Micafungin Viatris
Echinocandin antifungal for invasive Candida infections
Micafungin Viatris is an echinocandin antifungal medication administered intravenously to treat serious fungal infections caused by Candida species. It works by inhibiting the synthesis of beta-glucan, a critical component of fungal cell walls. Micafungin is used in hospitals for invasive candidiasis, esophageal candidiasis, and as prophylaxis in immunocompromised patients such as those undergoing hematopoietic stem cell transplantation.
Quick Facts
Key Takeaways
- Micafungin Viatris is a hospital-administered IV antifungal that targets serious Candida infections by disrupting fungal cell wall synthesis.
- It is used for invasive candidiasis, esophageal candidiasis (in adults and adolescents 16+), and prophylaxis in hematopoietic stem cell transplant recipients.
- Liver function must be monitored during treatment due to hepatic tumour risk observed in animal studies.
- Common side effects include nausea, headache, abnormal liver tests, low blood cell counts, and electrolyte disturbances.
- Micafungin interacts with amphotericin B, itraconazole, sirolimus, and nifedipine – dose adjustments may be needed.
What Is Micafungin Viatris and What Is It Used For?
Micafungin Viatris contains the active substance micafungin (as sodium salt), which belongs to the echinocandin class of antifungal agents. Echinocandins represent one of the most important advances in antifungal therapy over the past two decades, offering a unique mechanism of action that targets the fungal cell wall rather than the cell membrane, which is the target of older antifungals like azoles and polyenes.
The drug works by non-competitively inhibiting the enzyme 1,3-beta-D-glucan synthase, which is responsible for producing beta-glucan, an essential structural polysaccharide in the fungal cell wall. Without a functional cell wall, the fungal cell cannot maintain its structural integrity, leading to osmotic instability, cell lysis, and ultimately fungal death. Because human cells lack cell walls, this mechanism provides a favorable safety profile with relatively few off-target effects compared to some other antifungal classes.
Micafungin demonstrates potent in vitro and in vivo activity against a broad range of clinically important Candida species, including C. albicans, C. glabrata, C. tropicalis, C. krusei, and C. parapsilosis. It also has some activity against Aspergillus species, although it is not typically used as first-line therapy for aspergillosis.
Approved Indications
Your physician may prescribe Micafungin Viatris for the following conditions when no other suitable antifungal treatment is available:
- Invasive candidiasis – Treatment of serious systemic Candida infections in adults, adolescents, children, and neonates. Invasive candidiasis includes candidemia (Candida in the bloodstream) and deep-seated tissue infections affecting organs such as the liver, spleen, kidneys, or peritoneum.
- Esophageal candidiasis – Treatment in adults and adolescents aged 16 years and older when intravenous therapy is appropriate. This condition involves painful fungal infection of the esophagus, commonly seen in immunocompromised individuals such as those with HIV/AIDS.
- Prophylaxis of Candida infection – Prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) or in patients who are expected to have neutropenia (low neutrophil count) lasting 10 days or more.
Micafungin is particularly valuable in critically ill patients, including those in intensive care units, where invasive candidiasis carries a mortality rate of 30–50% if untreated. The Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) both recommend echinocandins as first-line therapy for most forms of invasive candidiasis, underscoring the clinical importance of this drug class.
What Should You Know Before Taking Micafungin Viatris?
Contraindications
Micafungin Viatris must not be used if you have a known hypersensitivity (allergy) to micafungin, to other echinocandin antifungals such as anidulafungin (Ecalta) or caspofungin (Cancidas), or to any of the inactive ingredients in the formulation, which include lactose monohydrate, citric acid, and sodium hydroxide.
Allergic reactions to echinocandins, while uncommon, can range from mild skin rashes to severe anaphylactic reactions. If you have previously experienced an allergic reaction to any antifungal medication, inform your healthcare provider before treatment begins.
Warnings and Precautions
In preclinical rat studies, long-term administration of micafungin caused hepatocellular damage and subsequent liver tumours. The potential risk for humans to develop liver tumours is not known. Your prescribing physician will conduct a careful benefit-risk assessment before initiating micafungin therapy. If you have severe liver problems (such as hepatic 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 using Micafungin Viatris if any of the following apply to you:
- Drug allergies – If you have a known allergy to any medication, particularly antifungals.
- Hemolytic anemia or hemolysis – If you have a history of red blood cell destruction. Micafungin has been rarely associated with hemolytic anemia and hemolysis.
- Kidney problems – If you have renal impairment or a history of abnormal kidney function tests, your kidney function may be monitored more closely during treatment.
- Severe skin reactions – Micafungin can, in rare cases, cause serious inflammatory conditions of the skin and mucous membranes, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If you develop a widespread rash with blistering or peeling skin, stop treatment and seek 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 using Micafungin Viatris. This medication should not be used during pregnancy unless it is considered absolutely necessary by your physician and the potential benefits clearly outweigh the potential risks to the fetus.
Animal reproduction studies have shown that micafungin crosses the placenta. While there are limited data from human pregnancies, the precautionary principle applies. If you are prescribed micafungin during pregnancy, your doctor has determined that the severity of your fungal infection warrants the use of this medication.
Breastfeeding should be discontinued during treatment with Micafungin Viatris, as it is not known whether micafungin is excreted in human breast milk. The risk to the nursing infant cannot be excluded.
Driving and Operating Machinery
Micafungin is unlikely to affect your ability to drive or operate machinery. However, some patients experience dizziness during treatment. If you experience dizziness or any other symptom that could impair your alertness, do not drive or operate machinery until the effect subsides. Inform your healthcare provider if you notice any such effects.
Micafungin Viatris contains less than 1 mmol (23 mg) of sodium per dose, meaning it is essentially sodium-free. This is relevant for patients on sodium-restricted diets.
How Does Micafungin Viatris Interact with Other Drugs?
Drug interactions are an important consideration during antifungal therapy, particularly in critically ill patients who often receive multiple concurrent medications. Micafungin is primarily metabolized via non-cytochrome P450 pathways, including arylsulfatase and catechol-O-methyltransferase (COMT), which gives it a relatively favorable drug interaction profile compared to azole antifungals. However, several clinically significant interactions have been identified.
Micafungin is a weak inhibitor of CYP3A4 in vitro. While this effect is generally modest, it can lead to clinically meaningful increases in the plasma concentrations of co-administered drugs that are CYP3A4 substrates. Your physician should be informed of all medications you are currently taking, have recently taken, or might take, including prescription drugs, over-the-counter medications, and herbal supplements.
Major Interactions
| Interacting Drug | Drug Class | Effect | Clinical Action |
|---|---|---|---|
| Amphotericin B deoxycholate | Polyene antifungal | Increased amphotericin B exposure; potential for increased nephrotoxicity | Monitor renal function closely; consider alternative antifungal |
| Itraconazole | Azole antifungal | Increased itraconazole AUC; enhanced pharmacological effect and toxicity risk | Monitor for itraconazole toxicity; dose adjustment may be needed |
| Sirolimus | Immunosuppressant (mTOR inhibitor) | Increased sirolimus levels due to CYP3A4 inhibition | Monitor sirolimus trough levels; adjust dose accordingly |
| Nifedipine | Calcium channel blocker | Increased nifedipine AUC; enhanced antihypertensive effect | Monitor blood pressure; adjust nifedipine dose if needed |
Minor Interactions
In clinical pharmacokinetic studies, micafungin did not significantly affect the pharmacokinetics of mycophenolate mofetil, cyclosporine, tacrolimus, prednisolone, fluconazole, ritonavir, rifampin, or voriconazole when co-administered. However, individual patient responses can vary, and monitoring is always advisable when multiple drugs are used concurrently.
As micafungin is administered intravenously in a hospital setting, there are no food or drink interactions to consider. The drug is not taken orally and does not interact with dietary components.
What Is the Correct Dosage of Micafungin Viatris?
Micafungin Viatris must be prepared and administered by a qualified healthcare professional. It is given as a once-daily intravenous infusion, typically over approximately one hour. The dose is determined by your physician based on the type and severity of infection, your body weight, your age, and your clinical response.
Adults and Adolescents (≥16 years)
| Indication | Body Weight >40 kg | Body 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 |
For invasive candidiasis, if the clinical response is inadequate, the dose may be increased to 200 mg/day (or 4 mg/kg/day for patients weighing 40 kg or less). This decision is at the discretion of the treating physician based on clinical and microbiological response.
Children (>4 months to <16 years)
| Indication | Body Weight >40 kg | Body 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)
Neonatal Dosing
- Invasive candidiasis: 4–10 mg/kg/day
- Prophylaxis: 2 mg/kg/day
Higher weight-based doses are required in neonates due to their faster drug clearance relative to body weight. The treating neonatologist will determine the appropriate dose based on clinical response and tolerability.
Elderly Patients
No dose adjustment is required for elderly patients. The same dosing recommendations as for other adults apply. However, elderly patients may have reduced hepatic and renal reserve, so careful monitoring of organ function is advisable throughout treatment.
Missed Dose
Because micafungin is administered in a hospital setting under direct supervision of healthcare professionals, missed doses are uncommon. If a dose is delayed or missed, your medical team will administer it as soon as possible and continue the regular dosing schedule. Do not double the dose to make up for a missed one.
Overdose
Micafungin overdose has not been commonly reported due to the controlled hospital administration setting. In the event of accidental overdose, your medical team will provide supportive care and monitor for any adverse effects. There is no specific antidote for micafungin. The drug is not removed by hemodialysis. Clinical experience with doses above 200 mg/day is limited, and careful monitoring of liver function, kidney function, and blood counts would be warranted.
Micafungin Viatris is reconstituted with 5 mL of sodium chloride 0.9% or glucose 5% solution per vial. The reconstituted concentrate is then further diluted in 100 mL of the same diluent. The solution should be used immediately as it contains no preservatives. Protect from light using an opaque bag during infusion. Do not use if the solution is cloudy or contains particles.
What Are the Side Effects of Micafungin Viatris?
Like all medicines, Micafungin Viatris can cause side effects, although not everyone will experience them. The side effects listed below are organized by frequency, from most common to rarest. If you experience an allergic reaction (such as difficulty breathing, swelling of the face, lips, tongue, or throat) or a severe skin reaction (blistering, peeling), inform your doctor or nurse immediately.
Common
- Decreased white blood cell count (leukopenia, neutropenia)
- Anemia (decreased red blood cell count)
- Low potassium (hypokalemia), low magnesium (hypomagnesemia), low calcium (hypocalcemia)
- Headache
- Phlebitis (vein inflammation at infusion site)
- Nausea, vomiting, diarrhea, abdominal pain
- Abnormal liver function tests (elevated alkaline phosphatase, AST, ALT)
- Elevated bilirubin (hyperbilirubinemia)
- Skin rash
- Fever, rigors (chills with shivering)
Uncommon
- Pancytopenia (decrease in all blood cell types), thrombocytopenia (low platelets), eosinophilia, hypoalbuminemia
- Hypersensitivity reactions, increased sweating
- Low sodium (hyponatremia), high potassium (hyperkalemia), low phosphate (hypophosphatemia), anorexia
- Insomnia, anxiety, confusion, somnolence, tremor, dizziness, taste disturbance
- Tachycardia, palpitations, irregular heartbeat
- Hypertension, hypotension, flushing
- Dyspnea (shortness of breath)
- Dyspepsia, constipation
- Liver failure, elevated GGT, jaundice, cholestasis, hepatomegaly, hepatitis
- Urticaria (hives), pruritus, erythema
- Abnormal renal function tests (elevated creatinine, elevated BUN), worsening renal failure
- Elevated lactate dehydrogenase
- Thrombosis at infusion site, injection site inflammation, injection site pain, peripheral edema
Rare
- Hemolytic anemia (destruction of red blood cells)
- Hemolysis (red blood cell breakdown)
Not Known
- Disseminated intravascular coagulation (DIC)
- Anaphylactic/anaphylactoid shock
- Hepatocellular damage including fatal cases
- Renal impairment, acute renal failure
Additional Side Effects in Children and Adolescents
Certain adverse reactions have been reported more frequently in pediatric patients than in adults. The following common side effects occur with higher incidence in children:
- Thrombocytopenia (low platelet count)
- Tachycardia (rapid heartbeat)
- Hypertension or hypotension
- Hyperbilirubinemia (elevated bilirubin)
- Hepatomegaly (enlarged liver)
- Acute renal failure, elevated blood urea nitrogen
It is important to report suspected adverse reactions after a medicine has been authorized. This helps continuous monitoring of the benefit-risk balance. Healthcare professionals and patients are encouraged to report suspected side effects to their national pharmacovigilance authority (e.g., FDA MedWatch in the USA, Yellow Card Scheme in the UK, or EMA EudraVigilance in the EU).
How Should You Store Micafungin Viatris?
Proper storage of Micafungin Viatris is critical to ensure the medication remains effective and safe. Because this is a hospital-administered medication, storage is typically managed by the pharmacy department, but the following information is important for all healthcare providers involved in its handling.
- Unopened vials: Store in the original packaging to protect from light. The vials can tolerate direct light exposure for up to 60 days (2 months). Check the expiry date printed on the carton and vial; the expiry date refers to the last day of the indicated month.
- Reconstituted concentrate: Should be used immediately as the product contains no preservatives to prevent bacterial contamination.
- Diluted infusion solution: Should also be used immediately. Chemical and physical stability has been demonstrated for up to 96 hours at 25°C when protected from light.
- Light protection: The infusion bag or bottle containing the diluted solution should be placed inside an opaque, sealable bag to protect from light during administration.
- Inspection: Do not use the solution if it appears cloudy or contains visible particles.
- Single-use vials: Each vial is for one-time use only. Discard any unused reconstituted concentrate immediately.
Keep all medications out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging.
What Does Micafungin Viatris Contain?
Active Ingredient
The active substance is micafungin (as sodium salt). The 50 mg vial contains 50 mg of micafungin, and the 100 mg vial contains 100 mg of micafungin. Micafungin sodium is a semi-synthetic lipopeptide derived from a fermentation product of Coleophoma empetri.
Inactive Ingredients (Excipients)
- Lactose monohydrate – Used as a stabilizer and bulking agent in the lyophilized formulation
- Citric acid – Used for pH adjustment
- Sodium hydroxide – Used for pH adjustment
Appearance and Packaging
Micafungin Viatris 50 mg and 100 mg are supplied as a white to off-white lyophilized (freeze-dried) powder in clear 10 mL Type I glass vials. Each vial is sealed with a grey isobutylene-isoprene rubber stopper and an aluminium seal with a colored plastic flip-off cap: blue for the 50 mg strength and red for the 100 mg strength. The vial is wrapped in a UV-protective film. Each carton contains one vial.
| Dose (mg) | Vials Required | Diluent per Vial | Reconstituted Volume | Final Concentration (in 100 mL) |
|---|---|---|---|---|
| 50 | 1 × 50 mg | 5 mL | ~5 mL (10 mg/mL) | 0.5 mg/mL |
| 100 | 1 × 100 mg | 5 mL | ~5 mL (20 mg/mL) | 1.0 mg/mL |
| 150 | 1 × 100 mg + 1 × 50 mg | 5 mL | ~10 mL | 1.5 mg/mL |
| 200 | 2 × 100 mg | 5 mL | ~10 mL | 2.0 mg/mL |
Frequently Asked Questions About Micafungin Viatris
Micafungin Viatris is used to treat invasive candidiasis (serious Candida fungal infections affecting the bloodstream and internal organs), esophageal candidiasis in adults and adolescents aged 16 and older, and to prevent Candida infections in patients undergoing hematopoietic stem cell transplantation or those with prolonged neutropenia. It is always administered intravenously in a hospital or clinical setting.
Micafungin Viatris is given as a slow intravenous (IV) infusion once daily, typically over approximately one hour. The powder must be reconstituted with sodium chloride 0.9% or glucose 5% solution and then further diluted before administration. Only trained healthcare professionals should prepare and administer this medication.
In preclinical rat studies, long-term micafungin treatment caused liver damage and liver tumours. The relevance of this finding to humans is not established. However, as a precaution, liver function is monitored during treatment, and your doctor will carefully assess the benefits versus risks before prescribing micafungin, especially if you have pre-existing liver disease.
Micafungin Viatris should not be used during pregnancy unless absolutely necessary. Animal studies have shown that the drug crosses the placenta, and there are limited human data. If you are pregnant or planning to become pregnant, discuss the risks and benefits with your doctor. Breastfeeding should be discontinued during treatment.
Micafungin is one of three echinocandins available, alongside caspofungin (Cancidas) and anidulafungin (Ecalta). All three share the same mechanism of action (inhibiting beta-glucan synthesis) and have comparable efficacy against Candida species. Key differences include: micafungin does not require a loading dose (unlike caspofungin), it has a relatively low drug interaction potential compared to caspofungin, and it is approved for use in neonates. The choice between echinocandins is often guided by local availability, cost, patient-specific factors, and drug interaction considerations.
All information is based on the European Medicines Agency (EMA) approved Summary of Product Characteristics (SmPC), FDA prescribing information, IDSA Clinical Practice Guidelines for the Management of Candidiasis (2016, updated 2023), ESCMID guidelines for invasive candidiasis, WHO Model List of Essential Medicines, and peer-reviewed literature from the Journal of Antimicrobial Chemotherapy and Clinical Infectious Diseases. Evidence level: 1A, the highest quality based on systematic reviews and randomized controlled trials.
References
- European Medicines Agency (EMA). Micafungin Viatris – Summary of Product Characteristics (SmPC). Last updated 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.
- World Health Organization. WHO Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023.
- de Wet N, Llanos-Cuentas A, Suleiman J, et al. A randomized, double-blind, parallel-group, dose-response study of micafungin compared with fluconazole for the treatment of esophageal candidiasis in HIV-positive patients. Clinical Infectious Diseases. 2004;39(6):842–849.
- 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.
- US Food and Drug Administration (FDA). Mycamine (micafungin sodium) for injection – Prescribing Information. Revised 2023.
Medical Editorial Team
This article was written and reviewed by iMedic's medical editorial team, comprising licensed physicians specializing in infectious disease, clinical pharmacology, and internal medicine. All content follows international guidelines from WHO, EMA, FDA, IDSA, and ESCMID.
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