Category: AHFS PMI

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

AHFS Patient Medication Information Update – October 2016

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

New PMI Monographs:

  • Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir (Viekira XR®)
    • Dasabuvir, ombitasvir, paritaprevir, and ritonavir is used alone or in combination with ribavirin (Copegus, Rebetol, Ribasphere) to treat chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus).
  • Calcifediol (Rayaldee®)
    • Calcifediol is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood] ) in certain adults with chronic kidney disease.
  • Doxercalciferol Injection (Hectoral®; also available generically)
    • Doxercalciferol injection is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood] in people receiving dialysis (medical treatment to clean the blood when the kidneys are not working properly).
  • Ergocalciferol (Drisdol®; also available generically)
    • Ergocalciferol is used in the treatment of hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone), refractory rickets (softening and weakening of bones that does not respond to treatment), and familial hypophosphatemia (rickets or osteomalacia caused by an inherited condition with a decreased ability to break down vitamin D in the body).
  • Dapsone Topical (Aczone®)
    • Dapsone topical is used to treat acne.
  • Doxercalciferol (Hectoral®; also available generically)
    • Doxercalciferol injection is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood] in people receiving dialysis (medical treatment to clean the blood when the kidneys are not working properly).
  • Methylnaltrexone (Relistor®)
    • Methylnaltrexone is used to treat constipation caused by opioid (narcotic) pain medications in patients with chronic (ongoing) pain that is not caused by cancer.
  • Furosemide Injection (Lasix®; also available generically)
    • Furosemide injection is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart failure, pulmonary edema (excess fluid in the lungs), and liver disease.

FDA MedWatch Alerts – Monograph Revisions

Warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus.

  • Affected monographs:
    • Simeprevir
    • Sofosbuvir
    • Ledipasvir and Sofosbuvir
    • Ombitasvir, Paritaprevir, and Ritonavir with Dasabuvir
    • Ombitasvir, Paritaprevir, and Ritonavir
    • Daclatasvir
    • Elbasvir and Grazoprevir
    • Sofosbuvir and Velpatasvir
    • Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir (XR)
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