sooner than [500:<50/mm3). Of the 166 patients in the large study who had culture-confirmed esophageal candidiasis at baseline, 120 had Candida albican s and 2 had Candida tropicalis as the sole baseline pathogen whereas 44 had mixed baseline cultures containing C. albicans and one or more additional Candida species. In the large, randomized, double-blind study comparing caspofungin 50 mg/day versus intravenous fluconazole 200 mg/day for the treatment of esophageal candidiasis, patients were treated for an average of 9 days (range 7-21 days). Favorable overall response at 5 to 7 days following discontinuation of study therapy required both complete resolution of symptoms and significant endoscopic improvement. The definition of endoscopic response was based on severity of disease at baseline using a 4-grade scale and required at least a two-grade reduction from baseline endoscopic score or reduction to grade 0 for patients with a baseline score of 2 or less. The proportion of patients with a favorable overall response was comparable for caspofungin and fluconazole as shown in Table 14. Table 14: Favorable Response Rates for Patients with Esophageal Candidiasis* Caspofungin Fluconazole % Difference (95% CI) Day 5-7 post-treatment 66/81 (81.5%) 80/94 (85.1%) -3.6 (-14.7, 7.5) * Analysis excluded patients without documented esophageal candidiasis or patients not receiving at least 1 day of study therapy. Calculated as caspofungin fluconazole The proportion of patients with a favorable symptom response was also comparable (90.1% and 89.4% for caspofungin and fluconazole, respectively). In addition, the proportion of patients with a favorable endoscopic response was comparable (85.2% and 86.2% for caspofungin and fluconazole, respectively). As shown in Table 15, the esophageal candidiasis relapse rates at the Day 14 post-treatment visit were similar for the two groups. At the Day 28 post-treatment visit, the group treated with caspofungin had a numerically higher incidence of relapse; however, the difference was not statistically significant. Table 15: Relapse Rates at 14 and 28 Days Post-Therapy in Patients with Esophageal Candidiasis at Baseline Caspofungin Fluconazole % Difference* (95% CI) Day 14 post-treatment 7/66 (10.6%) 6/76 (7.9%) 2.7 (-6.9, 12.3) Day 28 post-treatment 18/64 (28.1%) 12/72 (16.7%) 11.5 (-2.5, 25.4) *Calculated as caspofungin fluconazole In this trial, which was designed to establish noninferiority of caspofungin to fluconazole for the treatment of esophageal candidiasis, 122 (70%) patients also had oropharyngeal candidiasis. A favorable response was defined as complete resolution of all symptoms of oropharyngeal disease and all visible oropharyngeal lesions. The proportion of patients with a favorable oropharyngeal response at the 5- to 7-day post-treatment visit was numerically lower for caspofungin; however, the difference was not statistically significant. Oropharyngeal candidiasis relapse rates at Day 14 and Day 28 post-treatment visits were statistically significantly higher for Caspofungin than for fluconazole. The results are shown in Table-16 Table 16: Oropharyngeal Candidiasis Response Rates at 5 to 7 Days Post-Therapy and Relapse Rates at 14 and 28 Days Post-Therapy in Patients with Oropharyngeal and Esophageal Candidiasis at Baseline Caspofungin Fluconazole % Difference* (95% CI) Response Rate Day 5-7 post-treatment 40/56 (71.4%) 55/66 (83.3%) -11.9 (-26.8, 3.0) Relapse Rate Day 14 post-treatment 17/40 (42.5%) 7/53 (13.2%) 29.3 (11.5, 47.1) Relapse Rate Day 28 post-treatment 23/39 (59.0%) 18/51 (35.3%) 23.7 (3.4, 43.9) * Calculated as caspofungin fluconazole The results from the two smaller dose-ranging studies corroborate the efficacy of caspofungin for esophageal candidiasis that was demonstrated in the larger study. Caspofungin was associated with favorable outcomes in 7 of 10 esophageal C. albicans infections refractory to at least 200 mg of fluconazole given for 7 days, although the in -vitro susceptibility of the infecting isolates to fluconazole was not known. Invasive Aspergillosis Sixty-nine patients between the ages of 18 and 80 with invasive aspergillosis were enrolled in an open-label, noncomparative study to evaluate the safety, tolerability, and efficacy of caspofungin. Enrolled patients had previously been refractory to or intolerant of other antifungal therapy (ies). Refractory patients were classified as those who had disease progression or failed to improve despite therapy for at least 7 days with amphotericin B, lipid formulations of amphotericin B, itraconazole, or an investigational azole with reported activity against Aspergillus . Intolerance to previous therapy was defined as a doubling of creatinine (or creatinine 2.5 mg/dL while on therapy), other acute reactions, or infusion-related toxicity. To be included in the study, patients with pulmonary disease must have had definite (positive tissue histopathology or positive culture from tissue obtained by an invasive procedure) or probable (positive radiographic or computed tomography evidence with supporting culture from bronchoalveolar lavage or sputum, galactomannan enzyme-linked immunosorbent assay, and/or polymerase chain reaction) invasive aspergillosis. Patients with extrapulmonary disease had to have definite invasive aspergillosis. Patients were administered a single 70-mg loading dose of caspofungin and subsequently dosed with 50 mg daily. The mean duration of therapy was 33.7 days, with a range of 1 to 162 days. An independent expert panel evaluated patient data, including diagnosis of invasive aspergillosis, response and tolerability to previous antifungal therapy, treatment course on caspofungin, and clinical outcome. A favorable response was defined as either complete resolution (complete response) or clinically meaningful improvement (partial response) of all signs and symptoms and attributable radiographic findings. Stable, nonprogressive disease was considered to be an unfavorable response. Among the 69 patients enrolled in the study, 63 met entry diagnostic criteria and had outcome data; and of these, 52 patients received treatment for greater than 7 days. Fifty-three (84%) were refractory to previous antifungal therapy and 10 (16%) were intolerant. Forty-five patients had pulmonary disease and 18 had extrapulmonary disease. Underlying conditions were hematologic malignancy (N=24), allogeneic bone marrow transplant or stem cell transplant (N=18), organ transplant (N=8), solid tumor (N=3), or other conditions (N=10). All patients in the study received concomitant therapies for their other underlying conditions. Eighteen patients received tacrolimus and caspofungin concomitantly, of whom 8 also received mycophenolate mofetil. Overall, the expert panel determined that 41% (26/63) of patients receiving at least one dose of caspofungin had a favorable response. For those patients who received> 7 days of therapy with caspofungin, 50% (26/52) had a favorable response. The favorable response rates for patients who were either refractory to or intolerant of previous therapies were 36% (19/53) and 70% (7/10), respectively. The response rates among patients with pulmonary disease and extrapulmonary disease were 47% (21/45) and 28% (5/18), respectively.Among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible CNS involvement had a favorable response. Two of these 8 patients had progression of disease and manifested CNS involvement while on therapy. Caspofungin is effective for the treatment of invasive aspergillosis in patients who are refractory to or intolerant of itraconazole, amphotericin B, and/or lipid formulations of amphotericin B. However, the efficacy of caspofungin for initial treatment of invasive aspergillosis has not been evaluated in comparator-controlled clinical studies. Pediatric Patients The safety and efficacy of caspofungin were evaluated in pediatric patients 3 months to 17 years of age in two prospective, multicenter clinical trials. The first study, which enrolled 82 patients between 2 to 17 years of age, was a randomized, double-blind study comparing caspofungin (50 mg/m 2 IV once daily following a 70-mg/m 2 loading dose on Day 1 [not to exceed 70 mg daily]) to AmBisome (3 mg/kg IV daily) in a 2:1 treatment fashion (56 on caspofungin, 26 on AmBisome) as empirical therapy in pediatric patients with persistent fever and neutropenia. The study design and criteria for efficacy assessment were similar to the study in adult patients [see Clinical Studies (14.1) ]. Patients were stratified based on risk category (high-risk patients had undergone allogeneic stem cell transplantation or had relapsed acute leukemia). Twenty-seven percent of patients in both treatment groups were high risk. Favorable overall response rates of pediatric patients with persistent fever and neutropenia are presented in Table 17. Table 17: Favorable Overall Response Rates of Pediatric Patients with Persistent Fever and Neutropenia Caspofungin AmBisome* Number of Patients 56 25 Overall Favorable Response 26/56 (46.4%) 8/25 (32.0%) High risk 9/15 (60.0%) 0/7 (0.0%) Low risk 17/41 (41.5%) 8/18 (44.4%) * One patient excluded from analysis due to no fever at study entry. The second study was a prospective, open-label, non-comparative study estimating the safety and efficacy of caspofungin in pediatric patients (ages 3 months to 17 years) with candidemia and other Candida infections, esophageal candidiasis, and invasive aspergillosis (as salvage therapy). The study employed diagnostic criteria which were based on established EORTC/MSG criteria of proven or probable infection; these criteria were similar to those criteria employed in the adult studies for these various indications. Similarly, the efficacy time points and endpoints used in this study were similar to those employed in the corresponding adult studies [see Clinical Studies (14.2, 14.3, and 14.4) ]. All patients received caspofungin at 50 mg/m 2 IV once daily following a 70-mg/m 2 loading dose on Day 1 (not to exceed 70 mg daily). Among the 49 enrolled patients who received caspofungin, 48 were included in the efficacy analysis (one patient excluded due to not having a baseline Aspergillus or Candida infection). Of these 48 patients, 37 had candidemia or other Candida infections, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis. Most candidemia and other Candida infections were caused by C. albicans (35%), followed by C. parapsilosis (22%), C. tropicalis (14%), and C. glabrata (11%). The favorable response rate, by indication, at the end of caspofungin therapy was as follows: 30/37 (81%) in candidemia or other Candida infections, 5/10 (50%) in invasive aspergillosis, and 1/1 in esophageal candidiasis. REFERENCES Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter). Clinical and Laboratory Standards Institute (CLSI). Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard-Third Edition. CLSI document M27-A3.Clinical and Laboratory Standards Institute, 940 West ValleyRoad, Suite 1400,Wayne, Pennsylvania 19087, USA, 2008. Clinical and Laboratory Standards Institute (CLSI). Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Third Informational Supplement. CLSI document M27-S3.Clinical and Laboratory Standards Institute, 940 West ValleyRoad, Suite 1400,Wayne, Pennsylvania 19087, USA, 2008. How Supplied/Storage and Handling Caspofungin Acetate for Injection is supplied as follows: NDC Caspofungin Acetate for Injection Package Factor 68083-158-01 50 mg Single-Dose Vial 1 vial per carton 68083-159-01 70 mg Single-Dose Vial 1 vial per carton Caspofungin Acetate for Injection is a lyophilized white to off-white powder/cake for intravenous infusion in a vial with an aluminum flip off seal and plastic cap. The lyophilized vials should be stored refrigerated at 2 to 8 C (36 to 46 F). Patient Counseling Information Hypersensitivity Inform patients that anaphylactic reactions have been reported during administration of caspofungin . Caspofungin can cause hypersensitivity reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm. Inform patients to report these signs or symptoms to their healthcare providers. Hepatic Effects Inform patients that there have been isolated reports of serious hepatic effects from caspofungin therapy. The brand names mentioned in this document are the trademarks of their respective owners Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad -500-043,INDIA PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68083-158-01 Caspofungin Acetate For Injection50 mg/vial* FOR INTRAVENOUS USE ONLY *Vial contains 50 mg caspofungin equivalent to 55.5 mg caspofungin acetate. Reconstitute with 10.8 mL of diluent to obtain a concentration of 5 mg/mL. Requires further dilution prior to infusion. Single Dose Vial DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-glucose) Vial Label Carton Label NDC 68083-159-01 Caspofungin Acetate For Injection 70 mg/vial* FOR INTRAVENOUS USE ONLY *Vial contains 70 mg caspofungin equivalent to 77.7mg caspofungin acetate. Reconstitute with 10.8 mL of diluent to obtain a concentration of 7 mg/mL. Requires further dilution prior to infusion. Single Dose Vial DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-glucose) Vial Label Carton Label CASPOFUNGIN ACETATE Caspofungin Acetate Injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68083-158 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASPOFUNGIN ACETATE (CASPOFUNGIN) CASPOFUNGIN ACETATE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength MANNITOL 2.4 mg in 1 mL ACETIC ACID SODIUM HYDROXIDE SUCROSE 3.6 mg in 1 mL Packaging # Item Code Package Description 1 NDC:68083-158-01 01 VIAL in 1 CARTON 1 10 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207092 10/29/2017 CASPOFUNGIN ACETATE Caspofungin Acetate Injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68083-159 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASPOFUNGIN ACETATE (CASPOFUNGIN) CASPOFUNGIN ACETATE 7 mg in 1 mL Inactive Ingredients Ingredient Name Strength MANNITOL 3.3 mg in 1 mL ACETIC ACID SODIUM HYDROXIDE SUCROSE 5.0 mg in 1 mL Packaging # Item Code Package Description 1 NDC:68083-159-01 1 VIAL in 1 CARTON 1 10 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207092 10/29/2017 Labeler - Gland Pharma Limited (918601238) Establishment Name Address ID/FEI Operations Gland Pharma Limited 918601238 ANALYSIS(68083-158, 68083-159), MANUFACTURE(68083-158, 68083-159), PACK(68083-158, 68083-159) Revised: 09/2017 Gland Pharma Limited Next Interactions Print this page Add to My Med List More about caspofungin Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: echinocandins Consumer resources Caspofungin Caspofungin Intravenous (Advanced Reading) Professional resources Caspofungin Acetate (AHFS Monograph) Caspofungin (Wolters Kluwer) Other brands: Cancidas Related treatment guides Esophageal Candidiasis Aspergillosis, Invasive Candidemia Febrile Neutropenia ]} 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 C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Echinocandins Related Drugs echinocandins caspofungin , micafungin , Mycamine , Cancidas , anidulafungin , Eraxis Aspergillosis, Invasive itraconazole , voriconazole , amphotericin b , Sporanox , Cresemba , caspofungin , More... Candidemia fluconazole , Diflucan , itraconazole , voriconazole , amphotericin b , Sporanox , More... Esophageal Candidiasis fluconazole , Diflucan , itraconazole , voriconazole , amphotericin b , Sporanox , More... 1 more conditions... Caspofungin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } inexperienced persons
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