Definity

DEFINITY- perflutren injection, suspension
Lantheus Medical Imaging, Inc.

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.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Preparation and Administration Instructions

  • There are two formulations, DEFINITY and DEFINITY RT, that have differences in preparation and storage. Ensure of the correct product when following the directions for preparation and storage.
  • DEFINITY must be activated using the VIALMIX or VIALMIX RFID device before administration according to the instructions outlined below [see Dosage and Administration (2.5)].
  • DEFINITY is for intravenous use only and must not be administered by intra-arterial injection [see Warnings and Precautions (5.3)].
  • For adult patients, DEFINITY can be administered by either an intravenous bolus or infusion. The maximum dose is either two bolus doses or one single infusion. Do not administer the bolus and infusion dosing in combination or in sequence [see Dosage and Administration (2.2)].
  • For pediatric patients, DEFINITY is administered by an intravenous bolus injection only. The maximum dose is two bolus doses [see Dosage and Administration (2.3)].

2.2 Recommended Dosage in Adult Patients

Bolus Dosing

The recommended bolus dose in adult patients is 10 microL/kg of activated DEFINITY administered intravenously over 30 to 60 seconds followed by a 10 mL flush of 0.9% Sodium Chloride Injection, USP. If necessary, administer a second 10 microL/kg dose followed by a second 10 mL flush of 0.9% Sodium Chloride Injection, USP 30 minutes after the first injection to prolong contrast enhancement.

Infusion Dosing

The recommended infusion dose in adult patients is 1.3 mL of activated DEFINITY added to 50 mL of preservative-free 0.9% Sodium Chloride Injection, USP administered intravenously. Initiate infusion at 4 mL/minute, titrating the infusion rate as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.

2.3 Recommended Dosage in Pediatric Patients

Bolus Dosing

The recommended bolus dose in pediatric patients is 3 microL/kg of activated DEFINITY administered intravenously over 30 seconds to 60 seconds followed by a 5 mL flush of 0.9% Sodium Chloride Injection, USP. If necessary, administer a second bolus at a dose of 3 microL/kg to 5 microL/kg, followed by a second 5 mL flush of 0.9% Sodium Chloride Injection, USP 30 minutes after the first injection to prolong contrast enhancement.

2.4 Imaging Instructions

Adult Patients

After baseline non-contrast echocardiography is completed, set the mechanical index for the ultrasound device at 0.8 or below [see Warnings and Precautions (5.4)]. Then inject activated DEFINITY (as described above) and begin ultrasound imaging immediately [see Clinical Pharmacology(12.2). Evaluate the DEFINITY echocardiogram images in combination with the non-contrast echocardiogram images.

Pediatric Patients

After baseline non-contrast echocardiography is completed, set the mechanical index for the ultrasound transducer at 0.3 or below [see Warnings and Precautions (5.4)]. Then inject activated DEFINITY (as described above) and begin ultrasound imaging immediately [see Clinical Pharmacology(12.2). Evaluate the DEFINITY echocardiogram images in combination with the non-contrast echocardiogram images.

2.5 Instructions for Activation, Preparation, and Handling of DEFINITY

  1. Adhere to strict aseptic procedures during preparation.
  2. Allow the DEFINITY vial to warm to room temperature before starting the activation procedure.
  3. Activate DEFINITY by shaking the vial for 45 seconds using a VIALMIX device or VIALMIX RFID device. Note: Use only the drug activated in a properly functioning VIALMIX or VIALMIX RFID for a full 45 second activation cycle. Do not reactivate the vial if VIALMIX or VIALMIX RFID did not properly activate the vial. Never reactivate a successfully activated DEFINITY vial (see step 4). Refer to the VIALMIX or VIALMIX RFID User’s Guide for illustrations of the activation procedure and a properly functioning VIALMIX or VIALMIX RFID.
  4. Activated DEFINITY appears as a homogeneous milky white suspension with a presence of foam/bubbles. Use immediately after activation. If the product is not used within 5 minutes of activation, resuspend the microspheres by 10 seconds of hand agitation by inverting the vial before the product is withdrawn in a syringe.

  5. The activated DEFINITY may be used for up to 12 hours from the time of activation, but only after the microspheres are resuspended by hand agitation for 10 seconds. Store the activated DEFINITY at room temperature 20° to 25°C (68° to 77°F) in the original product vial.
  6. Invert the vial and withdraw the activated homogeneous milky white suspension using the Intellipin (Dispensing Pin), the PINSYNC (Vented Vial Adapter 13mm), or 18 gauge to 20 gauge syringe needle from the middle of the liquid. Do not inject air into the DEFINITY Vial.
  7. Use the product immediately after its withdrawal from the vial; do not allow the product to stand in the syringe.
  8. For infusion dosing in adult patients, dilute 1.3 mL of activated DEFINITY in 50 mL of preservative-free 0.9% Sodium Chloride Injection, USP.
  9. Parenteral drug products should be inspected visually for foreign particulate matter and discoloration prior to administration, whenever solution and container permit.

2.6 Instructions for RFID-Tagged Vials

The radio frequency identification (RFID) tag integrated on the back of the vial label when used with VIALMIX RFID allows for the exchange of product information such as activation time and activation rate. If the RFID tag is damaged or otherwise non-functional, the vial with the non-functional RFID tag cannot be activated with VIALMIX RFID. Discard the non-functional RFID-tagged vial. Do not activate RFID-tagged DEFINITY vials in the VIALMIX RFID within 6 inches (15 cm) of a pacemaker and/or defibrillator (see the VIALMIX RFID User’s Guide).

3 DOSAGE FORMS AND STRENGTHS

DEFINITY is supplied in a single-patient use vial containing 6.52 mg/mL perflutren in the headspace and 0.75mg/mL of a lipid blend as a clear colorless liquid with 1.5 mL volume. After activation, each mL contains a maximum of 1.2 × 1010 perflutren lipid microspheres as a homogeneous milky white injectable suspension, and about 150 microL/mL (1.1 mg/mL) perflutren.

4 CONTRAINDICATIONS

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)].

5 WARNINGS AND PRECAUTIONS

5.1 Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias). Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY administration and monitor all patients for acute reactions.

The reported reactions include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions [see Adverse Reactions (6.2)].

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.