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Once-daily bedtime dosing leads to HIGH steady-state plasma concentrations of GOCOVRI1,2

Once-daily bedtime dosing leads to sustained high levels of amantadine upon waking and throughout the next day

STEADY-STATE, 24-HR PHARMACOKINETIC PROFILE OF gocovri

PK curve showing GOCOVRI (amantadine) extended release capsules QHS dosing plasma concentrations
The extended release coating on GOCOVRI capsules slowly releases active ingredient

GOCOVRI

  • Steady-state Tmax ~8 hours
  • Half-life ~16 hours
  • Once-daily dosing at bedtime achieves peak plasma concentrations of ~1500 ng/mL and sustained levels throughout the day

Steady-state profile of GOCOVRI 274 mg QHS is scaled from steady-state data for GOCOVRI 137 mg QHS based on demonstrated dose-proportionality and reduced renal clearance seen in PD patients (70 mL/min/1.73 m2).

Pharmacokinetic data do not provide evidence of clinical safety or efficacy

GOCOVRI Dosing1

Starting and staying on gocovri

Starting dose:

Week 1

Once daily at bedtime

GOCOVRI (amantadine) extended release capsules starting dose is 137 mg, once daily at bedtime for one week

137 mg

INCREASE DOSE

Recommended target dose:

After Week 1

Once daily at bedtime

GOCOVRI (amantadine) extended release recommended dosage is 274 mg once daily at bedtime, given in two 137 mg capsules

274 mg
Two 137 mg capsules

  • If a dose of GOCOVRI is missed, the next dose should be taken as scheduled
  • GOCOVRI is also available in a 68.5 mg strength
GOCOVRI (amantadine) extended release 68.5 mg capsule68.5 mg

Discontinuing GOCOVRI

  • 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
GOCOVRI doses of 68.5 mg, 137 mg, and 274 mg are equivalent to 85 mg, 170 mg, and 340 mg amantadine HCl, respectively.

DOSING FOR PATIENTS WITH RENAL IMPAIRMENT1

initial daily dose and recommended dose

CREATININE CLEARANCE

DOSAGE

Mild renal impairment

(60 to 89 mL/min/1.73 m2)

Initial dosage: 137 mg once daily at bedtime. After 1 week, increase to recommended dosage of 274 mg once daily at bedtime

Moderate renal impairment

(30 to 59 mL/min/1.73 m2)

Initial dosage: 68.5 mg once daily at bedtime

Maximum recommended dosage: 137 mg once daily at bedtime*

Severe renal impairment

(15 to 29 mL/min/1.73 m2)

Initial dosage and maximum recommended dosage are 68.5 mg once daily at bedtime

End-stage renal disease

(below 15 mL/min/1.73 m2)

Contraindicated

*Increase, if needed, after 1 week of the initial dosage.

GOCOVRI Provides 274 mg amantadine once daily at bedtime1

Recommended dosage of GOCOVRI (amantadine) extended release capsules is 274 mg once daily at bedtime

RECOMMENDED DOSAGE:

274 mg (two 137 mg capsules) once daily at bedtime

Image of capsule with a glass of water

Gocovri can be taken with or without food:

  • GOCOVRI can be administered by carefully opening and sprinkling entire contents in 1 teaspoon of soft food, such as applesauce
  • Concomitant use of GOCOVRI with alcohol is not recommended
The recommended GOCOVRI dose of 274 mg is equivalent to 340 mg amantadine HCl.

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Important Safety Information

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.

Contraindications

GOCOVRI™ (amantadine) 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.

Drug Interactions

Other Anticholinergic Drugs: The dose of GOCOVRI should be reduced if atropine-like effects are observed.

Drugs Affecting Urinary pH: The pH of the urine has been reported to influence the excretion rate of amantadine. Monitor for efficacy or adverse reactions under conditions that alter the urine pH.

Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness, 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.

References: 1. GOCOVRITM (amantadine) [Prescribing Information]. Emeryville, CA: Adamas Pharma LLC; 2017. 2. Data On File. Adamas Pharma LLC, Emeryville, CA.