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AHFS Drug Information/Essentials Update – June 2016

The June update to the AHFS Drug Information/Essentials database was published today. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • Alirocumab (Praluent®)
    • Alirocumab is used as an adjunct to diet and maximally tolerated HMG-CoA reductase inhibitor (i.e., statin) therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical ASCVD who require additional reduction in low-density lipoprotein (LDL)-cholesterol concentrations
  • Talimogene Laherparepvec (Imlygic®)
    • Talimogene laherparepvec is used intralesionally for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma following initial surgery
  • Elosulfase Alfa (Vimizim®)
    • Elosulfase alfa is used as replacement therapy in patients with mucopolysaccharidosis IVA (MPS IVA, Morquio A syndrome) and is designated an orphan drug by FDA for use in this condition.
  • Evolocumab (Repatha®)
    • Evolocumab is used as an adjunct to diet and maximally tolerated HMG-CoA reductase inhibitor (i.e., statin) therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical ASCVD who require additional reduction in low-density lipoprotein (LDL)-cholesterol concentrations

FDA MedWatch Alerts

  • Fluoroquinolones
    • Serious adverse effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated UTIs
    • Affected monographs:
      • Moxifloxacin, ofloxacin, ciprofloxacin, levofloxacin, gemifloxacin
  • Ketoconazole
    • Avoid using oral tablets to treat skin and nail fungal infections
  • Canagliflozin
    • Increased risk of leg and foot amputations
  • Olanzapine
    • Rare but serious skin conditions

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