Dosing & Safety

Attruby is conveniently packaged and has a safety profile demonstrated in
patients with ATTR-CM

Convenient Dosing
Safety Profile

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Safety Profile icon

Safety outcomes from the ATTRibute-CM clinical trial1

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No contraindications

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Discontinuations due to adverse events were similar for Attruby (9.3%) and placebo (8.5%)

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Higher frequency of GI adverse reactions with Attruby vs placebo
Diarrhea (11.6% vs 7.6%)
Upper abdominal pain (5.5% vs 1.4%)

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No drug-drug interactions (DDIs) with statins (eg, rosuvastatin) per label

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See more on the safety profile
of Attruby 

*Based on ITT population (632 patients). The ITT population was defined as all randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy evaluation and included participants who had a baseline eGFR <30 mL/min/1.73 m2.2

ATTR-CM=transthyretin amyloid cardiomyopathy; DDI=drug-drug interaction; eGFR=estimated glomerular filtration rate; GI=gastrointestinal; ITT=intent-to-treat.

References: 1. Attruby. Prescribing information. BridgeBio Pharma, Inc.; 2024. 2. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2): 132-142. doi:10.1056/NEJMoa2305434 3. Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2)(suppl 1):1-34. doi:10.1056/NEJMoa2305434

Established Safety Profile3

Patients With One or More Events
Attruby
n=421
% (n)
Placebo
n=211
% (n)
Any treatment-emergent adverse events (TEAEs)
98.1% (413)
97.6% (206)
Any treatment-emergent serious adverse events (SAEs)
54.6% (230)
64.9% (137)
Any treatment-related TEAEs
11.9% (50)
5.2% (11)
Severe TEAEs
37.3% (157)
45.5% (96)

SAE=serious adverse event; TEAE=treatment-emergent adverse event.

Convenient Dosing
Safety Profile
Safety Profile icon

More information on DDIs1

Avoid concomitant use of Attruby with UGT inducers and strong CYP3A inducers as these can potentially decrease Attruby exposure.

Consider more frequent monitoring for evidence of increased exposure to CYP2C9 substrates when Attruby is co-administered with sensitive CYP2C9 substrates.

CYP=cytochrome P450; DDI=drug-drug interaction; UGT=uridine diphosphate glucuronosyltransferase.

Indication and Important safety information

INDICATION

Attruby® (acoramidis) is indicated for the treatment of the 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 including Patient Information.

INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

Attruby® (acoramidis) is indicated for the treatment of the 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 including Patient Information.