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Title: Study Shows The Antiepileptic Drug Keppra (Levetiracetam) Does Not Interact With An Oral Contraceptive

"Study Shows The Antiepileptic Drug Keppra (Levetiracetam) Does Not Interact With An Oral Contraceptive"

Important News for Women with Epilepsy SMYRNA, GA -- July 16, 2002 -- In a study published in the July issue of Epilepsia, the antiepileptic drug Keppra® (levetiracetam) did not affect the pharmacokinetics of an oral contraceptive containing ethinyl estradiol and levonorgestrel, and on the basis of blood serum progesterone and luteinizing hormone (LH) levels, it did not affect the contraceptive's efficacy, making Keppra® well suited for women of childbearing age with epilepsy. More than one million women in the United States live with seizure disorders, including epilepsy. Contraceptive failure and unplanned pregnancies have been well documented in women who must regularly take drugs to control their seizures, according to medical experts. "Drug interactions between antiepileptic drugs (AEDs) and oral contraceptives are a critical concern for women with epilepsy," said Isabelle Ragueneau-Majlessi, M.D., a research associate at the University of Washington School of Pharmacy in Seattle, Wash., and a co-author of the study. "To date, few AEDs have been shown not to impede the effect of oral contraceptives." While at least 90 percent of babies born to women with epilepsy are normal and healthy, the percentage can be even higher if the pregnancy is planned with the consultation of a neurologist and accompanied by ongoing prenatal care, according to the Epilepsy Foundation. "When prescribing an antiepileptic drug for a woman of childbearing age, it is important to select a drug that will not compromise the effectiveness of her oral contraceptive," said René Levy, Ph.D., chairman of the Department of Pharmaceutics at the University of Washington School of Pharmacy and a co-author of the study. "Keppra® has been shown to have a low potential to interact with other drugs, and this research shows that Keppra® can now be counted as an agent that is unlikely to interact with oral contraceptives." Keppra® tablets were approved by the U.S. Food and Drug Administration in November 1999 for the adjunctive treatment of partial onset seizures in adults with epilepsy. Keppra® use is associated with the occurrence of central nervous system adverse events, including somnolence and fatigue, coordination difficulties, and behavioral abnormalities, and with minor, but statistically significant, hematological abnormalities. Keppra® dosing must be individualized according to renal function status. Study Design and Results During a run-in phase, 18 healthy female patients received an oral contraceptive (OC) containing ethinyl estradiol, 0.03 mg, and levonorgestrel, 0.15 mg, for the first 21 days of two consecutive menstrual cycles. The subsequent treatment phase had a randomized, double-blind, placebo-controlled, two-way crossover design. Subjects received the OC concomitant with Keppra® in one menstrual cycle and with placebo in the other menstrual cycle, with the sequence of treatments determined according to a randomized schedule. Keppra® was not administered during the final seven days of each menstrual cycle. Plasma concentrations of ethinyl estradiol and levonorgestrel were measured on days 14 and 15 of each cycle for the evaluation of the 24-hour kinetic parameters, and an additional sample was collected on day 21 before drug administration to determine the trough plasma concentrations. Serum progesterone and LH levels were determined on days 13, 14, 15 and 21 of each cycle of the treatment phase. The mean plasma concentration-time curves and pharmacokinetic parameters of ethinyl estradiol and levonorgestrel were not statistically different during concomitant treatment with either Keppra® or placebo. The ratios of the log-transformed geometric mean areas under the plasma concentration-time curves, maximal and minimal plasma concentrations, and trough concentrations on day 21 ranged from 99.12 percent to 99.96 percent for ethinyl estradiol and from 97.13 percent to 99.41 percent for levonorgestrel. The 90 percent confidence intervals of these ratios were well within the 80 percent to 125 percent acceptance range for lack of interaction. Serum progesterone and LH concentrations were fairly constant during the run-in and treatment phases and remained markedly below their respective physiologic levels. Safety and menstrual-bleeding patterns were comparable during Keppra® and placebo administration. No serious adverse events or sustained idiosyncratic events were reported. Overall, 53 adverse events were reported during the cycle in which Keppra® was administered with the oral contraceptive, compared to 40 events during the cycle in which placebo and the oral contraceptive were given. As the leading international journal on the epilepsies for more than 30 years, Epilepsia provides comprehensive coverage of current clinical and research results. Each issue features articles on the diagnosis, treatment and management of epilepsy, written by the foremost experts worldwide. Articles encompass the entire range of epileptology, including clinical neurology, neurobiology, neurochemistry, neuropharmacology, neurophysiology, neuropsychology and neurosurgery. About UCB Pharma, Inc. UCB Pharma, Inc., with U.S. headquarters in Smyrna, Ga., is the North American subsidiary of the global, research-based pharmaceutical sector of UCB S.A. The pharmaceutical sector is dedicated to the development and commercialization of innovative pharmaceutical products for the treatment of neurological diseases and allergy-asthma. UCB S.A. has core businesses in pharmaceuticals, chemicals and films, and employs approximately 10,000 people globally, operating in more than 100 countries. Worldwide headquarters are located in Brussels, Belgium. For full prescribing information consult www.keppra.com SOURCE: UCB Pharma, Inc

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