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AHFS Drug Information/Essentials Update – June 2017

The June 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
    • Elotuzumab (Empliciti®) – 10:00 (Antineoplastic Agents)
      • Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.
    • Metreleptin (Myalept®) – 68:40 (Leptins)
      • Treatment of leptin deficiency in congenital or acquired generalized lipodystrophy.
    • Tenofovir Alafenamide Fumarate (Vemlidy®) – 8:18.32 (Nucleosides and Nucleotides)
      • Indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
  • New First-Release Monographs
    • Niraparib Tosylate (Zejula®) – 10:00 (Antineoplastic Agents)
      • Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
    • Valbenazine Tosylate (Ingrezza®) – 28:92 (Central Nervous System Agents, Miscellaneous)
      • Treatment of tardive dyskinesia in adults.
    • Durvalumab (Imfinzi®) – 10:00 (Antineoplastic Agents)
      • Treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
    • Brigatinib (Alunbrig®) – 10:00 (Antineoplastic Agents)
      • Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
    • Midostaurin (Rydapt®) – 10:00 (Antineoplastic Agents)
      • Acute Myeloid Leukemia
        • In combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by a FDA approved test (not indicated as a single-agent induction therapy).
      • Systemic Mastocytosis
        • Indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
    • Cerliponase Alfa (Brineura®) – 44:00 (Enzymes)
      • To slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
    • Abaloparatide (Tymlos®) – 68:24 (Parathyroid)
      • Human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
    • Safinamide Mesylate (Xadago®) – 28:36.32 (Monoamine Oxidase B Inhibitors)
      • Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.
    • Edaravone (Radicava®) – 28:92 (Central Nervous System Agents, Miscellaneous)
      • Treatment of amyotrophic lateral sclerosis (ALS).

FDA MedWatch Alerts

  • The FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years.
    • Affected Monographs:
      • 302025,”Propofol”,”28:04.92″
      • 302038,”Etomidate”,”28:04.92″
      • 382053,”LORazepam”,”28:24.08″
      • 382416,”PENTobarbital”,”28:24.04″
      • 387008,”Midazolam”,”28:24.08″
  • The FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.
    • Affected Monographs:
      • 313046,”Canagliflozin”,”68:20.18″

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