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

New First-Release Monographs

• Gemtuzumab Ozogamicin (Mylotarg^®) – 10:00 (Antineoplastic Agents)
  • Gemtuzumab was removed from US market June 2010 and reapproved September 2017 with many changes
  • New indications: 
    • Treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults.
    • Treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
• Deutetrabenazine (Austedo^®) – 28:92 (Central Nervous System Agents, Miscellaneous)
  • Treatment of chorea associated with Huntington’s disease.
  • Treatment of tardive dyskinesia in adults.
• Daunorubicin And Cytarabine (Vyxeos^®) – 10:00 (Antineoplastic Agents)
  • A liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
• Selenious Acid – 40:12 (Replacement Preparations)
  • Trace element
• Inotuzumab Ozogamicin (Besponsa^®) – 10:00 (Antineoplastic Agents)
  • Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

FDA MedWatch Alerts

• Increased risks associated with the use of pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
  • Affected monographs:
    • 315018,”Pembrolizumab”,”10:00″
• Obeticholic acid (Ocaliva) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.
  • Affected monographs:
    • 316059,”Obeticholic Acid”,”56:92″
• Avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth.
  • Affected monographs:
    • 382108,”Sodium Polystyrene Sulfonate”,”40:18.18″
• Opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).
  • Affected monographs:
    • 382134,”Methadone”,”28:08.08″
    • 387004,”Buprenorphine”,”28:08.12″