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REMS required for belatacept
Patients treated with belatacept (Nulojix) are at an increased risk for developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) and progressive multifocal leukoencephalopathy (PML), according to a recent Safety Alert. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV), and therefore is indicated for use only in transplant patients who are EBV seropositive.
Patients treated with belatacept (Nulojix) are at an increased risk for developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) and progressive multifocal leukoencephalopathy (PML), according to a recent Safety Alert. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV), and therefore is indicated for use only in transplant patients who are EBV seropositive.
Nulojix is a selective T-cell costimulation blocker that was recently approved in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids to prevent acute rejection in adult patients who have had a kidney transplant. The drug helps to prevent organ rejection after a kidney transplant. It is not recommended for use in liver transplant patients due to an increased risk of graft loss and death, and its use in patients with other transplanted organs has not been established.
FDA recommends that healthcare providers verify the patient’s EBV status before initiating therapy with Nulojix. Bristol-Myers Squibb has established the ENLiST Registry to determine the incidence of PTLD, CNS PTLD, and PML in US adult EBV seropositive kidney transplant recipients treated with Nulojix. The registry is intended to enroll all adult kidney transplant patients who are treated with Nulojix. The manufacturer encourages participation, and more information will be available on clinicaltrials.gov and information on how to enroll can be gained by calling (800) 321-1335.
Adverse events or side effects related to the use of Nulojix should be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program. (www.fda.gov/MedWatch/report.htm)
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
