Medication Monitor

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  • October 10, 2011

    A new propellant-free ipratropium and albuterol inhaler product has been approved by FDA, according to a Boehringer Ingelheim news release. This new inhalation spray, Combivent Respimat, uses a slow-moving mist to deliver the same active ingredients as the original Combivent metered dose inhaler (MDI). It is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

    Approval was based on data from a 12-week, randomized, double-blind, placebo and active-controlled clinical trial in which Combivent Respimat was shown to be clinically comparable with Combivent MDI, both administered four times daily, in terms of maximal amount of air that can be forcefully exhaled in one second (FEV1).

    Combivent Respimat differs from Combivent MDI in that it only requires one inhalation per dose compared with two inhalations per dose for the MDI. In addition, Combivent Respimat also offers a dose indicator to inform patients of the amount of remaining medication in the inhaler.

    According to the manufacturer, this new inhalation product will be available for patients in mid-2012, but Combivent MDI will be available until late 2013 to allow adequate time to transition. As of January 1, 2014, Combivent Respimat will be the only Combivent product available.

  • September 26, 2011


    Treatment of active ulcerative colitis in children

    Infliximab is now approved for the treatment of moderately to severely active ulcerative colitis in pediatric patients 6 years of age and older who have had inadequate response to conventional therapy, according to a FDA news release.

    Approval was based on data from a multicenter, randomized, open-label study in 60 children ages 6 years to 17 years with moderately to severely active ulcerative colitis who had failed to respond to or tolerate conventional treatment. Treatment with infliximab reduced the signs and symptoms of the disease and induced and maintained clinical remission in these patients.

    A main concern with use of infliximab is its safety profile. The drug carries a boxed warning for serious infections and cancer. Tuberculosis and infections caused by viruses, fungi, or bacteria have been reported and cases of unusual cancers in adolescent and young adult patients such as hepatosplenic T-cell lymphoma have also been reported with use of other biologics.

    FDA noted that the benefits and risks of treatment should be discussed with parents and families before treatment is initiated. In addition, children should have all of their vaccines brought up to date before starting treatment with infliximab and should not receive live vaccines while taking the drug.

    Infliximab is also approved for the treatment of Crohn's disease in adults and children older than 6 years, and for management of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in adults.

  • September 23, 2011

    Eculizumab is the first and only treatment to receive FDA approval for management of children and adults with atypical hemolytic uremic syndrome (aHUS), according to a release by Alexion Pharmaceuticals. It was approved for this indication on an accelerated basis.

    aHUS is an extremely rare condition that disproportionally affects children. It is characterized by a genetic deficiency in one or more complement regulatory genes, resulting in life-long uncontrolled complement activation and subsequent complement-mediated formation of blood clots in small blood vessels throughout the body. Patients can have life-threatening damage to vital organs such as the kidneys, brain, and heart. Within 1 year of diagnosis, more than 50% of patients die, require dialysis, or have permanent kidney damage.

    Eculizumab is a first-in-class terminal complement inhibitor. It was originally approved in 2007 for treatment of patients with paroxysmal nocturnal hemoglobinuria. For patients with aHUS, the drug works by targeting uncontrolled complement activation, thereby inhibiting complement-mediated thrombosis. Accelerated approval for this new indication was based on data from two prospective studies in 37 adult and adolescent patients and one retrospective study in 19 pediatric patients. All patients treated with eculizumab demonstrated a reduction in terminal complement activity, and all studies met key clinical objectives such as hematologic normalization, maintenance or improvement of kidney function, and improved quality of life.

    The most common adverse events observed in patients treated with eculizumab for aHUS were  hypertension, diarrhea, headache, anemia, vomiting, nausea, upper respiratory and urinary tract infections, and leukopenia. The drug also has a boxed warning for life-threatening and fatal meningococcal infections; patients should be monitored for this serious adverse event. Eculizumab is available only through the Soliris REMS program. Additional information is available by calling 888-SOLIRIS (888-765-4747).

  • September 19, 2011

    FDA has approved two new indications for denosumab: increasing bone mass in women at high risk for fracture while receiving adjuvant aromatase inhibitor therapy for breast cancer and increasing bone mass in men at high risk for fracture while receiving androgen-deprivation therapy for nonmetastatic prostate cancer. Approval was based on results from two double-blind, placebo-controlled, multinational Phase III clinical trials, according to an Amgen news release.

    In 252 postmenopausal women with breast cancer receiving aromatase inhibitor therapy, treatment with denosumab resulted in a significantly higher bone mineral density (BMD) at the lumbar spine at 12 months compared with placebo (+4.8% denosumab, –0.7% placebo; P < 0.0001). After 2 years of treatment with denosumab, increases in BMD were 7.6% at the lumbar spine, 4.7% at the (total) hip, and 3.6% at the femoral neck.

    Similar results were observed in a study involving 1,468 men with nonmetastatic prostate cancer undergoing androgen deprivation therapy. Men treated with denosumab had significantly higher BMD at the lumbar spine after 2 years of treatment compared with placebo (+5.6% denosumab, –1% placebo; P < 0.0001). In addition, the incidence of new vertebral fractures was 3.9% among placebo-treated men compared with 1.5% in denosumab-treated men after 3 years of treatment, a relative risk reduction of 62% (P = 0.0125).

    The most common adverse events with denosumab observed in these trials were arthralgia and back pain. Other events included pain in the extremity, musculoskeletal pain, hypocalcemia, and more cataract events in men.

    Denosumab was originally approved for treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available antiosteoporotic therapies.

  • August 29, 2011


    Treatment of moderate-to-severe chronic pain

    Janssen Pharmaceuticals announced the FDA approval of extended-release tapentadol tablets for management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This Schedule II product will be marketed in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths.

    The efficacy of extended-release tapentadol was proven in various studies, including trials of patients with moderate-to-severe chronic low back pain and those with pain of diabetic peripheral neuropathy. The most common (≥10%) adverse reactions with this formulation were nausea, constipation, headache, dizziness, and somnolence.

    The product was approved with a Risk Evaluation and Mitigation Strategy to educate prescribers about the potential for abuse, misuse, overdose, and addiction from use of this opioid product.