Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • 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

    Data from one Phase II and three Phase III studies involving more than 3,300 infants showed that two doses of the vaccine given 3 months apart elicited a robust immune response against the serogroups in the vaccine. In addition, data from these studies showed that the measles-mumps-rubella-varicella vaccine and pneumococcal conjugate vaccine can be administered at the same as Menactra in children. The most common adverse events included injection-site reactions (i.e., swelling and tenderness) and irritability.

  • 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.

  • May 1, 2011

    Teva has voluntarily withdrawn its lansoprazole delayed-release orally disintegrating tablets (ODT) after FDA received reports that the tablets clogged and blocked oral syringes and feeding tubes, including gastric and jejunostomy tubes. The ODT tablets reportedly do not fully disintegrate fully when water is added or disintegrate and later form clumps that clog oral syringes and feeding tubes.

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