If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  FDA Approves Cafcit Injection For Apnea In Preterm Infants COLUMBUS, OH -- February 15, 2000 -- Roxane Laboratories, Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. announced U.S. Food and Drug Administration (FDA) approval of Cafcit(R) (caffeine citrate) Injection for the short-term treatment of apnea of prematurity (AOP) in infants between 28 and <33 weeks gestational age. Cafcit is the only product approved for the treatment of AOP, a condition in which cessation of breathing in preterm infants can cause dangerously low levels of blood oxygen. Cafcit has received Orphan Drug Status from the U.S. government and is one of only three drugs approved for neonatal use.
"Given once daily, Cafcit has been shown to reduce the frequency of apnea spells in preterm babies," said Adam A. Rosenberg, MD, Director of Newborn Services at University of Colorado Hospital, Denver, CO, and Professor of Pediatrics, University of Colorado School of Medicine. "If normal breathing can be maintained, the damaging effects of AOP can be prevented." The American Academy of Pediatrics and the U.S. Birth Cohorts estimates there will be more than 4.2 million births in the U.S. in 2000. Of those, more than 300,000 will be born at less than 34 weeks gestational age and weighing less than 2,500 grams. Half of these infants (more than 150,000) will be diagnosed and treated for AOP. Historically AOP has been treated with theophylline, although this drug has not received regulatory approval from the FDA for the treatment of AOP. Caffeine citrate solution has also been previously used in AOP. However, until the introduction of Cafcit, it was necessary to prepare caffeine citrate solution in the hospital pharmacy -- a practice that requires time and precise compounding. Cafcit is the first available commercially manufactured formulation of caffeine citrate, and its long half-life (~ three - four days in neonates) allows for once-a-day dosing. Cafcit is available in ready-to-use, single-dose vials, which minimize the risk of compounding errors in the pharmacy and ensures product stability and sterility at the manufacturing level. Each 3-mL single-dose vial contains a concentration of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial). Results from a 10- to 12-day multicenter, randomized, double-blind placebo-controlled trial of 85 preterm infants (gestational age 28 to <33 weeks) with apnea of prematurity demonstrated that Cafcit treatment significantly eliminated apnea events on day two of treatment [percent of patients with zero apnea events: 26.7 percent (Cafcit) vs. 8.1 percent (placebo), p=0.03]. the mean number of days with zero apnea events was 3.0 in the Cafcit group and 1.2 in the placebo group. The mean number of days with a 50 percent reduction from baseline in apnea events was 6.8 in the Cafcit group and 4.6 in the placebo group. Overall, adverse events were similar between Cafcit and placebo in the double-blind trial. However, events described in published literature include CNS stimulation, cardiovascular effects, gastrointestinal effects, alterations in serum glucose and renal effects. Six cases of necrotizing enterocolitis (NEC) developed among the 85 infants studied during the double-blind, placebo-controlled trial. Five of the six patients with NEC were randomized to or had been exposed to Cafcit. Although a causal relationship between methylxanthine (theophylline and caffeine citrate) use and necrotizing enterocolitis (NEC) has not been established, infants should be carefully monitored for the development of NEC during treatment with Cafcit. Boehringer Ingelheim Pharmaceuticals, Inc., a leader in respiratory care, will market CAFCIT in the hospital environment. Roxane Laboratories, Inc. (Columbus, OH) is a leading manufacturer of ethical human pharmaceutical products with a strong commitment to palliative care and HIV. The company is a wholly owned subsidiary of Boehringer Ingelheim Corporation, located in Ridgefield, CT, and part of the Boehringer Ingelheim worldwide group of companies. The Boehringer Ingelheim group of companies, with headquarters in Ingelheim (Germany) is one of the 20 leading pharmaceutical corporations in the world. It reported revenues exceeding U.S. $1.4 billion in 1998. The corporation has more than 140 affiliated companies and it conducts business on every continent. Its product range is focused on human pharmaceuticals -- hospital, prescription and self-medication -- as well as animal health. The company has substantial research and development, production, and distribution facilities around the globe. In 1998 Boehringer Ingelheim spent U.S. $902 million on R&D, equivalent to 18 percent of total sales. Related Links: Roxane Laboratories, Inc. and Boehringer Ingelheim Pharmaceuticals, Inc.
|
