CRESEMBA- isavuconazonium sulfate capsule CRESEMBA- isavuconazonium sulfate injection, powder, lyophilized, for solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ISAVUCONAZONIUM SULFATE (UNII: 31Q44514JV) (ISAVUCONAZOLE - UNII:60UTO373KE)

Boleh didapati daripada:

Astellas Pharma US, Inc.

INN (Nama Antarabangsa):

ISAVUCONAZONIUM SULFATE

Komposisi:

ISAVUCONAZONIUM SULFATE 186 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

CRESEMBA® is indicated for the treatment of invasive aspergillosis as follows: CRESEMBA for injection : adults and pediatric patients 1   year of age and older [see Clinical Studies ( 14.1 ) and Clinical Pharmacology ( 12.4 )] CRESEMBA capsules : adults and pediatric patients 6 years of age and older who weigh 16 kilograms ( kg ) and greater [see Dosage and Administration ( 2.3 ) Clinical Studies ( 14.1 ) and Clinical Pharmacology ( 12.4 )] CRESEMBA is indicated for the   treatment of invasive mucormycosis as follows: CRESEMBA for injection : adults and pediatric patients 1   year of age and older [see Clinical Studies ( 14.1 ) and Clinical Pharmacology ( 12.3 , 12.4 )] CRESEMBA capsules : adults and pediatric patients 6 years of age and older who weigh 16 kg and greater [see Dosage and Administration ( 2.3 )], Clinical Studies ( 14.1 ) and Clinical Pharmacology ( 12.3 ,   12.4 )] Specimens for fungal culture and other relevant laboratory studies (including histopathology) to isolate and identify causative organism(s) should be obtained prior to initiating antifungal therapy. 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. Risk Summary Based on findings from animal studies, CRESEMBA may cause fetal harm when administered to a pregnant woman. There are no available human data on the use of CRESEMBA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, perinatal mortality was increased in the offspring of pregnant rats dosed orally with isavuconazonium sulfate at approximately 0.5 times the clinical exposure during pregnancy through the weaning period. In animal studies when isavuconazonium chloride was administered by oral gavage to pregnant rats and rabbits during organogenesis at exposures corresponding to less than the human maintenance dose, increases in the incidences of multiple skeletal abnormalities, including rudimentary cervical ribs and fused zygomatic arches, were observed (see Data). Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions (5.4)] . 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. Data Animal Data Isavuconazonium chloride administration during organogenesis (gestational days 6-17 in rats and gestational days 6-18 in rabbits) was associated with dose-related increases in the incidences of rudimentary cervical ribs in rats and rabbits at 30 and 45 mg/kg, respectively, equivalent to about 0.2 and 0.1 times of the clinical exposure based on AUC comparisons. In rats, dose-related increases in the incidences of zygomatic arch fusion and supernumerary ribs/rudimentary supernumerary ribs were also noted at 30 mg/kg and above, equivalent to 0.2 times the human AUC. Skeletal abnormalities have also been observed in embryo-fetal development studies of other azole antifungal agents. Isavuconazonium sulfate increased perinatal mortality in the pups when orally administered to pregnant rats during pregnancy and lactation (gestational day 6 through postpartum day 20) at doses up to 90 mg/kg/day (approximately 0.5 times the clinical exposure based on AUC comparison). No effect on the duration of pregnancy or delivery was seen in the pups at this same dose. Risk Summary There are no data on the presence of isavuconazole in human milk, the effects on the breastfed infant or the effects on milk production. Isavuconazole was present in the milk of lactating rats following intravenous administration. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Therefore, breastfeeding should be discontinued during treatment with CRESEMBA. Contraception CRESEMBA may cause embryo-fetal harm when administered to pregnant women [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1)]. Advise female patients of reproductive potential to use effective contraception during treatment with CRESEMBA and for 28 days after the final dose. Invasive Aspergillosis The safety and effectiveness of CRESEMBA for injection for the treatment of invasive aspergillosis have been established in pediatric patients 1 year of age and older. The safety and effectiveness of CRESEMBA capsules for the treatment of invasive aspergillosis have been established in pediatric patients 6 year of age and older weighing 16 kg and greater. Use of CRESEMBA in this age group for treatment of invasive aspergillosis is supported by evidence from one adequate and well-controlled trial in adult patients and additional pharmacokinetic and safety data in pediatric patients 1 year of age and older [see Clinical Pharmacology (12.3)]. Adverse reactions in this pediatric population were similar to those reported in the adult population [see Adverse Reactions (6.1)]. The safety and effectiveness of CRESEMBA capsules for treatment of invasive aspergillosis have not been established in pediatric patients younger than 6 years of age or who weigh less than 16 kg because the oral route of administration was not assessed in this pediatric patient age cohort. The safety and effectiveness of CRESEMBA for treatment of invasive aspergillosis in pediatric patients less than 1 year of age have not been established. Invasive Mucormycosis The safety and effectiveness of CRESEMBA for injection for the treatment of invasive mucormycosis have been established in pediatric patients 1 year of age and older. The safety and effectiveness of CRESEMBA capsules for the treatment of invasive mucormycosis have been established in pediatric patients 6 year of age and older weighing 16 kg and greater. Use of CRESEMBA in this age group for treatment of invasive mucormycosis is supported by one open-label trial in adult patients with invasive mucormycosis, a retrospective review of survival data for adult patients with untreated invasive mucormycosis, and additional pharmacokinetic and safety data in pediatric patients 1 year of age and older [see Clinical Pharmacology (12.3 )]. Adverse reactions in this pediatric population were similar to those reported in the adult population [see Adverse Reaction s (6.1)]. The safety and effectiveness of CRESEMBA capsules for treatment of invasive mucormycosis have not been established in pediatric patients younger than 6 years of age who weigh less than 16 kg because the oral route of administration was not assessed in this pediatric patient age cohort. The safety and effectiveness of CRESEMBA for treatment of invasive mucormycosis in pediatric patients less than 1 year of age have not been established. Of the 547 patients who received CRESEMBA in the Phase 2 and 3 trials, 86 (16%) of patients were greater than 65 years of age and 20 (4%) were greater than 75 years of age. The pharmacokinetics of isavuconazole are comparable in young and elderly subjects (65 years of age and older) [see Clinical Pharmacology (12.3)] . No dose adjustment of CRESEMBA is needed in elderly patients. 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. Of the 403 patients who received CRESEMBA in the Phase 3 trials, 79 (20%) of patients had an estimated glomerular filtration rate (GFR) less than 60 mL/min/1.73 m2 . No dose adjustment is needed in patients with mild, moderate, or severe renal impairment, including those patients with End-Stage Renal Disease (ESRD) [see Clinical Pharmacology (12.3)] . No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Class A and B) [see Clinical Pharmacology (12.3)] . CRESEMBA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and should be used in these patients only when the benefits outweigh the risks. Clinical monitoring for CRESEMBA-related adverse reactions is recommended when treating patients with severe hepatic impairment [see Warnings and Precautions (5.1)] .

Ringkasan produk:

CRESEMBA Capsules CRESEMBA (isavuconazonium sulfate) 74.5 mg capsules are supplied as opaque capsules and have a Swedish orange (reddish-brown) body imprinted with the Astellas logo in black ink and a Swedish orange cap imprinted with “557” in black ink. Each capsule contains 74.5 mg isavuconazonium sulfate (equivalent to 40 mg of isavuconazole) and is packaged as follows: 35-count carton (contains seven individual aluminum child-resistant blister packs of 5 capsules per sheet with desiccant) NDC 0469-2860-35 CRESEMBA (isavuconazonium sulfate) 186 mg capsules are supplied as opaque and elongated capsules and have a Swedish orange (reddish-brown) body imprinted with the Astellas logo in black ink and a white cap imprinted with “766” in black ink. Each capsule contains 186 mg isavuconazonium sulfate (equivalent to 100 mg of isavuconazole) and is packaged as follows: 14-count carton (contains two individual aluminum child-resistant blister packs of 7 capsules per sheet with desiccant) NDC 0469-0520-02 CRESEMBA for Injection CRESEMBA (isavuconazonium sulfate) for injection is supplied as white to yellow sterile lyophilized powder containing 372 mg isavuconazonium sulfate (equivalent to 200 mg isavuconazole) in a single-dose vial and is packaged as follows: Individually packaged single-dose vial NDC 0469-0420-01 CRESEMBA Capsules Store CRESEMBA capsules at 20°C to 25°C (68°F to 77°F) in the original packaging to protect from moisture. Excursions are permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. CRESEMBA for Injection Store CRESEMBA for injection unreconstituted vials at 2°C to 8°C (36°F to 46°F) in a refrigerator. CRESEMBA for injection is a single-dose vial of unpreserved sterile lyophile. Following reconstitution of the lyophile with water for injection USP, the reconstituted solution should be used immediately, or stored between 5°C to 25°C (41°F to 77°F) for a maximum of 1 hour prior to preparation of the patient infusion solution [see Dosage and Administration (2.4)] . The prepared infusion solution should be kept for not more than 6 hours at room temperature [20°C to 25°C (68°F to 77°F)] or 24 hours at 2°C to 8°C (36°F to 46°F) prior to use [see Dosage and Administration (2.5)] . For nasogastric tube use, the reconstituted solution should be stored between 5°C to 25°C (41°F to 77°F) and used within 1 hour of reconstitution [see Dosage and Administration (2.6)] .

Status kebenaran:

New Drug Application

Ciri produk

CRESEMBA- ISAVUCONAZONIUM SULFATE CAPSULE
CRESEMBA- ISAVUCONAZONIUM SULFATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ASTELLAS PHARMA US, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CRESEMBA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CRESEMBA .
CRESEMBA (ISAVUCONAZONIUM SULFATE) CAPSULES, FOR ORAL USE
CRESEMBA (ISAVUCONAZONIUM SULFATE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indications and Usage (1) 12/2023
Dosage and Administration (2) 12/2023
INDICATIONS AND USAGE
CRESEMBA is an azole antifungal indicated for the treatment of:
Invasive aspergillosis (1.1) and Invasive mucormycosis (1.2) as
follows:
•
•
DOSAGE AND ADMINISTRATION
Important Administration Instructions:
•
•
•
•
•
Recommended Dosage in Adult Patients (2.2):
Start maintenance doses 12 to 24 hours after the last loading dose
RECOMMENDED DOSAGE FOR CRESEMBA IN ADULT PATIENTS (2.2)
DOSAGE FORM
LOADING DOSE
MAINTENANCE DOSE
CRESEMBA FOR INJECTION,
372 MG/VIAL
372 mg of isavuconazonium
sulfate per vial
One reconstituted vial (372 mg)
intravenously
every 8 hours for 6 doses (48 hours)
One reconstituted vial (372 mg)
intravenously
once daily
CRESEMBA CAPSULES,
186 MG
186 mg of isavuconazonium
sulfate per capsule
Two 186 mg capsules (372 mg)
orally
every 8 hours for 6 doses (48 hours)
Two 186 mg capsules (372 mg)
orally
once daily
CRESEMBA CAPSULES,
74.5 MG
74.5 mg of
isavuconazonium sulfate
per capsule
Five 74.5 mg capsules (372 mg)
orally
every 8 hours for 6 doses (48 hours)
Five 74.5 mg capsules (372 mg)
orally
once daily
Recommended Dosage in Pediatric Patients (2.3):
•
®
®
®
®
®
CRESEMBA FOR INJECTION: adults and pediatric patients 1 year of age
and older
CRESEMBA CAPSULES: adults and pediatric patients 6 years of age and
older who weigh 16
kilograms (kg) and greater
CRESEMBA FOR INJECTION is intended for use in patients who are 1 year
of age and older (2.1, 2.3).
CRESEMBA FOR INJECTION via na