On February 16, 2018, a new formulation of Imbruvica (ibrutinib) was approved by the US FDA in multiple strengths as a 140, 280, 420, and 560 mg tablet. At that time, Pharmacyclics stated that the original 140 mg capsule will no longer be available after May 15, 2018. Please see the Full Prescribing Information(link is external) for indications, dosage, and usage.

On May 11, 2018, after feedback from various organizations – including the IWMF, LLS, LRF, and the CLL Society – the company has decided to continue the availability of the 140 mg capsule.

The net result is:

  • There will no longer be a May 15th changeover from capsule to tablet. Instead, both capsules and tablets will be available.
  • There will be no price increase for the capsule (the original product).
    • Patients will still be able to get the current 90 count or 120 count bottle of 140 mg capsules (90 count equates to three 140 mg capsules daily for 30 days; 120 count equates to four 140 mg capsules daily for 30 days). Patients will take the number of capsules daily prescribed by their doctors.
    • Dosage flexibility will be maintained. For example, some patients are being dosed at different amounts than typical based upon input from their doctors, or dosing may need to be quickly adjusted because of side effects.
  • Regarding the previously announced new tablet formulation:
    • The new tablets will come in 140 mg, 280 mg, 420 mg, or 560 mg doses, provided in a 28-day blister pack so that patients can easily see if they have removed the pill for that day. No matter what dosage a patient is on, the patient takes only a single pill daily. The price per pack will be based on the cost of a 420 mg per day dosage (whether you are prescribed more or less than 420 mg per day).
    • There will be no planned annual price increase as part of this change. However, since the blister packs will come 13 times a year, there may be an additional co-pay each year.
  • From a cost perspective, a rule of thumb might be that if your doctor prescribes a dose of less than 420 mg per day, you’re better off sticking with the capsules (the original formulation); if your doctor prescribes 420 mg or more per day, then it may be of benefit to go with the new tablet formulation. Additionally, the convenience of the new blister pack dosing guide may be of benefit to some patients.
  • NOTE: Pharmacyclics and Janssen personnel will be available at the IWMF Educational Forum to answer any and all questions. The IWMF will issue more detailed information, if it is becomes available, after the Ed Forum.

See the press release(link is external) for more information: