IMBRUVICA® Dosing Provides Options for You and Your Patients

Watch: Explore dosing information and outcomes data in 1L CLL patients following dose modifications for adverse reactions

The information in the video is also presented on this website.

See dose modifications

The most flexibility in formulation
choices of any BTKi

As the only BTKi with tablets, capsules and oral suspension, IMBRUVICA® offers different formulation options to meet your patient's administration needs.


IMBRUVICA® is the only BTKi:

  • Available in oral suspension—a formulation option for patients who have trouble swallowing tablets or capsules
  • With 3 formulation options approved once a day in 1L CLL

 

Once-daily dosing to fit your patient’s routine1

Continue IMBRUVICA® treatment until disease progression or unacceptable toxicity.

  • Dose should be taken at approximately the same time each day with a glass of water

  • Do not open, break, or chew the capsules.

  • Do not cut, crush, or chew the tablets

  • Follow Instructions for Use for further details of IMBRUVICA® oral suspension

  • If a dose of IMBRUVICA® is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day. Do not take extra doses of IMBRUVICA® to make up for the missed dose

Agents administered in combination with IMBRUVICA® require infusion. When administering IMBRUVICA® in combination with rituximab or obinutuzumab, consider administering IMBRUVICA® prior to rituximab or obinutuzumab when given the same day.

EddieIMBRUVICA® patient living with 1L CLL

We were able to reduce the dosage...and it helped with my side effects.”

Dose modifications, including discontinuation,
are for select adverse reactions.

Once-daily dosing is necessary to ensure inhibition of BTK enzymatic activity1

Discontinuation and dose reduction rates in the CLL/SLL registration studies1

The data below are pooled from 5 randomized controlled clinical trials (RESONATE™, RESONATE™-2, HELIOS, iLLUMINATE™, and E1912) and 1 single-arm, open-label clinical trial (Study 1102) in patients with CLL/SLL (N=2,016 total and n=1,133 patients exposed to IMBRUVICA®)

  • 4% to 10% of patients discontinued due to ARs
    • ARs leading to discontinuation included pneumonia, hemorrhage, atrial fibrillation, neutropenia, arthralgia, rash, and thrombocytopenia
  • Approximately 9% of patients had a dose reduction due to ARs
  • Patients requiring a dose reduction can exchange their unused tablets for the same number of tablets at the reduced dose strength
  • Your patient can receive their new dose before returning their unused tablets
  • In this safety-based returns program, there will be no additional cost to the patient for any tablets provided at the reduced dose strength

Patients must enroll in the program to apply. To be eligible for participation in the IMBRUVICA® By Your Side Dose Exchange Program, patients must have remaining pills from a current prescription for an FDA-approved indication for IMBRUVICA® and must return their remaining pills.

Abbreviations

1L=first-line, ARs=adverse reactions, BR=bendamustine + rituximab, BTK=Bruton's tyrosine kinase, BTKi=Bruton’s tyrosine kinase inhibitor, CLL=chronic lymphocytic leukemia, SLL=small lymphocytic lymphoma.

Reference

1IMBRUVICA® (ibrutinib) Prescribing Information.