Category: AHFS DI

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 Drug Information/Essentials Update – November 2016

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

New AHFS/Essentials Monographs

  • Alectinib (Alecensa®)
  • Atezolizumab (Tecentriq®)
  • Daratumumab (Darzalex®)
  • Elotuzumab (Empliciti®)
  • Ixazomib (Ninlaro®)
  • Necitumumab (Portrazza®)
  • Osimertinib (Tagrisso®)
  • Palbociclib (Ibrance®)
  • Sonidegib (Odomzo®)
  • Trabectedin (Yondelis®)
  • Trifluridine and Tipiracil (Lonsurf®)
  • Venetoclax (Venclexta®)

FDA MedWatch Alerts

  • FDA is warning about the risk of hepatitis B virus (HBV) reactivation in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral medicines for hepatitis C virus.
    • Affected monographs:
      • Simeprevir
      • Sofosbuvir
      • Ledipasvir and Sofosbuvir
      • Ombitasvir, Paritaprevir, and Ritonavir with Dasabuvir Sodium
      • Daclatasvir
      • Ombitasvir/Paritaprevir/Ritonavir
      • Elbasvir and Grazoprevir
  • FDA added a new warning and updating the Abuse and Dependence section to include new safety information regarding the risks associated with abuse and dependence of testosterone and other anabolic steroids.
    • Affected monographs:
      • Oxandrolone
      • Danazol
      • Testosterone
      • Methyltestosterone
      • Fluoxymesterone
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