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