Category: AHFS DI

AHFS Drug Information/Essentials Update – October 2016

20 October, 2016 no responses

The October update to the AHFS Drug Information/Essentials database was published today. Highlights from this month’s update include:

New AHFS/Essentials Monographs

Alectinib (Alecensa®)
Antihemophilic Factor (Recombinant), Porcine Sequence (Obizur®)
Antihemophilic Factor (recombinant), Fc Fusion Protein (Eloctate®)
Asfotase Alfa (Strensiq®)
Atezolizumab (Tecentriq®)
Avanafil (Stendra®)
Brexpiprazole (Rexulti®)
Brivaracetam (Briviact®)
Cariprazine (Vraylar®)
Cholic Acid (Cholbam®)
Coagulation Factor IX (Recombinant, Human) (Idelvion®)
Coagulation Factor X Human (Coagadex®)
Cobicistat (Tybost®, Evotaz®, Prezcobix®, Stribild®)
Daclizumab (Zinbryta®)
Daratumumab (Darzalex®)
Defibrotide Sodium  (Defitelio®)
Deoxycholic Acid (Kybella®)
Dichlorphenamide (Keveyis®)
Eliglustat (Cerdelga®)
Elotuzumab (Empliciti®)
Elvitegravir (Vitekta®)
Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (Genvoya®)
Eteplirsen (Exondys 51®)
Idarucizumab (Praxbind®)
Insulin Degludec (Tresiba®)
Ivabradine Hydrochloride (Corlanor®)
Ixazomib (Ninlaro®)
Ixekizumab (Taltz®)
Lesinurad (Zurampic®)
Lifitegrast (Xiidra®)
Lixisenatide (Adlyxin®)
Lumacaftor and Ivacaftor (Orkambi®)
Mepolizumab (Nucala®)
Metreleptin (Myalept®)
Necitumumab (Portrazza®)
Netupitant and Palonosetron (Akynzeo®)
Obeticholic Acid (Ocaliva®)
Obiltoxaximab (Anthim®)
Osimertinib (Tagrisso®)
Palbociclib (Ibrance®)
Patiromer (Veltassa®)
Pimavanserin (Nuplazid®)
Raxibacumab
Reslizumab (Cinqair®)
Rolapitant (Varubi®)
Sacubitril and Valsartan (Entresto (with valsartan)®)
Sebelipase Alfa (Kanuma®)
Selexipag (Uptravi®)
Sonidegib (Odomzo®)
Sugammadex (Bridion®)
Trabectedin (Yondelis®)
Trifluridine and Tipiracil (Lonsurf®)
Venetoclax (Venclexta®)

AHFS Drug Information/Essentials Update – July 2016

6 July, 2016 no responses

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

New AHFS/Essentials Monographs

  • Daclatasvir (Daklinza®)
    • Daclatasvir dihydrochloride is used in conjunction with sofosbuvir (with or without ribavirin) for the treatment of chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in adults who are treatment-naive (previously untreated) or previously treated, including those with cirrhosis (compensated or decompensated), liver transplant recipients, and those with human immunodeficiency virus (HIV) coinfection
  • Ombitasvir, paritaprevir, and ritonavir (Technivie®)
    • The fixed combination of ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/ritonavir) is used in conjunction with ribavirin for the treatment of chronic hepatitis C virus (HCV) genotype 4 infection in treatment-naive (previously untreated) or previously treated adults without cirrhosis

FDA MedWatch Alerts

  • Canagliflozin & Dapagliflozin
    • FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
  • Aspirin
    • The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach
  • Sumatriptan
    • Sumatriptan iontophoretic transdermal system patch (Zecuity) manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the sumatriptan iontophoretic transdermal system patch
  • Loperamide
    • FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death

AHFS Drug Information/Essentials Update – June 2016

6 June, 2016 no responses

The June update to the AHFS Drug Information/Essentials database was published today. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • Alirocumab (Praluent®)
    • Alirocumab is used as an adjunct to diet and maximally tolerated HMG-CoA reductase inhibitor (i.e., statin) therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical ASCVD who require additional reduction in low-density lipoprotein (LDL)-cholesterol concentrations
  • Talimogene Laherparepvec (Imlygic®)
    • Talimogene laherparepvec is used intralesionally for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma following initial surgery
  • Elosulfase Alfa (Vimizim®)
    • Elosulfase alfa is used as replacement therapy in patients with mucopolysaccharidosis IVA (MPS IVA, Morquio A syndrome) and is designated an orphan drug by FDA for use in this condition.
  • Evolocumab (Repatha®)
    • Evolocumab is used as an adjunct to diet and maximally tolerated HMG-CoA reductase inhibitor (i.e., statin) therapy for the treatment of patients with heterozygous familial hypercholesterolemia or clinical ASCVD who require additional reduction in low-density lipoprotein (LDL)-cholesterol concentrations

FDA MedWatch Alerts

  • Fluoroquinolones
    • Serious adverse effects generally outweigh benefits for patients with sinusitis, bronchitis, and uncomplicated UTIs
    • Affected monographs:
      • Moxifloxacin, ofloxacin, ciprofloxacin, levofloxacin, gemifloxacin
  • Ketoconazole
    • Avoid using oral tablets to treat skin and nail fungal infections
  • Canagliflozin
    • Increased risk of leg and foot amputations
  • Olanzapine
    • Rare but serious skin conditions
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