ERAXIS- anidulafungin injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ANIDULAFUNGIN (UNII: 9HLM53094I) (ANIDULAFUNGIN - UNII:9HLM53094I)

Available from:

Roerig

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ERAXIS is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis in adults and pediatric patients 1 month of age and older [see Clinical Studies (14.1) and Microbiology (12.4)] . ERAXIS is indicated for the treatment of esophageal candidiasis in adults [see Indications and Usage (1.3), Clinical Studies (14.2)] . Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. ERAXIS is contraindicated in: Risk Summary Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. There are no available human data on the use of ERAXIS in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies fetal toxicity was observed in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area (see Data . ) . Inform pregnant woman of the risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Animal Data In a combined fertility and embryo-fetal development study in rats dosed with anidulafungin for 4 weeks prior to cohabitation and through cohabitation for males or for 2 weeks prior to cohabitation and continuing through gestation day 19 for females, there was no maternal or embryo-fetal toxicity at intravenous doses up to 20 mg/kg/day (equivalent to 2 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area). In a rabbit embryo-fetal development study, intravenous administration of anidulafungin (0, 5, 10, and 20 mg/kg/day) from gestation day 7 through 19, resulted in reduced fetal weights and incomplete ossification in the presence of maternal toxicity (decreased body weight gain) at 20 mg/kg/day (equivalent to 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area). In a pre- and postnatal development study, pregnant rats were intravenously administered anidulafungin at doses of 2, 6, or 20 mg/kg/day from gestation day 7 through lactation day 20. Maternal toxicity was observed at ≥6 mg/kg/day (clinical signs at ≥6 mg/kg/day and reduced body weight gain and food consumption during gestation at 20 mg/kg/day group). There were no effects on the viability or growth and development of the offspring. In this study, anidulafungin was detected in fetal plasma, indicating that it crossed the placental barrier. Risk Summary There are no data on the presence of anidulafungin in human milk, the effects on the breastfed infant or the effects on milk production. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Anidulafungin was found in the milk of lactating rats (see Data) The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ERAXIS and any potential adverse effects on the breastfed child from ERAXIS or from the underlying maternal condition. Animal Data Pregnant rats were intravenously administered anidulafungin at doses of 2, 6, or 20 mg/kg/day from gestation day 7 through lactation day 20. Milk samples were collected from 5 rats per group on lactation day 14 at approximately 1 hours post dose. Approximately dose-proportional anidulafungin concentrations were found in the milk of lactating rats. The safety and effectiveness of ERAXIS for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis, have been established in pediatric patients 1 month of age and older. Use of ERAXIS for this indication in this age group is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety data in pediatric patients 1 month of age and older [see Indications and Usage (1), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)]. The safety and effectiveness of ERAXIS in patients younger than 1 month of age with candidemia/invasive candidiasis has not been established. Candidemia/invasive candidiasis in pediatric patients younger than 1 month of age has a higher rate of central nervous system (CNS) and multi-organ dissemination than in older patients. In addition, in patients younger than 1 month of age ERAXIS carries a potential risk of life-threatening toxicity associated with high doses of polysorbate 80, an inactive ingredient in ERAXIS [see Warnings and Precautions (5.3)] . The safety and effectiveness of ERAXIS in pediatric patients with esophageal candidiasis has not been established. ERAXIS is contraindicated in adult and pediatric patients with HFI. Because a diagnosis of HFI may not yet be established in pediatric patients, obtain a careful history of HFI symptoms with fructose/sucrose exposure prior to administration of ERAXIS [see Warnings and Precautions (5.4)] . Of the total number of subjects (N = 197) in the pivotal clinical studies of anidulafungin, 35% were 65 years and over, while 18% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dosage adjustments are not required for geriatric patients [see Clinical Pharmacology (12.3)] . No dosing adjustments are required for patients with any degree of hepatic insufficiency. Anidulafungin is not hepatically metabolized. Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency. Anidulafungin concentrations were not increased in subjects with any degree of hepatic insufficiency. 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 (12.3)] . Dosage adjustments are not required for patients with any degree of renal insufficiency including those on hemodialysis. Anidulafungin has negligible (<1%) renal clearance. In a clinical study of subjects with mild, moderate, severe or end stage (dialysis-dependent) renal insufficiency, anidulafungin pharmacokinetics were similar to those observed in subjects with normal renal function. Anidulafungin is not dialyzable and may be administered without regard to the timing of hemodialysis [see Clinical Pharmacology (12.3)] .

Product summary:

ERAXIS (anidulafungin) for Injection is supplied in a single-dose vial of sterile, lyophilized, preservative-free, white to off-white powder. ERAXIS (anidulafungin) is available in the following packaging configuration: Single-Dose Vial of ERAXIS 100 mg NDC 0049-2242-01 One - 100 mg vial ERAXIS vials ERAXIS (unreconstituted) vials should be stored in a refrigerator at 2°C – 8°C (36°F – 46°F). Do not freeze. Excursions for 96 hours up to 25°C (77°F) are permitted, and the vial can be returned to storage at 2°C – 8°C (36°F – 46°F). Reconstituted solution ERAXIS reconstituted solution can be stored at up to 25°C (77°F) for up to 24 hours [see Dosage and Administration (2.3)] . Infusion Solution ERAXIS infusion solution can be stored at temperatures up to 25°C (77°F) for up to 48 hours. Do not freeze [see Dosage and Administration (2.4)] .

Authorization status:

New Drug Application

Summary of Product characteristics

ERAXIS- ANIDULAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ROERIG
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ERAXIS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ERAXIS.
ERAXIS (ANIDULAFUNGIN) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
ERAXIS is an echinocandin antifungal indicated for the treatment of
the following infections:
•
•
Limitations of use
•
•
DOSAGE AND ADMINISTRATION
ADULTS
PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER
CANDIDEMIA AND OTHER FORMS OF _CANDIDA_ INFECTIONS
200 mg loading dose on Day 1, followed by 100 mg
once daily maintenance dose thereafter for at least
14 days after the last positive culture (2.1)
3 mg/kg (not to exceed 200 mg) loading dose on
Day 1, followed by 1.5 mg/kg (not to exceed 100 mg)
once daily maintenance dose thereafter for at least
14 days after the last positive culture (2.2)
ESOPHAGEAL CANDIDIASIS
100 mg loading dose on Day 1, followed by 50 mg
once daily maintenance dose thereafter for a
minimum of 14 days and for at least 7 days following
resolution of symptoms (2.1)
Not Approved
Rate of Infusion for Adults and Pediatric Patients
The rate of infusion should not exceed 1.1 mg/minute [equivalent to
1.4 mL/minute or 84 mL/hour when
reconstituted and diluted per instructions] (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 100 mg as a lyophilized powder in a single-dose vial
for reconstitution (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
®
Candidemia and other forms of _Candida_ infections (intra-abdominal
abscess and peritonitis) in adults
and pediatric patients (1 month of age and older) (1.1)
Esophageal candidiasis in adults (1.2)
ERAXIS has not been studied in adult and pediatric patients with
endocarditis, osteomyelitis, and
meningitis due to _Candida_ or in sufficient numbers of neutropenic
patients. The dosage of ERAXIS for
the treatment of _Candida_ dissemination into the CNS and the eye has
not