal therapy is critical for improving outcomes. The IDSA 2016 Clinical Practice Guidelines and ESCMID 2022 Guidelines recommend echinocandins, including micafungin, as first-line treatment for most forms of invasive candidiasis in both neutropenic and non-neutropenic patients.
What Should You Know Before Taking Mycamine?
Before receiving Mycamine, your healthcare provider must evaluate your medical history, including allergies to echinocandins, liver and kidney function, and current medications. Mycamine should not be used during pregnancy unless absolutely necessary, and breastfeeding should be discontinued during treatment.
Contraindications
Mycamine must not be administered if you have a known hypersensitivity (allergy) to micafungin, other echinocandins (such as anidulafungin or caspofungin), or any of the excipients contained in the formulation. Echinocandins share structural similarities, and cross-reactivity between agents in this class has been reported, although it remains uncommon. If you have previously experienced an allergic reaction to any echinocandin antifungal, you should inform your healthcare provider before receiving Mycamine.
Signs of a severe allergic reaction may include skin rash, hives, facial swelling, difficulty breathing, or a sudden drop in blood pressure (anaphylaxis). If any of these symptoms occur during the infusion, the administration should be stopped immediately and emergency medical treatment should be provided.
Warnings and Precautions
In preclinical studies, long-term administration of micafungin in rats caused hepatocellular damage and subsequent hepatocellular tumors (including hepatocellular carcinoma). The potential risk for humans to develop liver tumors is not established. Your physician will perform a benefit-risk assessment before initiating Mycamine treatment. If you have serious liver problems (e.g., hepatic failure, hepatitis) or a history of abnormal liver function tests, inform your doctor. Liver function will be monitored more closely during treatment.
Talk to your doctor or pharmacist before receiving Mycamine if any of the following apply to you:
- Allergies: If you are allergic to any medication, particularly other antifungal agents
- Hemolytic anemia or hemolysis: If you have a condition characterized by the premature breakdown of red blood cells. Micafungin has been associated with rare cases of hemolytic anemia and hemolysis
- Kidney problems: If you have renal impairment (e.g., renal failure or abnormal renal function tests). Your doctor may need to monitor your kidney function more closely during treatment
- Severe skin reactions: Micafungin has been associated with serious cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These are rare but potentially life-threatening conditions that require immediate medical attention
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medication. Mycamine should not be used during pregnancy unless it is absolutely necessary and the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not demonstrated teratogenicity, but adequate and well-controlled studies in pregnant women are lacking.
If you are receiving Mycamine, you should not breastfeed. Micafungin is excreted in the milk of lactating rats, and it is not known whether it passes into human breast milk. The decision to discontinue breastfeeding or to discontinue therapy should take into account the importance of the drug to the mother.
Driving and Operating Machinery
Micafungin is unlikely to affect your ability to drive or operate machinery. However, some patients may experience dizziness during treatment. If you experience dizziness or any other side effect that impairs your alertness, do not drive or operate machinery and inform your doctor.
Sodium Content
This medicine contains less than 1 mmol sodium (23 mg) per dose, and is therefore considered essentially sodium-free. This is relevant for patients on a controlled sodium diet.
How Does Mycamine Interact with Other Drugs?
Micafungin can interact with several medications, including amphotericin B deoxycholate, itraconazole, sirolimus, and nifedipine. These interactions may require dose adjustments or increased monitoring. Always inform your healthcare provider about all medications you are currently taking.
Drug interactions with micafungin are generally limited compared to azole antifungals, as micafungin is not a significant substrate or inhibitor of cytochrome P450 enzymes. However, important interactions have been identified that require clinical awareness. Micafungin is metabolized primarily by arylsulfatase, with minor involvement of catechol-O-methyltransferase (COMT) and several CYP450 isoforms (CYP1A2, CYP2B6, CYP2C, CYP3A). In vitro studies suggest that micafungin is a weak inhibitor of CYP3A.
| Interacting Drug | Effect | Clinical Significance | Recommendation |
|---|---|---|---|
| Amphotericin B deoxycholate | Increased renal toxicity when co-administered | Major | Avoid combination; use only with close renal monitoring |
| Itraconazole | Micafungin may increase itraconazole plasma levels (AUC increase ~22%) | Moderate | Monitor for itraconazole toxicity; dose adjustment may be required |
| Sirolimus | Micafungin may increase sirolimus plasma levels (AUC increase ~21%) | Moderate | Monitor sirolimus levels; dose adjustment may be required |
| Nifedipine | Micafungin may increase nifedipine plasma levels (AUC increase ~18%) | Moderate | Monitor for nifedipine toxicity (hypotension, edema); dose reduction may be needed |
Major Interactions
The combination of micafungin with amphotericin B deoxycholate is of particular clinical importance. Co-administration may increase the risk of nephrotoxicity (kidney damage). If this combination is unavoidable, close monitoring of renal function, including serum creatinine and blood urea nitrogen (BUN), is mandatory. Lipid formulations of amphotericin B (such as AmBisome) have not been studied in formal interaction studies with micafungin but are generally considered to have a lower nephrotoxic potential.
Minor Interactions
Micafungin does not significantly interact with mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, fluconazole, ritonavir, or rifampicin at clinically relevant doses. No dose adjustments are required when these drugs are co-administered with micafungin. However, as with all medications, you should always inform your healthcare provider of all prescription and non-prescription drugs, herbal supplements, and vitamins you are taking.
Since Mycamine is administered intravenously, there are no food or beverage interactions to consider. The drug does not need to be taken with food or on an empty stomach.
What Is the Correct Dosage of Mycamine?
Mycamine is given once daily by slow intravenous infusion. The dose depends on the indication, patient weight, and age. For invasive candidiasis in adults, the standard dose is 100 mg/day (or 2 mg/kg/day if weight is 40 kg or less). All doses must be prepared and administered by healthcare professionals.
Mycamine must be prepared (reconstituted and diluted) and administered by a qualified healthcare professional using aseptic technique. The reconstituted solution should be infused over approximately 1 hour. Rapid intravenous injection or bolus administration should be avoided, as it may increase the risk of histamine-mediated reactions.
Adults and Adolescents (16 years and older)
| Indication | Weight > 40 kg | Weight ≤ 40 kg |
|---|---|---|
| Invasive candidiasis | 100 mg/day | 2 mg/kg/day |
| Esophageal candidiasis | 150 mg/day | 3 mg/kg/day |
| Prophylaxis of Candida infection | 50 mg/day | 1 mg/kg/day |
Children and Adolescents (4 months to < 16 years)
| Indication | Weight > 40 kg | Weight ≤ 40 kg |
|---|---|---|
| Invasive candidiasis | 100 mg/day | 2 mg/kg/day |
| Prophylaxis of Candida infection | 50 mg/day | 1 mg/kg/day |
Neonates and Infants (< 4 months)
Neonates and infants under 4 months of age require higher weight-based doses than older children due to differences in drug clearance and volume of distribution. The recommended doses for this age group are:
Neonatal Dosing
- Invasive candidiasis: 4–10 mg/kg/day
- Prophylaxis of Candida infection: 2 mg/kg/day
Higher doses reflect increased drug clearance in neonates. The treating physician will determine the appropriate dose based on the infant's clinical response and tolerability.
Elderly Patients
No dosage adjustment is required for elderly patients. Clinical studies have included patients up to 92 years of age, and the pharmacokinetics of micafungin are not significantly altered in older adults. However, elderly patients should be monitored closely, as they may have decreased hepatic, renal, or cardiac function and a higher likelihood of concomitant medications.
Missed Dose
Since Mycamine is administered by healthcare professionals in a clinical setting, missed doses are uncommon. Your doctor monitors your condition and determines the dosing schedule. If you are concerned that a dose may have been missed, speak to your doctor or nurse immediately. Do not attempt to administer the medication yourself.
Overdose
Micafungin has been administered in clinical studies at doses up to 8 mg/kg (maximum total dose of 896 mg) without dose-limiting toxicity. In the event of accidental overdose, general supportive measures should be provided. Micafungin is highly protein-bound (>99%) and is therefore not dialyzable. Your healthcare team will monitor your condition and treat any symptoms that may arise.
Each 50 mg or 100 mg vial is reconstituted with 5 mL of sodium chloride 0.9% or glucose 5% solution, injected slowly along the inner wall of the vial to minimize foaming. The vial should be rotated gently (not shaken). The reconstituted concentrate is then added back to the 100 mL infusion bag. The final concentrations are 0.5 mg/mL (50 mg vial), 1.0 mg/mL (100 mg vial), 1.5 mg/mL (150 mg dose), or 2.0 mg/mL (200 mg dose).
What Are the Side Effects of Mycamine?
Like all medicines, Mycamine can cause side effects, although not everybody gets them. Common side effects include nausea, vomiting, diarrhea, headache, abnormal liver function tests, low blood cell counts, and injection site reactions. Serious but rare side effects include hemolytic anemia, liver failure, severe skin reactions, and anaphylaxis.
If you experience an allergic reaction (such as rash, swelling of the face or throat, difficulty breathing) or a severe skin reaction (such as blistering or peeling of the skin), you must inform your doctor or nurse immediately. The infusion will be stopped and emergency treatment provided if necessary.
Common Side Effects
May affect up to 1 in 10 patients
- Decreased white blood cell count (leukopenia, neutropenia)
- Decreased red blood cell count (anemia)
- Low potassium levels (hypokalemia)
- Low magnesium levels (hypomagnesemia)
- Low calcium levels (hypocalcemia)
- Headache
- Phlebitis (inflammation of the vein at the injection site)
- Nausea, vomiting, diarrhea, abdominal pain
- Abnormal liver function tests (elevated alkaline phosphatase, AST, ALT)
- Elevated bilirubin levels (hyperbilirubinemia)
- Skin rash
- Fever (pyrexia)
- Rigors (shaking chills)
Uncommon Side Effects
May affect up to 1 in 100 patients
- Decreased platelet count (thrombocytopenia), pancytopenia
- Increased eosinophils, decreased albumin
- Hypersensitivity reactions, increased sweating
- Low sodium (hyponatremia), high potassium (hyperkalemia), low phosphate
- Insomnia, anxiety, confusion, somnolence
- Tremor, dizziness, taste disturbance (dysgeusia)
- Tachycardia, palpitations, arrhythmia
- Hypertension or hypotension, flushing
- Dyspnea (shortness of breath)
- Dyspepsia, constipation
- Hepatic failure, elevated GGT, jaundice, cholestasis, hepatomegaly, hepatitis
- Urticaria (hives), pruritus (itching), erythema (skin redness)
- Elevated creatinine, elevated BUN, worsening renal failure
- Injection site thrombosis, inflammation, and pain
- Peripheral edema (fluid retention)
Rare Side Effects
May affect up to 1 in 1,000 patients
- Hemolytic anemia (anemia due to destruction of red blood cells)
- Hemolysis (breakdown of red blood cells)
Frequency Not Known
Cannot be estimated from available data
- Disseminated intravascular coagulation (DIC)
- Anaphylactic/anaphylactoid shock
- Hepatocellular damage including fatal cases
- Renal impairment, acute renal failure
- Stevens-Johnson syndrome, toxic epidermal necrolysis
Additional Side Effects in Children and Adolescents
The following adverse reactions have been reported more frequently in pediatric patients compared to adults:
- Common (up to 1 in 10): Thrombocytopenia (low platelets), tachycardia (increased heart rate), hypertension or hypotension, elevated bilirubin, hepatomegaly (liver enlargement), acute renal failure, elevated blood urea nitrogen
The overall safety profile in pediatric patients is consistent with that observed in adults. Healthcare providers should be particularly vigilant when administering micafungin to neonates and young infants, as they may be more susceptible to hepatic and renal adverse effects.
If you experience any side effects, including those not listed above, you can report them to your national pharmacovigilance authority. In the EU, reports can be submitted through the European Medicines Agency (EMA) at www.ema.europa.eu. In the US, contact the FDA MedWatch program. Reporting helps ensure continuous safety monitoring of medicines.
How Should You Store Mycamine?
Unopened Mycamine vials have no special storage requirements. Once reconstituted and diluted, the solution should be used immediately as it contains no preservatives. The diluted infusion solution must be protected from light.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the vial and carton. The expiry date refers to the last day of that month.
- Unopened vials: No special storage conditions are required for the unopened lyophilized powder
- Reconstituted and diluted solution: Should be used immediately after preparation, as the product does not contain antimicrobial preservatives. Chemical and physical in-use stability has been demonstrated for up to 96 hours at 25°C when protected from light, after dilution as described in the prescribing information
- Light protection: The infusion bag or bottle containing the diluted solution should be placed in an opaque, sealable bag to protect it from light during infusion
- Single-use vials: Each vial is for single use only. Any unused reconstituted concentrate should be discarded immediately
- Visual inspection: Do not use the diluted solution if it is cloudy or contains visible particles (precipitate)
What Does Mycamine Contain?
Mycamine contains micafungin sodium as the active ingredient, available in 50 mg and 100 mg vials of white, compact, freeze-dried powder. The excipients include lactose monohydrate, anhydrous citric acid, and sodium hydroxide.
Active Ingredient
Each vial contains either 50 mg or 100 mg of micafungin (as sodium salt). Micafungin sodium is a semisynthetic echinocandin lipopeptide compound synthesized by chemical modification of a fermentation product of the fungus Coleophoma empetri. The molecular formula of micafungin sodium is C56H70N9NaO23S, with a molecular weight of approximately 1292.3 daltons.
Excipients (Inactive Ingredients)
- Lactose monohydrate: Used as a stabilizer and bulking agent in the freeze-dried formulation. Patients with rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should discuss this with their healthcare provider
- Anhydrous citric acid: Used as a pH-adjusting agent to ensure optimal stability
- Sodium hydroxide: Used as a pH-adjusting agent
Physical Description
Mycamine is supplied as a white, compact, freeze-dried (lyophilized) powder in glass vials. Each carton contains 1 vial. The reconstituted solution is clear to opalescent and colorless to slightly yellow. Do not use the product if you observe discoloration, cloudiness, or particulate matter after reconstitution.
Frequently Asked Questions About Mycamine
Mycamine (micafungin) is an echinocandin antifungal medication used to treat invasive candidiasis (a serious systemic fungal infection involving the bloodstream or internal organs), esophageal candidiasis (a fungal infection of the esophagus), and for prophylaxis (prevention) of Candida infections in patients undergoing bone marrow transplantation or those expected to have prolonged neutropenia lasting 10 days or more.
Mycamine is given once daily as a slow intravenous (IV) infusion, typically over approximately 1 hour. The freeze-dried powder is reconstituted with sterile saline or glucose solution and then diluted for infusion. It must be prepared and administered by qualified healthcare professionals in a clinical setting such as a hospital. It is not available as an oral tablet or capsule.
Yes, Mycamine can be used in pediatric patients of all ages, including premature neonates. For children aged 4 months and older, the dose for invasive candidiasis is 2 mg/kg/day (or 100 mg/day if weight exceeds 40 kg). For neonates and infants under 4 months, higher weight-based doses of 4–10 mg/kg/day may be required for invasive candidiasis due to faster drug clearance in this age group.
In long-term animal studies (rats), micafungin was associated with liver cell damage and the development of liver tumors, including hepatocellular carcinoma. The relevance of these findings to humans is not established. As a precaution, your doctor will evaluate the benefit-risk balance before starting Mycamine and will monitor your liver function during treatment. Patients with pre-existing liver disease require closer monitoring. Cases of serious hepatic adverse events, including hepatic failure and fatal hepatocellular damage, have been reported in post-marketing surveillance.
The most clinically significant interaction is with amphotericin B deoxycholate, which may increase the risk of kidney damage when combined with micafungin. Micafungin can also increase plasma levels of itraconazole, sirolimus, and nifedipine, potentially requiring dose adjustments. However, micafungin has fewer drug interactions than azole antifungals because it does not significantly inhibit cytochrome P450 enzymes. Always inform your healthcare provider about all medications, supplements, and herbal products you are taking.
Mycamine belongs to the echinocandin class, which has a unique mechanism of action targeting the fungal cell wall rather than the cell membrane (like amphotericin B) or ergosterol synthesis (like azoles). Echinocandins are generally well-tolerated with fewer drug interactions than azoles. Micafungin is fungicidal against most Candida species, providing rapid killing of the organism. Unlike fluconazole, echinocandins are effective against fluconazole-resistant Candida species such as C. glabrata and C. krusei. However, micafungin is only available as an intravenous formulation, which limits its use to clinical settings.
References
This article is based on internationally recognized medical guidelines, regulatory documents, and peer-reviewed research:
- European Medicines Agency (EMA). Mycamine – Summary of Product Characteristics (SmPC). Last updated 2025. Available at: www.ema.europa.eu
- Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America (IDSA). Clinical Infectious Diseases. 2016;62(4):e1–e50. doi:10.1093/cid/civ933
- Cornely OA, Bassetti M, Calandra T, et al. ESCMID guideline for the diagnosis and management of Candida diseases 2012: non-neutropenic adult patients. Clinical Microbiology and Infection. 2012;18(Suppl 7):19–37.
- U.S. Food and Drug Administration (FDA). Mycamine (micafungin sodium) – Prescribing Information. Available at: www.accessdata.fda.gov
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- Kuse ER, Chetchotisakd P, da Cunha CA, et al. Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. The Lancet. 2007;369(9572):1519–1527.
- van Burik JA, Ratanatharathorn V, Stepan DE, et al. Micafungin versus fluconazole for prophylaxis against invasive fungal infections during neutropenia in patients undergoing hematopoietic stem cell transplantation. Clinical Infectious Diseases. 2004;39(10):1407–1416.
- British National Formulary (BNF). Micafungin. Available at: www.bnf.nice.org.uk
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in infectious disease, clinical pharmacology, and internal medicine.