pharmacopeia
GET
/api/v1/drug/anidulafungin

Mechanism of action

Sourced from openFDA

Anidulafungin is an anti-fungal drug [see Microbiology (12.4) ].

Glucan Synthase

Indications

Sourced from openFDA
  • ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1 ) • Esophageal candidiasis in adults ( 1.2 ) Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established.ICD-10: B37.9

Contraindications

Sourced from openFDA
  • ERAXIS is contraindicated in: • Patients with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins [see Warnings and Precautions (5.2) ] • Patients with known or suspected Hereditary Fructose Intolerance (HFI) [see Warnings and Precautions (5.4) ] • Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins ( 4 , 5.2 ) • Known or suspected Hereditary Fructose Intolerance (HFI) ( 4 , 5.4 )contraindicated

Dosage & administration

Sourced from openFDA

Adults Pediatric Patients 1 Month of Age and Older Candidemia and other forms of Candida infections 200 mg loading dose on Day 1, followed by 100 mg once daily maintenance dose thereafter for at least 14 days after the last positive culture ( 2.1 ) 3 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) once daily maintenance dose thereafter for at least 14 days after the last positive culture ( 2.2 ) Esophageal candidiasis 100 mg loading dose on Day 1, followed by 50 mg once daily maintenance dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms ( 2.1 ) Not Approved Rate of Infusion for Adults and Pediatric Patients The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions] ( 2.3 , 2.4 ) 2.1 Recommended Dosage in Adults Candidemia and other Candida infections (intra-abdominal abscess and peritonitis) The recommended dose is a single 200 mg loading dose of ERAXIS on Day 1, followed by a 100 mg once daily maintenance dose thereafter. Duration of treatment should be based on the patient's clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Esophageal Candidiasis The recommended dose is a single 100 mg loading dose of ERAXIS on Day 1, followed by a 50 mg once daily maintenance dose thereafter. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Warnings & precautions

Sourced from openFDA

• Hepatic Effects : Risk of abnormal liver tests, hepatitis, hepatic failure; monitor hepatic function during therapy. ( 5.1 , 13.2 ) • Hypersensitivity : Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute. ( 2.4 , 5.2 ) • Risk of Neonatal Toxicity Associated with Polysorbates : ERAXIS contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis haves been reported in low-birth weight infants receiving high doses of polysorbate. ERAXIS is not approved in pediatric patients younger than 1 month of age. ( 5.3 , 8.4 ) • Hereditary Fructose Intolerance (HFI) : ERAXIS contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before ERAXIS administration. ( 5.4 , 8.4 ) 5.1 Hepatic Adverse Reactions Laboratory abnormalities in liver tests have been seen in healthy volunteers and pediatric patients treated with ERAXIS. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with ERAXIS, clinically significant hepatic abnormalities have occurred.

Adverse reactions

Sourced from openFDA

The following most serious adverse reactions are described elsewhere in other labeling sections: • Hepatic Adverse Reactions [see Warnings and Precautions (5.1) ] • Anaphylactic and Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Adults • Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension. ( 6.1 ) • Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia. ( 6.1 ) Pediatric Patients (1 month and older) Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adults The safety of ERAXIS for Injection was assessed in 929 individuals, including 257 healthy subjects and 672 patients in clinical trials of candidemia, other forms of Candida infections, and esophageal candidiasis.

Use in specific populations

Sourced from openFDA

• Pregnancy : Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. Inform pregnant woman of the risk to the fetus. ( 8.1 ) • Pediatric Use : The safety and effectiveness in patients younger than 1 month of age has not been established. ( 8.4 ) 8.1 Pregnancy Risk Summary Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. There are no available human data on the use of ERAXIS in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies fetal toxicity was observed in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area ( see Data ) . Inform pregnant woman of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
General Pharmacokinetic Characteristics The pharmacokinetics of anidulafungin following intravenous (IV) administration of ERAXIS have been characterized in healthy subjects, special populations and patients. Systemic exposures of anidulafungin are dose-proportional and have low inter-subject variability (coefficient of variation <25%) as shown in Table 5.

Overdosage

Sourced from openFDA

During clinical trials a single 400 mg dose of ERAXIS was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 × ULN) [see Warnings and Precautions (5.1) ] . Anidulafungin is not dialyzable. The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.

Approval history

Sourced from openFDA
  • Feb 17, 2006NDANDA021632Vicuron Holdings

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,554 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective37624%
  2. 2Multiple Organ Dysfunction Syndrome17211%
  3. 3Off Label Use17211%
  4. 4Septic Shock1288.2%
  5. 5Sepsis1157.4%
  6. 6Pneumonia946.0%
  7. 7Candida Infection905.8%
  8. 8Pyrexia905.8%
  9. 9Death815.2%
  10. 10Neutropenia805.1%
  11. 11Renal Failure684.4%
  12. 12Respiratory Failure634.1%
  13. 13Condition Aggravated603.9%
  14. 14Drug Resistance583.7%
  15. 15Hypotension573.7%

Literature

View JSON

Recent PubMed references pinned to Anidulafungin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Anidulafungin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Anidulafungin work?
Anidulafungin is an anti-fungal drug [see Microbiology (12.4) ].
What is Anidulafungin used for?
According to FDA labeling, Anidulafungin carries indications including: ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1 ) • Esophageal candidiasis in adults ( 1.2 ) Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Anidulafungin?
Anidulafungin is classified as Other antimycotics for systemic use, Echinocandin Antifungal, Glucan Synthase Inhibitors, Decreased Cell Wall Integrity.
What are the brand names for Anidulafungin?
Anidulafungin is marketed under brand names including Eraxis.
What are the contraindications for Anidulafungin?
Anidulafungin labeling lists contraindications including: ERAXIS is contraindicated in: • Patients with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins [see Warnings and Precautions (5.2) ] • Patients with known or suspected Hereditary Fructose Intolerance (HFI) [see Warnings and Precautions (5.4) ] • Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins ( 4 , 5.2 ) • Known or suspected Hereditary Fructose Intolerance (HFI) ( 4 , 5.4 ). Always consult the full prescribing information and a clinician.
Note. Data for anidulafungin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients