Anidulafungin Sandoz
Echinocandin antifungal for invasive candidiasis (anidulafungin 100 mg)
Quick Facts About Anidulafungin Sandoz
Key Takeaways
- First-line echinocandin therapy: Anidulafungin Sandoz is recommended by IDSA and ESCMID guidelines as first-line treatment for invasive candidiasis and candidemia in adults and children
- Hospital-only IV infusion: This medication is given exclusively in clinical settings as a slow intravenous drip, never as a self-administered drug at home
- Loading dose required: Adults receive 200 mg on day 1 followed by 100 mg daily; pediatric dosing is weight-based at 3 mg/kg then 1.5 mg/kg daily
- Minimal drug interactions: Unlike azole antifungals, anidulafungin has very few clinically significant drug interactions due to its unique non-hepatic chemical degradation pathway
- Bioequivalent generic: Anidulafungin Sandoz is a generic formulation that has demonstrated bioequivalence to the originator product ECALTA, offering the same clinical efficacy and safety profile
What Is Anidulafungin Sandoz and What Is It Used For?
Anidulafungin Sandoz contains the active substance anidulafungin, an echinocandin antifungal used to treat invasive candidiasis — a serious fungal infection of the bloodstream and internal organs caused by Candida yeast species. It is approved for adults and pediatric patients aged 1 month to under 18 years.
Invasive candidiasis is a life-threatening systemic infection that occurs when Candida organisms enter the bloodstream (candidemia) or spread to deep tissues and organs such as the liver, spleen, kidneys, or peritoneum. This condition predominantly affects critically ill patients in intensive care units, individuals who are immunocompromised due to chemotherapy or organ transplantation, those who have undergone major abdominal surgery, and patients with central venous catheters. Without appropriate and timely treatment, invasive candidiasis carries a mortality rate of 30–60%, making prompt and effective antifungal therapy essential for patient survival.
Anidulafungin belongs to the echinocandin class of antifungal agents, which are considered first-line therapy for invasive candidiasis according to both the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). The echinocandin class includes three approved agents — anidulafungin, caspofungin, and micafungin — all of which target the same enzyme but differ in their pharmacokinetic properties, metabolism, and drug interaction profiles. Anidulafungin is distinguished from the other echinocandins by its unique degradation pathway: it undergoes slow chemical breakdown at physiological temperature and pH rather than hepatic metabolism.
The mechanism of action of anidulafungin involves non-competitive inhibition of 1,3-beta-D-glucan synthase, an enzyme that is essential for the synthesis of the fungal cell wall. Beta-D-glucan is a major structural polysaccharide of the Candida cell wall, accounting for approximately 30–60% of the wall's dry weight and providing critical structural rigidity. When glucan synthesis is inhibited by anidulafungin, the fungal cell develops an incomplete or defective cell wall, rendering it osmotically fragile and unable to maintain cellular integrity. This leads to cell lysis and death. Because human cells do not possess cell walls or glucan synthase, anidulafungin exhibits excellent selectivity for fungal cells with minimal toxicity to human tissues, contributing to its favorable safety profile.
Anidulafungin demonstrates potent fungicidal activity against most Candida species, including Candida albicans, C. glabrata, C. tropicalis, C. krusei, and C. parapsilosis, although minimum inhibitory concentrations (MICs) tend to be higher for C. parapsilosis. This broad spectrum of activity makes it a valuable tool in the empirical treatment of invasive candidiasis, where the causative species may not be immediately known at the time treatment must be initiated. In clinical trials, anidulafungin has demonstrated non-inferiority to fluconazole for the treatment of candidemia and other forms of invasive candidiasis, with some analyses suggesting a trend toward superior global response rates.
Anidulafungin Sandoz is manufactured by Sandoz and is a generic formulation of the originator product ECALTA (originally developed by Pfizer). As a generic medicine, it has undergone rigorous regulatory evaluation to demonstrate that it contains the same active substance in the same quantity and pharmaceutical form, and that it is bioequivalent to the reference product. This means that patients can expect the same therapeutic outcomes from Anidulafungin Sandoz as from the originator brand.
Anidulafungin has a unique pharmacokinetic profile among the echinocandins. It undergoes slow chemical degradation in the body at physiological temperature and pH, rather than being metabolized by the liver through cytochrome P450 or other hepatic enzyme systems. This means it has minimal hepatic metabolism and does not require dose adjustment in patients with hepatic impairment, nor does it significantly interact with drugs metabolized by the cytochrome P450 system. This characteristic makes anidulafungin particularly useful in critically ill patients receiving multiple concurrent medications.
What Should You Know Before Taking Anidulafungin Sandoz?
Anidulafungin Sandoz must not be used if you are allergic to anidulafungin, other echinocandins (e.g., caspofungin, micafungin), or any of the excipients. Your doctor will monitor your liver function and watch for signs of allergic or infusion-related reactions during treatment.
Before receiving Anidulafungin Sandoz, your healthcare team will conduct a comprehensive assessment to ensure the medication is appropriate for you. This includes evaluating your medical history, current medications, liver and kidney function, and any known drug allergies. Understanding the contraindications, warnings, and precautions is essential for safe and effective treatment.
Contraindications
The primary contraindication for Anidulafungin Sandoz is a known hypersensitivity to anidulafungin, other echinocandins (such as caspofungin or micafungin), or any of the excipients in the formulation. Cross-reactivity between echinocandins has been reported in post-marketing surveillance, so patients who have experienced an allergic reaction to any echinocandin should not receive anidulafungin. Additionally, patients with hereditary fructose intolerance must not use this medication, as each vial contains fructose as an excipient.
Before initiating treatment, your healthcare team will obtain a thorough medical history including any previous reactions to antifungal medications, particularly echinocandins. They will also review your complete medication list to identify any potential interactions, assess your hepatic and renal function through laboratory testing, and evaluate your overall clinical status to determine the most appropriate antifungal therapy.
Warnings and Precautions
Several important clinical considerations apply during treatment with Anidulafungin Sandoz:
- Hepatic effects: Elevated liver enzymes (ALT, AST, alkaline phosphatase) and clinically significant hepatic abnormalities have been reported during treatment with anidulafungin. Your doctor will monitor liver function tests regularly throughout the course of therapy. If clinically significant liver function abnormalities develop, the risks and benefits of continuing therapy should be carefully reassessed, and consideration should be given to alternative antifungal agents.
- Infusion-related reactions: These may include rash, urticaria (hives), flushing, pruritus (itching), bronchospasm, and dyspnea (difficulty breathing). To minimize these reactions, the infusion rate must not exceed 1.1 mg/min (equivalent to approximately 84 ml/hour of the diluted solution). If reactions occur, the infusion should be slowed or temporarily interrupted until symptoms resolve.
- Allergic reactions: Life-threatening allergic reactions, including anaphylaxis, have been reported rarely during post-marketing surveillance. Patients should be monitored during and after each infusion for signs of hypersensitivity. Healthcare professionals should be prepared to manage anaphylaxis with appropriate emergency medications and equipment if it occurs.
- Anesthesia considerations: If you are receiving general anesthesia while being treated with anidulafungin, your anesthesiologist should be informed, as histamine-mediated symptoms (including bronchospasm, facial flushing, and hypotension) have been reported in patients receiving concurrent anesthesia.
- Laboratory monitoring: Regular monitoring of hepatic function, renal function, electrolytes (particularly potassium), and complete blood count is recommended during treatment. Changes in these parameters should be evaluated in the context of the patient's overall clinical condition.
Seek immediate medical attention if you experience symptoms of a severe allergic reaction during or after the infusion, including sudden difficulty breathing, wheezing, swelling of the face or throat, severe skin rash or widespread hives, chest tightness, or a sudden drop in blood pressure. Although rare, these reactions can be life-threatening and require emergency treatment with epinephrine and supportive care.
Pregnancy and Breastfeeding
The effects of anidulafungin during pregnancy have not been adequately studied in humans. Animal reproductive toxicology studies have shown some evidence of developmental toxicity at high doses, including skeletal variations in rats and rabbits, but the clinical relevance of these findings to human pregnancy at therapeutic doses is uncertain. As a precautionary measure, Anidulafungin Sandoz is not recommended during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the developing fetus.
Women of childbearing potential should use effective contraception during treatment with anidulafungin. If you become pregnant while receiving this medication, contact your doctor immediately so that the risks and benefits of continuing treatment can be reassessed on an individual basis. The treating physician will consider the severity of the fungal infection, the gestational age, and the availability of alternative antifungal agents when making this decision.
It is not known whether anidulafungin or its degradation products are excreted in human breast milk. Given the serious nature of the infections for which anidulafungin is indicated, a decision must be made whether to discontinue breastfeeding or to discontinue therapy, taking into account the benefit of breastfeeding for the infant and the benefit of antifungal treatment for the mother. Discuss the options with your healthcare provider before starting treatment.
Special Populations and Excipient Warnings
Fructose content: Each vial of Anidulafungin Sandoz contains fructose as an excipient. Patients with hereditary fructose intolerance (HFI), a rare inherited metabolic disorder affecting approximately 1 in 20,000 individuals, must not receive this medication. Individuals with HFI cannot properly metabolize fructose due to a deficiency of aldolase B, which can lead to accumulation of fructose-1-phosphate, resulting in hypoglycemia, lactic acidosis, liver damage, and potentially fatal metabolic decompensation. If you or your child cannot consume sweet foods or drinks without experiencing nausea, vomiting, bloating, cramps, or diarrhea, inform your doctor before receiving this medicine.
Sodium content: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet, such as those with heart failure or severe hypertension.
Pediatric use: Anidulafungin Sandoz is approved for use in children aged 1 month to less than 18 years. Dosing in this population is weight-based and calculated by the treating physician. The medication should not be given to neonates younger than 1 month of age, as safety and efficacy data in this population are insufficient to support its use.
Renal impairment: No dose adjustment is required for patients with any degree of renal impairment, including those undergoing dialysis. Anidulafungin is not significantly removed by hemodialysis or continuous venovenous hemofiltration (CVVH). The drug undergoes chemical degradation rather than renal elimination, making renal function irrelevant to its pharmacokinetics.
Hepatic impairment: No dose adjustment is required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C). However, since hepatic adverse events have been reported, liver function should be monitored closely in patients with pre-existing liver disease.
How Does Anidulafungin Sandoz Interact with Other Drugs?
Anidulafungin has minimal drug interactions because it is not metabolized by cytochrome P450 enzymes and does not undergo hepatic metabolism. In vitro studies and clinical pharmacokinetic analyses have shown no clinically significant interactions with commonly co-administered medications in critically ill patients.
One of the most clinically important distinguishing features of anidulafungin is its unique degradation pathway. Unlike most medications and indeed unlike the other echinocandins (caspofungin is metabolized by hydrolysis and N-acetylation; micafungin is metabolized by arylsulfatase and catechol-O-methyltransferase), anidulafungin is not metabolized by hepatic enzymes at all. Instead, it undergoes slow chemical degradation to an open-ring peptide at physiological temperature (37°C) and pH. This unusual pathway means that anidulafungin does not interact with the cytochrome P450 (CYP) enzyme system, glucuronidation pathways, or drug transporters such as P-glycoprotein (P-gp) and organic anion transporting polypeptides (OATPs).
Clinical drug interaction studies have been conducted with several commonly co-administered medications in critically ill patients. The results are summarized in the table below. In general, no dose adjustments are required when anidulafungin is administered alongside other medications. However, you should always inform your healthcare provider about all medications you are currently taking, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins.
| Interacting Drug | Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Cyclosporine | Immunosuppressant | Slight increase in anidulafungin steady-state AUC (~22%); not considered clinically significant | No dose adjustment needed |
| Tacrolimus | Immunosuppressant | No significant pharmacokinetic changes observed for either drug | No dose adjustment needed |
| Voriconazole | Azole antifungal | No significant pharmacokinetic changes for either drug in co-administration | No dose adjustment needed |
| Amphotericin B | Polyene antifungal | No significant pharmacokinetic interaction expected based on distinct metabolic pathways | No dose adjustment needed |
| Rifampin (Rifampicin) | Antimycobacterial | No significant effect on anidulafungin concentrations despite rifampin being a potent CYP inducer | No dose adjustment needed |
| Liposomal Amphotericin B | Polyene antifungal | No significant pharmacokinetic interaction; combination may be considered in severe refractory infections | No dose adjustment needed |
The favorable drug interaction profile of anidulafungin makes it a particularly useful antifungal agent in critically ill patients who are typically receiving multiple concurrent medications, including immunosuppressants (e.g., after solid organ or hematopoietic stem cell transplantation), broad-spectrum antibiotics, antiviral agents, sedatives, vasopressors, and proton pump inhibitors. This advantage is consistently cited by clinical guidelines when recommending echinocandins as first-line therapy for invasive candidiasis in complex patients with polypharmacy.
It is worth noting that the absence of CYP-mediated metabolism also means that anidulafungin concentrations are unaffected by hepatic enzyme inducers (such as rifampin, phenytoin, or carbamazepine) or inhibitors (such as ketoconazole, ritonavir, or clarithromycin). This predictability of drug levels is a significant clinical advantage in patients whose medication regimens may change frequently during their hospital stay.
Anidulafungin is not an inhibitor, inducer, or substrate of cytochrome P450 isoenzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4). It is not a substrate of P-glycoprotein and is unlikely to interact with drugs metabolized by these pathways. Physical compatibility with IV substances other than 0.9% sodium chloride or 5% dextrose has not been established. Do not mix or co-infuse anidulafungin with other medications through the same IV line.
What Is the Correct Dosage of Anidulafungin Sandoz?
Anidulafungin Sandoz is administered as a slow intravenous infusion once daily. Adults receive a 200 mg loading dose on day 1 followed by 100 mg daily. Pediatric dosing is weight-based: 3 mg/kg loading dose (max 200 mg) followed by 1.5 mg/kg daily (max 100 mg). The infusion rate must not exceed 1.1 mg/min to minimize infusion-related reactions.
Anidulafungin Sandoz will always be prepared and administered by a healthcare professional in a clinical setting such as a hospital ward, intensive care unit, or oncology day unit. The powder must first be reconstituted with water for injection to form a concentrate, and then further diluted with either 0.9% sodium chloride solution or 5% glucose (dextrose) solution before intravenous infusion. The drug is never given as a rapid bolus injection and must be infused slowly over a specified minimum time period to minimize the risk of histamine-mediated infusion-related reactions.
Adults
Standard Adult Dosing for Invasive Candidiasis
- Loading dose (Day 1): 200 mg administered as a single intravenous infusion over a minimum of 3 hours (180 minutes)
- Maintenance dose (Day 2 onwards): 100 mg administered as a single intravenous infusion over a minimum of 1.5 hours (90 minutes)
- Maximum infusion rate: 1.1 mg/min (equivalent to approximately 1.4 ml/min or 84 ml/hour when reconstituted and diluted as directed)
| Dose | Vials Required | Reconstituted Volume | Diluent Volume | Total Volume | Min. Infusion Time |
|---|---|---|---|---|---|
| 100 mg (maintenance) | 1 | 30 ml | 100 ml | 130 ml | 90 minutes |
| 200 mg (loading) | 2 | 60 ml | 200 ml | 260 ml | 180 minutes |
Children and Adolescents (1 month to <18 years)
Weight-Based Pediatric Dosing
- Loading dose (Day 1): 3.0 mg/kg body weight (must not exceed 200 mg) administered as a single intravenous infusion
- Maintenance dose (Day 2 onwards): 1.5 mg/kg body weight (must not exceed 100 mg) administered as a single intravenous infusion once daily
- Maximum infusion rate: 1.1 mg/min; a programmable syringe pump or infusion pump is recommended for accurate delivery of the calculated volume
For pediatric patients, the volume of infusion solution varies depending on the patient's body weight. The reconstituted solution must be further diluted to a final concentration of 0.77 mg/ml. Healthcare professionals will calculate the required volumes based on the child's weight using the following formulas:
- Volume of reconstituted anidulafungin (ml) = dose (mg) ÷ 3.33 mg/ml
- Total volume of dosing solution (ml) = dose (mg) ÷ 0.77 mg/ml
- Volume of diluent (ml) = total volume of dosing solution − volume of reconstituted anidulafungin
Pediatric pharmacokinetic studies have demonstrated that weight-based dosing at 3 mg/kg (loading) and 1.5 mg/kg (maintenance) achieves comparable drug exposure in children and adolescents to the standard 200/100 mg regimen in adults. The maximum absolute dose should not exceed the adult dose regardless of body weight.
Elderly Patients
No dose adjustment is required for elderly patients. Clinical studies of anidulafungin have included patients over 65 years of age, and no significant differences in safety or efficacy were observed compared to younger adults. However, elderly patients may have reduced hepatic and renal reserve, multiple comorbidities, and polypharmacy, so clinical response and tolerability should be monitored carefully throughout the treatment course.
Missed Dose
Because anidulafungin is administered in a hospital setting under direct medical supervision, it is highly unlikely that a dose would be missed. However, if a dose is inadvertently omitted due to scheduling issues or clinical circumstances, a double dose must not be given to compensate. Instead, the normal daily maintenance dose should be resumed as soon as possible, and the treating physician should be notified to determine if any adjustments to the treatment plan are necessary based on the clinical situation.
Overdose
In clinical trials, single doses of up to 400 mg of anidulafungin have been administered without dose-limiting toxicity or specific adverse events attributable to overdosage. There is no specific antidote for anidulafungin overdose. Anidulafungin is not dialyzable, meaning that neither intermittent hemodialysis nor continuous renal replacement therapy will effectively remove it from the body. In the event of an accidental overdose, treatment should be supportive and symptomatic, with close monitoring for adverse reactions and management of any symptoms as they arise. If you suspect an overdose or have any concerns, contact your healthcare team immediately.
Duration of Treatment
The duration of antifungal treatment for invasive candidiasis is individualized based on the patient's clinical and microbiological response. As a general guideline supported by both IDSA and ESCMID recommendations, treatment should continue for at least 14 days after the last positive blood culture for Candida and resolution of signs and symptoms of infection. Your physician will arrange follow-up blood cultures (typically every 48 hours until clearance) and clinical assessments to determine when it is safe to discontinue intravenous therapy.
After clinical stabilization and documented clearance of candidemia, your doctor may prescribe an oral antifungal agent such as fluconazole as step-down therapy to complete the treatment course on an outpatient basis. This approach reduces hospital stay while maintaining effective antifungal coverage. Step-down therapy is generally appropriate when the patient is clinically improving, is able to tolerate oral medications, and has a Candida species that is susceptible to azole antifungals.
What Are the Side Effects of Anidulafungin Sandoz?
Like all medications, anidulafungin can cause side effects, although not everyone experiences them. The most common side effects are low potassium levels (hypokalemia), diarrhea, and nausea. Serious but rare side effects include life-threatening allergic reactions and significant liver abnormalities.
Side effects observed during clinical trials and post-marketing surveillance are categorized below by frequency according to the MedDRA (Medical Dictionary for Regulatory Activities) convention. It is important to note that many of the reported side effects occurred in critically ill patients with multiple underlying conditions, serious infections, and numerous concurrent medications, making it challenging to attribute specific adverse events solely to anidulafungin. In the pivotal clinical trial comparing anidulafungin to fluconazole for candidemia, the overall adverse event profile was comparable between the two treatment groups.
Seizures, severe difficulty breathing, wheezing, sudden widespread rash or hives, swelling of the face, lips, tongue, or throat, chest tightness, rapid heartbeat, or signs of a severe allergic reaction (anaphylaxis). These symptoms may indicate a life-threatening reaction that requires emergency treatment with epinephrine and cardiopulmonary support.
Very Common Side Effects
- Low potassium levels in the blood (hypokalemia)
- Diarrhea
- Nausea
Common Side Effects
- Seizures (convulsions)
- Headache
- Vomiting
- Elevated liver function tests (transaminases ALT/AST, alkaline phosphatase, GGT)
- Elevated bilirubin levels
- Skin rash, itching (pruritus)
- Abnormal kidney function tests (elevated creatinine)
- Cholestasis (abnormal bile flow from gallbladder to intestine)
- High blood sugar (hyperglycemia)
- High blood pressure (hypertension)
- Low blood pressure (hypotension)
- Bronchospasm (tightening of airway muscles causing wheezing and cough)
- Dyspnea (difficulty breathing or shortness of breath)
Uncommon Side Effects
- Coagulopathy (blood clotting disorders)
- Flushing (redness and warmth of the face and neck)
- Hot flush
- Abdominal pain (stomach pain, upper or lower)
- Urticaria (hives, raised itchy welts on the skin)
- Pain, redness, or swelling at the injection/infusion site
- Back pain
Rare / Frequency Not Known
- Life-threatening allergic reactions (anaphylaxis), which may include severe breathing difficulties with wheezing, angioedema, or worsening of an existing rash
- Hepatocellular damage (in very rare cases, severe liver injury)
If you experience any side effects, including those not listed above, talk to your doctor, pharmacist, or nurse promptly. Side effects can also be reported directly to national pharmacovigilance authorities, including the FDA MedWatch program in the United States, the Yellow Card Scheme in the United Kingdom, the European Medicines Agency (EMA) adverse reaction reporting system, or your country's corresponding regulatory body. Reporting side effects helps regulatory agencies continuously monitor the benefit-risk balance of medicines and identify previously unrecognized safety signals.
Patients receiving anidulafungin are typically critically ill with serious underlying conditions such as hematological malignancies, solid organ transplants, major surgery, or ICU admission. Many reported side effects may be attributable to the underlying disease process, concurrent medications (e.g., chemotherapy, immunosuppressants, antibiotics), or the intensive care environment rather than to anidulafungin itself. In the pivotal randomized controlled trial (Reboli et al., NEJM 2007), the overall safety profile of anidulafungin was comparable to that of fluconazole, with no significant differences in the rate of drug-related adverse events.
How Should You Store Anidulafungin Sandoz?
Unopened vials of Anidulafungin Sandoz should be stored in a refrigerator at 2–8°C. After reconstitution, the concentrate may be stored at up to 25°C for up to 24 hours. The final diluted infusion solution may be stored at room temperature (25°C) for up to 48 hours and must not be frozen.
Proper storage of anidulafungin is critical to ensuring the chemical stability, sterility, and therapeutic efficacy of the medication. As Anidulafungin Sandoz is prepared and administered in a hospital pharmacy or clinical setting, storage conditions are managed by trained healthcare professionals. However, understanding the general storage requirements is important for ensuring product quality throughout the preparation and administration process.
- Unopened vials: Store in a refrigerator at 2–8°C (36–46°F). Keep in the original carton to protect from light. Keep out of the reach and sight of children.
- Reconstituted concentrate: After reconstitution with water for injection, the concentrate (3.33 mg/ml) may be stored at up to 25°C (77°F) for up to 24 hours before further dilution. From a microbiological standpoint, it should ideally be used immediately to minimize the risk of microbial contamination.
- Final infusion solution: After dilution to the final concentration (0.77 mg/ml for pediatric patients or approximately 0.77 mg/ml for adults), the solution may be stored at 25°C (room temperature) for up to 48 hours, or in a refrigerator at 2–8°C for up to 48 hours. Must not be frozen at any stage.
- Do not use after the expiration date printed on the label and carton. The expiration date refers to the last day of the stated month.
- Visual inspection: Inspect the reconstituted and diluted solutions for particulate matter and discoloration before administration. The solution should be clear and free of visible particles. If particles or discoloration are observed, the solution should be discarded.
- Disposal: Do not dispose of medications via wastewater or household waste. Return unused medication or waste material to a pharmacy or healthcare facility for proper disposal according to local environmental regulations.
From a microbiological perspective, if the product is not used immediately after reconstitution or dilution, in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C unless reconstitution and dilution have been performed under controlled and validated aseptic conditions in a pharmaceutical isolator or laminar flow hood.
What Does Anidulafungin Sandoz Contain?
Each vial of Anidulafungin Sandoz contains 100 mg of anidulafungin as the active substance. The reconstituted solution has a concentration of 3.33 mg/ml, and the final diluted infusion solution has a concentration of approximately 0.77 mg/ml. Excipients include fructose, mannitol, polysorbate 80, lactic acid, sodium hydroxide, and hydrochloric acid.
Active Ingredient
The active substance is anidulafungin, a semi-synthetic echinocandin lipopeptide. Anidulafungin is produced by chemical modification of echinocandin B&sub0;, a natural fermentation product of the filamentous fungus Aspergillus nidulans. The chemical modification involves the addition of an alkoxytriphenyl side chain to the cyclic hexapeptide core, which enhances antifungal potency and pharmacokinetic properties. Each vial contains 100 mg of anidulafungin as a white to off-white lyophilized (freeze-dried) powder or cake.
Anidulafungin has a molecular weight of approximately 1140.3 g/mol and is practically insoluble in water. The lyophilized formulation allows for reconstitution with water for injection to produce a clear solution suitable for further dilution and intravenous administration. The drug has a prolonged elimination half-life of approximately 24 hours, which supports once-daily dosing and maintains consistent plasma concentrations throughout the treatment period.
Inactive Ingredients (Excipients)
- Fructose — used as a cryoprotectant and bulking agent in the lyophilized formulation (see warnings regarding hereditary fructose intolerance)
- Mannitol — a sugar alcohol used as a bulking agent and tonicity modifier in the lyophilized cake
- Polysorbate 80 — a non-ionic surfactant that aids in solubilization of anidulafungin during reconstitution
- Lactic acid — used for pH adjustment of the reconstituted solution
- Sodium hydroxide — used for pH adjustment to achieve the target pH range
- Hydrochloric acid — used for pH adjustment as needed during manufacture
Packaging and Appearance
Anidulafungin Sandoz is supplied as a single glass vial containing 100 mg of powder for concentrate for solution for infusion, packaged in a cardboard carton. The powder appears as a white to off-white lyophilized cake or powder. The glass vial is sealed with a bromobutyl rubber stopper and an aluminum flip-off cap. The product is for single use only; any unused portion of the reconstituted or diluted solution should be discarded and not saved for later administration. Any unused medicinal product or waste material should be disposed of in accordance with local requirements for the handling of pharmaceutical waste.
Frequently Asked Questions About Anidulafungin Sandoz
Anidulafungin Sandoz is used to treat invasive candidiasis, a serious fungal infection caused by Candida species that affects the bloodstream (candidemia) and/or internal organs such as the liver, spleen, and kidneys. It is approved for adult patients and pediatric patients aged 1 month to under 18 years. It belongs to the echinocandin class of antifungals, which are recommended as first-line therapy by international infectious disease guidelines from IDSA and ESCMID.
Anidulafungin Sandoz is given as a slow intravenous (IV) infusion, meaning it is dripped into a vein over a specified period of time. For adults, the loading dose (200 mg) is infused over at least 3 hours, and the daily maintenance dose (100 mg) is infused over at least 90 minutes. The infusion rate must not exceed 1.1 mg/min to minimize the risk of infusion-related reactions such as flushing, rash, and bronchospasm. The drug is always prepared and administered by healthcare professionals in a hospital or clinical setting.
The most common side effects (affecting more than 1 in 10 patients) include low potassium levels in the blood (hypokalemia), diarrhea, and nausea. Common side effects (up to 1 in 10 patients) include headache, vomiting, elevated liver enzymes, rash, and changes in kidney function tests. Serious but rare reactions include life-threatening allergic reactions (anaphylaxis). Many reported side effects may also be related to the patient's underlying critical illness rather than the medication itself.
Anidulafungin is not recommended during pregnancy because its effects on the developing fetus have not been adequately studied in humans. Women of childbearing potential should use effective contraception during treatment. If you become pregnant while receiving anidulafungin, contact your doctor immediately. The safety of anidulafungin during breastfeeding is also unknown, so a decision must be made about whether to stop breastfeeding or discontinue the medication, weighing the benefits of each for mother and child.
Anidulafungin has very few drug interactions compared to many other antifungal agents. Because it is not metabolized by liver enzymes (cytochrome P450 system) and instead undergoes slow chemical degradation, it does not significantly interact with most commonly used medications. Clinical studies have confirmed no significant interactions with cyclosporine, tacrolimus, voriconazole, or rifampin. However, always inform your healthcare team about all medications, supplements, and herbal products you are taking.
Anidulafungin Sandoz is a generic version of the originator product ECALTA (originally developed by Pfizer). Both products contain the same active substance (anidulafungin 100 mg), the same pharmaceutical form (powder for concentrate for solution for infusion), and have demonstrated bioequivalence through rigorous regulatory evaluation. This means patients can expect the same therapeutic efficacy and safety profile from Anidulafungin Sandoz as from ECALTA. The choice between brands is typically based on hospital formulary decisions, pricing, and availability in a given market.
References
- European Medicines Agency (EMA). Summary of Product Characteristics: Ecalta (anidulafungin). Last updated 2024. Available at: ema.europa.eu/en/medicines/human/EPAR/ecalta
- 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. Clin Infect Dis. 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. Clin Microbiol Infect. 2012;18(Suppl 7):19–37. doi:10.1111/1469-0691.12039
- Reboli AC, Rotstein C, Pappas PG, et al. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007;356(24):2472–2482. doi:10.1056/NEJMoa066906
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Available at: who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
- Denning DW. Echinocandin antifungal drugs. Lancet. 2003;362(9390):1142–1151. doi:10.1016/S0140-6736(03)14472-8
- British National Formulary (BNF). Anidulafungin. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
- Vazquez JA, Sobel JD. Anidulafungin: a novel echinocandin. Clin Infect Dis. 2006;43(2):215–222. doi:10.1086/505204
- Andes DR, Safdar N, Baddley JW, et al. Impact of treatment strategy on outcomes in patients with candidemia and other forms of invasive candidiasis. Clin Infect Dis. 2012;54(8):1110–1122. doi:10.1093/cid/cis021
- European Medicines Agency (EMA). Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1. 2010. Available at: ema.europa.eu
About This Article
This drug information article has been written and reviewed by the iMedic Medical Editorial Team, a team of licensed specialist physicians with expertise in infectious disease, clinical pharmacology, and internal medicine. All medical content follows the GRADE evidence framework and is based on international clinical guidelines and peer-reviewed research published in leading medical journals.
Medical Writing
iMedic Medical Editorial Team
Specialists in Infectious Disease & Clinical Pharmacology
Medical Review
iMedic Medical Review Board
Independent review according to IDSA, ESCMID & WHO guidelines
Evidence Level
Level 1A — Systematic reviews and meta-analyses of RCTs
GRADE evidence framework
Last Reviewed
Next review scheduled within 12 months