Eraxis treatment for esophageal candidiasis,yeast infection after episiotomy,chronic yeast infections in dogs,candidiasis systemic yeast - Plans Download
Author: admin, 01.02.2015Eraxis is indicated for use in adults for the treatment of the following fungal infections listed below.
Eraxis is indicated for the treatment of esophageal candidiasis [see Clinical Studies (14.2), Table 10 for higher relapse rates off Eraxis therapy]. Eraxis has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida, and has not been studied in sufficient numbers of neutropenic patients to determine efficacy in this group.
The recommended dose is a single 200 mg loading dose of Eraxis on Day 1, followed by 100 mg daily dose thereafter. The recommended dose is a single 100 mg loading dose of Eraxis on Day 1, followed by 50 mg daily dose thereafter.
Eraxis for Injection must be reconstituted with sterile Water for Injection and subsequently diluted only with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Eraxis is contraindicated in persons with known hypersensitivity to anidulafungin, any component of Eraxis, or other echinocandins. Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with Eraxis.
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. The data described below reflect exposure to Eraxis and fluconazole in 127 and 118 patients, respectively, with candidemia and other forms of invasive candidiasis, in the randomized, comparative trial of the efficacy and safety of Eraxis to that of fluconazole. Table 2 presents adverse reactions that were reported in ≥5% of subjects receiving Eraxis or fluconazole therapy in this trial. This trial was not designed to support comparative claims for Eraxis for the adverse reactions reported in this table. The data described below reflect exposure to Eraxis and fluconazole in 300 and 301 patients, respectively, with esophageal candidiasis in a randomized trial comparing the efficacy and safety of Eraxis to that of oral fluconazole.
Twenty eight (9%) patients in the Eraxis arm and 36 (12%) patients in the fluconazole arm had adverse reactions leading to discontinuation of study medication.
Table 3 presents adverse reactions that were reported in ≥5% of subjects receiving Eraxis therapy.
Dosage adjustments are not required for geriatric patients [see Clinical Pharmacology (12.4)].
Dosage adjustments are not required for patients with any degree of renal insufficiency including those on hemodialysis. During clinical trials a single 400 mg dose of Eraxis was inadvertently administered as a loading dose.
Eraxis for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin.
Eraxis (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N2-[[4"-(pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B. Prior to administration, Eraxis for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline). Anidulafungin minimal inhibitory concentrations (MICs) were determined for isolates of Candida spp. Echinocandin resistance is due to point mutations within the genes (FKS1 and FKS2) encoding for subunits in the glucan synthase enzyme complex. Anidulafungin was not genotoxic in the following in vitro studies: bacterial reverse mutation assays, a chromosome aberration assay with Chinese hamster ovary cells, and a forward gene mutation assay with mouse lymphoma cells.
Patients who received at least one dose of study medication and who had a positive culture for Candida species from a normally sterile site before entry into the study (modified intent-to-treat [MITT] population) were included in the analysis of global response at the end of IV therapy.
Two hundred and forty-five patients (127 Eraxis, 118 fluconazole) met the criteria for inclusion in the MITT population. 33 patients in each study arm (26% Eraxis and 29% fluconazole-treated) switched to oral fluconazole after the end of IV therapy. Table 9 presents global response by patients with candidemia or multiple sites of Candida infection and mortality data for the MITT population. Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. The compatibility of reconstituted Eraxis with intravenous substances, additives, or medications other than 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline) has not been established. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with Eraxis, clinically significant hepatic abnormalities have occurred. If these reactions occur, Eraxis should be discontinued and appropriate treatment administered [see Adverse Reactions (6.5)]. The most common adverse reactions leading to study drug discontinuation were multi-organ failure and systemic Candida infection in the Eraxis arm. The most common adverse reactions leading to study drug discontinuation were maculopapular rash for the Eraxis arm. Eraxis (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans.
There have been reports of Candida isolates with reduced susceptibility to anidulafungin, suggesting a potential for development of drug resistance.
For both species, hepatocellular hypertrophy was still noted one month after the end of dosing.
Patients were randomized to receive once daily IV Eraxis (200 mg loading dose followed by 100 mg maintenance dose) or IV fluconazole (800 mg loading dose followed by 400 mg maintenance dose).
A successful global response required clinical cure or improvement (significant, but incomplete resolution of signs and symptoms of the Candida infection and no additional antifungal treatment), and documented or presumed microbiological eradication.
In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported in patients; a causal relationship to Eraxis has not been established. Patients were randomized to receive IV Eraxis (100 mg on day 1, followed by 50 mg per day) or oral fluconazole (200 mg on day 1, followed by 100 mg per day) for 7 days beyond resolution of symptoms (range, 14–21 days). The most common adverse reactions leading to discontinuation were rash and increased AST for the fluconazole arm.
Because many drugs are excreted in human milk, caution should be exercised when Eraxis is administered to a nursing woman.
This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.
The median duration of IV therapy was 14 and 11 days in the Eraxis and fluconazole arms, respectively. Risk factors for candidemia among patients in both treatment arms in this study were: presence of a central venous catheter (78%), receipt of broad-spectrum antibiotics (69%), recent surgery (42%), recent hyperalimentation (25%), and underlying malignancy (22%). Because of the risk of relapse of esophageal candidiasis in patients with HIV infections, suppressive antifungal therapy may be considered after a course of treatment.
Because animal reproduction studies are not always predictive of human response, Eraxis should be used during pregnancy only if clearly needed. For those who received oral fluconazole, the median duration of oral therapy was 7 days for the Eraxis arm and 5 days for the fluconazole arm. Though a slight decrease in AUC was observed in patients with Child-Pugh C hepatic insufficiency, it was within the range of population estimates noted for healthy subjects [see Clinical Pharmacology (12.4)]. Though a slight decrease in AUC was observed in patients with Child-Pugh C hepatic insufficiency, it was within the range of population estimates noted for healthy subjects. Because of the potential for reduced susceptibility to anidulafungin, it is recommended that susceptibility be determined by a standardized method. Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medication, were afebrile for at least 24 hours, and the last blood cultures were negative for Candida species.
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