CHF and arrhythmias:
Indications for: VYNDAMAX
Treatment in adults with cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Clinical Trials:
The efficacy of tafamidis was evaluated in a randomized, double-blind, placebo-controlled study that included 441 patients with wild-type or hereditary ATTR-CM (ClinicalTrials.gov Identifier: NCT01994889). Patients were randomly assigned to receive tafamidis 20mg (n=88), tafamidis 80mg (n=176), or placebo (n=177) once daily for 30 months in addition to standard of care (eg, diuretics).
The primary endpoint of the study was the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations, which was defined as the number of times a patient was hospitalized for cardiovascular-related morbidity.
Results showed a significant reduction (P =.0006) in all-cause mortality and frequency of cardiovascular-related hospitalizations in the pooled tafamidis 20mg and 80mg groups vs placebo. An analysis of individual components showed a 30% relative reduction in the risk of death when compared with placebo (hazard ratio [HR] 0.70, 95% CI: 0.51, 0.96; P =.026).
There were significantly fewer cardiovascular-related hospitalizations with tafamidis compared with placebo with a reduction in risk of 32% corresponding to a relative risk ratio of 0.68 (P <.0001). A significant treatment effect favoring tafamidis was first observed at month 6 and remained consistent through month 30 on both the 6-Minute
Walk Test (6MWT) and the Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) score.
Results of the primary analysis, 6MWT at month 30 and KCCQ-OS at month 30 were statistically significant for both the 80mg and 20mg doses of tafamidis vs placebo, with similar results for both doses.
The frequency of adverse events in patients treated with tafamidis was similar to that with placebo.
Adult Dosage:
Swallow whole. 61mg once daily. Not substitutable with Vyndaqel on a per mg basis.
Children Dosage:
Not established.
VYNDAMAX Warnings/Precautions:
Pregnancy. Advise females of reproductive potential to consider pregnancy planning and prevention. Nursing mothers: not recommended.
VYNDAMAX Classification:
Transthyretin (TTR) stabilizer.
VYNDAMAX Interactions:
May potentiate BCRP substrates (eg, methotrexate, rosuvastatin, imatinib); monitor and may need to adjust dose of substrate.
Drug Elimination:
Mean half-life of tafamidis is ~ 49 hours.
Approximately 59% of the dose was recovered in feces and approximately 22% of the dose was recovered in urine.
Generic Drug Availability:
NO
How Supplied:
Caps—30
