HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------CONTRAINDICATIONS------------------------------

These highlights do not include all the information needed to use None. (4)
ATTRUBY safely and effectively. See full prescribing information for
ATTRUBY. To report SUSPECTED ADVERSE REACTIONS, contact BridgeBio
Pharma Inc. at 1-844-550-2246 or FDA at 1-800-FDA-1088 or
ATTRUBY™ (acoramidis) tablets, for oral administration, www.fda.gov/medwatch.
Initial U.S. Approval: 2024
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved
---------------INDICATIONS AND USAGE--------------------------- patient labeling.
ATTRUBY is a transthyretin stabilizer indicated for the treatment of the
cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis Issued:
(ATTR-CM) in adults to reduce cardiovascular death and cardiovascular- 11/2024
related hospitalization. (1, 2.1)

----------DOSAGE AND ADMINISTRATION----------------------- * Sections or subsections omitted from the full prescribing information are
The recommended dosage of ATTRUBY is 712 mg orally twice daily. (2.1) not listed

-------DOSAGE FORMS AND STRENGTHS----------------------

Tablets: 356 mg acoramidis (3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
8.5 Geriatric Use
10 OVERDOSAGE
FULL PRESCRIBING INFORMATION: CONTENTS*
11 DESCRIPTION
1 INDICATIONS AND USAGE 12 CLINICAL PHARMACOLOGY
2 DOSAGE AND ADMINISTRATION 12.1 Mechanism of Action
2.1 Recommended Dosage 12.2 Pharmacodynamics
3 DOSAGE FORMS AND STRENGTHS 12.3 Pharmacokinetics
4 CONTRAINDICATIONS 13 NONCLINICAL TOXICOLOGY
6 ADVERSE REACTIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
6.1 Clinical Trials Experience 14 CLINICAL STUDIES
7 DRUG INTERACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING
8 USE IN SPECIFIC POPULATIONS 17 PATIENT COUNSELING INFORMATION
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Reference ID: 5484268 1

 FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

ATTRUBY 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage of ATTRUBY is 712 mg orally twice daily (with or without food). Swallow
tablets whole; do not cut, crush, or chew.

3 DOSAGE FORMS AND STRENGTHS

ATTRUBY is available as 356 mg acoramidis, white, film-coated, oval tablets, printed with the BridgeBio
company logo followed by “ACOR” in black ink on one side.

4 CONTRAINDICATIONS

None.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in
the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and
may not reflect the rates observed in practice.
The safety data reflect the exposure of 421 participants with ATTR-CM to ATTRUBY 712 mg
(administered as two 356 mg tablets) administered orally twice daily in a randomized, double-blind,
placebo-controlled trial of 30 months fixed treatment duration. The median duration of exposure to
ATTRUBY in the safety population was 29 months. There was a higher frequency of gastrointestinal (GI)
adverse reactions such as diarrhea 11.6% versus 7.6% and upper abdominal pain 5.5% versus 1.4% in
the ATTRUBY versus placebo group, respectively. The majority of these GI adverse reactions were
categorized as mild and resolved without drug discontinuation.
A similar proportion of ATTRUBY-treated and placebo-treated participants discontinued study drug
because of an adverse event (9.3% and 8.5%, respectively).

Laboratory Tests
Increase in Serum Creatinine and Decrease in eGFR
Initiation of ATTRUBY causes an increase in serum creatinine and decrease in eGFR which
generally occurs within 4 weeks of starting therapy and stabilizes. In a trial of adults with ATTR-CM,
a 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 m 2 was observed in the ATTRUBY and placebo groups, respectively, at Day 28.
The changes in serum creatinine and eGFR were reversible after treatment discontinuatio n.

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 7 DRUG INTERACTIONS
UDP-glucuronosyltransferases (UGT) Inducers and Strong CYP3A Inducers
Acoramidis is metabolized by UGT enzyme-mediated glucuronidation. Concomitant use of UGT inducers
can potentially decrease acoramidis exposure. While acoramidis is not metabolized by CYP3A, strong
CYP3A inducers can also induce UGT enzymes. Avoid concomitant use of ATTRUBY with UGT inducers
and strong CYP3A inducers.
Sensitive Cytochrome P450 2C9 (CYP2C9) substrates
Acoramidis inhibits CYP2C9 and may result in an increase in CYP2C9 substrate concentrations when
these drugs are co administered. Consider more frequent monitoring of patients for evidence of increased
exposure (for example, signs of exposure related toxicity) when ATTRUBY is co administered with
sensitive CYP2C9 substrates.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary
Available data with acoramidis use in pregnant women are insufficient to establish a drug associated risk
of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproductive
studies in rats and rabbits, no embryofetal abnormalities were observed at exposures up to 34 times and
13 times the clinical exposure at the maximum recommended human dose, respectively (see Data).

The background risk of major birth defects and miscarriage for the indicated population is unknown. All
pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general
population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.

Report pregnancies to the BridgeBio reporting line at 1-844-550-2246.

Data
Animal Data

In pregnant rats, oral administration of acoramidis (0, 50, 350, and 1,000 mg/kg/day) throughout
organogenesis did not result in any adverse effects on embryofetal development at up to
1,000 mg/kg/day, approximately 34 times the clinical exposure at the maximum recommended human
dose (MRHD) based on AUC.

In pregnant rabbits, oral administration of acoramidis (0, 25, 75, and 200 mg/kg/day) throughout
organogenesis resulted in increased pre-implantation loss at 200 mg/kg/day, a dose that caused maternal
toxicity (26% reduced body weight gain). No embryofetal abnormalities were observed at 200 mg/kg/day,
approximately 13 times the clinical exposure at the MRHD based on AUC.

In a pre- and postnatal developmental toxicity study, pregnant rats received oral administration of
acoramidis at doses of 0, 50, 350, or 1,000 mg/kg/day throughout pregnancy and lactation (Gestation Day
6 to Lactation Day 20). Maternal death, body weight reduction, and decreased number of females with
live born pups (due to increase in resorbed litters) were observed at 1,000 mg/kg/day, approximately 43
times the clinical exposure at the MRHD based on AUC. Decreased body weight gain from the neonatal
period to weaning and learning deficits were observed in the offspring of dams given 1,000 mg/kg/day. No
adverse effects on pre- and postnatal development were observed at 350 mg/kg/day, approximately 18
times the clinical exposure at the MRHD based on AUC.

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 8.2 Lactation

Risk Summary
There are no available data on the presence of acoramidis in either human or animal milk or the effects of
the drug on the breastfed infant or maternal milk production.The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical need for ATTRUBY and any potential
adverse effects on the breastfed child from ATTRUBY or from the underlying maternal condition.

8.4 Pediatric Use

The safety and effectiveness of ATTRUBY have not been established in pediatric patients.

8.5 Geriatric Use

No dosage adjustment is required for elderly patients (≥65 years) [see Clinical Pharmacology (12.3)].
Of the total number of participants randomized in the clinical study (n=632), 97% were 65 years and
over, with a median age of 78 years.

10 OVERDOSAGE
There is no clinical experience with overdose. In case of suspected overdose, treatment should be
symptomatic and supportive.

11 DESCRIPTION
ATTRUBY contains 356 mg acoramidis equivalent to 400 mg acoramidis HCl.
Acoramidis HCl is a transthyretin stabilizer. The chemical name of acoramidis HCl is 3-[3-(3,5-dimethyl-
1H-pyrazol-4-yl)propoxy]-4-fluorobenzoic acid hydrochloride. The molecular formula is C15H18FN2O3Cl,
and the molecular weight is 328.77 g/mol. The structural formula is:

Me

F
Me

Acoramidis HCl is a white to tan solid. The solubility of acoramidis is  12 micrograms/mL from pH 1.2 to
6.8 in aqueous media.

ATTRUBY is supplied as a white, film-coated, oval tablet, contains 356 mg acoramidis, printed with the
BridgeBio company logo followed by “ACOR” in black ink on one side.
The inactive ingredients are croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and
silicon dioxide. The film coating and printing ink contain black iron oxide, glyceryl monocaprylocaprate,
hypromellose, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, and vinyl alcohol graft copolymer.

Reference ID: 5484268

 12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Acoramidis is a selective stabilizer of transthyretin (TTR). Acoramidis binds TTR at thyroxine binding sites
and slows dissociation of the TTR tetramer into its constituent monomers, the rate-limiting step in
amyloidogenesis.

12.2 Pharmacodynamics
TTR Stabilization
Changes in serum TTR level or in vitro TTR stabilization assays were utilized as pharmacodynamic
markers of TTR stabilization. Increases in mean serum TTR levels were observed by Day 28 in ATTR-
CM patients treated with ATTRUBY. Near-complete in vitro TTR stabilization was observed as early as
Day 28 and through completion of a 30-month study of patients with ATTR-CM (wild-type and variant)
treated with the recommended dosage [see Clinical Studies (14)].
Free thyroxine
ATTRUBY may decrease serum concentrations of free thyroxine without an accompanying change in
thyroid stimulating hormone (TSH). A reduction in free thyroxine values has been observed with
transthyretin stabilizers probably due to reduced thyroxine binding to or displacement from
transthyretin (TTR).
NT-proBNP and Troponin I
In a clinical study of ATTRUBY in patients with ATTR-CM, at Month 30, the increase in N-terminal
prohormone of brain natriuretic peptide [NT-proBNP] and troponin I was lower with ATTRUBY versus
placebo. The increase in NT-proBNP at Month 30 for ATTRUBY was about half that of placebo [see
Clinical Studies (14)].
Cardiac Electrophysiology
At approximately 1.2 times the steady state peak plasma concentrations (Cmax) at the recommended
dose, ATTRUBY does not prolong the QTc interval to any clinically relevant extent.

12.3 Pharmacokinetics
The systemic exposures (Cmax and AUC) increase in a less than dose proportional manner following
single and multiple doses of acoramidis. Over the dose range from 89 mg twice daily to 712 mg twice
daily, AUC increases only 130%. Acoramidis steady state is achieved by 4 days with approximately 1.3-
fold accumulation at the approved recommended dosage. At steady state, a dose of 712 mg twice daily
results in a mean (SD) Cmax of 13700 (6090) ng/mL and AUC0-12h of 47200 (10300) ng.h/mL.

Absorption
The time to Cmax of acoramidis (Tmax) is approximately 1 hour following oral administration.

Effect of Food
No clinically significant differences in acoramidis pharmacokinetics were observed following
administration of a high-fat meal (800-1000 total calories, ≥ 50% fat).

Distribution
The apparent steady-state volume of distribution for acoramidis is 654 liters. Acoramidis is 96% bound to
human plasma proteins in vitro. Acoramidis primarily binds to TTR.

Reference ID: 5484268

 Elimination
The effective half-life of acoramidis is approximately 6 hours with a steady state apparent clearance of
16 L/hr.

Metabolism
Acoramidis is primarily metabolized by glucuronidation via UGT1A9, UGT1A1 and UGT2B7. Acoramidis-
β-D-glucuronide (Acoramidis-AG) is the predominant metabolite of acoramidis (8% of total circulating
drug related moieties).

Acoramidis-AG is approximately 1/3 as pharmacologically active compared with acoramidis, has a low
potential for covalent binding, and does not contribute to pharmacological activity.

Excretion
After a single oral dose of radiolabeled acoramidis 712 mg to healthy adult subjects, approximately 32%
of the dose radioactivity was recovered in feces (15% unchanged), and approximately 68% was
recovered in urine (<10% unchanged).

Specific Populations
No clinically significant differences in the pharmacokinetics of acoramidis were observed based on age,
race/ethnicity (including Japanese and non-Japanese), sex, or renal impairment. The effect of hepatic
impairment (Child Pugh A, B, or C) on acoramidis pharmacokinetics is unknown.

Drug Interaction Studies

Clinical Studies
Following the administration of acoramidis (712 mg, BID) in a clinical study in healthy adult volunteers,
there was not a clinically significant increase in exposure to the organic anion transporter-1 (OAT1)
substrate (adefovir) and to OAT3 substrate (oseltamivir carboxylate).
Concomitant diuretic use in patients does not affect steady-state plasma acoramidis concentrations.
In Vitro Studies
Cytochrome P450 Enzymes:
Acoramidis is a time-dependent inhibitor of CYP2C9, but does not inhibit CYP1A2, CYP2B6,
CYP2C8, CYP2C19, CYP2D6, or CYP3A4/5. Acoramidis does not induce CYP1A2, CYP2B6, or
CYP3A4.

UDP-Glucuronosyl Transferase (UGT):

Acoramidis is a substrate of multiple UGT enzymes including UGT1A9, UGT1A1, and UGT2B7.

Transporter Systems:
Acoramidis is a substrate for OAT1 and breast cancer resistance protein (BCRP).
Acoramidis inhibits OAT1 and OAT3, but does not inhibit MATE1, OCT1, OCT2, OATP1B1, OATP1B3,
MATE2-K, BCRP, P-gp, or BSEP.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis
There was no evidence of increased incidence of neoplasia in a 2-year carcinogenicity study in male rats
Reference ID: 5484268
 dosed up to 50 mg/kg and in female rats dosed up to 350 mg/kg, which provided exposures
approximately equivalent to and 11 times the AUC at the maximum recommended human dose (MRHD),
respectively. There was no evidence of an increased incidence of neoplasia in transgenic (Tg.rasH2)
mice following repeated daily administration for 26 weeks at daily doses up to 300 mg/kg.

Mutagenesis
There was no evidence of mutagenicity or clastogenicity for acoramidis in an Ames assay or in vivo rat
micronucleus and alkaline comet assay.
Impairment of Fertility
In a male and female fertility study, rats were orally administered acoramidis at 0, 50, 350, and
1,000 mg/kg/day. Male rats were given acoramidis prior to and during cohabitation for a total of up to
52 days. Female rats were given acoramidis prior to and during cohabitation until implantation of the
embryo (Gestational Day 7) for a total of up to 34 days. There were no effects on fertility, reproductive
performance, or mating behavior in male or female rats at doses up to 1,000 mg/kg/day, approximately
38-times the AUC at the MRHD.

14 CLINICAL STUDIES

The efficacy of ATTRUBY was demonstrated in a multicenter, international, randomized, double-blind,

placebo-controlled study in 611 adult patients with wild-type or variant (hereditary or de novo) ATTR-CM
(NCT03860935).

Participants were randomized (2:1) to receive ATTRUBY 712 mg (n=409) or placebo (n=202) twice daily
for 30 months. Treatment assignment was stratified by type of ATTR-CM [variant (ATTRv-CM) or wild-
type (ATTRwt-CM)], NT-proBNP level, and estimated glomerular filtration rate (eGFR). The mean age of
study participants was 77 years, 90.8% were male, 87.9% were White, 4.7% Black or African American,
2.1% Asian, 5.3% race other, 19% had a history of permanent pacemaker and 58% had a history of atrial
fibrillation. No significant imbalance in baseline characteristics was observed between the two treatment
groups.
Participants were permitted to initiate open-label tafamidis after 12 months in the study. A total of 107
participants received tafamidis: 61 (14.9%) in the ATTRUBY arm and 46 (22.8%) in the placebo arm. The
median time to initiation of tafamidis for these 107 participants was 17 months.
The primary composite endpoint included all-cause mortality (ACM) and cumulative frequency of
cardiovascular-related hospitalizations (CVH) over 30 months, analyzed hierarchically using the stratified
Finkelstein-Schoenfeld (F-S) test. The F-S test demonstrated a statistically significant reduction (p=0.018)
in ACM and cumulative frequency of CVH in the ATTRUBY arm versus the placebo arm. All-cause
mortality was reported in 19% and 26% of participants in the ATTRUBY and placebo groups, respectively.
The majority (79%) of the deaths were cardiovascular. CVH was reported in 27% and 43% of participants
in the ATTRUBY and placebo groups, respectively. The mean number of CVH events was 0.3 vs 0.6 per
year. The majority (59%) of CVH were heart failure hospitalizations reported in 13% and 26% of the
participants in the ATTRUBY and placebo groups, respectively.

The treatment effect of ATTRUBY on functional capacity and health status was assessed by the 6MWD
and the Kansas City Cardiomyopathy Questionnaire-Overall Summary score (KCCQ-OS) respectively. At
month 30, the LS mean difference (95% CI) in change from baseline in 6MWD was 40 [21, 58] meters
(p < 0.0001) and change from baseline in KCCQ-OS was 10 [6, 14] points (p < 0.0001) (Figure 1 and
Figure 2).

Reference ID: 5484268

 Figure 1 - 6MWD Change from Baseline Figure 2 - KCCQ-OS Score Change from Baseline
0 0
e
g 8
-~
-20 "'u
.s -5
] -40 ]
§ Gi' E Gi' -10
"'"'
u -.!. -60
£";
""
c+ - ~~
.l! ] -15
u
~
-80 u ···1-........
::a:
"'
..J
-100
---! 1
"'
-20
--
----!
I- ATTRUBY •• •• •• Placebo I ..J
1- - ATTRUBY •••••• Placebo!

Baseline 6 9 12 18 24 30 Baseline 3 6 9 12 18 24 30
Month Month

ATTRUBY 407 35 1 347 369 363 392 384 ATTRUBY 408 263 389 390 397 404 407 405
Placebo 202 175 176 185 185 190 186 Placebo 202 134 192 194 1% 199 20 1 20 1

Abbreviations: 6MWD = Six-Minute Walk Distance; KCCQ-OS = Kansas City Cardiomyopathy Questionnaire Overall Summary Score; SE =
standard error; LS = least squares.
The changes from baseline in 6MWT and KCCQ-OS were analyzed using the mixed model for repeated measures (MMRM) with treatment
group, visit, genotype (ATTRv-CM vs ATTRwt-CM), NT-proBNP level (≤ 3000 vs > 3000 pg/mL), eGFR level (≥ 45 vs < 45 mL/min/1.73 m2)
and treatment group-by-visit interaction as factors, and baseline value as covariate.

A Cox regression analysis indicated a 35.5% decrease in the risk of the composite of ACM or first CV
hospitalization (hazard ratio: 0.645 [95% CI: 0.500, 0.832]). A Kaplan-Meier plot of time to first event of
ACM or CVH is shown in Figure 3.

Figure 3: Time to First All-cause Mortality or Cardiovascular-Related Hospitalization over

Month 30, mITT Population
1.0

0.8

..c
ro
..c
0 0.6
~

0..
Q)

- ~
..!,.

>
C:
Q)
0.4

w 0.2

0.0
--ATTRUBY - - - · Placebo I
0 3 6 9 12 15 18 21 24 27 30
Time since Randomization (Months)
Subjects Remaining at Risk (Cumulative Events)
ATTRUBY 409 (0) 389 (20) 370 (39) 355 (54) 337 (72) 319 (90) 308 (101 ) 298 (111) 284 (125) 270 (1 39) 0 (147)
Placebo 202 (0) 191 (11) 172 (30) 159 (43) 152(50) 143 (59) 135 (67) 129 (73) 121 (81 ) 108 (94) 0 (102)

Figure 4 shows the treatment effects by prespecified subgroups.

Reference ID: 5484268

 Figure 4: Win-Ratio Analyses for Hierarchical Combination of All-Cause Mortality and
Cardiovascular-Related Hospitalization by Overall and Subgroup, mITT Population
No.(%) of Win Ratio
Subgroup Patients Win Ratio [95% CI]

<--P lacebo Better ATTRUBY Better --->

Overall 611 (100.0) f-----9------i 1.5 [ 1.1, 2.0]

Sex
Male 555 (90.8) ~ 1.5 [ 1.1, 1.9 ]
Female 56 (9.2) - 2.0 [ 0.9, 4.7]
Age (years)
< 78 299 (48.9) I ■ I 2.0 [ 1.2, 3.1]
2'. 78 312 (51.1) - 1.1 [ 0.7, 1.8]
Race
White 537 (87.9) ~ 1.4 [ 1.1, 1.9 ]
Non-White 74 (12.1) - 2.2 [ 1.0, 4.8]
Country
United States 119 (19.5) - 1.4 [ 0.8, 2.4]
Rest of World 492 (80.5) i--e---t 1.5 [ 1.1, 2.0]
ATTR-CM Genotype
ATTRv-CM 59 (9. 7) - 2.4 [ 1.1, 5.0 ]
ATTRwt-CM 552 (90.3) ~ 1.4 [ 1.0, 2.0 ]
NT-proBNP (pg/mL)
'.S 3000 401 (65.6) - 1.4 [ 0.9, 2. 1]
> 3000 210 (34.4) I ■ I 1.7 [ 1.1, 2.6]
eGFR (mL/min/1. 73m2)
< 45 94 (15.4) ~ 1.0 [ 0.5, 2.0]
2'. 45 517 (84.6) ,------e--t 1.6 [ 1.2, 2.2]
ATTR NAC Stage
I
1I
361 (59.1)
196 (32.1) I
-- ■ I
1.4 [ 0.9, 2.1]
1.8 [ 1.1, 2.8]
Ill 54 (8 .8) ::: 1.1 [ 0.5, 2.5]
NYHAClass
I, 1I 512 (83.8) I ■ I 1.7 [ 1.2, 2.4]
Ill 99 (16.2) -- 0.7 [ 0.3, 1.6]

I I I I I

0.25 0.5 2 4 8
Abbreviations: ATTR-CM = transthyretin amyloid cardiomyopathy; ATTRv-CM = variant ATTR-CM; ATTRwt-CM = wild-type ATTR-CM;
eGFR = estimated glomerular filtration rate; mITT=modified intent-to-treat; NAC = National Amyloidosis Centre; NT-proBNP = N-terminal
prohormone of brain natriuretic peptide; NYHA = New York Heart Association
All-Cause Mortality includes heart transplant, CMAD and all-cause death. Cardiovascular-related hospitalizations include cardiovascular
hospitalizations and urgent unplanned visits requiring treatment with intravenous diuretic for decompensated heart failure. Non-White
includes American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, Other, multiple
races and Not reported.
ATTR NAC Stage: ATTR Stage I, defined as NT-proBNP ≤ 3000 ng/L and eGFR ≥ 45 mL/min/1.73 m2; Stage III, defined as NT-proBNP
> 3000 ng/L and eGFR < 45 mL/min/1.73 m2, the remainder categorized as Stage II.

16 HOW SUPPLIED/STORAGE AND HANDLING

ATTRUBY (acoramidis) tablets, 356 mg, are white, film-coated, oval tablets, printed with the BridgeBio
company logo followed by “ACOR” in black ink on one side.

ATTRUBY tablets are supplied as a carton of 112 tablets: 4 blister cards (each containing 28 tablets)–
(NDC 82228-712-28).

Reference ID: 5484268

 Store ATTRUBY at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to
15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in original blister card until
use to protect from moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Pregnancy
Advise patients who are exposed to ATTRUBY during pregnancy to contact the BridgeBio reporting line
at 1-844-550-2246. Advise patients to inform their healthcare provider of a known or suspected
pregnancy [see Use in Specific Populations (8.1)].

For more information about ATTRUBY, go to www.ATTRUBY.com

Distributed by:
BridgeBio Pharma, Inc.
Palo Alto, CA 94304

Reference ID: 5484268

 PATIENT INFORMATION
ATTRUBYTM (ah-troo-be)
(acoramidis)
tablets
What is ATTRUBY?
ATTRUBY is a prescription medicine used to treat adults with a disease that affects the heart muscle called
cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM), to reduce death and
hospitalization related to heart problems.
It is not known if ATTRUBY is safe and effective in children.
Before taking ATTRUBY, tell your healthcare provider about all your medical conditions, including if you:
• are pregnant or plan to become pregnant. It is not known if ATTRUBY will harm your unborn baby. Tell your
healthcare provider right away if you become pregnant or think you may be pregnant during treatment with
ATTRUBY. You may also report your pregnancy by calling the BridgeBio reporting line at 1-844-550-2246.
• are breastfeeding or plan to breastfeed. It is not known if ATTRUBY passes into your breast milk. Talk to your
healthcare provider about the best way to feed your baby during treatment with ATTRUBY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
How should I take ATTRUBY?
• Take ATTRUBY exactly as your healthcare provider tells you to.
• Take ATTRUBY tablets by mouth 2 times a day, with or without food.
• Swallow tablets whole. Do not cut, crush, or chew tablets.
What are the possible side effects of ATTRUBY?
The most common side effects of ATTRUBY were mild and include:
• stomach-area (abdominal) pain
• diarrhea
These are not all of the possible side effects of ATTRUBY.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ATTRUBY?
• Store ATTRUBY tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Store in original blister card until use to protect from moisture.
Keep ATTRUBY and all medicines out of the reach of children.
General information about the safe and effective use of ATTRUBY.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use
ATTRUBY for a condition for which it was not prescribed. Do not give ATTRUBY to other people, even if they have the
same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information
about ATTRUBY that is written for health professionals.
What are the ingredients in ATTRUBY?
Active ingredient: acoramidis
Inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The
film coating and printing ink contain black iron oxide, glyceryl monocaprylocaprate, hypromellose, polyvinyl alcohol,
propylene glycol, talc, titanium dioxide, and vinyl alcohol graft copolymer.
Distributed by: BridgeBio Pharma, Inc., Palo Alto, CA 94304
For more information about ATTRUBY, go to www.ATTRUBY.com or call 1-844-550-2246
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 11/2024

Reference ID: 5484268