Perflutren- Diagnostic agent-(May 2006)
Drug Name:Perflutren- Diagnostic agent-(May 2006)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Specific drug-drug interactions have not been studied.
Indication:
DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension
Initial U.S. Approval: 2001
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
See full prescribing information for complete boxed warning
Serious cardiopulmonary reactions, including fatalities, have occurred
uncommonly during or following perflutren-containing microsphere administration (5.1).
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.
RECENT MAJOR CHANGES
BOXED WARNING October/2011
INDICATIONS AND USAGE (1) October/2011
WARNINGS AND PRECAUTIONS (5) October/2011
LIST OF DRUGS DURING 2006
Sr.No- 54
Name of the Drug- Perflutren liquid microsphere injectable suspn Pharmacological Classification- For diagnostic use
Date of Approval- 31-05-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Perflutren Liquid Microsphere 31-05-2006
Injectable Suspension
For Diagnostic use
Adverse Reaction:
The most common adverse reactions (>0.5%) are headache, back/renal pain,
flushing, nausea, chest pain, injection site reactions, and dizziness
Contra-Indications:
CONTRAINDICATIONS
Do not administer DEFINITY® to patients with known or suspected:
Right-to-left, bi-directional, or transient right-to-left cardiac shunts,
Hypersensitivity to perflutren. Do not administer DEFINITY® by intra-arterial injection.
WARNINGS AND PRECAUTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred during
or following perflutren-containing microsphere administration.
Serious acute anaphylactoid reactions have occurred in patients with no prior
exposure to perflutren-containing microsphere products
Assess all patients for the presence of any condition that precludes
DEFINITY® administration
Always have cardiopulmonary resuscitation personnel and equipment readily
available prior to DEFINITY® administration and monitor all patients for
acute reactions
Dosages/ Overdosage Etc:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Perflutren Liquid Microsphere 31-05-2006
Injectable Suspension
For Diagnostic use
INDICATIONS AND USAGE
DEFINITY® is an ultrasound contrast agent indicated for: use in patients with
suboptimal echocardiograms to opacify the left ventricular chamber and to
improve the delineation of the left ventricular endocardial border.
DOSAGE AND ADMINISTRATION
DEFINITY® may be injected by either an intravenous (IV) bolus or infusion.
The maximum dose is either two bolus doses or one single intravenous infusion.
The recommended bolus dose for activated DEFINITY® is 10 microliters (microL)/kg
of the activated product by intravenous bolus injection within 3060 seconds,
followed by a 10 mL saline flush.
If necessary, a second 10 microliters (microL)/kg dose followed by a second 10 mL
saline flush may be administered 30 minutes after the first injection to prolong
contrast enhancement.
The recommended infusion dose for activated DEFINITY® is via an IV infusion of
1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should
be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image
enhancement, not to exceed 10 mL/minute.
DOSAGE FORMS AND STRENGTHS
DEFINITY® is supplied as a single use 2-mL clear glass vial containing
clear liquid. Each package contains four (4) single-use vials.
-
Patient Information:
PATIENT COUNSELING INFORMATION
Patients receiving activated DEFINITY® should be instructed to inform their healthcare
provider if they:
1.have a congenital heart defect, or recent worsening of heart or lung conditions ,
2.have had prior reactions to DEFINITY® ],
3.may be pregnant, are trying to become pregnant, or are nursing
.
Revised: October, 2011
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance
the intrinsic backscatter of blood. These physical acoustic properties of activated
DEFINITY® provide contrast enhancement of the left ventricular chamber and aid
delineation of the left ventricular endocardial border during echocardiography.
2. Pharmacokinetics
Human pharmacokinetics information is not available for the intact or degassed lipid microspheres.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category B
There are no adequate and well-controlled studies of DEFINITYR in pregnant women.
Reproduction studies performed in rats and rabbits at doses up to 24 and 15 times the
human dose based on body surface area (in rats and rabbits respectively) revealed
no evidence of impaired fertility or harm to the fetus due to DEFINITYR.
Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.
2. Nursing Mothers
It is not known whether DEFINITYR is excreted in human milk. Based on the rapid
clearance of this drug, advise nursing mothers to pump and discard breast milk
once after treatment .
Because many drugs are excreted in human milk, caution should be exercised
when DEFINITYR is administered to a nursing mother.
3. Pediatric Use
The safety and effectiveness of activated DEFINITYR have not been established
in the pediatric population.The safety of injecting activated DEFINITYR in neonates
and infants with immature pulmonary vasculature has not been studied.
4. Geriatric Use
In clinical trials, the overall incidence of adverse reactions was similar for
the <65 year age group and the .65 year age group. Of the total number of subjects
in clinical trials of DEFINITYR, 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 in responses between the elderly and younger patients,
but greater sensitivity of some older individuals cannot be ruled out.
