The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL)
The FDA has approved a new formulation of IMBRUVICA®. All patients will need to obtain a new prescription from their physician.
Please review the important information below.
What you should know:
IMBRUVICA® is now approved by the FDA in multiple strengths as a 140, 280, 420 and 560 mg tablet.
The FDA approved the tablet formulation of IMBRUVICA® on February 16, 2018 and it is now commercially available. The original 140-mg capsules will no longer be available after May 15, 2018.
Please see the full Prescribing Information for indications, dosage and usage.
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.
March 21, 2018
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