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AHFS Drug Information/Essentials Update – January 2017

The January update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • New Full-Length Monographs
    • Netupitant And Palonosetron (Akynzeo®)
      • Netupitant and palonosetron hydrochloride are used orally in fixed combination for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
    • Sugammadex (Bridion®)
      • Sugammadex is used for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in patients undergoing surgery.
  • New First-Release Monographs
    • Rucaparib (Rubraca®)
      • Rucaparib camsylate is a PARP inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.
    • Nusinersen (Spinraza®)
      • Nusinersen sodium is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

FDA MedWatch Alerts

  • FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
    • Affected Monographs:
      • Propofol
      • Etomidate
      • Lorazepam
      • Pentobarbital
      • Midazolam
      • Methohexital
  • As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer.
    • Affected Monographs:
      • Pioglitazone
  • FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines varenicline (Chantix®) and bupropion (Zyban®) is lower than previously suspected.
    • Affected Monographs:
      • Varenicline
      • Bupropion

AHFS Drug Information/Essentials Update – December 2016

The December update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • Sacubitril/valsartan (Entresto with Valsartan®)
  • Cariprazine (Vraylar®)
  • Idarucizumab (Praxbind®)
  • Brivaracetam (Briviact®)
  • Pimavanserin Tartrate (Nuplazid®)
  • Tenofovir Alafenamide Fumarate (Vemlidy®)

FDA MedWatch Alerts

  • No new MedWatch Alerts

AHFS Patient Medication Information Update – November 2016

The November update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

New PMI Monographs

  • Abacavir, Lamivudine, and Zidovudine (Trizivir®)
    • The combination of abacavir, lamivudine and zidovudine is used alone or along with other medications to treat human immunodeficiency virus (HIV) infection.
  • Efavirenz, Emtricitabine, and Tenofovir (Atripla®)
    • The combination of efavirenz, emtricitabine, and tenofovir is used is used alone or along with other medications to treat HIV infection in adults and children 12 years of age or older.
  • Cidofovir Injection (Vistide®; also available generically)
    • Cidofovir injection is used along with another medication (probenecid) to treat cytomegaloviral retinitis (CMV retinitis) in people with acquired immunodeficiency syndrome (AIDS).
  • Phenylephrine Nasal Spray (Little Noses®, Neosynephrine®; also available generically)
    • Phenylephrine nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure.

FDA MedWatch Alert Revisions

FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic steroids.

  • Affected PMI monographs:
    • Testosterone Transdermal Patch
    • Testosterone Buccal
    • Oxandrolone
    • Testosterone Topical
    • Testosterone Injection
    • Testosterone Nasal Gel
    • Danazol
    • Fluoxymesterone
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