Important Information About EXKIVITY® (mobocertinib)
Following discussions with the U.S. Food and Drug Administration (FDA), EXKIVITY (mobocertinib) will be officially withdrawn from the market in the United States no later than March 2024.
EXKIVITY remains available to prescribe until the official withdrawal; moreover, after withdrawal patients will be able to maintain access through an established compassionate use program.
The Compassionate Use Program is Now Accepting Enrollments.
- To enroll your patient(s) currently prescribed EXKIVITY (mobocertinib) please email Clinigen Customer Service at medicineaccess@clinigengroup.com to create a Clinigen direct portal account.
- If you already have an account, you can log in by accessing this through the link below:
We highly encourage you to begin the process as soon as possible as EXKIVITY will no longer be available for new patients after withdrawal in March 2024.
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