ASH Clinical News October 2016 | Page 20

Written in Blood – Mount Sinai Hospital in Toronto and McMaster University Medical Centre in Hamilton – between January 2000 and August 2014. Patients were identified through hospital medical records using International Classification of Diseases 10 codes for thrombocytopenia (platelets <100x109/L). Patients were excluded if they had: • thrombocytopenia of an alternate etiology, including preeclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, low platelets), or sepsis • platelet counts that remained above 70x109/L in pregnancy and normalized in the postpartum period (this was deemed gestational thrombocytopenia) Treatment intervention was not required in 137 pregnancies (58%). For the remaining 98 pregnancies (in 91 women), IVIg was the initial treatment in 47 pregnancies (48%), and corticosteroids were used in 51 pregnancies. Selection of the initial agent was determined by individual physicians. The mean dose of IVIg was 1 g/kg (standard deviation = 0.22). For those who received corticosteroids, the agents included: S:6.75” In the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy Approximately 30 to 35 percent of pregnant women with immune thrombocytopenia purpura (ITP) require therapeutic intervention during pregnancy, frequently with either corticosteroids or intravenous immune globulin (IVIg). Data supporting these treatments, though, comes predominantly from studies of non-pregnant patients with ITP. In a retrospective study published in Blood, Dongmei Sun, MD, MSc, from the Department of Medicine at the Schulich School of Medicine and Dentistry at Western University in Ontario, Canada, and authors evaluated whether treatment with corticosteroids or IVIg led to improved responses and how these drugs affected maternal and neonatal platelet counts, in women diagnosed with ITP prior to their pregnancies. Dr. Sun and colleagues analyzed data from 195 women who had 235 pregnancies (women who had subsequent pregnancies were included as long as they still met the eligibility criteria). Patients were recruited from two tertiary care centers in Canada 18 ASH Clinical News Everyone has a distinct profile Consider your patient.Consider BOSULIF. ( b o s u t inib) Bosutinib (BOSULIF®) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a treatment option for patients with CML in need of 2nd- or later-line TKI therapy.1 Study design: BOSULIF 500 mg once-daily treatment was studied in a single-arm, Phase 1/2, open-label, multicenter trial (N=546) in patients with CP, AP, or BP CML in second line (after imatinib) or in third line (after imatinib followed by dasatinib and/or nilotinib). Of the 546 patients enrolled, 73% were imatinib resistant and 27% were imatinib intolerant.2 AP=accelerated phase; BP=blast phase; CP=chronic phase. IMPORTANT SAFETY INFORMATION Contraindication: History of hypersensitivity to BOSULIF. Reactions have included anaphylaxis. Anaphylactic shock occurred in less than 0.2% of treated patients in clinical trials. Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain can occur. In the clinical trial, median time to onset for diarrhea was 2 days, median duration was 1 day, and median number of episodes per patient was 3 (range 1-221). Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce, or discontinue BOSULIF as necessary. Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur. Perform complete blood counts weekly for the first month and then monthly or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF as necessary. Hepatic Toxicity: Twenty percent of patients experienced an increase in either ALT or AST. Liver enzyme elevation usually occurs early in treatment. Perform T:15.25” G:.5” BOSULIF is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome–positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. Corticosteroids and Intravenous Immune Globulin Lead to Similar Outcomes in Pregnant Women With Immune Thrombocytopenia Purpura B:15.5” hepatic enzyme tests monthly for the first 3 months and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently. Drug-induced liver injury has occurred. Withhold, dose reduce, or discontinue BOSULIF as necessary. In patients with mild, moderate, or severe hepatic impairment, the recommended starting dose is 200 mg daily. Renal Toxicity: An on-treatment decline in estimated glomerular filtration rate has occurred in patients treated with BOSULIF. Monitor renal function at baseline and during therapy, with particular attention to patients with preexisting renal impairment or risk factors. Consider dose adjustment in patients with baseline and treatment emergent renal impairment. The recommended starting doses for patients with severe renal impairment (CrCL <30 mL/min) or moderate renal impairment (CrCL 30-50 mL/min) are 300 mg and 400 mg daily, respectively. Fluid Retention: Fluid retention can occur and may cause pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary.