Acoramidis is an oral transthyretin (TTR) stabilizer used to treat transthyretin mediated amyloidosis cardiomyopathy (ATTR-CM).

1、 Drug name

1. Common name: Acoramidis

2. Product Name: ATTRUBY ™

2、 Indications

Used to treat adult wild-type or mutant transthyretin mediated amyloidosis cardiomyopathy (ATTR-CM) to reduce cardiovascular mortality and cardiovascular related hospitalization risk.

3、 Specifications and characteristics

Specification: Each tablet contains 356 milligrams of Aconitude (equivalent to 400 milligrams of Aconitude hydrochloride).

4、 Main components

Active ingredient: Acoramidis.

5、 Usage and dosage

1. Recommended dosage: 712 milligrams per dose (i.e. 2 tablets of 356 milligrams), twice daily, orally.

2. Usage: Swallow the whole tablet, do not cut, crush or chew. Can be taken with food or alone.

6、 Dose adjustment

No mention was made of the need for dose adjustment based on conventional factors such as liver and kidney function. Elderly patients (≥ 65 years old) do not need to adjust the dosage.

7、 Medication precautions

1. Before and after meals: The timing of taking is not affected by eating.

2. Missed dose: Follow medical advice or general principles: If it is close to the next dose, skip the missed dose and take the next dose at the regular time. Do not double the dose.

3. Vomiting: If vomiting occurs, consult a doctor.

4. Swallowing: The entire piece must be swallowed.

8、 Medication for special populations

1. Pregnancy period: There is insufficient data on the use of drugs by pregnant women, and animal experiments have not shown teratogenicity at much higher than clinical exposure levels.

2. Breastfeeding period: There is no data on the presence of acaomidi in breast milk, and the benefits of breastfeeding should be balanced against the mother's treatment needs and potential risks to the baby.

3. Children: Safety and effectiveness have not yet been established.

4. Elderly individuals (≥ 65 years old): No dosage adjustment is required. 97% of participants in clinical studies are aged 65 years or older.

5. Liver and kidney dysfunction: Patients with kidney dysfunction do not need to adjust the dosage. The impact of liver dysfunction (Child Pugh A, B, C grades) is unknown.

9、 Adverse reactions

1. Common adverse reactions: mainly gastrointestinal reactions, such as diarrhea (11.6% vs placebo 7.6%), upper abdominal pain (5.5% vs 1.4%), most of which are mild and do not lead to discontinuation of medication.

2. Laboratory examination: Within 4 weeks of starting treatment, there is a common increase in serum creatinine and a decrease in estimated glomerular filtration rate (eGFR), which stabilizes thereafter and is reversible upon discontinuation of medication.

3. Discontinuation rate: The proportion of drug discontinuation due to adverse events was similar to that of the placebo group (9.3% vs 8.5%).

10、 Contraindications

None.

11、 Drug interactions

1. Avoid co use: It should be avoided to use UDP glucuronosyltransferase (UGT) inducers and potent CYP3A inducers simultaneously, as they may reduce the blood concentration of Acomidi.

2. Cautious combination and monitoring: Acomida can inhibit CYP2C9, and when used in combination with sensitive CYP2C9 substrates such as warfarin, it may lead to an increase in the latter's blood drug concentration. Therefore, monitoring should be strengthened.

3. Other: Combination with diuretics does not affect its blood drug concentration. Clinically relevant interactions do not involve OAT1/OAT3 substrates (such as adefovir, oseltamivir carboxylate).

12、 Storage method

1. Store at room temperature of 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Please keep it in the original aluminum-plastic foam cover panel until use to prevent moisture.

3. Please keep out of reach of children.

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