Effectiveness of Risk Evaluation and Mitigation Strategies (REMS) for Lenalidomide and Thalidomide: Patient Comprehension and Knowledge Retention.

Introduction: The effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages.

Methods: Results from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category.

Results: In total, 73,645 patients were enrolled into the REMS programs for lenalidomide and thalidomide and completed mandatory surveys prior to medication dispense.

The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals.

Introduction: Educational brochures are an important tool for communicating risk to health-care professionals. It is important to evaluate the impact of any risk minimization tool to understand the effectiveness of the strategy. The objective of this study was to assess the effectiveness (i.

Teratogenic Drugs and Risk Management: An Implementation Assessment.

About half of all pregnant women are prescribed medication during their pregnancy, including drugs with teratogenic potential. There is a need to manage teratogenic risk and prevent fetal harm. In the US, risk management strategies may range from product labeling to the US Food and Drug Administration requiring a risk evaluation and mitigation strategy, including elements to assure safe use.

Managing the teratogenic risk of thalidomide and lenalidomide: an industry perspective.

Celgene has developed and operated pregnancy prevention programs since 1998 with the first approval of thalidomide in the US. With the development and marketing of lenalidomide, an analog of thalidomide, the company further advanced its risk management activities, which now cover several territories across the globe. To date, the program is a success in as much as it has minimized the risk of fetal exposure and subsequent development of fetal malformations.

Venous thromboembolism in myelodysplastic syndrome patients receiving lenalidomide: results from postmarketing surveillance and data mining techniques.

Background And Objectives: Multiple myeloma treatment with lenalidomide-based regimens is associated with risk of venous thromboembolism (VTE), particularly during concomitant use with erythropoiesis-stimulating agents (ESAs). The risk of VTE in myelodysplastic syndrome (MDS) patients treated with lenalidomide is not well characterized and the background risk in untreated patients is not known. This study set out to determine the reporting rate of VTE in MDS patients on lenalidomide in the two years of postmarketing experience in the US, and to investigate whether there is a disproportional signal of VTE in MDS patients on lenalidomide by screening the US FDA Adverse Event Reporting System (AERS) safety database.

RevAssist: a comprehensive risk minimization programme for preventing fetal exposure to lenalidomide.

Lenalidomide (Revlimid) is an immunomodulatory drug and an analogue of thalidomide, a known teratogen. To prevent fetal exposure, in the US lenalidomide is available only under a special restricted distribution programme called RevAssist. Under this risk minimization programme, only prescribers and contract pharmacies registered with the programme are able to prescribe and dispense the product.

Finding patients eligible for antiretroviral therapy using TB services as entry point for HIV treatment.

Objective: To estimate the proportion of antiretroviral therapy (ART) eligible adults (15-49 years) with tuberculosis potentially identifiable through tuberculosis services using a CD4 count below 350 cells/mm3 as cut-off value for ART initiation.

Methods: Using TB notification rate data, HIV seroprevalence data, and estimates of the size of the adult population (15-49 years) in 18 sub-Saharan African countries with an HIV seroprevalence of > 5%, calculations of the number of ART eligible adults with tuberculosis presenting to tuberculosis services were made. Assumptions were made on the tuberculosis notification rates in the age-group 15-49 years, the HIV-infected population with a CD4 count below 350 cells/mm3 and the relative risk of developing tuberculosis, and average duration from HIV infection to death.