Medication Monitor

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Generic Name (Trade Name—Company)
  • January 1, 2011


    Prevention of skeletal-related events in patients with bone metastases from solid tumors

    Data from three randomized, double-blind trials comparing denosumab 120 mg with zoledronic acid 4 mg (Zometa—Novartis), both given once every 4 weeks, showed that denosumab was superior to zoledronic acid in preventing skeletal-related events in patients with breast or prostate cancer and bone metastasis and was noninferior to zoledronic acid in preventing these events in patients with multiple myeloma or other solid tumors. The FDA-recommended dose is 120 mg administered as a subcutaneous injection every 4 weeks. It is important to distinguish the dosing and indication differences between Prolia and Xgeva, both of which contain denosumab. Prolia is dosed as a 60-mg subcutaneous injection once every 6 months and is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

  • June 30, 2016

    A new combination agent, linagliptin and metformin hydrochloride extended-release tablets, has received FDA approval for the treatment of type 2 diabetes in adults. According to the manufacturers, the product offers adults with type 2 diabetes the convenience of a combination pill taken once a day to help lower blood glucose levels.

    The product combines 2.5 mg or 5 mg of linagliptin with 1,000 mg of metformin. Linagliptin, a dipeptidyl peptidase-4 inhibitor, works by increasing hormones that stimulate the pancreas to produce more insulin and the liver to produce less glucose.

    Metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.

    It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate. It should not be used in patients with type 1 diabetes or to treat diabetic ketoacidosis and has not been studied in people with a history of pancreatitis.

    The label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can result from metformin accumulation during treatment.

    Safety and efficacy were based on adequate and well-controlled studies of linagliptin and metformin coadministered in patients with type 2 diabetes inadequately controlled by diet and exercise and in combination with sulfonylurea.

     It is the seventh new treatment from the Boehringer Ingelheim–Lilly Diabetes alliance to be approved by FDA in the past 5 years.

  • January 1, 2011


    Treatment of type 2 diabetes as an adjunct to diet and exercise as monotherapy or in combination with other oral antidiabetic agents

    The exact mechanism by which bromocriptine improves glycemic control is unknown; it may normalize aberrant hypothalamic neurotransmitter activities that induce, potentiate, and maintain the insulin-resistant, glucose-intolerant state. Data from four double-blind, placebo-controlled trials (one monotherapy and three add-on trials) involving more than 3,700 patients with type 2 diabetes showed that bromocriptine produced clinically significant improvements in glycosylated hemoglobin (A1C) (difference from placebo [range –0.4% to –0.6%]) and postprandial glucose, and more patients given bromocriptine reached an A1C goal of 7% or less compared with placebo. The recommended dose is 1.6–4.8 mg once daily. The tablets are currently available in pharmacies in a 0.8-mg strength.

  • February 2, 2015

    FDA has expanded the approved uses of lisdexamfetamine dimesylate to treat binge-eating disorder in adults. The first FDA-approved medication to treat this condition, the drug was approved in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients aged 6 years and older. 

    Efficacy of lisdexamfetamine dimesylate in treating binge-eating disorder was shown in two clinical studies that included 724 adults with moderate to severe binge-eating disorder. Participants taking lisdexamfetamine dimesylate experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared with those on placebo.

    Lisdexamfetamine dimesylate was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. It is a Schedule II controlled substance because it has high potential for abuse, with use potentially leading to dependence. It is not approved for, or recommended for, weight loss, as efficacy for weight loss has not been studied.

    The most common adverse effects reported by people taking lisdexamfetamine dimesylate in the clinical trials included dry mouth, insomnia, increased heart rate, jittery feelings, constipation, and anxiety.

    The medication's most serious risks include psychiatric problems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants such as lisdexamfetamine dimesylate may cause psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness.

  • December 13, 2014

    FDA has expanded the approved use of ramucirumab to treat patients with metastatic non–small cell lung cancer (NSCLC), the most common type of lung cancer.

    Ramucirumab works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has grown during or following treatment with platinum-based chemotherapy and is used in combination with docetaxel, another type of chemotherapy.

    The approval is the third indication that ramucirumab has received in 2014. On April 21, FDA approved ramucirumab as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma. On November 5, FDA expanded ramucirumab's use to treat patients with advanced gastric or GEJ adenocarcinoma to include paclitaxel, another chemotherapy drug.

    Approval of ramucirumab plus docetaxel for metastatic NSCLC was based on a clinical study of 1,253 participants with previously treated and progressive lung cancer. Study participants were randomly assigned to receive ramucirumab plus docetaxel or a placebo plus docetaxel. Treatment was given until disease progression or development of intolerable adverse effects.The trial was designed to measure overall survival rate. Results showed that half of the participants treated with ramucirumab plus docetaxel survived an average of 10.5 months from the start of treatment, compared with an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.

    The most common adverse effects associated with ramucirumab plus docetaxel observed in the clinical study included neutropenia, fatigue, and stomatitis.Ramucirumab can cause severe bleeding, blood clots, and elevation in blood pressure and may impair wound healing.

    FDA reviewed ramucirumab’s application for this new use under the agency’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.