INDICATIONS AND USAGE. KOVALTRY®, Antihemophilic Factor (Recombinant), is a recombinant, human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes KOVALTRY is not indicated for the treatment of von Willebrand disease I NTR O D U C TI O N “[Bayer] is engaged in the business of developing, manufacturing and distributing human health care products and has been conducting this business for more than 70 years . . . within the City Typically, this requires a development process with an average time frame of 10–12 years and an average investment of in excess of $200 million. As a consequence, long range planning is mandatory for business, financial, and competitive reasons.” —Development Agreement, 1992, page 4 Bayer’s 30-year Development Agreement with the City of Berkeley (DA) is the product of a company acutely aware of the long-term risk it was taking in building one of the earliest biopharmaceutical manufacturing facilities—with all the long-term investment and complex processes the venture required—and a city willing to under- stand and respond to those risks. In 1992, after a year of negotiations, Bayer and the City signed this historic agreement which provides the streamlined development processes that have allowed Bayer to develop the site over time. In return, the City has received a broad array of mitigations and community benefits. 2015 was a watershed year for the DA, showing that foresight and decades of collaboration pay off for a business and its employees, a community and its citizens, and patients around the world. Since 1992, Berkeley has served as Bayer’s global hub of biotech manufacturing, producing Kogenate®, a recombinant Factor VIII protein that replaces the clotting factors missing in patients born with the devastating disease of hemophilia A. Over the years, Kogenate® has become one of Bayer’s best-selling products. The construction of the new Product Testing Facility, begun in 2015 near Xxxxx’x Xxxxxxx Street entrance, represents the most recent investment in a site development process that began seven years ago with the mission of building state-of-the-art facilities, housing the state-of-the-art equipment needed for the manufacture of new generations of Bayer’s hemophilia treatments. As Bayer’s...
INDICATIONS AND USAGE. EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia. EXPAREL has not been studied for use in patients younger than 18 years of age.
INDICATIONS AND USAGE. LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study, at the end of both 2-week studies and at the end of the 6-month study. CONTRAINDICATIONS: None known. WARNINGS: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including LUNESTA. Because some of the important adverse effects of LUNESTA appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly (see DOSAGE AND ADMINISTRATION). A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with LUNESTA alone at therapeutic doses, the use of alcohol and other CNS depressants with LUNESTA appears to increase the risk of such behaviors, as does the use of LUNESTA at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of LUNESTA should be strongly considered for patients who report a “sleep-driving” episode. Other com...
