Category: AHFS DI

AHFS Drug Information/Essentials Update – July 2017

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 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″

AHFS Drug Information/Essentials Update – May 2017

The May 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
    • Lumacaftor And Ivacaftor (Orkambi®) – 48:14.04 (Cystic Fibrosis Transmembrane Conductance Regulator Correctors)
      • Treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene.
    • Uridine Triacetate (Xuriden, Vistogard®) – 92:12 (Antidotes)
      • Xuriden®: Treatment of hereditary orotic aciduria.
      • Vistogard®: A separate NDA approved for emergency treatment of fluorouracil or capecitabine overdose or patients who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., GI toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
  • New First-Release Monographs
    • Ocrelizumab (Ocrevus®) – 92:20 (Immunomodulatory Agents)
      • Treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis.
    • Dupilumab (Dupixent®) – 84:92 (Skin and Mucous Membrane Agents, Miscellaneous)
      • Treatment of adults with moderate-to-severe eczema (atopic dermatitis) not controlled adequately by topical therapies, or those for whom topical therapies are not advisable.
    • Etelcalcetide Hydrochloride (Parsabiv®) – 92:92 (Other Miscellaneous Therapeutic Agents)
      • A calcium-sensing receptor agonist indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
    • Naldemedine Tosylate (Symproic®) – 56:92 (GI Drugs, Miscellaneous)
      • Treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.
    • Deutetrabenazine (Austedo®) – 28:92 (Central Nervous System Agents, Miscellaneous)
      • Treatment of chorea associated with Huntington’s disease.

FDA MedWatch Alerts

  • FDA is restricting the use of codeine and tramadol medicines in children.
    • Affected Monographs
      • 382065,”Codeine”,”28:08.08″
      • 382491,”Codeine”,”48:08″
      • 395011,”traMADol”,”28:08.08″
    •  FDA is now adding the following changes to the labeling of codeine and tramadol:
      • FDA’s strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
      • A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
      • A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
      • A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
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