Transcript
Dr. Mitchell:
Going back to those characteristics that might increase uh my suspicion, on top of just having that thickened heart uh and—and potentially heart failure, carpal tunnel syndrome, especially bilateral carpal tunnel syndrome can—can predate cardiac amyloid by 6 years or so. We might um see patients with previous aortic valve replacement, um especially these are patients that are probably over the age of 60 or 65, and younger patients that’s much less likely. If I’m seeing neuropathy, that might tune me in um to possible amyloid. That’s more likely in hereditary amyloid, as opposed to wild type. As the disease progresses, I might see low blood pressure. So newly low blood pressure can be uh a red flag. Um Also, they may start to have GI illness, as far as weight loss or dysphagia as the disease progresses. Other things that heighten my awareness would be spinal stenosis, um either lumbar or—or cervical stenosis. Biceps tendon rupture is supposed to be very specific, although I’ve done a workup in a couple and haven’t found it yet.
Um, with that, it’s also important to add that in someone with previous carpal tunnel syndrome, uh it can take a while for that cardiac amyloid to develop. And so if I do have bilateral carpal tunnel and that triggers a workup that’s negative, that person might still develop amyloid a few years later down the road. And so I should still think about it and consider it in the future.
Voiceover:
Indication and Important Safety Information.
Indication
Attruby® (acoramidis) is indicated for the treatment of cardiomyopathy of wild type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation.
Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
Laboratory Tests
Mean increase in serum creatinine of 0.2 and 0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/min/1.73 m2 was observed in the adults with ATTR-CM treated with Attruby versus placebo, respectively, at Day 28 and then stabilized. These changes were reversible after treatment discontinuation.
Use in Specific Populations
Pregnancy & Lactation: There are no data on the use of Attruby in pregnant women. Animal data have not shown developmental risk associated with the use of Attruby in pregnancy. There are no available data on the presence of Attruby in either human or animal milk or the effects of the drug on the breastfed infant or maternal milk production.
Please see Full Prescribing Information for Attruby at Attruby.com/PI