Gocovri

Primary Indications

Gocovri is an extended-release medication used to manage specific symptoms in adults with Parkinson's disease who are also taking levodopa-based treatments. Its primary uses include:

• Dyskinesia: This refers to involuntary, uncontrolled, and often jerky movements. These movements are a common complication for people who have used levodopa for a long time.
• Off Episodes: These are periods during the day when Parkinson's symptoms return because other medications, such as carbidopa/levodopa, are no longer working effectively between doses.

How It Is Used

Gocovri is specifically indicated for patients who are already receiving levodopa or carbidopa/levodopa, with or without other medications for Parkinson's disease. It is designed to help reduce the amount of time patients spend experiencing bothersome involuntary movements and to decrease the frequency of "off" periods when mobility is limited.

Mechanism of Action

The exact way Gocovri works to treat Parkinson's disease symptoms and dyskinesia is not fully understood. However, researchers believe it works by affecting two key chemicals in the brain: dopamine and glutamate.

Dopamine Regulation

Dopamine is a chemical messenger that helps control body movements. In Parkinson's disease, dopamine levels are low. Gocovri is thought to help by:

• Increasing the release of dopamine from nerve cells.
• Preventing the brain from reabsorbing dopamine too quickly, which keeps more of the chemical available for use.

Glutamate Blocking

Gocovri also acts as a weak NMDA receptor antagonist. This means it interferes with the activity of glutamate, another chemical messenger. High levels of glutamate activity are linked to dyskinesia, which are the sudden, uncontrolled movements often experienced by people taking levodopa for Parkinson's. By blocking some of these signals, Gocovri helps reduce these involuntary movements.

Extended-Release Delivery

Gocovri is formulated as an extended-release capsule. It is typically taken once daily at bedtime. This delivery method allows the medication levels in the blood to rise slowly overnight, reaching their highest concentration during the day when patients are most likely to experience movement difficulties.

Common Side Effects

Many people using Gocovri experience mild to moderate side effects. These may include:

• Dizziness or lightheadedness
• Dry mouth
• Constipation
• Swelling in the legs, ankles, or feet
• Nausea
• Falls
• Difficulty falling or staying asleep
• Headache
• Blurred vision
• Mottled, purplish skin discoloration (livedo reticularis)

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Seek help right away if you experience:

• Hallucinations (seeing or hearing things that are not real)
• Delusions, paranoia, or extreme confusion
• Suicidal thoughts or behaviors
• New or increased urges that are difficult to control, such as gambling, binge eating, or sexual urges
• Severe dizziness or fainting, particularly when standing up quickly
• Shortness of breath

Stopping this medication abruptly can cause a serious withdrawal reaction. Always talk to a healthcare professional before making any changes to how you take Gocovri.

Serious Mental Health and Behavioral Changes

Gocovri may cause hallucinations (seeing or hearing things that are not real), confusion, and paranoia. Some people may experience suicidal thoughts or behaviors. These risks may be higher in individuals with a history of mental health conditions.

Sudden Sleep Onset

Some people taking this medication have reported falling asleep suddenly during daily activities, including while driving. This can occur without prior warning or feelings of drowsiness. Caution is advised when performing tasks that require alertness.

Impulse Control Issues

There is a risk of developing intense urges to gamble, spend money, binge eat, or engage in increased sexual activity. Because patients may not recognize these behaviors as abnormal, caregivers should monitor for unusual changes in behavior.

Dizziness and Fainting

Gocovri can cause a sudden drop in blood pressure when standing up, leading to dizziness, lightheadedness, or fainting. This risk may increase if the medication is taken with alcohol.

Kidney Function

This medication is cleared by the kidneys. It is not recommended for individuals with severe kidney disease or end-stage renal disease. Dosage adjustments may be necessary for those with mild to moderate kidney impairment.

Withdrawal Risks

Stopping Gocovri suddenly can lead to serious side effects, including a condition similar to neuroleptic malignant syndrome. Symptoms may include high fever, muscle stiffness, and mental changes. The dose should be reduced gradually under medical supervision.

Pregnancy

There is limited data regarding the safety of Gocovri in pregnant women. In animal studies, amantadine (the active ingredient in Gocovri) was shown to cause birth defects and other developmental issues when administered at high doses. Because of these findings, healthcare providers typically advise using this medication during pregnancy only when the potential benefit to the mother justifies the potential risk to the fetus.

If you are pregnant or planning to become pregnant, it is important to discuss your treatment options and the potential risks with your doctor.

Breastfeeding

Amantadine is known to pass into breast milk. There is a risk that the medication could cause adverse effects in a nursing infant. Additionally, amantadine may interfere with the body's production of breast milk by lowering prolactin levels.

Due to the potential for serious side effects in the infant and the possible reduction in milk supply, breastfeeding is generally not recommended while taking Gocovri. Patients should consult with their healthcare provider to weigh the benefits of treatment against the risks of breastfeeding.

Available Forms

Gocovri is supplied as an oral medication in the following form:

• Extended-release capsules: This formulation is designed to release the medication slowly over a period of time.

FDA Approval and Indications

Gocovri is an extended-release form of amantadine approved by the U.S. Food and Drug Administration (FDA). It was the first medication specifically approved to treat dyskinesia (sudden, involuntary movements) in people with Parkinson’s disease who are also taking levodopa-based medications.

The FDA also approved Gocovri as an add-on treatment for Parkinson’s disease patients experiencing "off" episodes. These episodes occur when the benefits of levodopa/carbidopa wear off, causing symptoms like tremors or stiffness to return between doses.

Safety and Monitoring

The FDA does not require a boxed warning or a Risk Evaluation and Mitigation Strategy (REMS) for Gocovri. However, the regulatory labeling includes warnings about the risk of hallucinations, unusual urges (such as gambling or sexual urges), and dizziness or fainting upon standing. Healthcare providers are encouraged to monitor patients for these behavioral and physical changes.

Factors Influencing Cost

The price of Gocovri can vary based on several factors, including your specific health insurance plan, the pharmacy you choose, and the dosage prescribed. Because Gocovri is a brand-name medication without a generic equivalent for its specific extended-release formulation, it may be more expensive than other forms of amantadine.

Insurance and Prior Authorization

Many insurance providers require prior authorization for Gocovri. This means your doctor must confirm with the insurance company that the medication is medically necessary before they will agree to cover the cost.

Financial Assistance

The manufacturer of Gocovri offers support programs to help manage out-of-pocket expenses. These may include:

• Copay cards for eligible patients with commercial insurance.
• Patient assistance programs for those who are uninsured or meet specific financial criteria.

Patients should consult their pharmacist or the manufacturer to determine which programs they may be eligible for.