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Drug overview for ATTRUBY (acoramidis hcl):
Generic name: ACORAMIDIS HCL
Drug class: Amyloidosis Agents - Protein Stabilizers
Therapeutic class: Endocrine
Acoramidis hydrocholoride is a transthyretin (TTR) stabilizer.
No enhanced Uses information available for this drug.
Generic name: ACORAMIDIS HCL
Drug class: Amyloidosis Agents - Protein Stabilizers
Therapeutic class: Endocrine
Acoramidis hydrocholoride is a transthyretin (TTR) stabilizer.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ATTRUBY (acoramidis hcl) have been approved by the FDA:
Indications:
Transthyretin-related amyloid cardiomyopathy
Professional Synonyms:
Cardiomyopathy due to ATTR
Transthyretin amyloid cardiomyopathy
Indications:
Transthyretin-related amyloid cardiomyopathy
Professional Synonyms:
Cardiomyopathy due to ATTR
Transthyretin amyloid cardiomyopathy
The following dosing information is available for ATTRUBY (acoramidis hcl):
Acoramidis is commercially available as the hydrochloride salt; dosage is expressed in terms of acoramidis.
Administer acoramidis orally with or without food. Swallow the tablets whole; do not cut, crush, or chew. Store acoramidis at 20-25degreesC with permitted excursions between 15-30degreesC. Keep in the original blister card until use to protect from moisture.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ATTRUBY 356 MG TABLET | Maintenance | Adults take 2 tablets (712 mg) by oral route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for ATTRUBY (acoramidis hcl):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Acoramidis/UGT and Selected CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: UGT and selected CYP3A4 inducers may induce the metabolism of acoramidis, which is glucuronidated by UGT1A9, UGT1A1, and UGT2B7.(1) CLINICAL EFFECTS: Concurrent use of UGT and selected CYP3A4 inducers may result in decreased levels and effectiveness of acoramidis.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of acoramidis states to avoid concomitant use of acoramidis with UGT inducers and strong CYP3A inducers.(1) DISCUSSION: UGT and selected CYP3A4 inducers linked to this monograph include: carbamazepine, efavirenz, etravirine, fosphenytoin, phenobarbital, phenytoin, primidone, rifampin, rifapentine, and ritonavir. |
CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, DILANTIN, DILANTIN-125, DONNATAL, EFAVIRENZ, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EPITOL, EQUETRO, ETRAVIRINE, FOSPHENYTOIN SODIUM, INTELENCE, KALETRA, LOPINAVIR-RITONAVIR, MYSOLINE, NORVIR, PAXLOVID, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PRIFTIN, PRIMIDONE, RIFADIN, RIFAMPIN, RITONAVIR, SEZABY, SYMFI, TEGRETOL, TEGRETOL XR |
There are 0 moderate interactions.
The following contraindication information is available for ATTRUBY (acoramidis hcl):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ATTRUBY (acoramidis hcl):
Adverse reaction overview.
In a clinical trial, adverse effects reported more often in patients receiving acoramidis than placebo were diarrhea and upper abdominal pain.
In a clinical trial, adverse effects reported more often in patients receiving acoramidis than placebo were diarrhea and upper abdominal pain.
There are 0 severe adverse reactions.
There are 2 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea |
Upper abdominal pain |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ATTRUBY (acoramidis hcl):
The safety and efficacy in pediatric patients have not been studied.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data on acoramidis use in pregnancy are insufficient to assess risks of birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, no embryofetal abnormalities were observed at exposures up to 34 times the human dose in rats and 13 times the human dose in rabbits. Report pregnancies to the BridgeBio reporting line at 1-844-550-2246.
Data on acoramidis in human milk or whether the drug has any effects on a breastfed child or on milk production are unavailable. The benefits of breastfeeding should be weighed against the mother's need for acoramidis and potential risks to the infant.
No dosage adjustment is needed for patients >=65 years of age. In the principal clinical study, 97% of patients were >=65 years of age, with a median of 78 years of age.
The following prioritized warning is available for ATTRUBY (acoramidis hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ATTRUBY (acoramidis hcl)'s list of indications:
| Transthyretin-related amyloid cardiomyopathy | |
| E85.4 | Organ-limited amyloidosis |
| E85.82 | Wild-type transthyretin-related (ATTr) amyloidosis |
| I43 | Cardiomyopathy in diseases classified elsewhere |
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