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

New Full-Length Monographs

• None

New First-Release Monographs

• Trientine (Syprine^®) – 64:00 (Heavy Metal Antagonists)
  • Indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine
• Delafloxacin (Baxdela^®) – 8:12.18 (Quinolones)
  • Indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria
• Betrixaban (Bevyxxa^®) – 20:12.04.14 (Direct Factor Xa Inhibitors)
  • Indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE
• Naltrexone And Bupropion (Contrave^®) – 28:20.08.92 (Anorexigenic Agents, Miscellaneous)
  • Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)
• Guselkumab (Tremfya^®) – 84:92 (Skin and Mucous Membrane Agents, Miscellaneous)
  • Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
• L-Glutamine (Endari^®) – 92:92 (Other Miscellaneous Therapeutic Agents)
  • Indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older

FDA MedWatch Alerts

• None

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

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″