Imbruvica Capsules to be Replaced by Tablets
April 17, 2018 – Pharmacyclics and Janssen have announced that production of their 140mg capsule form of Imbruvica® (ibrutinib) will cease in mid-May. The capsules will be replaced by once-daily Imbruvica tablets, which the U.S. FDA approved on February 16, 2018.
Originally approved in 2014, Imbruvica is indicated to treat mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström’s macroglobulinemia. It works by blocking Bruton’s tyrosine kinase (BTK), thus inhibiting the development and spread of abnormal B cells in the body. Recommended dosing is based on indication.
Imbruvica tablets will be available in 140mg, 280mg, 420mg and 560mg strengths, which may reduce the number of pills patients need to take on a daily basis. However, dosage adjustments may be more challenging compared to the capsules, as the tablets will be dispensed in 28-day blister packs.
All Imbruvica tablet dosage strengths will be available at the same list cost, according to Pharmacyclics and Janssen.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.