Acoramidis Hydrochloride
Generic Name: acoramidis hydrochloride
Brand Names:
Attruby
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 C 15 H 18 FN 2 O 3 Cl, and the molecular weight is 328.77 g/mol. The structural formula is: 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.
Overview
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 C 15 H 18 FN 2 O 3 Cl, and the molecular weight is 328.77 g/mol. The structural formula is: 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.
Uses
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. ATTRUBY is a transthyretin stabilizer 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. ( 1 , 2.1 )
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage of ATTRUBY is 712 mg orally twice daily. ( 2.1 ) 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.
Side Effects
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.
Interactions
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.
Warnings
4 CONTRAINDICATIONS None. None. ( 4 ) To report SUSPECTED ADVERSE REACTIONS, contact BridgeBio Pharma Inc. at 1-844-550-2246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Pregnancy
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.
Storage
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).
Frequently Asked Questions
What is Acoramidis Hydrochloride used for?▼
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. ATTRUBY is a transthyretin stabilizer 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. ( 1 , 2.1 )
What are the side effects of Acoramidis Hydrochloride?▼
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.
Can I take Acoramidis Hydrochloride during pregnancy?▼
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.
What are the important warnings for Acoramidis Hydrochloride?▼
4 CONTRAINDICATIONS None. None. ( 4 ) To report SUSPECTED ADVERSE REACTIONS, contact BridgeBio Pharma Inc. at 1-844-550-2246 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.