most desirable [1:10 mg/mL). However, standardized techniques for susceptibility testing for antifungal agents have not been established, and results of susceptibility studies do not necessarily correlate with clinical outcome. Abelcet is active in animal models against Aspergillus fumigatus, Candida albicans, C. guillermondii, C. stellatoideae , and C. tropicalis, Cryptococcus sp., Coccidioidomyces sp., Histoplasma sp., and Blastomyces sp. in which end-points were clearance of microorganisms from target organ(s) and/or prolonged survival of infected animals. Drug Resistance Fungal species with decreased susceptibility to amphotericin B have been isolated after serial passage in culture media containing the drug, and from some patients receiving prolonged therapy. Although the relevance of drug resistance to clinical outcome has not been established, fungal species which are resistant to amphotericin B may also be resistant to Abelcet . Slideshow Top 11 Reasons Why You Should Get Your Flu Vaccine Now Abelcet - Clinical Pharmacology Pharmacokinetics The assay used to measure amphotericin B in the blood after the administration of Abelcet does not distinguish amphotericin B that is complexed with the phospholipids of Abelcet from amphotericin B that is uncomplexed. The pharmacokinetics of amphotericin B after the administration of Abelcet are nonlinear. Volume of distribution and clearance from blood increase with increasing dose of Abelcet , resulting in less than proportional increases in blood concentrations of amphotericin B over a dose range of 0.6-5 mg/kg/day. The pharmacokinetics of amphotericin B in whole blood after the administration of Abelcet and amphotericin B desoxycholate are: Pharmacokinetic Parameters of Amphotericin B in Whole Blood in Patients Administered Multiple Doses of Abelcet or Amphotericin B Desoxycholate Pharmacokinetic Parameter Abelcet 5 mg/kg/day for 5-7 days Mean SD Amphotericin B 0.6 mg/kg/day for 42 days a Mean SD Peak Concentration ( μg/mL) 1.7 0.8 (n=10) b 1.1 0.2 (n=5) Concentration at End of Dosing Interval (μg/mL) 0.6 0.3 (n=10 b 0.4 0.2 (n=5) Area Under Blood Concentration-Time Curve (AUC 0-24h ) (μg*h/mL) 14.0 7.0 (n=14) b,c 17.1 5 (n=5) Clearance (mL/h*kg) 436.0. 188.5 (n=14) b,c 38.0 15 (n=5) Apparent Volume of Distribution (Vd area ) (L/kg) 131.0. 57.7 (n=8) c 5.0. 2.8 (n=5) Terminal Elimination Half-Life (h) 173.4 78.0 (n=8) c 91.1 40.9 (n=5) Amount Excreted in Urine Over 24 h After Last Dose (% of dose) d 0.9 0.4 (n=8) c 9.6 2.5 (n=8) a Data from patients with mucocutaneous leishmaniasis. Infusion rate was 0.25 mg/kg/h. b Data from studies in patients with cytologically proven cancer being treated with chemotherapy or neutropenic patients with presumed or proven fungal infection. Infusion rate was 2.5 mg/kg/h. c Data from patients with mucocutaneous leishmaniasis. Infusion rate was 4 mg/kg/h. d Percentage of dose excreted in 24 hours after last dose. The large volume of distribution and high clearance from blood of amphotericin B after the admistration of Abelcet probably reflect uptake by tissues. The long terminal elimination half-life probably reflects a slow redistribution from tissues. Although amphotericin B is excreted slowly, there is little accumulation in the blood after repeated dosing. AUC of amphotericin B increased approximately 34% from day 1 after the administration of Abelcet 5 mg/kg/day for 7 days. The effect of gender or ethnicity on the pharmacokinetics of Abelcet has not been studied. Tissue concentrations of amphotericin B have been obtained at autopsy from one heart transplant patient who received three doses of Abelcet at 5.3 mg/kg/day: Concentration in Human Tissues Organ Amphotericin B Tissue Concentration (µg/g) Spleen 290.0 Lung 222.0 Liver 196.0 Lymph Node 7.6 Kidney 6.9 Heart 0 5. Brain 1.6 This pattern of distribution is consistent with that observed in preclinical studies in dogs in which greatest concentrations of amphotericin B after Abelcet administration were observed in the liver, spleen, and lung; however, the relationship of tissue concentrations of amphotericin B to its biological activity when administered as Abelcet is unknown. Special Populations Hepatic Impairment: The effect of hepatic impairment on the disposition of Abelcet is not known. Renal Impairment: The effect of renal impairment on the disposition of Abelcet is not known. The effect of dialysis on the elimination of Abelcet has not been studied; however, amphotericin B is not removed by hemodialysis when administered as amphotericin B desoxycholate. Pediatric and Elderly Patients: The pharmacokinetics and pharmacodynamics of pediatric patients ( 16 years of age) and elderly patients ( 65 years of age) have not been studied. Indications and Usage for Abelcet Abelcet is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. This is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin B therapy (See DESCRIPTION OF CLINICAL STUDIES). DESCRIPTION OF CLINICAL STUDIES Fungal Infections Data from 473 patients were pooled from three open-label studies in which Abelcet was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin B, or who had preexisting nephrotoxicity. Results of these studies demonstrated effectiveness of Abelcet in the treatment of invasive fungal infections as a second line therapy. Patients were defined by their individual physician as being refractory to or failing conventional amphotericin B therapy based on overall clinical judgement after receiving a minimum total dose of 500 mg of amphotericin B. Nephrotoxicity was defined as a serum creatinine that had increased to >2.5 mg/dL in adults and >1.5 mg/dL in pediatric patients, or a creatinine clearance of] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Manufacturer Sigma-Tau Pharmaceuticals, Inc. Drug Class Polyenes Related Drugs polyenes nystatin , Mycostatin , amphotericin b , AmBisome Candidemia fluconazole , Diflucan , itraconazole , voriconazole , amphotericin b , Sporanox , More... Coccidioidomycosis ketoconazole , fluconazole , Diflucan , Nizoral , itraconazole , amphotericin b , More... Blastomycosis ketoconazole , fluconazole , Diflucan , Nizoral , itraconazole , voriconazole , More... 5 more conditions... Abelcet Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! come across
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