Opicapon is a peripheral selective, reversible catechol-O-methyltransferase (COMT) inhibitor. By inhibiting COMT enzyme activity, the metabolism of levodopa in the periphery is reduced, thereby prolonging its action time and enhancing its therapeutic effect.

1、 Drug name

1. Common name: Opicapone

2. Product Name: ONGENTYS ®

3. English name: OpicaponeCapsules

2、 Indications

Opicapon is a catechol-O-methyltransferase (COMT) inhibitor used as an adjuvant therapy for levodopa/carbidopa in patients with Parkinson's disease (PD) who experience "off phase" episodes.

3、 Specifications and characteristics

25mg capsule: light blue opaque cap and light pink opaque body, both with blue "OPC" and "25" printed on the cap and body.

4、 Main components

1. The active ingredient in each capsule is opicarpone.

2. The inactive ingredients include lactose, magnesium stearate, pre gelatinized starch, and sodium hydroxypropyl starch. The capsule shell contains: FD&C Blue No.2, FD&C Red No.3, gelatin, and titanium dioxide.

5、 Usage and dosage

1. The recommended dosage is once daily, 50mg each time, taken orally before bedtime.

2. Avoid eating within 1 hour before and after taking medication.

6、 Dose adjustment

1. The recommended dose for patients with moderate liver dysfunction (Child Pugh B grade) is 25mg, taken once daily before bedtime.

2. Patients with severe liver dysfunction (Child Pugh C grade) should avoid using it.

3. Patients with end-stage renal disease (CLcr<15mL/min) should also avoid using it. Mild to moderate renal insufficiency patients do not require dose adjustment.

7、 Medication precautions

1. Dietary requirements: Fasting within 1 hour before and after taking medication.

2. Omission treatment: If missed, take the regular dose as scheduled the next day without the need for supplementation.

3. Vomiting treatment: Not clearly stated, it is recommended to consult a doctor.

4. Discontinuation method: When discontinuing medication, monitor the patient's symptoms and adjust the dosage of other dopaminergic drugs if necessary.

8、 Medication for special populations

1. Pregnant women: Based on animal data, it may cause harm to the fetus and should be used with caution.

2. Breastfeeding women: There is no human data available, it is recommended to weigh the pros and cons before deciding whether to use it.

3. Children: Safety and efficacy have not been established.

4. Elderly: No need to adjust dosage, but be aware that they may be more sensitive to adverse reactions.

9、 Adverse reactions

1. The most common adverse reactions (incidence ≥ 4% and higher than placebo) include: movement disorders, constipation, elevated creatine kinase, hypotension/syncope, and weight loss.

2. Other serious adverse reactions include daytime sleepiness, hallucinations, impulse control disorders, high fever and confusion after discontinuation of medication.

10、 Contraindications

1. Do not use in combination with non selective monoamine oxidase inhibitors (MAOIs).

2. Prohibited for patients with a history of pheochromocytoma, paraganglioma, or other catecholamine secreting tumors.

11、 Drug interactions

1. Combined use with non selective MAOIs can lead to elevated levels of catecholamines and increased cardiovascular risk.

2. When used in combination with drugs metabolized by COMT (such as isoproterenol, adrenaline, etc.), heart rate, rhythm, and blood pressure changes need to be monitored.

12、 Storage method

The storage temperature should be below 30 ° C (86 ° F).

Opicaponeinformation