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