Version May 2024
Candidiasis, treatment: Limited data available: IV: Initial: 3 mg/kg/dose once on day 1; on day 2 begin 1.5 mg/kg/dose once daily (Ref). Dosing based on a pharmacokinetic and safety study of 8 neonates (GA: 26 to 39 weeks; PNA: 2 to 28 days); anidulafungin was well-tolerated and doses resulted in exposures similar to or slightly lower than those observed in older pediatric patients and adults (Ref). Duration of therapy should be individualized based on clinical response and presence of deep foci; treat for a minimum of 14 days from the first negative blood culture for candidemia (Ref). Note: An experimental model indicates that dosage may be inadequate for CNS infections (Ref).
Aspergillosis, invasive (salvage therapy): Very limited data available: Infants, Children, and Adolescents: IV: Initial: 1.5 to 3 mg/kg/dose once on day 1; maximum initial dose: 200 mg/dose; on day 2 begin 0.75 to 1.5 mg/kg/dose once daily; maximum dose: 100 mg/dose. Duration of therapy should be individualized based on patient-specific factors including site of infection, immunosuppression, and response to therapy; minimum duration is 6 to 12 weeks (Ref): Note: Doses on the higher end of the provided range result in exposures similar to those observed in standard adult dose (Ref).
Candidemia; intra-abdominal or peritoneal candidiasis: Infants, Children, and Adolescents: IV: Initial: 3 mg/kg/dose once on day 1; maximum initial dose: 200 mg/dose; on day 2 begin 1.5 mg/kg/dose once daily; maximum dose: 100 mg/dose (Ref). Duration of therapy should be individualized (based on deep-tissue foci, clinical response, etc); candidemia should be treated for a minimum of 14 days from the first negative blood culture and resolution of symptoms (Ref).
Altered kidney function: Infants, Children, and Adolescents: IV:
Mild to severe impairment: No dosage adjustment necessary in patients with any degree of renal impairment.
Hemodialysis: No dosage adjustment necessary.
Infants, Children, and Adolescents: No dosage adjustment necessary in patients with any degree of hepatic impairment.
(For additional information see "Anidulafungin: Drug information")
Aspergillosis, invasive (including disseminated and extrapulmonary) (alternative agent) (off-label use):
Note: Reserve for salvage therapy, typically as part of an appropriate combination regimen. Monotherapy is further reserved for patients who are intolerant of or refractory to azoles and polyenes; for patients with severe or progressive infection, some experts use as initial therapy in combination with voriconazole (Ref).
IV: 200 mg on day 1, then 100 mg once daily (Ref).
Duration: When given as monotherapy, the minimum duration is 6 to 12 weeks depending on degree/duration of immunosuppression, disease site, and response to therapy (Ref); immunosuppressed patients may require more prolonged treatment (Ref). When given as part of a combination regimen, the optimal duration is uncertain. Some experts have given anidulafungin for ~2 weeks in combination with voriconazole before step-down to voriconazole monotherapy (Ref).
Candidiasis:
Candidemia (neutropenic and nonneutropenic patients), including disseminated candidiasis: IV: 200 mg on day 1, then 100 mg once daily. Total duration (including oral step-down therapy) is ≥14 days after first negative blood culture and continues until signs/symptoms of candidemia and neutropenia, if present, have resolved; metastatic complications warrant a longer duration (Ref).
Cardiac device infection (including implantable cardiac defibrillator, pacemaker, ventricular assist device) (off-label use) : IV: 200 mg once daily; step down to azole therapy in clinically stable patients with susceptible isolates and negative repeat cultures; total antifungal duration is ≥4 weeks after device removal for isolated generator pocket infection and ≥6 weeks after device removal for wire infection (Ref).
Chronic disseminated (hepatosplenic) (off-label use): IV: 200 mg on day 1, then 100 mg once daily for several weeks, followed by oral azole step-down therapy until lesion resolution and through periods of immunosuppression (Ref).
Empiric therapy, suspected invasive candidiasis (nonneutropenic ICU patients) (off-label use):
Note: Antifungal therapy is not routinely warranted for initial management of nonneutropenic patients with sepsis. Consider use for critically ill patients with unexplained fever or unexplained hypotension despite broad-spectrum antimicrobial therapy and risk factors for invasive candidiasis (eg, indwelling venous catheter, hemodialysis, trauma or burns, recent surgery, parenteral nutrition) (Ref).
IV: 200 mg on day 1, then 100 mg once daily. For those who improve, continue empiric antifungal therapy for 2 weeks; consider discontinuing after 4 to 5 days in patients with no evidence of invasive candidiasis and no clinical response (Ref).
Endocarditis, native or prosthetic valve (off-label use): IV: 200 mg once daily; step down to azole therapy in clinically stable patients with susceptible isolates and negative repeat cultures; total antifungal duration is ≥6 weeks after valve replacement surgery, with longer duration for perivalvular abscesses, other complications, or a nonsurgical approach (Ref).
Esophageal, refractory disease (alternative agent):
Note: Reserve for fluconazole-refractory disease in patients who require IV therapy (eg, severe disease) (Ref).
IV: 200 mg once daily (Ref). Transition to an oral antifungal once patient tolerates oral intake if susceptibility allows; total antifungal duration is 14 to 28 days (Ref).
Intra-abdominal infection (eg, peritonitis, abdominal abscess): IV: 200 mg on day 1, then 100 mg once daily. Total duration (including oral step-down therapy) is ≥14 days and continues until source control and clinical resolution (Ref).
Oropharyngeal, refractory disease (alternative therapy) (off-label use):
Note: Reserve for fluconazole-refractory disease in patients who require IV therapy (eg, severe disease) (Ref).
IV: 200 mg on day 1, then 100 mg once daily. Transition to an oral antifungal once patient tolerates oral intake if susceptibility allows; total antifungal duration is 14 to 28 days (Ref).
Osteoarticular infection (osteomyelitis or septic arthritis) (off-label use): IV: 200 mg on day 1, then 100 mg once daily for ≥2 weeks; total duration of therapy (including oral step-down therapy) is 6 to 12 months for osteomyelitis and ≥6 weeks for septic arthritis (Ref).
Thrombophlebitis, suppurative (off-label use): IV: 200 mg once daily; continue antifungal therapy until catheter removed and thrombus resolved, and for ≥2 weeks after candidemia (if present) has cleared (Ref).
Neutropenic fever, empiric antifungal therapy (alternative agent) (off-label use):
Note: Recommended for patients with persistent or recurrent fever after ≥4 days of antimicrobial therapy when the duration of neutropenia is expected to exceed 7 days (Ref). Some experts reserve for patients without suspicion for mold infection (eg, pulmonary nodules) (Ref).
IV: 200 mg on day 1, then 100 mg once daily (Ref).
Prophylaxis against invasive fungal infections (off-label use):
Hematologic malignancy or hematopoietic cell transplant (alternative agent):
Note: Some experts reserve for patients at low risk for mold infection (Ref).
IV: 200 mg on day 1, then 100 mg once daily. Duration is at least until resolution of neutropenia and varies based on degree and duration of immunosuppression (Ref).
Solid organ transplant (alternative agent): IV: 200 mg on day 1, then 100 mg once daily; duration varies based on patient risk factors and transplant center protocol (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment necessary for any degree of kidney impairment (Ref).
Hemodialysis, intermittent (thrice weekly): Not significantly dialyzed: No supplemental dose or dosage adjustment necessary (Ref).
Peritoneal dialysis: Unlikely to be dialyzed (highly protein bound): No dosage adjustment necessary (Ref).
CRRT: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).
No dosage adjustment necessary.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Hypotension (15%), hypertension (12%), peripheral edema (11%)
Central nervous system: Insomnia (15%)
Endocrine & metabolic: Hypokalemia (≤25%), hypomagnesemia (12%)
Gastrointestinal: Nausea (7% to 24%), diarrhea (9% to 18%), vomiting (7% to 18%)
Genitourinary: Urinary tract infection (15%)
Hepatic: Increased serum alkaline phosphatase (12%)
Infection: Bacteremia (18%)
Respiratory: Dyspnea (12%)
Miscellaneous: Fever (9% to 18%)
2% to 10%:
Cardiovascular: Deep vein thrombosis (10%), chest pain (5%)
Central nervous system: Confusion (8%), headache (8%), depression (6%)
Dermatologic: Decubitus ulcer (5%)
Endocrine & metabolic: Hypoglycemia (7%), dehydration (6%), hyperglycemia (6%), hyperkalemia (6%)
Gastrointestinal: Constipation (8%), dyspepsia (7%), abdominal pain (6%), oral candidiasis (5%)
Hematologic & oncologic: Anemia (8% to 9%), leukocytosis (5% to 8%), thrombocythemia (6%)
Hepatic: Increased serum transaminases (≤5%)
Infection: Sepsis (7%)
Neuromuscular & skeletal: Back pain (5%)
Renal: Increased serum creatinine (5%)
Respiratory: Pleural effusion (10%), cough (7%), pneumonia (6%), respiratory distress (6%)
<2%, postmarketing, and/or case reports: Anaphylactic shock, anaphylaxis, angioedema, atrial fibrillation, blood coagulation disorder, blurred vision, bronchospasm, cholestasis, clostridium infection, diaphoresis, dizziness, ECG abnormality (including ECG changes – prolonged QT interval), erythema, eye pain, flushing, hepatic insufficiency, hepatic necrosis, hepatitis, hot flash, increased amylase, increased blood urea nitrogen, increased creatine phosphokinase, increased gamma-glutamyl transferase, increased serum bilirubin, increased serum lipase, infusion related reaction, prolonged prothrombin time, pruritus, right bundle branch block, rigors, seizure, sinus arrhythmia, skin rash, thrombocytopenia, thrombophlebitis, urticaria, ventricular premature contractions, visual disturbance
Hypersensitivity to anidulafungin, other echinocandins, or any component of the formulation; known or suspected hereditary fructose intolerance.
Concerns related to adverse effects:
• Anaphylactic reactions: Severe hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock, have been reported; immediate treatment for hypersensitivity reactions should be available. Discontinue treatment immediately if reactions occur.
• Hepatic effects: Elevated LFTs, hepatitis, and hepatic failure have been reported; monitor for progressive hepatic impairment if increased transaminase enzymes noted.
• Infusion reactions: Infusion reactions (eg, bronchospasm, dyspnea, flushing, hypotension, pruritus, rash, urticaria) may occur; do not exceed recommended rate of infusion.
Special populations:
• Obesity: Data suggest that clearance increases as a function of body weight (Dowell 2004). Based on data from another echinocandin, higher doses may be necessary in patients with obesity (Hall 2011).
Dosage form specific issues:
• Fructose: Some dosage forms may contain fructose; may precipitate a metabolic crisis (eg, life-threatening hepatic failure, hypoglycemia, hypophosphatemia, lactic acidosis) in patients with hereditary fructose intolerance. Obtain history of hereditary fructose intolerance prior to therapy.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Eraxis: 50 mg (1 ea); 100 mg (1 ea) [contains polysorbate 80]
No
Solution (reconstituted) (Eraxis Intravenous)
50 mg (per each): $114.54
100 mg (per each): $229.07
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Eraxis: 100 mg (1 ea) [contains polysorbate 80]
Parenteral: IV: Infuse at ≤1.1 mg/minute (≤1.4 mL/minute or 84 mL/hour for concentration of 0.77 mg/mL). Do not concurrently infuse with other medications or electrolytes.
IV: For IV use only; infusion rate should not exceed 1.1 mg/minute (1.4 mL/minute or 84 mL/hour). Do not concurrently infuse with other medications or electrolytes.
Store intact vials at 2°C to 8°C (36°F to 46°F); excursions up to 25°C (77°F) are permitted for 96 hours, and the vial may be returned to storage at 2°C to 8°C (36°F to 46°F). Do not freeze. The reconstituted solution can be stored for up to 24 hours at temperatures up to 25°C (77°F) prior to dilution into the infusion solution (D5W or NS). The infusion solution may be stored for up to 48 hours at temperatures up to 25°C (77°F) prior to administration; do not freeze.
Treatment of candidemia and intra-abdominal or peritoneal candidiasis (FDA approved in ages ≥1 month and adults); treatment of esophageal candidiasis (FDA approved in adults); has also been used for treatment of invasive Aspergillosis.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination
Adverse effects were observed in animal reproduction studies. Other agents are currently preferred for the treatment of Candida infections in pregnant women (IDSA [Pappas 2016]).
Liver function tests; anaphylaxis or infusion-related reactions.
Noncompetitive inhibitor of 1,3-beta-D-glucan synthase resulting in reduced formation of 1,3-beta-D-glucan, an essential polysaccharide comprising 30% to 60% of Candida cell walls (absent in mammalian cells); decreased glucan content leads to osmotic instability and cellular lysis
Distribution: 30 to 50 L.
Protein binding: >99%.
Metabolism: No hepatic metabolism observed; undergoes slow chemical hydrolysis to open-ring peptide-lacking antifungal activity.
Half-life elimination: Terminal: 40 to 50 hours.
Excretion: Feces (30%, 10% as unchanged drug); urine (<1%).
Obesity: Data suggest that clearance increases as a function of body weight (Dowell 2004).
Pediatric: Concentrations and exposure in infants, children, and adolescents receiving a 3 mg/kg loading dose followed by a 1.5 mg/kg maintenance dose were similar to those observed in adults receiving a 200 mg loading dose followed by a 100 mg maintenance dose.
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