Amyloid cardiomyopathy: Oral: 712 mg twice daily.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely as no clinically significant differences in pharmacokinetics were observed based on kidney impairment.
Child-Turcotte-Pugh class A to C: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%: Gastrointestinal: Diarrhea (12%)
1% to 10%: Gastrointestinal: Upper abdominal pain (6%)
Frequency not defined: Renal: Decreased estimated GFR (eGFR), increased serum creatinine
There are no contraindications listed in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Therapy Pack, Oral:
Attruby: 356 mg (28 ea)
No
Tablet Therapy Pack (Attruby Oral)
356 mg (per each): $200.99
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Oral: May be administered without regard to meals. Swallow tablet whole; do not cut, crush, or chew.
Amyloid cardiomyopathy : Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
Substrate of BCRP, OAT1/3, UGT1A1, UGT1A9, UGT2B7;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors): Acoramidis may increase serum concentration of CYP2C9 Substrates (Narrow Therapeutic Index/Sensitive with Inhibitors). Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Acoramidis. Risk X: Avoid
Mitapivat: May decrease serum concentration of UGT1A1 Substrates. Risk C: Monitor
UGT1A1 Inducers: May decrease serum concentration of Acoramidis. Risk X: Avoid
Adverse events were not observed in animal reproduction studies with doses up to ~34 times the maximum recommended human dose, based on AUC.
Health care providers and patients should report pregnancies exposed to acoramidis to the BridgeBio reporting line (844-550-2246).
It is not known if acoramidis is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
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.
Distribution: Vd: 654 L.
Protein binding: 96%.
Metabolism: 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).
Half-life elimination: ~6 hours.
Time to peak: ~1 hour.
Excretion: Feces: ~32% (15% as unchanged drug); urine: ~68% (<10% as unchanged drug).
Clearance: 16 L/hour.
Other: Molecular weight: 328.77 grams/mole.