U.S. Food and Drug Administration (FDA) Approves a Label Expansion for IMBRUVICA® (ibrutinib) 

On February 26th, Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for IMBRUVICA® (ibrutinib) with an oral suspension formulation for adult patients in the treatment of WM after failure of one or more lines of systemic therapy.

IMBRUVICA® is now the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation, providing additional flexibility for patients who may have difficulty swallowing tablets or capsules. Read the full article HERE.


A couple of notes about the new IMBRUVICA formulation:

  • Patients will receive the oral suspension the same way they would receive tablets. If they are covered/work through a specialty pharmacy, this would continue based on the type of insurance carried.
  • The oral suspension does not require special storage instruction, such as refrigeration; everything is room temperature and dosed per the physician’s instructions.