b'Brief Summary of Full Prescribing Information 8 USE IN SPECIFIC POPULATIONS Attruby (acoramidis) tablets, for oral administration 8.1 Pregnancy 1 INDICATIONS AND USAGERisk SummaryAvailable data with acoramidis use in pregnant womenAttruby is indicated for the treatment of the cardiomyopathy NOW APPROVED of wild-type or variant transthyretin mediated amyloidosisare insufficient to establish a drug associated risk of major (ATTR-CM) in adults to reduce cardiovascular death andbirth defects, miscarriage or other adverse maternal or fetal cardiovascular-related hospitalization. outcomes. In animal reproductive studies in rats and rabbits, 4 CONTRAINDICATIONS no embryofetal abnormalities were observed at exposuresNone.up to 34 times and 13 times the clinical exposure at the maximum recommended human dose, respectively. 6 ADVERSE REACTIONSThe background risk of major birth defects and miscarriage6.1 Clinical Trials Experience for the indicated population is unknown. All pregnancies haveBecause clinical trials are conducted under widely varyinga background risk of birth defects, loss, or other adverse conditions, adverse reaction rates observed in the clinicaloutcomes. In the U.S. general population, the estimated trials of a drug cannot be directly compared to rates in thebackground risk of major birth defects and miscarriageWhen managing your membersclinical trials of another drug and may not reflect the ratesin clinically recognized pregnancies is 2% to 4% andobserved in practice. 15% to 20%, respectively.with ATTR-CM,consider a new treatment The safety data reflect the exposure of 421 participants Report pregnancies to the BridgeBio reporting linewith ATTR-CM to Attruby 712 mg (administered as twoat 1-844-550-2246.option to reduce cardiovascular death and356 mg tablets) administered orally twice daily in a8.2 Lactation randomized, double-blind, placebo-controlled trial of Risk Summarycardiovascular-related hospitalizations 1 30 months fixed treatment duration. The median durationThere are no available data on the presence of acoramidis of exposure to Attruby in the safety population wasin either human or animal milk or the effects of the drug29 months. There was a higher frequency of gastrointestinal on the breastfed infant or maternal milk production. The (GI) adverse reactions such as diarrhea 11.6% versus 7.6%developmental and health benefits of breastfeeding should and upper abdominal pain 5.5% versus 1.4% in the Attrubybe considered along with the mothers clinical need for versus placebo group, respectively. The majority of these Attruby and any potential adverse effects on the breastfed GI adverse reactions were categorized as mild and resolvedchild from Attruby or from the underlying maternal Scan code to visitwithout drug discontinuation. condition.A similar proportion of Attruby-treated and placebo-treated 8.4 Pediatric UseAttrubyHCP.com participants discontinued study drug because of an adverseThe safety and effectiveness of Attruby have not been and learn more event (9.3% and 8.5%, respectively). established in pediatric patients.Laboratory Tests 8.5 Geriatric UseIncrease in Serum Creatinine and Decrease in eGFR No dosage adjustment is required for elderly patients ATTR-CM=transthyretin amyloid cardiomyopathy. Initiation of Attruby causes an increase in serum creatinine(65 years). Of the total number of participants randomizedand decrease in eGFR which generally occurs within 4 weeksin the clinical study (n=632), 97% were 65 years and over, of starting therapy and stabilizes. In a trial of adults withwith a median age of 78 years.ATTR-CM, a mean increase in serum creatinine of 0.2 and 10 OVERDOSAGE0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/2 There is no clinical experience with overdose. In case of INDICATION Laboratory Tests min/1.73 mwas observed in the Attruby and placebosuspected overdose, treatment should be symptomaticgroups, respectively, at Day 28. The changes in serum Attruby (acoramidis) is indicated for the treatmentMean increase in serum creatinine of 0.2 and creatinine and eGFR were reversible after treatmentand supportive.of cardiomyopathy of wild-type or variant0.0 mg/dL and a mean decrease in eGFR of 8.2 discontinuation.17 PATIENT COUNSELING INFORMATIONtransthyretin-mediated amyloidosis (ATTR-CM) and 0.7 mL/min/1.73 m 2was observed in the adults7 DRUG INTERACTIONSAdvise the patient to read the FDA-approved patient in adults to reduce cardiovascular death andwith ATTR-CM treated with Attruby versus placebo,UDP-glucuronosyltransferases (UGT) Inducers and Strong CYP3A labeling (Patient Information).cardiovascular-related hospitalization.respectively, at Day 28 and then stabilized. TheseInducers Pregnancychanges were reversible after treatment discontinuation.Acoramidis is metabolized by UGT enzyme-mediatedAdvise patients who are exposed to Attruby during IMPORTANT SAFETY INFORMATION glucuronidation. Concomitant use of UGT inducers canpregnancy to contact the BridgeBio reporting line at Adverse Reactions Use in Specific Populationspotentially decrease acoramidis exposure. While acoramidis1-844-550-2246. Advise patients to inform their healthcare Diarrhea (11.6% vs 7.6%) and upper abdominal painPregnancy & Lactation: There are no data on the is not metabolized by CYP3A, strong CYP3A inducers canprovider of a known or suspected pregnancy. also induce UGT enzymes. Avoid concomitant use of Attruby (5.5% vs 1.4%) were reported in patients treated withuse of Attruby in pregnant women. Animal data havewith UGT inducers and strong CYP3A inducers. For more information about Attruby, go to Attruby versus placebo, respectively. The majority ofnot shown developmental risk associated with the Sensitive Cytochrome P450 2C9 (CYP2C9) substrates www.Attruby.com. these adverse reactions were mild and resolveduse of Attruby in pregnancy. There are no availableAcoramidis inhibits CYP2C9 and may result in an increase in without drug discontinuation.data on the presence of Attruby in either human orCYP2C9 substrate concentrations when these drugs are coThe risk information provided here is not comprehensive.animal milk or the effects of the drug on the breastfedadministered. Consider more frequent monitoring ofThe FDA-approved product labeling can be found at Discontinuation rates due to adverse events wereinfant or maternal milk production. patients for evidence of increased exposure (for example,Attruby.com/PI or by calling 1-844-550-2246.similar between patients treated with Attruby versusReference: 1. Attruby. Prescribing information. BridgeBio, Inc.; 2024. signs of exposure related toxicity) when Attruby is coDistributed by:placebo (9.3% and 8.5%, respectively). administered with sensitive CYP2C9 substrates. BridgeBio Pharma, Inc.Palo Alto, CA 94304Please read the accompanying Brief Summary on the adjacent page; the Full Prescribing Information for Attruby is available at Attruby.com/PI.Attruby and the BridgeBio, Inc. corporate logo are trademarks of BridgeBio, Inc. 2024 BridgeBio, Inc. All rights reserved. MAT-US-ACO-0240 V17062660_002_bbio_attruby_payer_journal_ad_us_medicine_lo.indd All Pages 12/3/24 4:56PM'