How long does it take Vyndamax to work?

Key Points

• Vyndamax, when compared to a placebo, was shown to improve the survival rates (71% vs. 57%, respectively) for patients with wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) over a 30-month long clinical study.
• Quality-of-life measurements improved as early as 6 months.

The effectiveness of Vyndamax (tafamidis) in 441 patients with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) was demonstrated in a clinical trial of Vyndamax compared to placebo (an inactive pill) over a period of 30 months. The clinical studies of Vyndaqel (tafamidis meglumine) supported the FDA-approval of Vyndamax (tafamidis).

After 30 months, patients in the Vyndamax group had a survival rate of 71% (186 patients) compared to 57% (101 patients) in the placebo group, a statistically significant outcome. Those receiving tafamidis meglumine had 32% less hospitalizations due to heart problems, also statistically significant.

Patients in the tafamidis meglumine group had improved quality-of-life measures (including physical abilities and social activities). These quality of life measures were seen as soon as 6 months, and lasted throughout the study period.

How do Vyndamax capsules work?

Cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) is a rare disease caused by the buildup of amyloid in the main pumping chamber of the heart. This build-up of amyloid leads to weakening and stiffening of the heart muscle and progressive heart failure. ATTR-CM makes it hard to pump blood to the rest of your body.

The transthyretin protein normally carries thyroid hormone and vitamin A (retinol) throughout the body. Due to a genetic problem or aging in people, the transthyretin protein can clump and form amyloid fibrils. Vyndamax, a transthyretin stabilizer, attaches to the transthyretin protein, slowing down its breakdown into amyloid and the development of ATTR-CM.

Symptoms of ATTR-CM heart involvement can result include shortness of breath, fatigue, heart failure, loss of consciousness, abnormal heart rhythms and death.

Vyndamax, from Pfizer, is approved by the FDA to reduce death and hospitalization due to heart problems in people with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).

Vyndamax is taken as one 61 mg capsule by mouth once per day. Swallow the capsule whole and do not cut or crush it. It must be taken every day, or as directed by your doctor, to be effective.

Vydamax may cause fetal harm in pregnancy. Women taking Vyndamax should discuss pregnancy planning and prevention with their health care professional before treatment begins.

This is not all the information you need to know about Vyndamax (tafamidis) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Vyndamax information here, and discuss this information and any questions you have with your doctor or other health care provider.