Medication Monitor



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Generic Name (Trade Name—Company)
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  • May 13, 2011

    Uses:

    Treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adult patients with compensated liver disease, including those with cirrhosis

    Boceprevir, the first HCV protease inhibitor to reach the U.S. market, is used only in combination with peginterferon alfa and ribavirin. In clinical studies of patients poorly responsive to interferon, oral boceprevir administered three times daily (every 7–9 hours) with food improved the sustained virologic response (SVR) rate by threefold (up to 66%, compared with 23% with placebo). In treatment-naive patients, the SVR was also in the 66% range, compared with 38% for patients in a control group. In combination boceprevir therapy, the most commonly reported adverse reactions (greater than 35%) have been fatigue, anemia, nausea, headache, and dysgeusia.    

  • May 10, 2011

    Uses:

    Active immunization against influenza virus in adults 18 to 64 years of age  

    Sanofi pasteur announced the approval of the first influenza vaccine licensed in the United States that uses a novel microinjection system for intradermal delivery. Fluzone Intradermal differs from the I.M. formulation of Fluzone in that it features an ultrafine needle that is 0.06 inches in length and the vaccine contains 9 µg of hemagglutinin per strain of influenza in a 0.1 mL dose. The Fluzone I.M. formulation is administered using a needle 1 to 1.5 inches in length and contains 15 µg of hemagglutinin per strain of influenza in a 0.5 mL dose. In a Phase III clinical trial involving 4,276 adults, Fluzone Intradermal was found to induce immunologic responses that were comparable with the I.M. formulation. Since this new formulation deposits medication near the surface of the skin, local reactions occurred frequently, including redness, swelling, induration, pain, and pruritus. Fluzone Intradermal will be available during the upcoming 2011–12 influenza season.

     

  • May 1, 2011

    Uses:

    Treatment of patients with metastatic castration-resistant prostate cancer who have already received prior chemotherapy with docetaxel; abiraterone should be used in combination with prednisone

    Abiraterone is a once-daily, oral androgen biosynthesis inhibitor. It is unique from other androgen deprivation therapies because abiraterone blocks androgen production from three sources (testicular, adrenal, and prostate tumor tissues) compared with only one source (testicular) for other treatments. FDA relied on data from a pivotal Phase III trial involving 1,195 patients with metastatic advanced prostate cancer previously treated with docetaxel showed that patients given abiraterone 1,000 mg once daily plus prednisone/prednisolone 5 mg twice daily had a 35% reduction in the risk of death compared with those given placebo plus corticosteroids. Some of the most common adverse events reported during this trial in patients treated with abiraterone were joint swelling or discomfort (29.5%) and edema (26.7%).

  • May 1, 2011

    Uses:

    Treatment of adult patients with type 2 diabetes as an adjunct to diet and exercise

    Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that has some unique features compared with other DPP-4 inhibitors on the market. It does not require dosage modifications in patients with renal impairment, it has a long terminal half-life (> 100 h), and it will only be marketed in a single strength of 5 mg for once-daily dosing. The efficacy and safety of linagliptin have been evaluated in numerous trials involving nearly 4,000 patients with type 2 diabetes, FDA said. When given as monotherapy, treatment with linagliptin resulted in glycosylated hemoglobin (A1C) reductions of up to 0.7% compared with placebo. When used in combination with other oral antidiabetic agents, the addition of linagliptin resulted in reductions in A1C levels of 0.5% to 0.6% compared with placebo. Nasopharyngitis was the most commonly reported adverse event with the drug.

  • May 1, 2011

    Uses:

    Treatment of medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease

    Vandetanib is a tyrosine kinase inhibitor that is thought to work by inhibiting the vascular endothelial growth factor pathway, epidermal growth factor receptor, and rearranged during transfection pathways. FDA approval of vandetanib for patients with advanced medullary thyroid cancer was based on results of the Phase III ZETA study. The trial showed that patients given vandetanib 300 mg daily (n = 231) had a significant improvement in progression-free survival compared with the 100 patients given placebo (22.6 vs. 16.4 mo). Because of its potential to cause torsades de pointes and sudden death, only prescribers and pharmacists certified with the vandetanib Risk Evaluation and Mitigation Strategy program can prescribe and dispense the drug, respectively.

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