Category: AHFS PMI

AHFS Patient Medication Information Update – May 2017

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

New PMI Monographs

  • Ribociclib (Kisqali®)
    • Ribociclib is used in combination with another medication to treat a certain type of hormone receptor–positive, advanced breast cancer breast cancer that depends on hormones such as estrogen to grow) in women who have experienced menopause (change of life; end of monthly menstrual periods).
  • Niraparib (Zejula®)
    • Niraparib is used to help maintain the response of certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the stomach) cancer to chemotherapy medications after the cancer has returned from previous treatment(s).
  • Avelumab Injection (Bavencio®)
    • Avelumab injection is used to treat a certain type of skin cancer that has spread to other parts of the body in adults and children 12 years of age and older.

FDA MedWatch Alert Revisions

  • FDA is restricting the use of codeine and tramadol medicines in children.
    • These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.
    • Affected Monographs:
      • Acetaminophen and Codeine
      • Acetaminophen, Butalbital, and Caffeine
      • Codeine
      • Tramadol
  • FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years.
    • Affected Monographs:
      • Midazolam

AHFS Patient Medication Information Update – March 2017

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

New PMI Monographs

  • Hydrocortisone Rectal (Anusol HC®, Colocort®, Cortenema®, Preparation H Anti-Itch®, Proctocort®, Proctofoam HC®)
    • Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum).
  • Lixisenatide Injection (Adlyxin®)
    • Lixisenatide injection is used along with diet and exercise to treat type 2 diabetes.
  • Cromolyn Ophthalmic (Crolom®)
    • Cromolyn ophthalmic is used to treat the symptoms of allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances) and keratitis (a condition that causes swelling of the cornea [tissue in the front of the eye] that causes eye redness, pain, and tearing and changes in vision).
  • Bezlotoxumab Injection (Zinplava®)
    • Bezlotoxumab injection is used to decrease the risk of Clostridium difficile infection (a type of bacteria that can cause severe or life-threatening diarrhea) from coming back in people at high risk for C. difficile infection.

FDA MedWatch Alert Revisions

FDA is warning that eluxadoline (Viberzi®), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder.

AHFS Patient Medication Information Update – November 2016

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

New PMI Monographs

  • Abacavir, Lamivudine, and Zidovudine (Trizivir®)
    • The combination of abacavir, lamivudine and zidovudine is used alone or along with other medications to treat human immunodeficiency virus (HIV) infection.
  • Efavirenz, Emtricitabine, and Tenofovir (Atripla®)
    • The combination of efavirenz, emtricitabine, and tenofovir is used is used alone or along with other medications to treat HIV infection in adults and children 12 years of age or older.
  • Cidofovir Injection (Vistide®; also available generically)
    • Cidofovir injection is used along with another medication (probenecid) to treat cytomegaloviral retinitis (CMV retinitis) in people with acquired immunodeficiency syndrome (AIDS).
  • Phenylephrine Nasal Spray (Little Noses®, Neosynephrine®; also available generically)
    • Phenylephrine nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure.

FDA MedWatch Alert Revisions

FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic steroids.

  • Affected PMI monographs:
    • Testosterone Transdermal Patch
    • Testosterone Buccal
    • Oxandrolone
    • Testosterone Topical
    • Testosterone Injection
    • Testosterone Nasal Gel
    • Danazol
    • Fluoxymesterone
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