Author: AHFS

AHFS Drug Information/Essentials Update – October 2017

19 October, 2017 no responses

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

New First-Release Monographs

  • Gemtuzumab Ozogamicin (Mylotarg®) – 10:00 (Antineoplastic Agents)
    • Gemtuzumab was removed from US market June 2010 and reapproved September 2017 with many changes
    • New indications: 
      • Treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults.
      • Treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
  • Deutetrabenazine (Austedo®) – 28:92 (Central Nervous System Agents, Miscellaneous)
    • Treatment of chorea associated with Huntington’s disease.
    • Treatment of tardive dyskinesia in adults.
  • Daunorubicin And Cytarabine (Vyxeos®) – 10:00 (Antineoplastic Agents)
    • A liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
  • Selenious Acid – 40:12 (Replacement Preparations)
    • Trace element
  • Inotuzumab Ozogamicin (Besponsa®) – 10:00 (Antineoplastic Agents)
    • Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

FDA MedWatch Alerts

  • Increased risks associated with the use of pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
    • Affected monographs:
      • 315018,”Pembrolizumab”,”10:00″
  • Obeticholic acid (Ocaliva) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.
    • Affected monographs:
      • 316059,”Obeticholic Acid”,”56:92″
  • Avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth.
    • Affected monographs:
      • 382108,”Sodium Polystyrene Sulfonate”,”40:18.18″
  • Opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).
    • Affected monographs:
      • 382134,”Methadone”,”28:08.08″
      • 387004,”Buprenorphine”,”28:08.12″

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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