ASH Clinical News ACN_5.1_Digital - Page 15

UP FRONT school, I showed up to an exam on the wrong day because I read the calendar wrong, and the test administrator turned me away. It was devastating. So, I learned to hide the fact that I was dyslexic. But, in the past couple of years, I hit a brick wall and realized that I had to tell my boss because, of course, the higher I went in my career, the harder it was to cover up these challenges. When I started telling people about this, I noticed that people were more understanding about some of my quirks. Like, now they know why I need infor- mation presented a certain way with visual cues, need frequent reminders, or why I spend extra time making sure that I’m dotting my i’s and crossing my t’s before I send an email. I’m great with the big picture, but I need partners who have affinity for the smaller details. Before, they might have been aggravated by these things, or just assumed that I was extremely demanding, but now they un- derstand that this is part of the structure that I’ve created for myself to be able to do things more efficiently. Living with dyslexia and ADHD also taught me that everybody struggles with something – sometimes we know what it is, and sometimes we don’t. This is what makes us human – to our colleagues and our patients. If I can’t disclose what I’m NEW dosing option: 70 mg/m 2 Kd once weekly Priming dose of KYPROLIS ® Target therapeutic dose of KYPROLIS ® 30 minutes 20 mg/m 2 on Day 1 of Cycle 1 to evaluate tolerability 70 mg/m 2 starting on Day 8 of Cycle 1 Treatment schedule Administer KYPROLIS ® (70 mg/m 2 ) on 1 day each week for 3 weeks followed by a 13-day rest period as part of a 28-day treatment cycle Continue until disease progression or unacceptable toxicity occurs Refer to the dexamethasone Prescribing Information for other concomitant medications. References: 1. Amgen Inc. “FDA approves KYPROLIS ® (carfi lzomib) once-weekly 70 mg/m 2 in combination with dexamethasone (Kd70) for patients with relapsed or refractory multiple myeloma.” News release; October 1, 2018. 2. KYPROLIS ® (carfi lzomib) prescribing information, Onyx Pharmaceuticals Inc., an Amgen Inc. subsidiary. 3. Moreau P, Mateos M-V, Berenson JR, et al. Once weekly versus twice weekly carfi lzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study. Lancet Oncol. 2018;19:953-964. IMPORTANT SAFETY INFORMATION FOR KYPROLIS (cont.) • Patients using hormonal contraception associated with a risk of thrombosis should consider an alternative method of effective contraception during treatment. Posterior Reversible Encephalopathy Syndrome (PRES) Infusion Reactions • Cases of PRES have occurred in patients receiving KYPROLIS. If PRES is suspected, discontinue and evaluate with appropriate imaging. The safety of reinitiating KYPROLIS is not known. Hemorrhage • In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma. • Infusion reactions, including life-threatening reactions, have occurred. Symptoms include fever, chills, arthralgia, myalgia, facial fl ushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. These reactions can occur immediately following or up to 24 hours after administration. Premedicate with dexamethasone to reduce the incidence and severity of infusion reactions. Inform patients of the risk and of symptoms and seek immediate medical attention if they occur. • Fatal or serious cases of hemorrhage have been reported. Hemorrhagic events have included gastrointestinal, pulmonary, and intracranial hemorrhage and epistaxis. Promptly evaluate signs and symptoms of blood loss. Reduce or withhold dose as appropriate. Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant- ineligible Patients Embryo-fetal Toxicity Hepatic Toxicity and Hepatic Failure • KYPROLIS can cause fetal harm when administered to a pregnant woman. • Females of reproductive potential should be advised to avoid becoming pregnant while being treated with KYPROLIS and for 6 months following the fi nal dose. Males of reproductive potential should be advised to avoid fathering a child while being treated with KYPROLIS and for 3 months following the fi nal dose. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus. Thrombotic Microangiopathy ADVERSE REACTIONS The most common adverse reactions in the combination therapy trials: anemia, neutropenia, diarrhea, dyspnea, fatigue, thrombocytopenia, pyrexia, insomnia, muscle spasm, cough, upper respiratory tract infection, hypokalemia. Thrombocytopenia • KYPROLIS causes thrombocytopenia with recovery to baseline platelet count usually by the start of the next cycle. Monitor platelet counts frequently during treatment. Reduce or withhold dose as appropriate. • Cases of hepatic failure, including fatal cases, have occurred. KYPROLIS can cause increased serum transaminases. Monitor liver enzymes regularly regardless of baseline values. Reduce or withhold dose as appropriate. • Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), including fatal outcome, have occurred. Monitor for signs and symptoms of TTP/HUS. Discontinue if diagnosis is suspected. If the diagnosis of TTP/ HUS is excluded, KYPROLIS may be restarted. The safety of reinitiating KYPROLIS is not known. Please see Brief Summary of full Prescribing Information on adjacent pages. © 2018 Amgen Inc. All rights reserved. 09/18 USA-171-80362 Printed in USA h s MORE CONVENIENT: Once-weekly dosing means 50% fewer KYPROLIS ® infusions KYPROLIS ® infusion time To read more from our interview with Dr. Osunkwo, and learn about the mentors and advisors who she says “taught her how to be a doctor,” visit pulling-back-the-curtain. CMYK BETTER CONVENIENCE Kd70 dealing with to other people, then I’m not really being true to myself. ●