Important Information About EXKIVITY^® (mobocertinib)

Following discussions with the U.S. Food and Drug Administration (FDA), Takeda announced the initiation of the withdrawal of EXKIVITY (mobocertinib) on October 2, 2023.

As of April 8, 2024, Takeda will no longer provide EXKIVITY commercially in the U.S. market.

Takeda launched a Compassionate Use Program (“Program”) in January 2024 to ensure patients prescribed EXKIVITY before April 1, 2024 could have access to the drug. Only patients who were prescribed EXKIVITY prior to April 1, 2024 will be eligible for the Program. If you have a patient and you wish to enroll them into the Program, you should do so immediately by contacting Clinigen at medicineaccess@clinigengroup.com or 877-768-4303.

For additional questions, please contact Takeda at 844-662-8532 between the hours of 8:00am and 6:00pm EST, or globaloncologymedinfo@takeda.com.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc.
at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch