Micafungin Bioglan
Echinocandin Antifungal for Invasive Candidiasis
Quick Facts About Micafungin Bioglan
Key Takeaways About Micafungin Bioglan
- Hospital-administered antifungal: Micafungin Bioglan is given by slow intravenous infusion once daily and must be prepared and administered by trained healthcare professionals
- Broad Candida activity: Effective against most Candida species including C. albicans, C. glabrata, C. tropicalis, C. krusei, and C. parapsilosis, making it suitable for invasive and oesophageal candidiasis
- Suitable for all ages: Approved for use in adults, adolescents, children, and neonates, with weight-based dosing for patients weighing 40 kg or less
- Liver monitoring required: Animal studies showed liver tumours with long-term use; liver function tests should be monitored during treatment, particularly in patients with pre-existing liver conditions
- Prophylaxis in immunocompromised patients: Used to prevent Candida infections in patients undergoing bone marrow transplantation or those with prolonged neutropenia (10 days or more)
What Is Micafungin Bioglan and What Is It Used For?
Micafungin Bioglan is an echinocandin antifungal medicine that contains the active substance micafungin (as sodium salt). It is used to treat serious fungal infections caused by Candida yeast, including invasive candidiasis, oesophageal candidiasis, and as prophylaxis against Candida infections in immunocompromised patients.
Micafungin belongs to the echinocandin class of antifungal agents, which are considered first-line therapy for most forms of invasive candidiasis according to the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Unlike azole antifungals that target the cell membrane, echinocandins work by inhibiting the synthesis of 1,3-beta-D-glucan, an essential structural component of the fungal cell wall that is not found in mammalian cells.
By disrupting the production of 1,3-beta-D-glucan, micafungin creates defects in the fungal cell wall. Without an intact cell wall, the fungal cell cannot maintain osmotic stability, which leads to cell lysis and death. This unique mechanism of action means that micafungin is generally well tolerated, as it targets a structure specific to fungi and absent from human cells. Micafungin demonstrates fungicidal activity (kills the fungus) against most Candida species, as opposed to merely fungistatic (stopping growth) activity.
Micafungin Bioglan is prescribed in the following clinical situations, typically when other suitable antifungal treatments are not available or appropriate:
- Invasive candidiasis: Treatment of serious Candida infections that have spread into the bloodstream (candidaemia) or to internal organs in adults, adolescents, and children including neonates. Invasive candidiasis is a life-threatening condition with mortality rates ranging from 30% to 60% without appropriate treatment, according to published data from the European Centre for Disease Prevention and Control (ECDC).
- Oesophageal candidiasis: Treatment of Candida infection of the oesophagus (food pipe) in adults and adolescents aged 16 years and older, when intravenous therapy is appropriate. Oesophageal candidiasis is particularly common in patients with HIV/AIDS or other immunosuppressive conditions.
- Antifungal prophylaxis: Prevention of Candida infections in patients undergoing allogeneic haematopoietic stem cell transplantation (bone marrow transplantation) or in patients who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 or more consecutive days. These patients are at particularly high risk for invasive fungal infections due to severely compromised immune function.
Micafungin was first approved by the United States Food and Drug Administration (FDA) in 2005 and subsequently by the European Medicines Agency (EMA). It is available under various brand names worldwide, including Mycamine and Micafungin Bioglan. The echinocandin class also includes caspofungin (Cancidas) and anidulafungin (Ecalta), all of which share a similar mechanism of action but differ in their pharmacokinetic properties and approved indications.
What Should You Know Before Receiving Micafungin Bioglan?
Before starting micafungin treatment, your doctor must assess the benefit-risk balance, particularly regarding liver health. You should not receive micafungin if you are allergic to micafungin, other echinocandins (caspofungin or anidulafungin), or any of the excipients. Inform your doctor about all medical conditions, especially liver problems, kidney disease, and haemolytic anaemia.
Contraindications
You should not receive Micafungin Bioglan if any of the following apply:
- Allergy to micafungin or to any other echinocandin antifungal (caspofungin/Cancidas or anidulafungin/Ecalta) – hypersensitivity reactions including anaphylaxis have been reported
- Allergy to any excipient in Micafungin Bioglan, including lactose monohydrate, anhydrous citric acid, or sodium hydroxide
If you have previously experienced an allergic reaction to any antifungal medication, inform your doctor before treatment is initiated. Cross-reactivity between echinocandin agents is possible, and your doctor will need to assess whether micafungin is safe for you.
Warnings and Precautions
There are several important warnings and precautions that your doctor will consider before and during treatment with Micafungin Bioglan:
In animal studies, long-term treatment with micafungin in rats caused liver damage and subsequent liver tumours (hepatocellular carcinoma). The potential risk of developing liver tumours in humans is not known. Your doctor will perform a careful benefit-risk assessment before starting treatment with Micafungin Bioglan. If you have serious liver problems (such as liver failure or hepatitis) or a history of abnormal liver function tests, your liver function will be monitored more closely during treatment.
Talk to your doctor or pharmacist before receiving Micafungin Bioglan if you have or have had any of the following:
- Liver disease – including hepatic failure, hepatitis, or previously abnormal liver function tests. Micafungin can cause elevated liver enzymes, hepatic failure, and hepatocellular damage, including fatal cases reported in post-marketing surveillance
- Haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis (breakdown of red blood cells) – micafungin may worsen these conditions in rare cases
- Kidney problems (such as renal failure or abnormal renal function tests) – your doctor may need to monitor your kidney function more closely during treatment, as renal impairment has been reported with micafungin use
- Allergy to any medicine – including food allergies or allergies to other substances, as this may increase the risk of hypersensitivity reactions
Micafungin can also cause severe skin and mucous membrane reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These are rare but potentially life-threatening conditions. If you develop blistering, peeling skin, or a widespread rash during treatment, your healthcare team must be informed immediately so that treatment can be stopped and appropriate medical care provided.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before receiving this medicine. Micafungin Bioglan should not be used during pregnancy unless absolutely necessary. There is limited data from the use of micafungin in pregnant women. Animal reproduction studies have not demonstrated direct harmful effects, but a potential risk for human pregnancy cannot be excluded. Your doctor will carefully weigh the benefits of treating the fungal infection against the potential risks to the developing baby.
If you are being treated with Micafungin Bioglan, you should not breastfeed. It is not known whether micafungin passes into human breast milk, and a risk to the nursing infant cannot be ruled out. A decision must be made whether to discontinue breastfeeding or to discontinue micafungin therapy, taking into account the benefit of treatment for the mother.
Driving and Operating Machinery
Micafungin is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness during treatment. If you feel dizzy while receiving micafungin, do not drive, use any tools, or operate machinery. You are responsible for assessing whether you are in a condition to perform activities that require alertness.
Sodium Content
Micafungin Bioglan contains less than 1 mmol sodium (23 mg) per dose, meaning it is essentially sodium-free. This is important information for patients on a controlled sodium diet.
How Does Micafungin Bioglan Interact with Other Drugs?
Micafungin may interact with several medications, including other antifungals, immunosuppressants, and certain cardiovascular drugs. It is particularly important to tell your doctor if you are taking amphotericin B, itraconazole, sirolimus, or nifedipine, as dose adjustments of those medicines may be required.
Micafungin is primarily metabolised in the liver via arylsulfatase and catechol-O-methyltransferase (COMT) rather than the cytochrome P450 (CYP) system. While micafungin is not a major CYP inhibitor or inducer, clinical studies have shown that it can modestly affect the pharmacokinetics of certain co-administered drugs. Below are the most clinically relevant interactions that your healthcare team should be aware of.
Clinically Significant Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Amphotericin B deoxycholate | Antifungal (polyene) | Concurrent use may increase the risk of nephrotoxicity and hepatotoxicity | Monitor renal and liver function closely; combination generally avoided unless benefits outweigh risks |
| Itraconazole | Antifungal (azole) | Micafungin may increase itraconazole exposure (AUC increased by approximately 22%) | Monitor for itraconazole toxicity; dose adjustment may be needed |
| Sirolimus | Immunosuppressant (mTOR inhibitor) | Micafungin may increase sirolimus exposure (AUC increased by approximately 21%) | Monitor sirolimus blood levels and adjust dose accordingly |
| Nifedipine | Calcium channel blocker | Micafungin may increase nifedipine exposure (AUC increased by approximately 18%) | Monitor blood pressure and for signs of nifedipine toxicity (oedema, flushing, headache) |
Other Interactions to Be Aware Of
In clinical pharmacokinetic studies, micafungin did not significantly alter the pharmacokinetics of mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, fluconazole, or voriconazole. Nevertheless, the prescribing information recommends that patients should always inform their doctor or pharmacist about all medicines they are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Since Micafungin Bioglan is given by intravenous infusion, there are no food or drink interactions to consider. However, the reconstituted solution must not be mixed or co-infused with other medicines through the same intravenous line, except for sodium chloride 0.9% or glucose 5% infusion solutions.
What Is the Correct Dosage of Micafungin Bioglan?
Micafungin Bioglan must be prepared and administered by a doctor or other healthcare professional. It is given once daily by slow intravenous infusion. The dose depends on the indication (treatment or prevention), the patient's age, and body weight. Standard adult doses range from 50 mg/day for prophylaxis to 150 mg/day for oesophageal candidiasis.
Micafungin Bioglan is available as a powder for concentrate for solution for infusion. Before administration, it must be reconstituted with sodium chloride 0.9% or glucose 5% solution, and then further diluted for infusion. The infusion is typically administered over approximately 1 hour. Rapid injection should be avoided as it has not been studied and may increase the risk of histamine-mediated reactions.
Adults and Adolescents (≥ 16 Years)
| Indication | Body Weight > 40 kg | Body Weight ≤ 40 kg |
|---|---|---|
| Invasive candidiasis | 100 mg/day | 2 mg/kg/day |
| Oesophageal candidiasis | 150 mg/day | 3 mg/kg/day |
| Prophylaxis of Candida infection | 50 mg/day | 1 mg/kg/day |
Children (> 4 Months) and Adolescents (< 16 Years)
Invasive Candidiasis
Body weight > 40 kg: 100 mg/day. Body weight ≤ 40 kg: 2 mg/kg/day.
Prophylaxis of Candida Infection
Body weight > 40 kg: 50 mg/day. Body weight ≤ 40 kg: 1 mg/kg/day.
Oesophageal candidiasis is not an approved indication for children and adolescents under 16 years of age.
Neonates and Infants (< 4 Months)
Invasive Candidiasis
The recommended dose is 4–10 mg/kg/day. The higher dosing in this age group reflects the faster clearance of micafungin in very young infants and the need to achieve adequate drug exposure for effective treatment.
Prophylaxis of Candida Infection
The recommended dose is 2 mg/kg/day.
Elderly Patients
No dose adjustment is necessary in elderly patients. Micafungin pharmacokinetics are not significantly affected by age in adults. However, elderly patients may be more susceptible to certain adverse effects, and careful clinical monitoring is recommended during treatment.
Missed Dose
Since Micafungin Bioglan is administered by healthcare professionals in a hospital setting, missed doses are managed by your medical team. Your doctor monitors your condition and treatment response to determine the appropriate dosing schedule. If you are concerned that a dose may have been missed, speak with your doctor or nurse immediately.
Overdose
Your doctor supervises your treatment and monitors your condition to determine the correct dose. Because micafungin is administered in a controlled clinical environment, overdose is unlikely but not impossible. There is no specific antidote for micafungin overdose. In the event of an overdose, general supportive measures should be employed and your vital signs monitored. Micafungin is highly protein-bound and is not dialysable, meaning haemodialysis is not effective for removing it from the body.
What Are the Side Effects of Micafungin Bioglan?
Like all medicines, Micafungin Bioglan can cause side effects, although not everybody gets them. Common side effects include nausea, vomiting, diarrhoea, headache, fever, abnormal liver function tests, low blood cell counts, and rash. If you experience an allergic reaction or severe skin reaction (blistering, peeling), inform your healthcare team immediately.
The following side effects have been reported during clinical trials and post-marketing surveillance. They are organised by frequency according to the standard medical classification.
Common
- Low white blood cell count (leucopenia, neutropenia)
- Anaemia (low red blood cell count)
- Low potassium (hypokalaemia), low magnesium (hypomagnesaemia), low calcium (hypocalcaemia)
- Headache
- Phlebitis (inflammation of veins at the injection site)
- Nausea, vomiting, diarrhoea, abdominal pain
- Abnormal liver function tests (elevated alkaline phosphatase, AST, ALT)
- Elevated bilirubin (hyperbilirubinaemia)
- Rash
- Fever (pyrexia)
- Rigors (chills with shivering)
Uncommon
- Pancytopenia (low counts of all blood cells), thrombocytopenia (low platelets), eosinophilia, hypoalbuminaemia
- Hypersensitivity reactions, increased sweating
- Low sodium (hyponatraemia), high potassium (hyperkalaemia), low phosphate (hypophosphataemia), anorexia
- Insomnia, anxiety, confusion
- Somnolence (drowsiness), tremor, dizziness, taste disturbance
- Tachycardia (fast heartbeat), palpitations, arrhythmia (irregular heartbeat)
- Hypertension or hypotension, flushing
- Dyspnoea (shortness of breath)
- Dyspepsia (indigestion), constipation
- Hepatic failure, elevated gamma-glutamyltransferase, jaundice (yellowing of skin/eyes), cholestasis (reduced bile flow), hepatomegaly (enlarged liver), hepatitis
- Urticaria (hives), pruritus (itching), erythema (skin redness)
- Abnormal renal function tests (elevated creatinine, elevated blood urea), worsening renal failure
- Elevated lactate dehydrogenase
- Thrombosis at injection site, injection site inflammation, injection site pain, peripheral oedema
Rare
- Haemolytic anaemia (anaemia due to destruction of red blood cells)
- Haemolysis (breakdown of red blood cells)
Not Known
- Disseminated intravascular coagulation (DIC – a disorder of blood clotting)
- Anaphylactic/anaphylactoid shock (severe allergic reaction)
- Hepatocellular damage including fatal cases
- Renal impairment, acute renal failure
Additional Side Effects in Children and Adolescents
The following reactions have been reported more frequently in children than in adults:
- Common (may affect up to 1 in 10): Thrombocytopenia (low platelets), tachycardia (fast heart rate), hypertension or hypotension, elevated bilirubin (hyperbilirubinaemia), hepatomegaly (enlarged liver), acute renal failure, elevated blood urea
Healthcare professionals monitor paediatric patients particularly closely for these effects. Parents and caregivers should report any unusual symptoms or changes in their child's condition to the medical team immediately.
If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed here. You can also report side effects directly to your national pharmacovigilance authority (e.g., the FDA MedWatch programme in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA EudraVigilance system in Europe). By reporting side effects, you help provide more information on the safety of this medicine.
How Should Micafungin Bioglan Be Stored?
Micafungin Bioglan should be kept out of the sight and reach of children. Unopened vials do not require special storage conditions. The reconstituted solution and diluted infusion should be used immediately as the product contains no preservatives.
Proper storage of Micafungin Bioglan is essential to ensure its efficacy and safety. Here are the key storage requirements:
- Before opening: Unopened vials of Micafungin Bioglan do not require any special storage conditions. Store at room temperature and keep the vial in the original carton to protect from light.
- After reconstitution: The reconstituted concentrate should be used immediately, as it does not contain preservatives to prevent bacterial contamination. Only trained healthcare professionals who have read the full preparation instructions should reconstitute this medicine.
- After dilution: The diluted infusion solution should also be used immediately. Chemical and physical in-use stability has been demonstrated for up to 96 hours at 25°C and 24 hours at 2–8°C when protected from light and diluted as directed. However, from a microbiological perspective, the product should be used immediately.
- Light protection: The infusion bag or bottle containing the diluted solution should be placed in an opaque, resealable bag to protect from light during administration.
- Visual inspection: Do not use the diluted infusion if it is cloudy or contains visible particles. The solution should be clear and colourless.
- Single use only: Each vial is for single use only. Any unused reconstituted concentrate must be discarded immediately.
- Expiry date: 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.
What Does Micafungin Bioglan Contain?
Micafungin Bioglan contains the active substance micafungin as sodium salt. Each vial contains either 50 mg or 100 mg of micafungin. The excipients are lactose monohydrate, anhydrous citric acid, and sodium hydroxide.
Active Ingredient
The active substance is micafungin (as sodium salt), a semi-synthetic lipopeptide derived from a natural product of the fungus Coleophoma empetri. Micafungin sodium is a white to off-white powder that is freely soluble in water. Each vial contains either 50 mg or 100 mg of micafungin (as sodium salt).
Excipients (Inactive Ingredients)
- Lactose monohydrate – used as a bulking agent to give the powder its structure and facilitate reconstitution. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should inform their doctor.
- Anhydrous citric acid – used as a pH adjuster to maintain the stability of the solution
- Sodium hydroxide – used as a pH adjuster
Appearance and Pack Size
Micafungin Bioglan 50 mg powder for concentrate for solution for infusion is a white to off-white powder. It is supplied in glass vials within cartons containing 1 vial. The 100 mg strength is also available in the same presentation. After reconstitution with 5 mL of sodium chloride 0.9% or glucose 5%, each vial provides a concentration of approximately 10 mg/mL (50 mg vial) or 20 mg/mL (100 mg vial).
| Dose (mg) | Vials Required | Diluent per Vial | Final Concentration (in 100 mL) |
|---|---|---|---|
| 50 mg | 1 × 50 mg | 5 mL NaCl 0.9% or Glucose 5% | 0.5 mg/mL |
| 100 mg | 1 × 100 mg | 5 mL NaCl 0.9% or Glucose 5% | 1.0 mg/mL |
| 150 mg | 1 × 100 mg + 1 × 50 mg | 5 mL each | 1.5 mg/mL |
| 200 mg | 2 × 100 mg | 5 mL each | 2.0 mg/mL |
Frequently Asked Questions About Micafungin Bioglan
Micafungin Bioglan is used to treat invasive candidiasis (a serious fungal infection that has spread into the bloodstream or internal organs), oesophageal candidiasis (fungal infection of the food pipe) in adults and adolescents aged 16 and older, and to prevent Candida infections in patients undergoing bone marrow transplantation or those with prolonged neutropenia. It belongs to the echinocandin class of antifungals and works by disrupting the fungal cell wall.
Micafungin Bioglan is given as a slow intravenous (IV) infusion once daily. It must be reconstituted and diluted by trained healthcare professionals before administration. The infusion is typically given over approximately 1 hour. It is always administered in a hospital or clinical setting – it is not available as an oral medication.
Yes, Micafungin Bioglan is approved for use in neonates (newborn babies) and infants under 4 months of age for the treatment of invasive candidiasis at a dose of 4–10 mg/kg/day, and for prophylaxis at 2 mg/kg/day. The higher treatment doses in neonates reflect the faster clearance of micafungin in very young patients. Treatment is always supervised by specialist physicians experienced in neonatal care.
Long-term treatment with micafungin in animal studies (rats) caused liver damage and subsequent liver tumours. Although the relevance to humans is unknown, your doctor will perform a benefit-risk assessment before starting treatment and will monitor your liver function through regular blood tests. Elevated liver enzymes, hepatic failure, and hepatocellular damage have been reported in patients treated with micafungin, including rare fatal cases. Report any symptoms such as yellowing of the skin or eyes, dark urine, unusual fatigue, or abdominal pain to your doctor immediately.
Micafungin belongs to the echinocandin class, which targets the fungal cell wall by inhibiting 1,3-beta-D-glucan synthesis – a mechanism unique to fungi. This is different from azole antifungals (such as fluconazole and itraconazole) that target the cell membrane, and polyene antifungals (such as amphotericin B) that also target the cell membrane but through a different mechanism. Echinocandins are generally well tolerated with fewer drug interactions than azoles, and they are active against many Candida species that may be resistant to azole antifungals.
If you notice any unusual symptoms during or shortly after the infusion, such as difficulty breathing, rash, swelling, dizziness, rapid heartbeat, or fever, inform your healthcare team immediately. They can slow or stop the infusion and provide appropriate treatment. Allergic reactions, including anaphylaxis, have been reported rarely with micafungin. In most cases, common side effects such as mild nausea or headache do not require stopping treatment, but all side effects should be reported to your medical team.
References
- European Medicines Agency (EMA). Micafungin – Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed January 2026.
- 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.
- Hashimoto S. Micafungin: a sulfated echinocandin. Journal of Antibiotics. 2009;62(1):27–35. doi:10.1038/ja.2008.3
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: World Health Organization; 2023.
- Denning DW. Echinocandin antifungal drugs. The Lancet. 2003;362(9390):1142–1151. doi:10.1016/S0140-6736(03)14472-8
- European Centre for Disease Prevention and Control (ECDC). Surveillance of candidaemia in Europe: epidemiological trends and clinical outcomes. ECDC Technical Report. 2022.
- British National Formulary (BNF). Micafungin. Available at: bnf.nice.org.uk. Accessed January 2026.
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