Dermatology World May 2011 : Page-42
academy update STELARA™ (ustekinumab) were observed in the developmental and reproductive toxicology studies performed in cynomolgus monkeys at doses up to 45 mg/kg ustekinumab, which is 45 times (based on mg/kg) the highest intended clinical dose in psoriasis patients (approximately 1 mg/kg based on administration of a 90 mg dose to a 90 kg psoriasis patient). Ustekinumab was tested in two embryo-fetal development toxicity studies. Pregnant cynomolgus monkeys were administered ustekinumab at doses up to 45 mg/kg during the period of organogenesis either twice weekly via subcutaneous injections or weekly by intravenous injections. No significant adverse developmental effects were noted in either study. In an embryo-fetal development and pre-and post-natal development toxicity study, three groups of 20 pregnant cynomolgus monkeys were administered subcutaneous doses of 0, 22.5, or 45 mg/kg ustekinumab twice weekly from the beginning of organogenesis in cynomolgus monkeys to Day 33 after delivery. There were no treatment-related effects on mortality, clinical signs, body weight, food consumption, hematology, or serum biochemistry in dams. Fetal losses occurred in six control monkeys, six 22.5 mg/kg-treated monkeys, and five 45 mg/kg-treated monkeys. Neonatal deaths occurred in one 22.5 mg/kg-treated monkey and in one 45 mg/kg-treated monkey. No ustekinumab-related abnormalities were observed in the neonates from birth through six months of age in clinical signs, body weight, hematology, or serum biochemistry. There were no treatment-related effects on functional development until weaning, functional development after weaning, morphological development, immunological development, and gross and histopathological examinations of offsprings by the age of 6 months. Nursing Mothers Caution should be exercised when STELARA™ is administered to a nursing woman. The unknown risks to the infant from gastrointestinal or systemic exposure to ustekinumab should be weighed against the known benefits of breast-feeding. Ustekinumab is excreted in the milk of lactating monkeys administered ustekinumab. IgG is excreted in human milk, so it is expected that STELARA™ will be present in human milk. It is not known if ustekinumab is absorbed systemically after ingestion; however, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulation in substantial amounts. Pediatric Use Safety and effectiveness of STELARA™ in pediatric patients have not been evaluated. Geriatric Use Of the 2266 psoriasis subjects exposed to STELARA™, a total of 131 were 65 years or older, and 14 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects. OVERDOSAGE: Single doses up to 4.5 mg/kg intravenously have been administered in clinical studies without dose-limiting toxicity. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment be instituted immediately. PATIENT COUNSELING INFORMATION: Instruct patients to read the Medication Guide before starting STELARA™ therapy and to reread the Medication Guide each time the prescription is renewed. Infections Inform patients that STELARA™ may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the doctor, and contacting their doctor if they develop any symptoms of infection. Malignancies Patients should be counseled about the risk of malignancies while receiving STELARA™. Allergic Reactions Advise patients to seek immediate medical attention if they experience any symptoms of seriousc allergic reactionsc. Prefilled Syringe Macnufactured by: Centocor Ortho Biotcech Inc., Horsham, PA 19044, c License No. 1821 atc Baxter Pharmaceuticacl Solutions, Bloomington, IN 47c403 © Centocor Ortho Bicotech Inc. 2010 Vial Manufactured bcy: Centocor Ortho Biotcech Inc., Horsham, PA 19044, License No. 1821 atc Cilag AG, Schaffhausen, Switzecrland 25ST11 019 international scholarships to 2012 annual Meeting available poster exhibit and registration scholarships MaKe it possible for young dermatologists from around the world to attend the Academy’s Annual Meeting each year. Information on applying for scholarships for the 70th Annual Meeting, being held March 16-20 in San Diego, appears below. (Previous scholarship recipients are not eligible.) poster exhibit scholarships Applicants must be from developing countries and within three years of the completion of their dermatology residency training at the time of the Annual Meeting. The scholarship includes a regis-tration waiver, free admission to a one-day course, and a stipend. There is a limit of two scholarships per country. Applicants must be endorsed by an officer of their national dermatologic society and must submit a poster abstract. Applications are due July 15, 2011 at www.aad.org/scholarshipop portunities/#ampes. registration scholarships Designed to give young dermatologists from outside the U.S. and Canada an opportunity to attend the Annual Meeting, these scholarships are limited to two recipients per country. They include complimentary tuition to a one-or two-day post-graduate course at the Annual Meeting. Successful candidates must have adequate funds for travel and housing, and should be able to understand spoken English. Applications are due Sept. 1, 2011 at www.aad.org/ scholarshipopportunities/#regschol. Both applicants and officers of national dermatologic societies must complete and submit an application and a nomination form. For more information about either scholarship, contact Coura Badiane, international affairs specialist, at cbadiane@aad.org or (847) 240-1241. – coura badiane leadership circle passes million-hour mark the acadeMy’s leadership circle for volunteerisM program has recorded 1,063,114 hours of volunteer work submitted by 1,213 members. These hours are valued at $118,258,690! Submit your hours and earn a lapel pin to wear at the next Annual Meeting at www.aad.org/members/ leadership/leadershipcircle.html. – Marlene baniKe correction In the April issue Members Making a Difference column (p. 42), it was reported that Jeffrey Thompson, D.O., traveled to Haiti following the 2010 earthquake. Dr. Thompson’s five volunteer visits actually occurred prior to that event. Dermatology World regrets the error. www.aad.org
