Month: June 2017

AHFS Drug Information/Essentials Update – July 2017

30 June, 2017 no responses

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

New Full-Length Monographs

  • Bezlotoxumab (Zinplava®) – 80:04 (Antitoxins and Immune Globulins)
    • Indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.

New First-Release Monographs

  • Sarilumab (Kevzara®) – 92:36 (Disease-modifying Antirheumatic Drugs)
    • Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.
  • Becaplermin (Regranex®) – 84:16 (Cell Stimulants and Proliferants)
    • Indicated for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.
  • Prasterone (Intrarosa®) – 68:04 (Adrenals)
    • Indicated for treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

FDA MedWatch Alerts

  • None

AHFS Patient Medication Information Update – June 2017

30 June, 2017 no responses

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

New PMI Monographs

  • Ocrelizumab Injection (Ocrevus®)
    • Ocrelizumab injection is used to treat adults with relapsing-remitting forms (course of disease where symptoms flare up from time to time) or primary-progressive forms (symptoms gradually become worse over time) of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control).
  • Valbenazine (Ingrezza®)
    • Valbenazine is used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts).
  • Deutetrabenazine (Austedo®)
    • Deutetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington’s disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain).
  • Safinamide (Xadago®)
    • Safinamide is used along with the combination of levodopa and carbidopa (Duopa, Rytary, Sinemet, others) to treat “off” episodes (times of difficulty moving, walking, and speaking that may happen as medication wears off or at random) in people with Parkinson’s disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance).
  • Deflazacort (Emflaza®)
    • Deflazacort is used to treat Duchenne muscular dystrophy (DMD; a progressive disease in which the muscles do not function properly) in adults and children 5 years of age and older.
  • Dupilumab Injection (Dupixent®)
    • Dupilumab injection is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in people who cannot use other medications for their condition or whose eczema has not responded to other medications.
  • Plecanatide (Trulance®)
    • Plecanatide is used in adults to treat chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication).
  • Crisaborole Topical (Eucrisa®)
    • Crisaborole is used to treat eczema (atopic dermatitis; a skin condition which causes the skin to be dry and itchy and to sometimes develop red, scaly rashes).
  • Oxymetazoline Topical (Rhofade®)
    • Oxymetazoline is used to treat ongoing facial redness caused by rosacea (a skin disease that causes redness and pimples on the face).

FDA MedWatch Alert Revisions

  • FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.
    • Based on new data from two large clinical trials, 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:
      • Canagliflozin

AHFS Drug Information/Essentials Update – June 2017

5 June, 2017 no responses

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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