Perflutren
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
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 RT administration [see Contraindications (4) ] . Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1) ] . 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 RT administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
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Dosing in kidney impairment
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Preparation and administration
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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 RT must be activated using the VIALMIX RFID device and diluted before administration according to the instructions outlined below [see Dosage and Administration ] .
DEFINITY RT is for intravenous use only and must not be administered by intra-arterial injection [see Warnings and Precautions ] . For adult patients, DEFINITY RT 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 ] .
For pediatric patients, DEFINITY RT is administered by an intravenous bolus injection only. The maximum dose is two bolus doses [see Dosage and Administration ].
Instructions for Activation, Preparation, and Handling of Definity RT Adhere to strict aseptic procedures during preparation. Activate DEFINITY RT by shaking the vial for 45 seconds using a VIALMIX RFID device. Note: Use only the drug activated in a properly functioning VIALMIX RFID for a full 45 second activation cycle.
Do not reactivate the vial if VIALMIX RFID did not properly activate the vial. Never reactivate a successfully activated DEFINITY RT vial (see step 3 ). Refer to the VIALMIX RFID User's Guide for illustrations of the activation procedure and a properly functioning VIALMIX RFID Immediately after activation, but no more than 15 minutes, place the activated DEFINITY RT vial in the upright position and remove the flip top cap.
Insert the 13mm ViaLok (Vented Vial Access Device) into the center of the rubber stopper and push down until properly engaged and locked onto the vial. Attach a syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP to the 13mm ViaLok luer-lok hub. Add 1.4 mL of preservative-free 0.9% Sodium Chloride Injection, USP to the activated DEFINITY RT vial.
Do not inject air into the DEFINITY RT vial. With the 13mm ViaLok still inserted and syringe attached, rapidly swirl the upright vial for 10 seconds to mix the contents. Activated and diluted DEFINITY RT appears as a homogenous milky white suspension with a presence of foam/bubbles. Use the product within 5 minutes of dilution.
If not used within 5 minutes resuspend the microspheres by rapidly swirling the upright vial for 10 seconds before the product is withdrawn in a syringe. The activated DEFINITY RT may be used for up to 4 hours from the time of dilution, with the 13mm ViaLok still attached, but only after the microspheres are resuspended by rapidly swirling the upright vial for 10 seconds.
Store the activated, diluted DEFINITY RT at room temperature 20° to 25°C (68° to 77°F) in the original product vial with the 13mm ViaLok still attached. A sterile syringe or cap should be attached to the Luer fitting on the ViaLok until use. Invert the vial and withdraw the activated homogeneous milky white suspension through the 13mm ViaLok into the syringe.
Do not inject air into the DEFINITY RT vial. Use the product immediately after its withdrawal from the vial: do not allow the product to stand in the syringe. For infusion dosing in adult patients, dilute 1.3 mL of activated, diluted Definity RT further in 50 mL of preservative-free 0.9% Sodium Chloride Injection, USP. Parenteral drug products should be inspected visually for foreign particulate matter and discoloration prior to administration, whenever solution and container permit .
Contraindications
4 CONTRAINDICATIONS DEFINTY RT 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) ]. Known or suspected hypersensitivity to perflutren lipid microsphere or its Components, such as polyethylene glycol (PEG) ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from case reports with DEFINITY RT use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. DEFINITY RT has a very short half-life; therefore, administration of DEFINITY RT 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, another formulation of perflutren lipid microspheres, 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 0.1mL/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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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