Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • March 1, 2011

    Uses:

    Reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations

    Roflumilast is an oral agent that has a unique mechanism of action because it and the active metabolite roflumilast N-oxide are selective inhibitors of phosphodiesterase 4, the main cyclic adenosine monophosphate–metabolizing enzyme in inflammatory and immune cells. FDA said that roflumilast, given as a 500 µg tablet once daily to patients with severe COPD associated with chronic bronchitis, resulted in a significant reduction in the rate of moderate or severe exacerbations compared with placebo-treated patients; long-acting beta-2–adrenergic receptor agonists and short-acting muscarinics was used by approximately 40% of patients in both groups. In addition, roflumilast was also shown to be more efficacious in improving lung function when used concomitantly with salmeterol (Serevent—GlaxoSmithKline) or tiotropium (Spiriva—Boehringer Ingelheim) over a 6-month period compared with these agents alone. Use of this agent has been associated with psychiatric adverse events.

  • March 1, 2011

    Uses:

    Reduce the risk of preterm birth in women with a singleton pregnancy and a history of singleton spontaneous preterm birth

    FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women; however, the original manufacturer requested withdrawal of the product from the market in 2000 for reasons unrelated to safety. This newly available synthetic progestin is given as a 250-mg intramuscular injection once weekly by a health professional beginning between 16 weeks, 0 days, and 20 weeks, 6 days gestation, and continuing until week 37 of gestation or delivery, whichever occurs first. Approval was based on data showing that women treated with weekly hydroxyprogesterone caproate injections were less likely to deliver babies before 32, 35, and 37 weeks of gestation compared with those given a vehicle injection. Injection site reactions, urticaria, pruritus, nausea, and diarrhea occurred more commonly with active therapy.

  • March 1, 2011

    Uses:

    Routine prophylactic treatment of congenital factor XIII deficiency

    The first and only factor XIII concentrate has been approved by FDA for congenital factor XIII deficiency, a rare condition affecting only 150 patients in the United States. The effectiveness of this product is based on maintaining a trough factor XIII activity level of approximately 5% to 20%. The drug has not been evaluated for the treatment of bleeding disorders in this patient population. The most common adverse events observed in clinical trials were hypersensitivity reactions, chills, elevations in temperature, arthralgia, headache, elevated thrombin–antithrombin levels, and increases in hepatic enzymes.

  • March 1, 2011

    Uses:

    Treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy

    Belimumab is a monoclonal antibody that blocks human B lymphocyte stimulator protein, a B-cell survival factor, resulting in reduced circulating naive and activated B cells, plasmacytoid cells, and the SLE B-cell subset. It is administered as a 10 mg/kg I.V. infusion at 2-week intervals for the first three doses and then once every 4 weeks thereafter. FDA approved the agent based on two clinical trials in which belimumab resulted in a greater number of patients achieving a response compared with placebo. Adverse events associated with therapy include serious infections, risk of malignancy, hypersensitivity reactions, and infusion-related reactions.

  • February 1, 2011

    Uses:

    Treatment of head lice infestations in patients 4 years of age and older

    This new prescription 0.9% topical suspension lice product is derived from a soil microbe. In two Phase III clinical trials involving 1,038 patients, 84.6% (study 1) and 86.7% (study 2) of patients treated with spinosad were lice free 14 days after the last treatment, compared with 44.9% (study 1) and 42.9% (study 2) of patients treated with permethrin 1% (Nix—Insight), FDA said. The most commonly reported adverse events with spinosad were application-site erythema (3%), ocular hyperemia (2%), and application-site irritation (1%). Spinosad is recommended to be applied to dry scalp and hair, left in place for 10 minutes, and rinsed off with warm water. No nit combing is required. Repeat applications are needed only if live lice are seen 7 days after the first treatment. ParaPRO expects spinosad to launch in the first half of 2011.

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