Month: September 2017

AHFS Drug Information/Essentials Update – September 2017

20 September, 2017 no responses

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

New Full-Length Monographs

  • Etelcalcetide Hydrochloride (Parsabiv®) – 68:24.04 (Antiparathyroid Agents)
    • A calcium-sensing receptor agonist indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on  hemodialysis.
  • Obeticholic Acid (Ocaliva®) – 56:92 (GI Drugs, Miscellaneous)
    • Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA; [ursodiol per USAN]) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
  • Lifitegrast (Xiidra®) – 52:08.92 (Anti-inflammatory Agents, Miscellaneous)
    • Treatment of the signs and symptoms of dry eye disease.

New First-Release Monographs

  • Sofosbuvir, Velpatasvir, And Voxilaprevir (Vosevi®) – 8:18.40.16 (HCV Polymerase Inhibitors)
    • Treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
  • Enasidenib Mesylate (Idhifa®) – 10:00 (Antineoplastic Agents)
    • Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
  • Neratinib Maleate (Nerlynx®) – 10:00 (Antineoplastic Agents)
    • Extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
  • Glecaprevir And Pibrentasvir (Mavyret®) – 8:18.40.20 (HCV Protease Inhibitors)
    • Treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

FDA MedWatch Alerts

  • None

AHFS Patient Medication Information Update – September 2017

20 September, 2017 no responses

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

New PMI Monographs

  • Neratinib (Nerlynx®)
    • Neratinib is used to treat a certain type of hormone receptor-positive breast cancer (breast cancer that depends on hormones such as estrogen to grow) in adults after treatment with trastuzumab (Herceptin®) and other medications.
  • L-glutamine (Endari®)
    • L-glutamine is used to is used to reduce the frequency of painful episodes (crises) in adults and children 5 years of age and older with sickle cell anemia (an inherited blood disorder in which the red blood cells are abnormally shaped [shaped like a sickle] and cannot bring enough oxygen to all parts of the body).
  • Guselkumab Injection (Tremfya®)
    • Guselkumab injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in people whose psoriasis is too severe to be treated by topical medications alone.
  • Sofosbuvir, Velpatasvir, and Voxilaprevir (Vosevi®)
    • The combination of sofosbuvir, velpatasvir, and voxilaprevir is used to treat chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in adults who have already received other HCV treatments.
  • Abaloparatide Injection (Tymlos®)
    • Abaloparatide injection is used to treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause (‘change in life,’ end of menstrual periods), who are at high risk of fractures (broken bones) or who could not be treated successfully with other medications.

FDA MedWatch Alert Revisions

  • Sodium Polystyrene Sulfonate (Kayexalate®)
    • FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate at the same time as other medicines taken by mouth.
  • Pembrolizumab Injection (Keytruda®)
    • FDA is warning about the risks associated with the use of pembrolizumab in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Pembrolizumab is not approved for treatment of multiple myeloma.
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