Final package insert for eraxis anidulafungin for injection. Arava may cause fetal harm when administered to a pregnant woman. Highlights of prescribing information these highlights do not include all the information needed to use prevymissafely and effectively. Amytal sodium amobarbital sodium injection, powder. The pharmacy bulk package is for preparation of solutions for iv infusion only. Fda approved anidulafungin in febru ary 2006 for the treatment of candidemia, esophageal candidiasis, and intraabdom. What should i discuss with my health care provider before using anidulafungin eraxis. Do not use if there is any evidence of precipitation or foreign matter. 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. The in vitro degradation halflife of anidulafungin under physiologic conditions is about 24 hours.
Drug interaction studies were performed with anidulafungin and other medicinal products likely to be. 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. Eraxis anidulafungin dosing, indications, interactions. 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. 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. Intensive plasma sampling was performed over a dosing interval at steady state from 21 icu patients with candidemiainvasive candidiasis. Pharmacokinetics of anidulafungin in critically ill patients with. 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. Eraxis anidulafungin side effects, images, uses, dosage. Dglucan, an essential component of the fungal cell wall. Currently, three echinocandins, anidulafungin, caspofungin and micafungin are licensed for clinical use in various indications. Cancidas caspofungin 70 mg summary of product characteristics caspofungin package insert. Simplify yeast susceptibility testing with the thermo scientific sensititre yeastone yo9 ast plate with nine antifungals, including amphotericin b and micafungin.
Anidulafungin is a cyclic lipopeptide echinocandin derivative with antifungal activity. Stability of anidulafungin in concentrated pharmaceutical. 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. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively.
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. Dglucan, an essential component of fungal cell walls. Biafungin cd101, a novel echinocandin, displays a long halflife in the chimpanzee, suggesting a onceweekly iv dosing option k. Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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. Anidulafungin fda orange book approved drug product. The recommended starting dose of lantus in patients with type 1 diabetes should. Anidulafungin is a noncompetitive inhibitor of 1,3betad. Teratogenicity and embryolethality occurred in animal reproduction studies with leflunomide at doses lower than the human exposure level see use in specific populations 8. Correlation of mic with outcome for candida species tested. Eraxis fda prescribing information, side effects and uses. The clsi antifungal subcommittee followed the m23a2 blueprint to develop interpretive mic breakpoints for anidulafungin, caspofungin, and micafungin against candida species. Compare prices, print coupons and get savings tips for eraxis anidulafungin and other candidiasis and thrush drugs at cvs, walgreens, and other pharmacies. In critically ill patients the incidence of invasive fungal infections caused by candida spp. They have a broad spectrum of activity against all candida species. 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. Micafungin versus anidulafungin in critically ill patients with invasive candidiasis. Eraxis anidulafungin this product information is intended only for residents of the united states.
Amytal sodium amobarbital sodium injection, powder, lyophilized, for solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they. Echinocandins represent the newest class of antifungal agents. In 2006 a third echinocandin, anidulafungin, was approved in the usa for the treatment of candida. In the study that evaluated the efficacy of caspofungin in the treatment of. Arava is contraindicated for use in pregnant women see contraindications 4. This agent is active against candida species and aspergillus. Anidulafungin vicuron pharmaceuticals is a new echinocandin antifungal with potent activity against aspergillus and candida spp.
Eraxis anidulafungin dosage and administration pfizer. 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. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Etest single pack blister selfcontained, individually wrapped etest strips with desiccant. Find patient medical information for anidulafungin intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Cancidas has not been approved for the treatment of oropharyngeal candidiasis opc.
Levetiracetam in sodium chloride injection is an antiepileptic drug indicated for adult patients 16 years and older when oral administration is temporarily not feasible. As the only fdacleared assay for micafungin susceptibility testing of. Micafungin versus anidulafungin in critically ill patients. List of approved drug products containing anidulafungin in the fda orange book on.
Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3. Pharmacokinetics of anidulafungin in critically ill. Collaborative studies conducted by the clinical and labo. The sensititre yeastone yo9 ast plate is intended for research use only. A694 biafungin cd101, a novel echinocandin, displays a. Package insert for eraxis anidulafungin for injection rx. Pharmacology and metabolism of anidulafungin, caspofungin.
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. Aseptically transfer the contents of the reconstituted vials into an iv bag or bottle containing either 9 mgml 0. Anidulafungin is not dialyzable and may be administered without regard to the timing of hemodialysis. Eraxis anidulafungin is a semisynthetic lipopeptide synthesized from a fermentation product of aspergillus nidulans. This results in inhibition of the formation of 1,3. Each pharmacy bulk package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin. Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells.
Ecalta, innanidulafungin european medicines agency. Pdf micafungin versus anidulafungin in critically ill. One strip per package eliminates the need to store opened strips. Colorimetric thermo scientific alamarblue agent provides reliabl. Cancidas is indicated for the treatment of esophageal candidiasisin adult and pediatric patients 3 months of age and older see clinical studies 14. Ecalta 100 mg powder for concentrate for solution for infusion. Easytoread drug name and dosage strength to aid in identifying the right product. The active substance in caspofungin accord, caspofungin, belongs to a group of antifungal medicines known as echinocandins. Etest single pack blister packaging option provides the following benefits.
Bar codes included on the vial and carton for ease of scanning. Easy to open with one hand simply remove strip with forceps or manual applicator device. Esophageal candidiasis see package insert for clinical studies table 7 for higher relapse rates off eraxis therapy. Tell your doctor if you have ever had liver disease it is not known whether this medicine will harm an unborn baby. 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. You should not use this medicine if you are allergic to anidulafungin, caspofungin, micafungin, or similar antifungal medicines.