Ecalta

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Ecalta

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Ecalta

What is Ecalta? (Anidulafungin)

Ecalta is a prescription-only drug used for serious infections, defined by its active ingredient, Anidulafungin (INN), and its classification as a powerful Systemic Antifungal Agent. It belongs to the specialized echinocandin group, which is reserved for treating deep-seated fungal infections within the body, most notably those caused by the Candida species.


Quick Facts

Property Description
Active ingredient Anidulafungin (INN)
Form Lyophilized powder for concentrate for solution
Pharmacological class Echinocandin, Systemic Antifungal Agent
General use Treatment of systemic fungal infections (e.g., candidiasis)
Origin Semi-synthetic lipopeptide

What Type of Medicine is Ecalta? (Definition and Classification)

Ecalta is an echinocandin antifungal agent, representing one of the most modern pharmacological classes used in clinical settings against invasive candidiasis. Anidulafungin is structurally a semi-synthetic lipopeptide compound, meaning it is derived from a natural fermentation product that is then chemically processed to optimize its therapeutic properties. This medicine is clinically recognized for use against invasive candidiasis in both adult and pediatric patients.


Composition and Form: Is Anidulafungin Natural or Synthetic?

The primary component of Ecalta is the single active ingredient, Anidulafungin, which is provided as a lyophilized powder for concentrate for solution. This specialized form is a distinguishing feature because it requires reconstitution using an aqueous solvent system immediately prior to use. The product is strictly administered via intravenous infusion, confirming its status as a drug intended for systemic use. The echinocandin class of drugs, including Anidulafungin, possesses a potent fungicidal effect against Candida.

What side effects are possible with Ecalta?

Possible side effects and safety information

The safety profile of Ecalta (Anidulafungin) is defined by adverse reactions categorized by frequency and the body system they affect, as detailed in official regulatory documents.

Frequency-Classified Adverse Reactions

The most frequently documented effects (Very Common: affecting 1 in 10 patients) include hypokalaemia (low potassium), diarrhoea, and nausea. Effects classified as Common (affecting 1 in 100 to < 1 in 10 patients) involve several systems, notably increases in liver enzymes (ALT, AST, alkaline phosphatase), changes in blood pressure, headache, and skin rash. Uncommon reactions (1 in 1,000 to < 1 in 100 patients) include coagulopathy, flushing, and cholestasis.

System Organ Class (SOC) Focus Key Common/Uncommon Effects
Hepatobiliary Disorders Increased hepatic enzymes, Cholestasis
Metabolism and Nutrition Hyperglycaemia, Hypokalaemia
Vascular Disorders Hypotension, Hypertension, Flushing
Nervous System Disorders Headache, Convulsion

Serious Reactions and Safety Constraints

The regulatory profile lists the potential for serious adverse reactions, including anaphylaxis (an acute allergic reaction) and serious hepatic dysfunction (liver failure). Hypersensitivity events, such as rash and flushing, have been reported to occur during or shortly after the intravenous infusion, representing a documented time-related pattern.

Contraindications include known hypersensitivity to anidulafungin or any other echinocandin. For specific populations, official prescribing information states no dose adjustment is required solely based on the presence of hepatic or renal impairment. However, the drug is not recommended for neonates (under one month old) or in cases of known or suspected Hereditary Fructose Intolerance (HFI) due to excipient safety concerns.

Overdose and Emergency Response

Overdose and when to seek help

The following information on overdose is derived exclusively from official government regulatory documents, detailing the documented clinical response and procedural management for Ecalta (Anidulafungin).


Documented Manifestations and Outcomes

Official regulatory records state that following the inadvertent administration of a single 400 mg dose, which is four times the standard maintenance dose, no clinical adverse events were reported.

In high-dose study regimens, the only documented change was the observation of transient, asymptomatic transaminase elevations (liver enzymes). These findings define the officially known profile of exposure to doses exceeding the recommended level.


Emergency Actions and Procedural Guidance

Seek immediate medical attention for any suspected overdose event or if severe, unexpected symptoms occur.

Management of Anidulafungin overdose is limited to symptomatic and supportive treatment. This approach is required because no specific antidote is known for the substance. Furthermore, official documentation confirms a critical procedural constraint: Anidulafungin is not dialyzable, meaning hemodialysis is ineffective for drug removal.

Due to the observed enzyme changes in high-dose scenarios, monitoring of hepatic tests is a necessary procedural step during management.

Therapeutic Uses of Ecalta

What Ecalta Treats: Main Uses and Benefits

Ecalta (Anidulafungin) is a systemic antifungal agent generally used in clinical settings to address serious, invasive infections caused by the Candida species. Its therapeutic focus plays a role in managing the spread of the fungal pathogen.


The medication is commonly used to help with invasive candidiasis, which includes candidemia, and also manages fungal infections localized to the esophagus (esophageal candidiasis) in adults. This therapeutic domain is relevant in contexts marked by increased discomfort or tension related to inflammatory states. It is commonly used in clinical settings that involve acute or unstable symptom patterns.

The core benefit is that Ecalta supports the process of microbiological clearance. This process is applied in addressing symptoms related to acute systemic imbalance and is commonly used across conditions characterized by periods of heightened symptoms. Furthermore, it is relevant for easing pronounced symptoms like painful and difficult swallowing.


Quick Fact: Support for Systemic Symptom Management

Ecalta is applied in addressing symptom clusters that may become intense or disruptive, particularly those related to systemic imbalance and physical discomfort.

Eligibility and Restrictions for Use

The eligibility for Ecalta (Anidulafungin) is governed by official regulatory classifications, which define populations for whom the medicine is permitted, restricted, or strictly contraindicated. This information is based solely on government-approved prescribing labels.

Contraindicated Populations

Use of Ecalta is contraindicated in patients with known hypersensitivity to the active ingredient, Anidulafungin, any of its excipients, or to other medicines in the echinocandin class. Due to the formulation's content, it is also strictly prohibited for individuals with Hereditary Fructose Intolerance (HFI).

Age and Condition Eligibility

Ecalta is permitted for adults and pediatric patients aged mathbf1 month and older. Treatment is not recommended for neonates (mathbf< 1 month), as safety and efficacy are not established. Official labeling notes that no dosage adjustments are required for patients with renal impairment or hepatic impairment, allowing standard use in these populations.

Use in Pregnancy and Lactation

For pregnant and breastfeeding women, Ecalta is generally not recommended unless the benefit to the mother clearly outweighs the potential risk to the fetus or child, as documented in regulatory guidelines. The medicine has not been studied for use in specific deep-seated infections, such as Candida endocarditis or meningitis.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Ecalta (anidulafungin) has a low potential for drug-drug interactions because its primary elimination pathway involves non-enzymatic chemical degradation rather than metabolism by the liver's cytochrome P450 (CYP) enzyme system. Anidulafungin is officially documented as not being a clinically relevant substrate, inhibitor, or inducer of the major CYP enzymes.


Documented Pharmacokinetic Interactions

Official regulatory documents confirm that co-administration studies with several commonly used medications resulted in no significant alteration to the drug levels (pharmacokinetics) of anidulafungin or the co-administered drug. Therefore, no dosage adjustment is required for anidulafungin when used with the following substances:

Co-administered Substance Regulatory Finding
Ciclosporin No significant alteration in pharmacokinetics.
Voriconazole No significant alteration in anidulafungin exposure.
Tacrolimus No significant alteration in anidulafungin exposure.
Amphotericin B (Liposomal) No significant alteration in anidulafungin exposure.
Rifampicin No significant alteration in anidulafungin exposure.

Other Interaction Considerations

  • Contraindicated Combinations: The only formal restrictions are based on known hypersensitivity to anidulafungin or other medicines in the echinocandin class.
  • Food/Products: The regulatory label does not specify any interactions with food, alcohol, or herbal products.
  • Timing: No dose separation or specific timing requirements are documented or needed for co-administration of Ecalta with the tested substances.
  • Population: Interaction studies have been conducted primarily in adults.

Mechanism of Action

How Ecalta Works: Mechanism of Action

The mechanism of Anidulafungin (Ecalta) is one of selective action, focusing exclusively on the fungal cell's structural integrity.


Targeted Fungal Enzyme Inhibition

Anidulafungin functions as a non-competitive inhibitor of the essential fungal enzyme beta-(1,3)-D-glucan synthase. This action directly arrests the synthesis of beta-(1,3)-D-glucan, the key polymer providing structural rigidity to the fungal cell wall.


Cell Wall Destabilization and Osmotic Lysis

The immediate structural failure of the cell wall prevents the organism from counteracting its internal osmotic pressure, triggering a sequence known as osmotic lysis (cell rupture). This mechanistic cascade results in the direct and swift rupture (lysis) of the susceptible fungal pathogen, a consequence of irreversible cellular damage.


Mechanistic Constraints and FKS Gene Resistance

The mechanism's inhibitory action can be constrained by acquired mutations within the fungal FKS genes, which encode subunits of the target enzyme, reducing the enzyme's sensitivity to inhibition. This resistance pathway may allow the pathogen to maintain partial cell wall synthesis, limiting the drug's overall fungicidal impact.

Dosage and Administration Information

The usage of Ecalta (Anidulafungin) follows specific protocols for its administration, dosing, and treatment duration. As a lyophilized powder, the medicine must undergo a two-step process: it is first reconstituted with Sterile Water for Injection and then diluted only with 0.9% Sodium Chloride or 5% Dextrose solution to a final concentration of 0.77 mg/mL. The medicine must be prepared for systemic delivery via intravenous infusion only; it cannot be given as a rapid injection or administered by any other route.


Official Dosing and Administration

Usage Parameter Requirement
Route and Rate Strictly Intravenous Infusion; the rate must not exceed 1.1 mg/minute (without regard to meals).
Adult Dosing Schedule Candidemia: 200 mg loading dose (Day 1), followed by 100 mg once daily. Esophageal: 100 mg loading dose (Day 1), followed by 50 mg once daily.
Duration For invasive infections, treatment continues for at least 14 days after the last positive culture; for esophageal infection, treatment must be maintained for at least 7 days following symptom resolution.

Population-Specific Rules

No dosage adjustment is required for patients with any degree of renal impairment (including those undergoing dialysis) or hepatic impairment. Dosing for pediatric patients (1 month to less than 18 years) with invasive candidiasis uses a 3.0 mg/kg loading dose (max 200 mg) followed by a 1.5 mg/kg maintenance dose (max 100 mg), aligned with established clinical parameters. The infusion solution must not be frozen or co-infused with any other medicines.

Recent Clinical Evidence

Ecalta (caspofungin) is an antifungal medication belonging to the echinocandin class, which targets the fungal cell wall. Its research profile focuses primarily on the management of serious, invasive fungal infections, including those caused by Candida and Aspergillus species.


Clinical Trial Findings

Clinical research has evaluated the agent across several key patient populations, including those with compromised immune systems and critically ill individuals in intensive care units (ICU).

Candidiasis (Invasive and Esophageal)

Studies have assessed Ecalta's role in treating candidemia (fungal infection in the blood) and other serious Candida infections. In one large, randomized trial, Ecalta was evaluated against amphotericin B for invasive candidiasis, with studies reporting similar overall response rates. Further, in a study focusing on esophageal candidiasis, the drug's use was compared to fluconazole, with the reported overall treatment success rates being comparable between the two agents.

Empirical Therapy and Aspergillosis

Ecalta is also studied as empirical therapy for presumed fungal infections in adults and pediatric patients (3 months and older) who have persistent fever and neutropenia (low white blood cell count). Research has also examined its application in treating invasive aspergillosis in patients whose conditions were refractory to, or who were intolerant of, other standard antifungal therapies.


Safety Profile Observations

The most commonly observed adverse events reported in clinical trials include changes in liver enzyme levels, fever, headache, and flushing. Ecalta's mechanism of action, which specifically targets a component of the fungal cell wall absent in human cells, suggests a favorable toxicity profile compared to some older antifungal classes.

Frequently Asked Questions (FAQ)

Common questions about Ecalta (FAQ)


Q: What is the main difference between Ecalta and other common antifungals?

A: Ecalta (Anidulafungin) belongs to a group of antifungals called echinocandins, which work by blocking the formation of beta-(1,3)-D-glucan, a substance that provides the fungal cell wall with its structure. Official product information also notes that the medicine is eliminated primarily through a slow chemical breakdown process. This non-enzymatic pathway is different from many other antifungals and means Ecalta is not expected to have significant drug interactions via the CYP450 system, which is a frequent pathway for drug interactions for other medications.

Q: Does Ecalta treat all types of fungal infections?

A: Ecalta is specifically indicated for the treatment of serious, established fungal infections caused by Candida species, such as candidemia. Official documents specify that the drug has not been studied in adults or pediatric patients for specific deep-seated infections, such as endocarditis or meningitis.

Q: Is Ecalta known to cause hair loss?

A: According to the official product information, hair loss (alopecia) is not listed among the common or very common adverse reactions that were reported in clinical trials for Ecalta.

Q: How long does Ecalta typically stay in the body after the last dose?

A: The time it takes for the concentration of Ecalta in the body to be reduced by half is approximately 40 to 50 hours. This measure is referred to as the terminal elimination half-life and is part of the drug’s pharmacological profile.

Q: Why is Ecalta given only by IV (intravenous infusion)?

A: Ecalta is supplied as a powder that must be mixed and given strictly through intravenous infusion (a slow drip into a vein). It cannot be taken as a pill. The medicine is eliminated primarily through a slow chemical breakdown process, and its chemical properties necessitate intravenous administration for effective systemic delivery.

Q: Is Ecalta considered a first-line treatment for certain infections?

A: Ecalta is indicated for the treatment of specific invasive Candida infections. Clinical studies showed that Ecalta achieved comparable outcomes when evaluated against other established antifungal treatments for these conditions. This information places it as an established option for managing these types of infections.

Q: Can Ecalta interact with common pain relievers?

A: Official information indicates that Ecalta has a low potential for drug interactions because it is not processed by the liver's CYP450 enzyme system. Because of this, Ecalta is unlikely to affect the levels of many common medications. Studies have shown that it is unlikely to affect the levels of co-administered drugs.

Q: Is Ecalta safe for older patients?

A: Clinical trials did not show any geriatric-specific problems that would limit the usefulness of Ecalta in patients 65 years and older. Official regulatory documents confirm that no dosage adjustment is required solely based on the age of elderly patients.

Q: Is Ecalta used to prevent infections, or only to treat them?

A: Ecalta is indicated by regulatory bodies for the treatment of specific established fungal infections. Official documentation supports its use for the resolution of active infections, and it is not indicated for routine prophylaxis (prevention).

Q: Can Ecalta cause changes in mood or behavior?

A: Some changes in mood and behavior are listed in the official safety profile. Psychiatric events such as confusional state and depression are classified as Common side effects (affecting up to 1 in 10 patients), and anxiety and delirium have been reported as Uncommon (affecting up to 1 in 100 patients).

Q: What is the general success rate of Ecalta in clinical studies?

A: In a major clinical trial assessing the treatment of invasive candidiasis, the overall success rate reported for Ecalta was approximately 75.6% at the end of the intravenous treatment period.

Q: Does Ecalta interact with high blood pressure medications?

A: The regulatory label does not list any specific interaction study with high blood pressure medications. However, the drug is noted for its low potential for drug interactions because it is eliminated by a chemical breakdown process rather than through the liver's CYP450 enzyme system.

Q: Are there any specific warnings about Ecalta and pre-existing heart conditions?

A: The official label does not contain specific restrictions or warnings regarding pre-existing heart conditions. However, adverse reactions involving the vascular system, such as hypotension (low blood pressure) and hypotension (high blood pressure), have been reported as common side effects.

Q: Is it true that Ecalta has fewer drug interactions compared to other antifungals?

A: Ecalta is generally described as having a low potential for drug-drug interactions. This is because the active ingredient is not metabolized by the CYP450 enzyme system, which is a frequent source of interactions for many other classes of antifungals and co-administered drugs.

Q: What is the purpose of the 'loading dose' for Ecalta?

A: The initial dose of Ecalta, called the loading dose, is typically twice the amount of the regular daily maintenance dose. The pharmacological purpose of administering a larger initial dose is to help the drug quickly reach a steady-state concentration in the bloodstream at the start of therapy.

Q: Can Ecalta affect the effectiveness of birth control pills?

A: Official information indicates that Ecalta is not expected to affect the effectiveness of hormonal medications, including birth control pills. This is based on its non-CYP450 elimination pathway, meaning it does not interfere with the major liver enzymes responsible for breaking down these hormones.

Q: Does Ecalta cause drowsiness or affect the ability to drive?

A: The drug manufacturer has reported that no formal studies have been performed to assess the effects of Ecalta on the ability to drive or operate machinery. The official documentation does not contain patient guidance regarding managing potential side effects that may affect concentration.

Q: Can Ecalta be used by people who have diabetes?

A: Metabolism and nutrition changes, including hyperglycaemia (high blood sugar), have been reported as common adverse reactions in clinical trials. This is an important consideration for people with diabetes; monitoring of blood sugar levels may be necessary during treatment.

Q: What does the term 'Echinocandin' mean in simple terms?

A: The term echinocandin refers to the pharmacological class of Ecalta. These medicines are structurally derived from natural products but are chemically modified (semi-synthetic). The class is known for working by targeting and disrupting the fungal cell wall, which results in the direct destruction of the susceptible fungal organism.

Q: Are there any specific monitoring requirements during Ecalta treatment?

A: Official warnings and precautions state that patients who show abnormal liver function tests during therapy should be monitored. Official documentation states that if a patient develops abnormal liver tests, an evaluation is needed to determine the risk of continuing the medicine.

Q: Can Ecalta cause reactions at the injection site?

A: Adverse reactions such as flushing (redness), rash, and pruritus (itching) have been reported to occur during or shortly after the intravenous infusion. These effects are categorized as adverse reactions which can occur during or shortly after the intravenous infusion.

Q: Does the dose of Ecalta need to be adjusted for obese patients?

A: Official regulatory documents and the manufacturer's licensed dosing schedule do not specify a different dose based solely on a patient's body weight or status, including obesity. Standard doses are typically used regardless of weight.

Q: Can Ecalta be administered outside of a hospital setting?

A: Ecalta is a sterile powder that requires complex preparation, including reconstitution and subsequent dilution with specific solutions, followed by a controlled intravenous infusion. The requirements for preparation and controlled intravenous infusion are usually managed in a clinical or hospital setting.

Q: Is Ecalta often used as part of a combination therapy?

A: The clinical studies that led to Ecalta’s approval were based on its use as a single-agent therapy (monotherapy). Official documents provide interaction data for when Ecalta is co-administered with other drugs, but there is no regulatory statement on its common or recommended use as part of a combination antifungal therapy.

Q: Is Ecalta affected by taking proton pump inhibitors (PPIs)?

A: Specific interaction studies with proton pump inhibitors (PPIs) are not documented in the official prescribing information. However, the low potential for drug interactions suggests that a clinically relevant effect from PPIs on Ecalta is not expected.

How should Ecalta be stored and disposed of?

How to Store and Dispose of Ecalta (Anidulafungin)

The storage and disposal of Ecalta must follow strict regulatory requirements to maintain its stability.

Storage Requirements

Unopened vials must be stored under refrigeration at 2 C to 8 C (36 F to 46 F) and must not be frozen. The product should be stored in its original carton to protect from light.

Stability and Handling

The reconstituted solution is stable for up to 24 hours at 25 C. The final diluted solution is stable for 48 hours when refrigerated. This medicine must be kept out of the sight and reach of children.

Disposal

Unused medicine and waste material must be disposed of in accordance with local requirements and established procedures.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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