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General Discussions

May Adverse Events Report: FDA Labeling Changes

By Anita Shaffer


Adverse Reactions added:

  • Adverse reactions occurring at an overall incidence of <10% of patients receiv- ing palbociclib plus letrozole in Study 1 included alanine aminotransferase in- creased (9.9%), aspartate aminotransferase increased (9.7%), epistaxis (9.2%), lacrimation increased (5.6%), dry eye (4.1%), vision blurred (3.6%), and febrile neutropenia (2.5%).
  • Additional adverse reactions occurring at an overall incidence of less than 10.0% of patients receiving palbociclib plus fulvestrant in Study 2 included as- thenia (7.5%), aspartate aminotransferase increased (7.5%), dysgeusia (6.7%), epistaxis (6.7%), lacrimation increased (6.4%), dry skin (6.1%), alanine amino- transferase increased (5.8%), vision blurred (5.8%), dry eye (3.8%), and febrile neutropenia (0.9%).

Use in Specific Populations updated:

  • Based on animal studies, IBRANCE can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a pregnancy test prior to starting treatment with IBRANCE.


Warnings and Precautions added:

  • Colitis and gastrointestinal perforation, including fatal outcomes, have been re- ported in patients taking MEKINIST as a single-agent and when administered with dabrafenib.
  • Across clinical trials of trametinib administered as a single agent (N = 329) and with dabrafenib (N = 559), colitis occurred in 0.6% of patients and gastrointesti- nal perforation occurred in 0.3% of patients.
  • ​Monitor patients closely for colitis and gastrointestinal perforations.

Patient Counseling Information updated:

  • Patients receiving trametinib are advised tocontact their healthcare provider immediately if they experience diarrhea, stomach or abdominal pain, fever, or nausea

Use in Specific Populations updated:

  • A Pregnancy Safety Surveillance Study has been established to collect informa- tion about pregnancies in women who have received ipilimumab.
  • Healthcare providers are encouraged to enroll patients or have their patients en- roll directly by calling (844)-593-7869.
  • Lactation—it is not known whether ipilimumab is present in human milk.

Patient Counseling Information updated:

  • Healthcare providers should review steps for appropriate administration of filgrastim-sndz with prefilled syringe with patients and caregivers, particularly if the entire prefilled dosage will not be used
  • Patients who self-administer prefilled syringes should receive instructions about the dangers of reusing needles and syringes, the importance of proper disposal, and importance of informing healthcare provider if difficulty occurs when mea- suring or administering partial contents of prefilled syringe.
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