Opicapone (Ongentys) is a novel, highly selective and reversible peripheral catechol-O-methyltransferase (COMT) inhibitor, which was approved for marketing in the United States in 2020.

Dosage and Administration, Recommended Dosage of Opicapone (Ongentys)

Recommended Dosage and Administration Time

The recommended dosage of opicapone is 50 mg, administered orally once daily at bedtime.

The once-daily administration regimen improves patients' medication compliance.

Management of Missed Dose and Discontinuation

Missed dose: If a single dose is missed, there is no need to make up the dose. The regular dose should be taken at the scheduled time on the following day as planned.

Discontinuation: If it is necessary to discontinue opicapone, the process shall be carried out under the guidance of a physician, and the patient's condition shall be closely monitored.

It may be necessary to adjust the dosage of other dopaminergic drugs (e.g., levodopa) to prevent the occurrence of withdrawal-related malignant symptoms, such as hyperthermia and confusion.

Dosage Adjustment of Opicapone (Ongentys)

Patients with Moderate to Severe Hepatic Impairment

For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage shall be reduced to 25 mg once daily, taken at bedtime.

This drug should be avoided in patients with severe hepatic impairment (Child-Pugh Class C).

Patients with Renal Impairment

Dosage adjustment is generally not required for patients with mild to moderate renal impairment.

However, it should be noted that opicapone is mainly excreted through the kidneys, and thus should be avoided in patients with end-stage renal disease (CLcr < 15 mL/min).

Administration of Opicapone (Ongentys) in Special Populations

Pregnant Women

Adequate human pregnancy safety data are currently lacking.

Animal studies have shown that opicapone may cause harm to the fetus.

The use of this drug during pregnancy requires a careful weighing of benefits and risks, and should only be administered after evaluation by a physician when clearly necessary.

Lactating Women

It is unknown whether opicapone is excreted in human milk.

Considering the potential risks of the drug to infants, lactating women should use it with caution, and it is recommended to consult a physician to decide whether to continue breastfeeding.

Geriatric Patients

Dosage adjustment based on age is generally not required.

Geriatric patients may be more sensitive to the side effects of the drug, and thus require close monitoring.