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PERFLUTREN
At a glance
| Generic name | PERFLUTREN |
|---|---|
| Drug class | Contrast Agent for Ultrasound Imaging [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1998 |
Approved indications
Boxed warnings
- 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 [see Warnings and Precautions (5.1) ]. Assess all patients for the presence of any condition that precludes OPTISON administration [see Contraindications (4) ]. Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1) ] . 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. Most serious reactions occur within 30 minutes of administration ( 5.1 ). Assess all patients for the presence of any condition that precludes OPTISON administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
Common side effects
- Headache
- Back/renal pain
- Dizziness
- Nausea
- Chest pain
- Injection site reactions
- Application Site Disorders
- Body as a Whole: Fatigue
- Cardiovascular: Abnormal ECGs
- Cardiovascular: Bradycardia
- Cardiovascular: Tachycardia
- Cardiovascular: Palpitation
Key clinical trials
- Influence of Tamponade on Retinal Shift in Eyes Undergoing Vitrectomy for Rhegmatogenous Retinal Detachment: A Comparison of Gas Versus Silicone Oil in a Pakistani Population (NA)
- Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy (EARLY_PHASE1)
- SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial (PHASE2)
- Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease (PHASE2)
- Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma (NA)
- Prediction of Neoadjuvant Chemotherapy Response Using Contrast-Enhanced Ultrasound in Patients With Locally Advanced Breast Cancer (PHASE2, PHASE3)
- 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
- Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PERFLUTREN CI brief — competitive landscape report
- PERFLUTREN updates RSS · CI watch RSS