Eraxis for injection is a sterile, lyophilized product for intravenous iv infusion that contains anidulafungin. Anidulafungin inhibits 1,3 betadglucan synthase, an enzyme involved in fungal cell wall synthesis, resulting in cell lysis and death. Pdf micafungin versus anidulafungin in critically ill. Currently, the reconstitution instructions in the package insert indicate that 100 mg of anidulafungin powder is to be dissolved in 30 ml of sterile water for injection and this reconstituted solution is to be further mixed with 100 ml of either normal saline ns or dextrose 5% wv d5 to give a final infusion solution of concentration 0. In the study that evaluated the efficacy of caspofungin in the treatment of. The pharmacokinetics of intravenous anidulafungin in adult intensive care unit icu patients were assessed in this study and compared with historical data from a general patient population and healthy subjects. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. List of approved drug products containing anidulafungin in the fda orange book on. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Aseptically transfer the contents of the reconstituted vials into an iv bag or bottle containing either 9 mgml 0. Eraxis anidulafungin dosage and administration pfizer. Tell your doctor if you have ever had liver disease it is not known whether this medicine will harm an unborn baby. Micafungin versus anidulafungin in critically ill patients. Package insert for eraxis anidulafungin for injection anidulafungin undergoes slow chemical degradation at physiologic temperature and ph to a ringopened peptide that lacks antifungal activity.
The active substance in caspofungin accord, caspofungin, belongs to a group of antifungal medicines known as echinocandins. Echinocandins represent the newest class of antifungal agents. Easy to open with one hand simply remove strip with forceps or manual applicator device. Dglucan, an essential component of fungal cell walls. Simplify yeast susceptibility testing with the thermo scientific sensititre yeastone yo9 ast plate with nine antifungals, including amphotericin b and micafungin. Eliminate the time required to manage multiple protocols and increase productivity and efficiency by consolidating your antifungal susceptibility testing onto a single format with thermo scientific sensititre yeastone plates. Dglucan, an essential component of the fungal cell wall. Anidulafungin produced no adverse effects on fertility in male or female rats at intravenous doses of 20 mgkgday equivalent to 2 times the proposed therapeutic maintenance dose of 100 mgday on the basis of relative body surface area.
Echinocandins are recommended as initial treatment for invasive fungal infections. As the only fdacleared assay for micafungin susceptibility testing of. Eraxis fda prescribing information, side effects and uses. Anidulafungin fda orange book approved drug product. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Arava may cause fetal harm when administered to a pregnant woman. The in vitro degradation halflife of anidulafungin under physiologic conditions is about 24 hours. Eraxis anidulafungin side effects, images, uses, dosage. Bar codes included on the vial and carton for ease of scanning. Pharmacokinetics of anidulafungin in critically ill patients with. Anidulafungin is a cyclic lipopeptide echinocandin derivative with antifungal activity. Eraxis anidulafungin is a semisynthetic lipopeptide synthesized from a fermentation product of aspergillus nidulans. In 2006 a third echinocandin, anidulafungin, was approved in the usa for the treatment of candida.
Currently, three echinocandins, anidulafungin, caspofungin and micafungin are licensed for clinical use in various indications. What should i discuss with my health care provider before using anidulafungin eraxis. Anidulafungin vicuron pharmaceuticals is a new echinocandin antifungal with potent activity against aspergillus and candida spp. Stability of anidulafungin in concentrated pharmaceutical. Micafungin versus anidulafungin in critically ill patients with invasive candidiasis. Anidulafungin is not dialyzable and may be administered without regard to the timing of hemodialysis.
They have a broad spectrum of activity against all candida species. Pharmacokinetics of anidulafungin in critically ill. Pharmacology and metabolism of anidulafungin, caspofungin. Esophageal candidiasis see package insert for clinical studies table 7 for higher relapse rates off eraxis therapy. Eraxis anidulafungin this product information is intended only for residents of the united states. In critically ill patients the incidence of invasive fungal infections caused by candida spp. Arava is contraindicated for use in pregnant women see contraindications 4. Compare prices, print coupons and get savings tips for eraxis anidulafungin and other candidiasis and thrush drugs at cvs, walgreens, and other pharmacies. The safety and efficacy of micafungin compared to caspofungin is similar, but no comparison is made between anidulafungin and micafungin concerning safety and efficacy. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells. Final package insert for eraxis anidulafungin for injection anidulafungin undergoes slow chemical degradation at physiologic temperature and ph to a ringopened peptide that lacks antifungal activity. Etest single pack blister selfcontained, individually wrapped etest strips with desiccant. Biafungin cd101, a novel echinocandin, displays a long halflife in the chimpanzee, suggesting a onceweekly iv dosing option k.
Do not use if there is any evidence of precipitation or foreign matter. Easytoread drug name and dosage strength to aid in identifying the right product. Intensive plasma sampling was performed over a dosing interval at steady state from 21 icu patients with candidemiainvasive candidiasis. Pfizer is the newest echinocandin antifungal to be approved by the us food and drug administration for the treatment of esophageal candidiasis, candidemia, and deeptissue candidiasis. It works by interfering with the production of a component of the fungal cell wall called glucan polysaccharide, which is necessary for the fungus to survive and grow. A694 biafungin cd101, a novel echinocandin, displays a. Eraxis anidulafungin dosing, indications, interactions. Colorimetric thermo scientific alamarblue agent provides reliabl. Study 970034, a randomized, doubleblind, comparative multicenter trial, evaluated the safety of ambisome 3 and 5 mgkgday compared with amphotericin b lipid complex 5 mgkgday in the empirical treatment of 202 adult and 42 pediatric neutropenic patients.
Ecalta, innanidulafungin european medicines agency. Ampicillin for injection, usp is white to offwhite crystalline powder. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Collaborative studies conducted by the clinical and labo.
The clsi antifungal subcommittee followed the m23a2 blueprint to develop interpretive mic breakpoints for anidulafungin, caspofungin, and micafungin against candida species. The infusion solution may be stored for up to 48 hours at temperatures up to 25c 77f, or stored frozen for at least 72 hours prior to administration. Ecalta 100 mg powder for concentrate for solution for infusion. Reconstitution after calculating the number of vials needed, using aseptic technique, reconstitute each vial of thymoglobulin with 5 ml of sterile water for injection, usp swfi. Amytal sodium amobarbital sodium injection, powder. Find patient medical information for anidulafungin intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
Anidulafungin is indicated to treat invasive candidosis in adults who are not granulocytopenic but not in children or adolescents below the age of 18 years. Fda approved anidulafungin in febru ary 2006 for the treatment of candidemia, esophageal candidiasis, and intraabdom. This agent is active against candida species and aspergillus. Highlights of prescribing information these highlights do not include all the information needed to use prevymissafely and effectively. The sensititre yeastone yo9 ast plate is intended for research use only. Teratogenicity and embryolethality occurred in animal reproduction studies with leflunomide at doses lower than the human exposure level see use in specific populations 8. The pharmacy bulk package is for preparation of solutions for iv infusion only. Hepatotoxicity see full prescribing information for complete boxed warning. Cancidas is indicated for the treatment of esophageal candidiasisin adult and pediatric patients 3 months of age and older see clinical studies 14. Cancidas has not been approved for the treatment of oropharyngeal candidiasis opc. Drug interaction studies were performed with anidulafungin and other medicinal products likely to be. Anidulafungin is a noncompetitive inhibitor of 1,3betad. Amytal sodium amobarbital sodium injection, powder, lyophilized, for solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they.
Anidulafungin is an antifungal medication that fights infections caused by fungus anidulafungin treats candida yeast infections in the blood, or in the stomach or esophagus anidulafungin may also be used for purposes not listed in this medication guide. Correlation of mic with outcome for candida species tested. Package insert for eraxis anidulafungin for injection rx. The recommended starting dose of lantus in patients with type 1 diabetes should. Cancidas caspofungin 70 mg summary of product characteristics caspofungin package insert. This results in inhibition of the formation of 1,3. Unasyn should be administered by slow intravenous injection over at least 1015 minutes or can also be delivered in greater dilutions with 50100 ml of a compatible diluent as an intravenous infusion over 1530 minutes. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. One strip per package eliminates the need to store opened strips. You should not use this medicine if you are allergic to anidulafungin, caspofungin, micafungin, or similar antifungal medicines. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3. Etest single pack blister packaging option provides the following benefits. Each pharmacy bulk package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin.
1194 1389 562 885 205 944 699 1495 989 1128 1521 306 123 828 711 1016 1515 462 1374 1229 1358 616 1380 58 38 1557 1367 883 1478 912 325 352 663