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Ed Forum 2016 SGL

US FDA Approves New Imbruvica/Ibrutinib Formulation

Apr 6, 2018

On February 16, 2018, Imbruvica (ibrutinib) was approved by the US FDA in multiple strengths as a 140, 280, 420, and 560 mg tablet. 

The new formulations are now commercially available, and the original 140 mg capsule will no longer be available after May 15, 2018. Please see the full Prescribing Information for indications, dosage and usage.

A press release from Pharmacyclics (the maker of Imbruvica) provided additional details:

What’s different about the package?
IMBRUVICA® now comes in a 28-day blister pack.

What is the difference between the capsules and tablets?
IMBRUVICA® contains the same active ingredient in capsule and tablet forms at the corresponding prescribed dose. The existing capsules are available in 70 mg and 140 mg dosage strengths; the new formulation tablets are available in 140, 280, 420 and 560 mg dosage strengths.

How do patients switch from capsule to tablet?
Physicians will need to provide patients with a new prescription for the new tablet formulation of IMBRUVICA®.

Where should patients find more information?
Patients should talk to their doctors about their IMBRUVICA® prescription.

For answers to common questions patients may have, please visit: www.IMBRUVICAONEPILL.com.

You can also find additional details in Pharmacyclic’s brochure about Imbruvica.

NOTES:

  • The IWMF is providing this information as a service for WM patients who are taking Imbruvica. We are in no way endorsing this particular treatment. Which treatment you select, if any, is always a decision you need to make with your doctor.
  • The FDA has approved packaging for patients in the USA. For patients in other countries where Imbruvica/ibrutinib is available, contact your physician for further details regarding availability.
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