PK Profile & Dosing | GOCOVRI® (amantadine)

GO with all-day medication coverage with a straightforward nightly dosing regimen

A single bedtime dose of GOCOVRI^® delivers high morning levels before the first levodopa dose and decreases in the last hours of the day¹

A. An initial lag in drug release

B. Gradual increase in plasma concentrations during the night

C. High levels reached in the morning, providing all-day coverage that slowly tapers

D. Plasma concentrations decrease in the hours before bedtime

PK data do not provide evidence of clinical safety or efficacy.

There are no head-to-head studies in patients with PD comparing the safety and efficacy of GOCOVRI^® to that of amantadine IR.

These simulated data are derived from a steady-state PK study using the 137 mg QHS dose of GOCOVRI^® and amantadine IR 81 mg BID.¹

GOCOVRI^® is not interchangeable with other amantadine immediate- or extended-release products²

A convenient, single nightly dose provides all-day medication coverage²

Starting dose – week 1

137 mg QHS²

(CrCI ≥ 60 mL/min/1.73 m²)

Treatment dose – after week 1

274 mg QHS²

(CrCI ≥ 60 mL/min/1.73 m²)

Renal Considerations: A lower dose of GOCOVRI is recommended for patients with moderate to severe renal impairment.^*

GOCOVRI is not contraindicated for patients with moderate to severe renal impairment. 68.5 mg is the recommended initial and maximum dosage for patients with severe renal impairment (CrCI ≥ 15-29 mL/min/1.73 m²). For patients with moderate renal impairment (CrCI ≥ 30-59 mL/min/1.73 m²), recommended initial dosage is 68.5 mg to a maximum dosage of 137 mg.^*

^*Please see full Prescribing Information for additional dosing information for patients with renal impairment. GOCOVRI^® is contraindicated in patients with end-stage renal disease (creatinine clearance below 15 mL/min/1.73 m²).

Administration and discontinuation

If a dose is missed, the next dose should be taken as scheduled.²

GOCOVRI^® can be taken with or without food. GOCOVRI^® may be administered by carefully opening and sprinkling the entire content in 1 teaspoon of soft food, such as applesauce. Concomitant use of GOCOVRI^® with alcohol is not recommended.²

Because rapid dose reduction or withdrawal may cause adverse reactions, it is recommended to avoid sudden discontinuation of GOCOVRI^®. To avoid sudden discontinuation, patients who have taken GOCOVRI^® for more than 4 weeks should reduce their dose by half during their final week of dosing.²

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Important Safety Information

IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATIONS

GOCOVRI is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m².

WARNINGS AND PRECAUTIONS

Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with Parkinson’s disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.

Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression.

Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.

Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.

Withdrawal-Emergent Hyperpyrexia and Confusion: Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. Avoid sudden discontinuation of GOCOVRI.

Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.

ADVERSE REACTIONS

The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.

INDICATION

GOCOVRI^® (amantadine) extended release capsules is indicated:

For the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
As adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes

It is not known if GOCOVRI is safe and effective in children.

Please see full Prescribing Information and Patient Information.

Abbreviations: BID, twice daily; CrCl, creatinine clearance; IR, immediate release; PD, Parkinson's disease; PK, pharmacokinetic; QAM, once in the morning; QHS, once at bedtime.

References: 1. Hauser RA, Pahwa R, Wargin WA, et al. Pharmacokinetics of ADS-5102 (amantadine) extended release capsules administered once daily at bedtime for the treatment of dyskinesia. Clin Pharmacokinet. 2018;58(1):77-88. doi:10.1007/s40262-018-0663-4 2. GOCOVRI^® (amantadine). Prescribing Information. Adamas Pharma LLC.