DEFINITY- perflutren injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PERFLUTREN (UNII: CK0N3WH0SR) (PERFLUTREN - UNII:CK0N3WH0SR)

Available from:

Lantheus Medical Imaging, Inc.

INN (International Name):

PERFLUTREN

Composition:

PERFLUTREN 6.52 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DEFINITY is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. DEFINITY is contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG) [see Warnings and Precautions (5.2) and Description (11)] . Risk Summary Available data from case reports with DEFINITY use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. DEFINITY has a very short half-life; therefore, administration of DEFINITY to a pregnant woman is not expected to result in clinically relevant fetal exposure. No adverse developmental outcomes were observed in animal reproduction studies with administration of activated DEFINITY in pregnant rats and rabbits during organogenesis at doses up to 8 and 16 times, respectively, the maximum human dose based on body surface area (see Data) . All pregnancies have a background risk of birth defects, 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 DEFINITY was administered intravenously to rats at doses of 0.1 mL/kg, 0.3 mL/kg, and 1 mL/kg (approximately 0.8, 2.4, and 8 times the recommended maximum human dose based on body surface area); DEFINITY doses were administered daily from day 6 to day 17 of gestation. DEFINITY was administered intravenously to rabbits at doses of 0.1mL/kg, 0.3 mL/kg, and 1 mL/kg (approximately, 1.6, 4.8, and 16 times the recommended maximum human dose based on body surface area); DEFINITY doses were administered daily from day 7 to day 19 of gestation. No significant findings on the fetus were observed. Risk Summary There are no data on the presence of perflutren lipid microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEFINITY and any potential adverse effects on the breastfed infant from DEFINITY or from the underlying maternal condition. The safety and effectiveness of DEFINITY have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. Use of DEFINITY for this indication is supported by evidence from adequate and well-controlled studies in adults [see Clinical Studies (14)] , a pharmacodynamic and safety study in 40 pediatric patients 1 month of age and older [see Adverse Reactions (6.1) and Clinical Pharmacology (12.2)] , and published studies in 149 patients 5 years to 24 years of age [see Adverse Reactions (6.1)] . Of the total number of subjects in clinical trials of DEFINITY, 144 (33%) were 65 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 between the elderly and younger patients.

Product summary:

How Supplied DEFINITY (perflutren lipid microsphere) injectable suspension is supplied in a single- patient use clear glass vial or a single patient use clear glass Radio Frequency Identification (RFID)-tagged vial containing 6.52 mg/mL perflutren in the headspace of the vial and 0.75 mg/mL of a lipid blend in a clear, colorless liquid phase with 1.5 mL volume. DEFINITY is available in the following packages: Order VIALMIX or VIALMIX RFID from Lantheus Medical Imaging. Storage and Handling Before activation store between 2° to 8°C (36° to 46°F). Regarding interference with medical devices, the RFID tag and VIALMIX RFID unit meets the IEC 60601-1-2 requirements for emission and immunity standards for medical devices.

Authorization status:

New Drug Application

Summary of Product characteristics

DEFINITY- PERFLUTREN INJECTION, SUSPENSION
LANTHEUS MEDICAL IMAGING, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFINITY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEFINITY.
DEFINITY (PERFLUTREN LIPID MICROSPHERE) INJECTABLE SUSPENSION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
SERIOUS CARDIOPULMONARY REACTIONS, INCLUDING FATALITIES, HAVE OCCURRED
UNCOMMONLY
DURING OR FOLLOWING PERFLUTREN-CONTAINING MICROSPHERE ADMINISTRATION.
MOST SERIOUS
REACTIONS OCCUR WITHIN 30 MINUTES OF ADMINISTRATION.
ASSESS ALL PATIENTS FOR THE PRESENCE OF ANY CONDITION THAT PRECLUDES
DEFINITY
ADMINISTRATION (4).
ALWAYS HAVE RESUSCITATION EQUIPMENT AND TRAINED PERSONNEL READILY
AVAILABLE(5.1) .
RECENT MAJOR CHANGES
Indications and Usage (1)
3/2024
Dosage and Administration (2.1,2.3,2.4)
3/2024
Warnings and Precautions, Pain Episodes in Patients with Sickle Cell
Disease (5.5)
6/2023
INDICATIONS AND USAGE
DEFINITY is an ultrasound contrast agent indicated, after activation,
for use in adult and pediatric patients
with suboptimal echocardiograms to opacify the left ventricular
chamber and to improve the delineation of
the left ventricular endocardial border. (1)
DOSAGE AND ADMINISTRATION
Adult Patients
Bolus: 10 microL/kg intravenously over 30 seconds to 60 seconds
followed by a 10 mL flush of 0.9%
Sodium Chloride Injection.
Infusion: 1.3 mL added to 50 mL of 0.9% Sodium Chloride Injection
intravenously starting at 4
mL/minute, titrating as necessary, not to exceed 10 mL/minutes.
The maximum dose is two bolus doses 30 minute apart or one single
infusion. (2.2)
Pediatric Patients
Bolus: 3 microL/kg over 30 seconds to 60 seconds by intravenous bolus
injection followed by a 5 mL
flush of 0.9% Sodium Chloride Injection.
The maximum dose is two bolus doses 30 minute apart. (2.3)
See Full Prescribing Information for imaging instructions and
preparation. (2.4, 2.5)
DOSAGE FORMS AND STRENGTHS
DEFINITY: 6.52