New molecular entity: Ecallantide (Kalbitor) was approved in December 2009, to treat hereditary angioedema (HAE).
Ecallantide 30 mg (3 mL) subcutaneous injection was approved by FDA in December 2009 to treat hereditary angioedema (HAE). HAE is a rare genetic condition caused by a mutation in the C1 esterase-inhibitor (C1-INH) gene, resulting in low levels of the blood protein. C1-INH plays a role in regulating a person's immune system and intrinsic clotting pathways through inhibiting kallikrein, and ultimately, reducing the downstream production of bradykinin (a vasodilator thought to be responsible for HAE symptoms). HAE attacks result in sudden fluid buildup in the face and other parts of the body, and may lead to permanent disfigurement, disability or death. It is estimated that 10,000 people in the United States have HAE. This is the second drug marketed in the United States to treat HAE attacks. Earlier in 2009, FDA approved human blood derived C1-INH (Berinert) to treat facial and abdominal attacks of HAE.
Efficacy. The safety and efficacy of ecallantide was evaluated in 2 randomized, double-blind, placebo-controlled trials (dubbed EDEMA3 and EDEMA4) enrolling 168 patients with HAE. Patients having an attack of HAE, at any anatomic location (abdominal, peripheral or laryngeal), and having at least 1 moderate or severe symptom, were treated with 30 mg subcutaneous injections of ecallantide or placebo. Both trials demonstrated that patients treated with ecallantide had significantly greater reductions in their symptom severity and were more likely to report a positive response to treatment compared with patients receiving placebo.
Safety. The most worrisome side-effect of ecallantide is anaphylaxis. In 255 HAE patients treated with the drug as part of clinical trials, 10 patients (3.9%) experienced anaphylaxis. Anaphylaxis most commonly occurs within the first hour after injection of ecallantide. Because of the risk of anaphylaxis, ecallantide should only be administered by a healthcare professional, in a healthcare setting where serious anaphylactic reactions and HAE can be treated. Other common side-effects of ecallantide use include headache, nausea, fatigue, diarrhea, upper respiratory tract infection, injection site reactions, nasopharyngitis, vomiting, pruritus, upper abdominal pain, and pyrexia.
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.