|Age:||18 years or older|
|Keywords:||Cardiomyopathy, Transthyretin Amyloid Cardiomyopathy, heart failure, enlarged heart|
|Type:||Drug study, Phase 3|
If the FDA approves your use of tafamidis, the drug will be shipped directly to the Investigational Drug Pharmacy at UC Davis Medical Center. The medication will then be dispensed to you through the UC Davis Investigational Pharmacy and your physician. You will be prescribed the study drug, tafamidis, by your physician. The prescriptions will be refilled over an indefinite period of time. This is unless you transition to a commercial version of the drug or do not tolerate the drug well.
You will be taking a 80 mg dose of tafamidis orally, once a day, from the date you are enrolled until you are no longer enrolled in the study. The dose may be reduced to 40mg daily if the treating physician believes it is clinically indicated by your condition.
If you agree to take this drug, you will be followed closely by your treating physician approximately every 3 months. You may see your treating physician more or less often based on their judgment.
To monitor any effects of the drugs, your treating physician may perform: - physical exams, - draw blood, - order EKGs, - echocardiograms, and - do other tests based on your individual condition.
Whether or not they choose to do these tests will be at their discretion. Some of these procedures and tests may be done in between your visits with your treating physician should you choose so and will be interpreted by your treating physician shortly after results become available.
Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028 Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028
-Liver and/or heart transplant, or implanted cardiac mechanical assist device
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.