Author: AHFS

AHFS Drug Information/Essentials Update – August 2017

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

AHFS Patient Medication Information Update – July 2017

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

New PMI Monographs

  • Naldemedine (Symproic®)
    • Naldemedine is used to treat constipation caused by opioid (narcotic) pain medications in adults with chronic (ongoing) pain that is not caused by cancer.
  • Ammonium Lactate Topical (Lac-Hydrin®)
    • Ammonium lactate is used to treat xerosis (dry or scaly skin) and ichthyosis vulgaris (an inherited dry skin condition) in adults and children.
  • Telotristat (Xermelo®)
    • Telotristat is used in combination with another medication (a samotostatin analog [SSA] such as lanreotide, octreotide, pasinreotide) to control diarrhea caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms like diarrhea) in patients with diarrhea not controlled by a somatostatin analog alone.
  • Durvalumab Injection (Imfinzi®)
    • Durvalumab injection is used to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that spread to nearby tissues or other parts of the body that cannot be removed by surgery and has worsened during or after being treated with other chemotherapy medications.

FDA MedWatch Alert Revisions

  • None

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
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