Opicapone

Opicapone is a prescription medication used as an adjunct to levodopa/carbidopa to reduce “off” episodes in patients with Parkinson's disease.

• Opicapone is available under the following different brand names: Ongentys

Common side effects of Opicapone include:

• involuntary muscle movements (dyskinesia)
• constipation
• increased blood creatine kinase
• low blood pressure (hypotension)/fainting
• weight loss

Serious side effects of Opicapone include:

• hallucinations (seeing things or hearing voices that do not exist)
• delusions (having strange thoughts or beliefs that have no basis in reality)
• aggressive behavior
• fainting

Rare side effects of Opicapone include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 25 mg
• 50 mg

Parkinson's disease

Adult dosage

• 50 mg orally once a day during bedtime

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Opicapone has severe interactions with the following drugs:
  • isocarboxazid
  • phenelzine
  • tranylcypromine
• Opicapone has serious interactions with no other drugs.
• Opicapone has moderate interactions with the following drugs:
  • acrivastine
  • amisulpride
  • asenapine
  • asenapine transdermal
  • avapritinib
  • benzhydrocodone/acetaminophen
  • brexpiprazole
  • brimonidine
  • brivaracetam
  • buprenorphine subdermal implant
  • buprenorphine transdermal
  • buprenorphine, long-acting injection
  • dobutamine
  • dopamine
  • epinephrine
  • epinephrine inhaled
  • epinephrine racemic
  • isoproterenol
  • methyldopa
  • norepinephrine
• Opicapone has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Concomitant use of nonselective monoamine oxidase (MAO) inhibitors
• History of pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasm

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Opicapone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Opicapone?”

Cautions

• Patients treated with dopaminergic medications and/or medications that increase levodopa exposure have reported falling asleep while engaged in activities of daily living (eg, operating motor vehicles); advise not to drive and to avoid other potentially dangerous activities
• Hypotension (orthostatic and non-orthostatic), syncope, and presyncope occurred; monitor for hypotension; if hypotension occurs, consider discontinuing or adjusting the dosage of other medications that may lower blood pressure
• May potentiate the effects of levodopa and may cause or exacerbate dyskinesia; consider levodopa or dopaminergic medication dose reduction
• Hallucinations, delusions, agitation, or aggressive behavior occurred; consider discontinuing if hallucinations or psychotic-like behaviors occur; avoid treating patients with a major psychotic disorder because of the risk of exacerbating the psychosis with an increase in central dopaminergic tone
• May intensify urges (eg, gambling, increased sexual activity, spending, binge eating) and the inability to control these urges while taking one or more dopaminergic therapies that increase central dopaminergic tone; reevaluate and consider discontinuing therapy if urges develop during treatment
• Symptoms resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, have been reported in association with rapid dose reduction, withdrawal of, or changes in drugs that increase central dopaminergic tone; when discontinuing therapy, monitor and consider adjustment of other dopaminergic therapies as needed
• Drug interaction overview
  • Opicapone is a substrate of P-gp, BCRP, MRP2, OATP1B2, and OATP2B1 transporters; no clinically significant transporter-mediated interaction is expected for opicapone
  • Nonselective MAO inhibitors
    • Coadministration is contraindicated
    • Concomitant use with nonselective MAO inhibitors (eg, phenelzine, isocarboxazid, tranylcypromine) may inhibit catecholamine metabolism, leading to increased levels of catecholamines
    • Selective MAO-B inhibitors can be used concomitantly with opicapone
  • Drugs metabolized by catechol-O-methyltransferase (COMT)
    • Use with caution
    • Coadministration with drugs metabolized by COMT may affect the pharmacokinetics of those drugs, which may increase the risk for possible arrhythmias, increased heart rate, and excessive changes in blood pressure
    • Monitor for changes in heart rate, rhythm, and blood pressure in patients concomitantly treated with opicapone and drugs metabolized by COMT

Pregnancy and Lactation

• No adequate data available on use in pregnant women
• Lactation
  • No data available on drug presence in human milk and its effects on breastfeeding or milk production