- FDA authorizes StemCells to conduct trial of product candidate in patients with age-related macular degeneration
- Bayer receives approval to begin expanded access program for investigational prostate cancer therapy
- FDA removes clinical hold on trial of Idenix's investigational HCV therapy
- Discovery Labs' aerosol drug delivery system approved
- Merck's Janumet XR approved for type 2 diabetes
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA approves revised prescribing information for eptifibatide
Sunday, January 02 2005 | Comments
What's This?
The FDA approved revised prescribing information for eptifibatide (Integrilin), COR Therapeutics Inc. and Schering-Plough Corp reported.
The revised label includes a new dosing regimen for patients undergoing percutaneous coronary intervention (PCI) and specific reference within the product's indications for use in patients undergoing intracoronary stenting.
According to the companies, most of the changes are based on results from the ESPRIT (Enhanced Suppression of Platelet Receptor GP IIb-IIIa using Integrilin Therapy) study. ESPRIT showed a significant reduction in the combined end point of death, myocardial infarction, urgent target vessel revascularization, or need for thrombotic bail out with eptifibatide as compared with placebo at 48 hours and 30 days.
The new recommended dosing regimen for eptifibatide in patients undergoing PCI is based on that used in ESPRIT: an initial 180-mcg/kg bolus injection, immediately followed by a 2.0-mcg/kg/min infusion and a second 180-mcg/kg bolus injection 10 minutes after the first bolus.
The other labeling changes reflect new dosing guidelines for renally impaired patients, revised heparin dosing recommendations in PCI, and updates to the safety sections of the prescribing information.
Comments
Be the first to write a comment for this article!
You must be logged in to post a comment.
- White blood cell count in presence of elevated ESR, CRP level predicts infection status in patients undergoing total hip arthroplasty, researchers report
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
- Symptoms of early, delayed puberty demand close clinical attention, in spite of shifting norms for pubertal onset
- Low-dose doxepin improves wake after sleep onset among individuals with primary insomnia, data indicate
- School-based nutrition, exercise intervention program may not maintain BMI decreases through 10 months in overweight students, data indicate
- Careful discharge planning, follow-up vital for high-risk neonates facing hospital discharge, updated AAP guidelines state
- Nissen fundoplication in children with GERD reduces need for antireflux medication, researchers find
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
