Category: Uncategorized

AHFS Drug Information/Essentials Update – October 2017

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″

AHFS Patient Medication Information Update – March 2017

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

New PMI Monographs

  • Hydrocortisone Rectal (Anusol HC®, Colocort®, Cortenema®, Preparation H Anti-Itch®, Proctocort®, Proctofoam HC®)
    • Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum).
  • Lixisenatide Injection (Adlyxin®)
    • Lixisenatide injection is used along with diet and exercise to treat type 2 diabetes.
  • Cromolyn Ophthalmic (Crolom®)
    • Cromolyn ophthalmic is used to treat the symptoms of allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances) and keratitis (a condition that causes swelling of the cornea [tissue in the front of the eye] that causes eye redness, pain, and tearing and changes in vision).
  • Bezlotoxumab Injection (Zinplava®)
    • Bezlotoxumab injection is used to decrease the risk of Clostridium difficile infection (a type of bacteria that can cause severe or life-threatening diarrhea) from coming back in people at high risk for C. difficile infection.

FDA MedWatch Alert Revisions

FDA is warning that eluxadoline (Viberzi®), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.

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