The side-effect profiles of anidulafun-gin and its comparator, fluconazole, seem very similar (Table 4). In clinical studies, oral fluconazole canadian was associated with a higher incidence of hepatic ADEs than anidulafungin, although these differences are probably not clinically significant.
Rare histamine-mediated symptoms, such as rash, hypotension, urticaria, flushing, pruritus, and dyspnea, have been noted in studies. These symptoms occurred when the infusion rate did not exceed 1.1 mg/minute.
DOSAGE AND ADMINISTRATION
Anidulafungin should be administered by IV infusion at a rate not exceeding 1.1 mg/minute. Simulated Y-site compatibility studies have found that anidula-fungin is physically compatible for four hours at room temperature with 73 drugs, whereas amphotericin B (AmBisome, Fujisawa), ertapenem sodium (Ivanz for Injection, Merck), and sodium bicarbonate are not physically compatible with it. (When medications are known to be compatible, Y-site devices are used to allow multiple medications to be administered via the same IV port.)
Table 4 Incidence of Treatment-Related Adverse Events in Trials of Anidulafungin
|Candidemia or Other Candidal Infections||Esophageal Candidiasis|
|IV Anidulafungin||Oral Fluconazole generic||
|(n = 131) (%)||(n = 125) (%)||
(n = 300) (%)
|(n = 301) (%)|
|Blood and lymphatic disorders|
|• Dyspepsia aggravation||
|Central nervous system|
|• Deep vein thrombosis||0.8||2.4|
|• ALT increase||2.3||3.2||
|• AST increase||0.8||2.4||
|• Alkaline phosphatase increase||1.5||4.0|
|• Hepatic enzyme increase||1.5||7.2|
|• GGT increase||
|ALT = alanine transaminase; AST =||aspartate transaminase; GGT = gamma-glutamyl transferase.|
|Data from Eraxis prescribing information.|
Candidemia and Other Candidal Infections
The recommended dosage for patients with candidemia and other candidal infections (e.g., intra-abdominal abscess and peritonitis) is a loading dose of anidulafungin 200 mg IV on day one, followed by 100 mg IV daily.
The duration of therapy should be based on the patient’s response.
Anidulafungin has not been studied as therapy for endocarditis, osteomyelitis, or meningitis caused by Candida species, and it has not been studied in enough patients with neutropenia to determine its efficacy and safety in those patients. kamagra soft tabs
For patients with esophageal candi-diasis, a loading dose of anidulafungin 100 mg IV is given on day one, followed by 50 mg IV daily.
Patients should be treated for a minimum of 14 days and for at least seven days after symptoms resolve.
The efficacy and safety of anidulafun-gin have not been studied in children.
Hepatic or Renal Insufficiency
No dose adjustments of anidulafungin are required for patients with hepatic or renal insufficiency.
The 50-mg vial of anidulafungin lyoph-ilized powder should first be reconstituted with 15 ml of accompanying diluent of 20% w/w dehydrated alcohol in water for injection to a concentration of 3.33 mg/ml. The reconstituted solution should be transferred to an IV bag containing 5% dextrose injection or 0.9% sodium chloride injection to a final concentration of 0.5 mg/ml.
The lyophilized powder, reconstituted solution, and final dilution should be stored at room temperature (15°to 30°C).
Reconstituted vials should be used within 24 hours.
In vitro and in vivo studies have shown that anidulafungin is not a substrate, inhibitor, or inducer of CYP 450 isoenzymes (see Table 2, page 647). Less than 1% of anidulafungin is excreted in the urine. Therefore, drug interactions are not expected with this product.
A blinded, randomized, crossover study by Dowell et al. found no pharma-cokinetic interaction between IV anidula-fungin and oral voriconazole (Vfend, Pfizer). It was concluded that these two drugs may be given together safely without dose adjustments.
In an open-label study of healthy volunteers, multiple doses of oral cyclosporine were found to increase anidulafungin’s area-under-the curve concentration by 22%. However, this change was deemed to be small and clinically insignificant. Therefore, dose adjustments are not required when anidulafungin is administered concomitantly with oral cyclo-sporine.
CONTRAINDICATIONS AND PRECAUTIONS
Anidulafungin is contraindicated in patients with hypersensitivity to the drug, its formulation, or any other echinocandins.
Elevations in liver enzymes have been noted with anidulafungin in clinical studies. Patients with abnormal liver function test results during anidulafungin therapy should be monitored.
Anidulafungin, a member of the drug class of echinocandin antifungal agents, has activity against aspergillosis and candidal infections, including non-albi-cans species. Anidulafungin is approved for the treatment of candidemia, esoph-ageal candidiasis, and intra-abdominal abscess and peritonitis caused by Candida species.
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Because of the increase in the number of immunocompromised patients seen in health care settings, it is important to bring new antifungal therapies to market. Although anidulafungin is the second drug in the class of echinocandins, in vitro data from one large surveillance study involving C. albicans coverage indicates that it can offer an advantage over caspofungin.