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  1. No Access

    Article

    A multinational, drug utilization study of lipegfilgrastim use in real-world setting in Europe

    Lipegfilgrastim (Lonquex, Teva Pharma B.V.) is approved for reduction in neutropenia duration and febrile neutropenia incidence. In the framework of lipegfilgrastim regulatory approval in the EU, the Health Au...

    Sigal Kaplan, Dana Ilic Bogojevic, Carolyn Rainville in Supportive Care in Cancer (2022)

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    Article

    Pregnancy, Fetal, and Infant Outcomes Following Maternal Exposure to Glatiramer Acetate During Pregnancy and Breastfeeding

    Published data support the safety of glatiramer acetate in patients with multiple sclerosis who are pregnant or breastfeeding, but long-term data are limited.

    Sigal Kaplan, Mikhail Zeygarnik, Tal Stern in Drug Safety (2022)

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    Article

    Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance

    Fentanyl buccal tablet (FBT), a potent opioid, was approved in Canada in 2013 for breakthrough pain in opioid-tolerant adult cancer patients. Additional risk minimization measures (aRMMs), consisting of commun...

    Sigal Kaplan, Aurore Bergamasco, Martin Sergerie, Anne-Marie Castilloux in Drug Safety (2020)

  4. Article

    Open Access

    Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe

    Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance w...

    Daniel Fife, John Waller, Sigal Kaplan, Peter Hu in Clinical Drug Investigation (2019)

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    Article

    The Prevalence and Trends of Antiviral Medication Use During Pregnancy in the US: A Population-Based Study of 664,297 Deliveries in 2001–2007

    To evaluate the prevalence, trends, timing and duration of exposure to antiviral medications during pregnancy within a US cohort of pregnant women and to evaluate the proportion of deliveries with a viral infe...

    Lyndsay A. Avalos, Hong Chen, Chunmei Yang in Maternal and Child Health Journal (2014)

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    Article

    Medication Exposure in Pregnancy Risk Evaluation Program: The Prevalence of Asthma Medication Use During Pregnancy

    Asthma is one of the most common chronic diseases in women of reproductive age, occurring in up to 8 % of pregnancies. The objective of this study is to assess the prevalence of asthma medication use during pr...

    Craig Hansen, Peter Joski, Heather Freiman in Maternal and Child Health Journal (2013)