Perflutren is a contrast agent for ultrasound imaging sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Definity (application NDA021064). Other perflutren products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 ). 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 RT must be activated using the VIALMIX RFID device and diluted before administration according to the instructions outlined below [see Dosage and Administration (2.5) ] . DEFINITY RT is for intravenous use only and must not be administered by intra-arterial injection [see Warnings and Precautions (5.3) ] . For adult patients, DEFINITY RT can be administered by either an intravenous bolus or infusion. The maximum dose is either two bolus doses…
The following serious adverse reactions are described elsewhere in the labeling: Serious Cardiopulmonary Reactions [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Pain Episodes in Patients with Sickle Cell Disease [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Medical Imaging, Inc. at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults Safety of DEFINITY RT was evaluated in a total of 1,716 adult subjects who received DEFINITY, another formulation of perflutren lipid microspheres, in pre-market clinical trials. In this group, 1,063 (62%) were male and 653 (38%) were female, 1,328 (77%) were White, 258 (15%) were Black or African American, 74 (4%) were Hispanic, and 56 (3%) were classified as other racial or ethnic groups. The mean age was 56 years (range 18 to 93). Among the 1,716 subjects, 19 (1.1%)…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 )
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| Prescription |
| Injectable |
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