BEGIN:VCALENDAR VERSION:2.0 PRODID:-//wp-events-plugin.com//7.2.3.1//EN BEGIN:VEVENT UID:11@siliconvalleyons.org DTSTART:20170113T020000Z DTEND:20170113T030000Z DTSTAMP:20170117T130407Z URL:https://www.siliconvalleyons.org/events/rubraca-prescribing-overview/ SUMMARY:Rubraca Prescribing Overview DESCRIPTION:You are Invited to Attend a Live Video Broadcast and Dinner\n\n Rubraca (rucaparib) Prescribing Overview\nJanuary 12\, 2017\nIntroducing R ubraca\n\nPanelists: Michael J. Birrer\, MD\, PhD\nHarvard Medical School\ nMassachusetts General Hospital\n\nTina Atkinson\, RN\nMassachusetts Gener al Hospital\n\nRubraca™ is indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associa ted advanced ovarian cancer who have been treated with two or more chemoth erapies. Select patients for therapy based on an FDA-approved companion di agnostic for Rubraca.\n\nThis indication is approved under accelerated app roval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and desc ription of clinical benefit in confirmatory trials.\n(650) 329-8457\n\nRSV P: CLICK HERE \n\nOr go to www.rubracaspeakers.com\n\nand enter EVENT CODE : 2017\n\nRegistration questions? Call or e-mail\nJoyce Creamer ( jcreamer @rrhealthcare.com) at\nR&\;R Healthcare Communications – 813-855-5533 .\n\nOr contact your Clovis Territory Manager:\n\nRenel Gologhlan\n\n(323) 363-2124\n\nrgologhlan@clovisoncology.com\n\nConsistent with the PhRMA Co de on Interactions with Healthcare Professionals\, attendance at this educ ational program is limited to healthcare professionals. Accordingly\, atte ndance by guests or spouses is not appropriate and cannot be accommodated. The value of a meal and other transfers of value\, if any are provided\, may be disclosed pursuant to state and federal law.\n\nSELECT IMPORTANT SA FETY INFORMATION\nPlease Note: This is not a CME event.\nThere are no cont raindications with Rubraca.\nMyelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) was reported in 2 of 377 (0.5%) patients with ovarian cance r treated with Rubraca. The duration of Rubraca treatment prior to the dia gnosis of MDS/AML was 57 days and 539 days. Both patients received prior t reatment with platinum and other DNA damaging agents.\nAML was reported in 2 (<\;1%) patients with ovarian cancer enrolled in a blinded\, randomiz ed trial evaluating Rubraca versus placebo. One case of AML was fatal. The duration of treatment prior to the diagnosis of AML was 107 days and 427 days. Both patients had received prior treatment with platinum and other D NA damaging agents.\nDo not start Rubraca until patients have recovered fr om hematological toxicity caused by previous chemotherapy (≤ Grade 1).\n Monitor complete blood count testing at baseline and monthly thereafter. F or prolonged hematological toxicities\, interrupt Rubraca and monitor bloo d counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks\, refer the patient to a hematologist for further investigations\, including bone marrow analysis and blood sample for cytog enetics. If MDS/AML is confirmed\, discontinue Rubraca.\nRubraca can cause fetal harm when administered to pregnant women based on its mechanism of action and findings from animal studies.\nApprise pregnant women of the po tential risk to a fetus. Advise females of reproductive potential to use e ffective contraception during treatment and for 6 months following the las t dose of Rubraca.\nMost common adverse reactions (≥20%\; Grade 1-4) wer e nausea (77%)\, asthenia/fatigue (77%)\, vomiting (46%)\, anemia (44%)\, constipation (40%)\, dysgeusia (39%)\, decreased appetite (39%)\, diarrhea (34%)\, abdominal pain (32%)\, dyspnea (21%)\, and thrombocytopenia (21%) .\nMost common laboratory abnormalities (≥35%\; Grade 1-4) were increase in creatinine (92%)\, increase in alanine aminotransferase (ALT) (74%)\, increase in aspartate aminotransferase (AST) (73%)\, decrease in hemoglobi n (67%)\, decrease in lymphocytes (45%)\, increase in cholesterol (40%)\, decrease in platelets (39%)\, and decrease in absolute neutrophil count (3 5%).\nBecause of the potential for serious adverse reactions in breast-fed infants from Rubraca\, advise lactating women not to breastfeed during tr eatment with Rubraca and for 2 weeks after the final dose.\nYou may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You ma y also report side effects to\nClovis Oncology\, Inc. at 1-844-258-7662.\n \nPlease see accompanying full Prescribing Information for additional Impo rtant Safety Information. LOCATION:Fleming's Prime Steakhouse and Wine Bar\, 180 El Camino Real\, Pal o Alto\, CA\, 94304\, United States GEO:37.4442891;-122.17107920000001 X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=180 El Camino Real\, Palo A lto\, CA\, 94304\, United States;X-APPLE-RADIUS=100;X-TITLE=Fleming's Prim e Steakhouse and Wine Bar:geo:37.4442891,-122.17107920000001 END:VEVENT END:VCALENDAR