Anidulafungin Reig Jofre
Echinocandin antifungal for intravenous infusion — treatment of invasive candidiasis in adults
Anidulafungin Reig Jofre is a prescription echinocandin antifungal medication administered by intravenous infusion for the treatment of invasive candidiasis in adult patients. It works by inhibiting the synthesis of 1,3-beta-D-glucan, a critical component of the fungal cell wall, providing broad-spectrum activity against Candida species. This medication is used exclusively in hospital settings under medical supervision.
Quick Facts
Key Takeaways
- Anidulafungin is an echinocandin antifungal that works by inhibiting fungal cell wall synthesis, making it effective against most Candida species.
- It is administered exclusively by slow intravenous infusion in hospital settings — the standard regimen is a 200 mg loading dose on day 1, followed by 100 mg daily.
- Unlike azole antifungals, anidulafungin has minimal drug interactions because it undergoes chemical degradation rather than hepatic metabolism via cytochrome P450 enzymes.
- Common side effects include diarrhea, elevated liver enzymes, nausea, and infusion-related reactions — liver function should be monitored during treatment.
- Treatment duration is typically at least 14 days after the last positive blood culture for candidemia, with the treating physician determining the optimal duration.
What Is Anidulafungin Reig Jofre and What Is It Used For?
Quick Answer: Anidulafungin Reig Jofre is an intravenous echinocandin antifungal medication used to treat invasive candidiasis, including candidemia (bloodstream infections caused by Candida fungi) and esophageal candidiasis in adult patients.
Anidulafungin Reig Jofre belongs to the echinocandin class of antifungal medications, which are considered first-line therapy for invasive candidiasis according to international guidelines from the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). The medication contains the active substance anidulafungin, a semi-synthetic lipopeptide compound that was originally derived from a fermentation product of Aspergillus nidulans.
The primary mechanism of action of anidulafungin involves the non-competitive inhibition of 1,3-beta-D-glucan synthase, an enzyme that is essential for the synthesis of the fungal cell wall. Beta-glucan is a major structural polysaccharide that provides rigidity and integrity to the fungal cell wall. By inhibiting its production, anidulafungin disrupts the structural framework of the fungal cell, leading to osmotic instability, cell lysis, and ultimately fungal cell death. This mechanism is highly selective because mammalian cells do not contain beta-glucan, which contributes to the favorable safety profile of echinocandins compared to other antifungal classes.
Anidulafungin demonstrates potent fungicidal activity against most clinically relevant Candida species, including Candida albicans, Candida glabrata, Candida tropicalis, Candida krusei, and Candida parapsilosis. It also shows fungistatic activity against certain Aspergillus species, although it is not approved for the treatment of aspergillosis. The European Medicines Agency (EMA) has approved anidulafungin for the treatment of invasive candidiasis in adult non-neutropenic patients, while the U.S. Food and Drug Administration (FDA) has approved it for candidemia and other forms of Candida infections including esophageal candidiasis.
Invasive candidiasis represents a serious and potentially life-threatening fungal infection that predominantly affects hospitalized patients, particularly those in intensive care units, patients who have undergone major surgery, those with central venous catheters, individuals receiving broad-spectrum antibiotics, and immunocompromised patients. Without appropriate antifungal treatment, invasive candidiasis carries a mortality rate of approximately 40–60%, underscoring the critical importance of timely and effective therapy.
Echinocandins, including anidulafungin, are recommended as first-line empirical therapy for invasive candidiasis by both the IDSA (2016 Clinical Practice Guidelines) and ESCMID (2022 Guidelines). This recommendation is based on their broad-spectrum activity against Candida species, favorable safety profile, and demonstrated efficacy in randomized controlled trials.
What Should You Know Before Receiving Anidulafungin Reig Jofre?
Quick Answer: Anidulafungin Reig Jofre should not be used if you are allergic to anidulafungin, other echinocandins, or any of the excipients. Inform your physician about all medications you take, any liver disease, and if you are pregnant or breastfeeding.
Contraindications
Anidulafungin Reig Jofre is contraindicated in patients with known hypersensitivity to anidulafungin, to any other echinocandin antifungal (such as caspofungin or micafungin), or to any of the excipients contained in the formulation. Patients who have previously experienced anaphylaxis or severe allergic reactions to echinocandin-class antifungals should not receive this medication under any circumstances.
While cross-reactivity between different echinocandins has been reported rarely, healthcare providers should exercise caution when considering anidulafungin for patients who have had adverse reactions to other members of this drug class. A thorough medication history should be obtained before initiating treatment, and the patient should be closely monitored during the first infusion for any signs of hypersensitivity.
Warnings and Precautions
Several important warnings and precautions should be considered before and during treatment with anidulafungin:
- Hepatic effects: Elevated liver enzymes (ALT, AST, alkaline phosphatase) and bilirubin have been reported during treatment. In some cases, clinically significant hepatic abnormalities, including hepatitis and hepatic failure, have occurred. Liver function tests should be performed at baseline and monitored periodically during treatment. If abnormal liver tests develop, the benefit-risk balance of continuing therapy should be carefully reassessed.
- Infusion-related reactions: Infusion-related adverse events including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension have been reported. These reactions are more likely to occur when the infusion rate exceeds the recommended maximum of 1.1 mg/min. If infusion-related reactions occur, the infusion should be slowed or temporarily interrupted.
- Anaphylaxis: Anaphylactic reactions, including anaphylactic shock, have been reported rarely with echinocandin use. If such a reaction occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated.
- Hereditary fructose intolerance: The reconstituted solution contains fructose. Patients with hereditary fructose intolerance should not receive this medication as it may cause serious adverse reactions.
Pregnancy and Breastfeeding
The use of anidulafungin during pregnancy has not been adequately studied in humans. Animal reproductive toxicity studies have shown that anidulafungin crosses the placental barrier and, at high doses, has been associated with skeletal developmental effects in animals. However, the relevance of these findings to human pregnancy is uncertain. Anidulafungin should only be used during pregnancy when the severity of the invasive fungal infection clearly justifies the potential risk to the fetus, and when no safer alternative antifungal therapy is available.
It is not known whether anidulafungin is excreted in human breast milk. In animal studies, the drug was detected in breast milk at concentrations similar to plasma levels. Given the potential for adverse effects in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue treatment, taking into account the importance of the medication to the mother. In most cases, breastfeeding is not recommended during anidulafungin therapy.
If you experience sudden shortness of breath, facial swelling, rash with itching, drop in blood pressure, or difficulty swallowing during the infusion, alert medical staff immediately. These may be signs of a serious allergic reaction requiring immediate treatment.
How Does Anidulafungin Reig Jofre Interact with Other Drugs?
Quick Answer: Anidulafungin has a favorable drug interaction profile compared to other antifungals because it is not metabolized by cytochrome P450 enzymes. However, some interactions may occur, particularly with cyclosporine, and caution is advised when combining it with other hepatotoxic medications.
One of the key pharmacological advantages of anidulafungin over other antifungal classes, particularly the azoles (fluconazole, voriconazole, posaconazole, itraconazole), is its minimal potential for drug-drug interactions. Unlike azole antifungals, which are substrates and inhibitors of cytochrome P450 enzymes, anidulafungin undergoes slow chemical degradation at physiological temperature and pH rather than enzymatic hepatic metabolism. This unique elimination pathway means that anidulafungin does not significantly inhibit or induce CYP450 enzymes, nor is it a substrate for P-glycoprotein transport.
Despite this favorable profile, healthcare providers should be aware of certain interactions that have been documented or are theoretically possible. Clinical pharmacokinetic studies have evaluated the interaction potential of anidulafungin with several commonly co-administered medications in critically ill patients.
Documented Interactions
| Drug | Interaction Type | Clinical Effect | Recommendation |
|---|---|---|---|
| Cyclosporine | Pharmacokinetic | 22% increase in anidulafungin AUC; no significant change in cyclosporine levels | No dose adjustment required; monitor for anidulafungin-related adverse effects |
| Tacrolimus | Minimal | No clinically significant pharmacokinetic interaction observed | No dose adjustment required |
| Voriconazole | Minimal | No clinically significant pharmacokinetic interaction; combination therapy may be used | No dose adjustment required; additive hepatotoxicity risk |
| Amphotericin B | Pharmacodynamic | Potential additive antifungal activity but also additive toxicity risk | Combination use generally not recommended; monitor renal and hepatic function |
| Rifampin | Minimal | No significant effect on anidulafungin pharmacokinetics (not CYP-metabolized) | No dose adjustment required |
| Liposomal Amphotericin B | Pharmacodynamic | Potential additive nephrotoxicity and hepatotoxicity | Use with caution; monitor renal and hepatic function closely |
Hepatotoxic Medications
While anidulafungin itself has a relatively low incidence of hepatotoxicity, caution is warranted when combining it with other medications known to affect liver function. Patients receiving concomitant hepatotoxic drugs such as acetaminophen (paracetamol) at high doses, methotrexate, isoniazid, certain statins, or other antifungal agents should have liver function tests monitored more frequently. The combination of anidulafungin with azole antifungals, while pharmacokinetically non-interacting, may result in additive hepatic effects that require vigilance.
It is important for patients to inform their healthcare provider about all medications they are currently taking, including prescription drugs, over-the-counter medications, herbal supplements, and nutritional supplements. Although anidulafungin has fewer drug interactions than many other antifungal agents, a comprehensive medication review ensures the safest possible treatment approach.
What Is the Correct Dosage of Anidulafungin Reig Jofre?
Quick Answer: For invasive candidiasis and candidemia, the standard adult dose is a 200 mg intravenous loading dose on day 1, followed by 100 mg once daily thereafter. For esophageal candidiasis, the loading dose is 100 mg on day 1, followed by 50 mg once daily.
Adults
The dosage of anidulafungin varies depending on the type and severity of the fungal infection being treated. All doses are administered as a slow intravenous infusion at a maximum rate of 1.1 mg/min to minimize the risk of infusion-related adverse effects. The medication must be reconstituted and diluted before administration, and the resulting solution should be used within 24 hours when stored at room temperature.
| Indication | Loading Dose (Day 1) | Maintenance Dose | Minimum Duration | Infusion Rate |
|---|---|---|---|---|
| Invasive candidiasis / Candidemia | 200 mg IV | 100 mg IV once daily | 14 days after last positive blood culture | Max 1.1 mg/min (~3 hours for 200 mg) |
| Esophageal candidiasis | 100 mg IV | 50 mg IV once daily | 14–21 days | Max 1.1 mg/min (~1.5 hours for 100 mg) |
Children
Anidulafungin Reig Jofre is not approved for use in pediatric patients. The safety and efficacy of anidulafungin in children and adolescents under 18 years of age have not been established through adequate controlled clinical trials. Pediatric studies have been conducted with limited data suggesting potential weight-based dosing, but no official pediatric dosing recommendations exist. For pediatric patients requiring echinocandin therapy, alternative agents such as caspofungin or micafungin, which have established pediatric dosing guidelines, should be considered.
Elderly
No dose adjustment is required for elderly patients. Clinical studies have included patients over 65 years of age, and pharmacokinetic analyses have not shown clinically significant differences in drug exposure between elderly and younger adult patients. However, elderly patients may be more susceptible to adverse effects, particularly hepatic effects, and should be monitored accordingly. Renal impairment, which is more common in elderly patients, does not require dose adjustment as anidulafungin is not significantly eliminated by the kidneys.
Renal and Hepatic Impairment
No dose adjustment is necessary for patients with any degree of renal impairment, including those undergoing dialysis. Anidulafungin is not dialyzable and is not significantly eliminated through renal pathways. Similarly, no dose adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class A or B). However, anidulafungin has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), and caution is advised in this population.
Missed Dose
Since anidulafungin is administered in a hospital setting by healthcare professionals, missed doses are uncommon. If a dose is inadvertently missed, it should be administered as soon as possible. The loading dose should not be repeated; instead, the standard maintenance dose should be given and the regular dosing schedule resumed. There is no need to double the dose to compensate for a missed infusion.
Overdose
There is no specific antidote for anidulafungin overdose. In clinical studies, single doses of up to 400 mg have been administered without dose-limiting toxicity. The maximum daily dose that has been safely administered is 400 mg. In the event of accidental overdose, treatment should be supportive and symptomatic. Anidulafungin is not removed by hemodialysis, so dialysis would not be beneficial in managing an overdose situation. Healthcare providers should monitor liver function, renal function, and electrolytes closely following any suspected overdose.
Each 100 mg vial of Anidulafungin Reig Jofre must be reconstituted with 30 mL of water for injections, then further diluted with 5% dextrose or 0.9% sodium chloride to a final concentration of 0.77 mg/mL. The reconstituted and diluted solution should be administered within 24 hours at room temperature. Do not use if the solution is cloudy or contains particulate matter.
What Are the Side Effects of Anidulafungin Reig Jofre?
Quick Answer: The most common side effects of anidulafungin include diarrhea, elevated liver enzymes, nausea, and infusion-related reactions (flushing, rash, pruritus). Serious but rare side effects include hepatotoxicity, anaphylaxis, and coagulopathy. Most side effects are mild to moderate in severity.
Like all medications, anidulafungin can cause side effects, although not everyone will experience them. The adverse reaction profile of anidulafungin has been established through multiple clinical trials involving over 900 patients with invasive candidiasis and esophageal candidiasis. Overall, anidulafungin is well-tolerated compared to other antifungal agents, with a safety profile that is generally favorable for critically ill patients.
The following side effects have been reported during clinical trials and post-marketing surveillance. They are classified according to their frequency of occurrence using the standard international convention:
Very Common
Affects more than 1 in 10 patients (>10%)
- Diarrhea
- Hypokalemia (low potassium levels)
Common
Affects 1 to 10 in 100 patients (1–10%)
- Nausea and vomiting
- Elevated liver enzymes (ALT, AST, alkaline phosphatase)
- Elevated bilirubin
- Infusion-related reactions (flushing, rash, pruritus, urticaria)
- Headache
- Coagulopathy (abnormal blood clotting)
- Hyperglycemia (elevated blood sugar)
- Hypomagnesemia (low magnesium levels)
- Abdominal pain
- Fever (pyrexia)
Uncommon
Affects 1 to 10 in 1,000 patients (0.1–1%)
- Hepatotoxicity (liver damage)
- Seizures
- Hot flush
- Bronchospasm
- Dyspnea (shortness of breath)
- Cholestasis (impaired bile flow)
- Upper abdominal pain
- Injection site pain or erythema
Rare
Affects fewer than 1 in 1,000 patients (<0.1%)
- Anaphylactic shock
- Hepatic failure
- Stevens-Johnson syndrome (suspected, post-marketing reports)
- Disseminated intravascular coagulation (DIC)
The hepatic effects of anidulafungin deserve particular attention. While mild elevations in liver transaminases are relatively common and often transient, clinically significant hepatotoxicity has been reported in post-marketing surveillance. Patients should have baseline liver function tests performed before starting treatment, with regular monitoring throughout the course of therapy. If liver enzymes rise to more than three times the upper limit of normal, the treating physician should carefully evaluate whether to continue treatment, considering the severity of the underlying infection and the availability of alternative antifungal agents.
Infusion-related reactions can often be managed by reducing the infusion rate. The recommended maximum infusion rate of 1.1 mg/min should be strictly adhered to, as faster infusion rates have been associated with a higher incidence of histamine-mediated reactions including flushing, rash, and in rare cases, bronchospasm or hypotension. If a patient experiences an infusion-related reaction, the infusion should be slowed and symptomatic treatment with antihistamines or corticosteroids may be considered.
Contact medical staff immediately if you experience: severe skin reactions (widespread rash, blistering, peeling skin), signs of liver problems (yellowing of skin or eyes, dark urine, severe upper abdominal pain), signs of a severe allergic reaction (difficulty breathing, swelling of face or throat, rapid heartbeat, severe dizziness), or unusual bleeding or bruising.
How Should You Store Anidulafungin Reig Jofre?
Quick Answer: Unopened vials should be stored in a refrigerator (2–8°C). After reconstitution, the solution can be stored for up to 24 hours at room temperature (25°C). The diluted infusion solution should be used within 24 hours at room temperature.
Proper storage of Anidulafungin Reig Jofre is essential to maintain its stability, efficacy, and safety. Since this medication is handled exclusively by healthcare professionals in hospital pharmacies and clinical settings, storage conditions are typically managed by trained personnel. However, understanding the storage requirements is important for ensuring optimal treatment outcomes.
Unopened vials of Anidulafungin Reig Jofre powder for concentrate should be stored in a refrigerator at 2–8°C (36–46°F). The vials should be kept in the original carton to protect from light. Do not freeze the powder. The product has a shelf life as indicated on the packaging, and should not be used after the expiration date.
After reconstitution with water for injections, the concentrate solution may be stored at 25°C (77°F) for up to 24 hours. The reconstituted solution should be clear and free of visible particulate matter. After further dilution with 5% dextrose or 0.9% sodium chloride to the final infusion concentration, the solution should also be used within 24 hours at room temperature. From a microbiological perspective, the diluted solution should be used immediately to minimize the risk of microbial contamination.
- Unopened vials: Store at 2–8°C in original packaging, protected from light
- Reconstituted concentrate: Stable for up to 24 hours at 25°C
- Diluted infusion solution: Use within 24 hours at room temperature
- Do not freeze at any stage of preparation
- Discard any unused solution — do not save for later use
What Does Anidulafungin Reig Jofre Contain?
Quick Answer: Each vial contains 100 mg of anidulafungin as the active substance, along with fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide, and hydrochloric acid as excipients. The product requires reconstitution and dilution before intravenous administration.
Understanding the composition of Anidulafungin Reig Jofre is important for identifying potential allergens and for patients with specific metabolic conditions. The following describes the complete formulation of the product:
Active substance: Each vial contains 100 mg of anidulafungin. Anidulafungin is a semi-synthetic echinocandin lipopeptide with the molecular formula C58H73N7O17 and a molecular weight of approximately 1140.3 daltons. The substance is a white to off-white powder that is practically insoluble in water but soluble in dimethyl sulfoxide.
Excipients (inactive ingredients):
- Fructose: Used as a bulking agent and cryoprotectant. Important consideration for patients with hereditary fructose intolerance, who should not receive this medication.
- Mannitol: A sugar alcohol used as a stabilizer and bulking agent in the lyophilized powder.
- Polysorbate 80: A non-ionic surfactant that aids in the solubilization of anidulafungin and ensures uniform reconstitution.
- Tartaric acid: Used as a pH adjuster to maintain the appropriate acidity of the reconstituted solution.
- Sodium hydroxide and/or hydrochloric acid: Used for final pH adjustment.
The reconstituted concentrate and the final diluted infusion solution do not contain preservatives. Therefore, aseptic technique must be maintained throughout the reconstitution and dilution process to prevent microbial contamination. The product is intended for single use only, and any unused portion should be discarded in accordance with local requirements for pharmaceutical waste disposal.
Frequently Asked Questions About Anidulafungin Reig Jofre
Anidulafungin Reig Jofre is used to treat invasive candidiasis in adult patients, including candidemia (Candida bloodstream infections) and esophageal candidiasis. It belongs to the echinocandin class of antifungal medications and is administered intravenously in hospital settings. It is considered a first-line treatment option for these serious fungal infections according to international medical guidelines.
Anidulafungin Reig Jofre is given as a slow intravenous infusion by healthcare professionals. The powder is first reconstituted with water for injections, then diluted further before infusion. The infusion rate must not exceed 1.1 mg/min to reduce the risk of infusion-related reactions. A typical infusion of the 200 mg loading dose takes approximately 3 hours, while the 100 mg maintenance dose takes approximately 1.5 hours.
The most common side effects include diarrhea, hypokalemia (low potassium), nausea, elevated liver enzymes, and infusion-related reactions such as flushing, rash, and pruritus. Most side effects are mild to moderate and manageable. Liver function should be monitored regularly during treatment. Serious side effects such as hepatic failure and anaphylaxis are rare.
Anidulafungin should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. There are no adequate studies in pregnant women, and animal studies have shown some developmental effects at high doses. Breastfeeding is generally not recommended during treatment, as the drug may pass into breast milk. Your physician will assess the risks and benefits in your specific situation.
Anidulafungin belongs to the echinocandin class, which works differently from azole antifungals (like fluconazole) and polyene antifungals (like amphotericin B). It inhibits fungal cell wall synthesis by targeting beta-glucan production. A key advantage is that it has very few drug interactions because it undergoes chemical degradation rather than liver enzyme metabolism. Within the echinocandin class, anidulafungin is unique in its elimination pathway and has demonstrated non-inferiority to fluconazole in clinical trials for invasive candidiasis.
Treatment duration depends on the infection type and clinical response. For invasive candidiasis and candidemia, treatment continues for at least 14 days after the last positive blood culture. For esophageal candidiasis, a typical course is 14 to 21 days. The physician determines when to stop treatment based on clinical improvement, microbiological clearance, and resolution of signs and symptoms. Premature discontinuation may lead to treatment failure or relapse.
References
This article is based on the following peer-reviewed sources and international medical guidelines:
- European Medicines Agency (EMA). Anidulafungin — Summary of Product Characteristics. EMA/CHMP Assessment Report. Available at: www.ema.europa.eu
- Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. 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.
- Reboli AC, Rotstein C, Pappas PG, et al. Anidulafungin versus fluconazole for invasive candidiasis. New England Journal of Medicine. 2007;356(24):2472-2482. doi:10.1056/NEJMoa066906
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: WHO; 2023.
- Andes DR, Safdar N, Baddley JW, et al. The epidemiology and outcomes of invasive Candida infections among organ transplant recipients in the United States. Transplant Infectious Disease. 2016;18(5):695-705.
- Chen SCA, Slavin MA, Sorrell TC. Echinocandin antifungal drugs in fungal infections: a comparison. Drugs. 2011;71(1):11-41.
- Vazquez JA, Sobel JD. Anidulafungin: a novel echinocandin. Clinical Infectious Diseases. 2006;43(2):215-222.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising specialists in infectious disease, clinical pharmacology, and critical care medicine.
iMedic Medical Editorial Team — specialists in infectious disease and clinical pharmacology with expertise in antifungal therapy and hospital-acquired infections.
iMedic Medical Review Board — independent panel of physicians who verify all medical content against current international guidelines (IDSA, ESCMID, EMA, FDA).
All content follows the iMedic Editorial Standards and is based on the GRADE evidence framework. This article contains no commercial funding or pharmaceutical company sponsorship.