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GOCOVRI ADVERSE REACTIONS1

Adverse reactions (ARs) reported for ≥5% of patients treated with 274 mg GOCOVRI in Study 1 and Study 2 (pooled analysis)

Adverse Reactions

Placebo

N = 98

%

GOCOVRI 274 MG

N = 100

%

Psychiatric disorders

Hallucinationa

3

21

Anxietyb

3

7

Insomnia

2

7

Depression/depressed mood

1

6

Nervous system disorders

Dizziness

1

16

Headache

4

6

Gastrointestinal disorders

Dry mouth

1

16

Constipation

3

13

Nausea

3

8

General disorders and administration-site conditions

Peripheral edema

1

16

Injury, poisoning, and procedural complications

Fall

7

13

Contusion

1

6

Infections and infestations

Urinary tract infection

5

10

Skin and subcutaneous tissue disorders

Livedo reticularis

0

6

Metabolism and nutrition disorders

Decreased appetite

1

6

Vascular disorders

Orthostatic hypotensionc

1

13

Reproductive system and breast disorders

Benign prostatic hyperplasiad

2

6

  • Additional ARs reported in 3% to 4% of GOCOVRI patients were abnormal dreams, confusional state, dystonia, vomiting, gait disturbance, pigmentation disorder, blurred vision, cataract, dry eye, joint swelling, muscle spasms, and cough
  • Other clinically relevant ARs observed at <3% included somnolence, fatigue, suicide ideation or attempt, apathy, delusions, illusions, and paranoia
  • aIncludes visual hallucinations and auditory hallucinations.
  • bIncludes anxiety and generalized anxiety.
  • cIncludes orthostatic hypotension, postural dizziness, syncope, presyncope, and hypotension.
  • dThe denominator is all male patients in the safety population randomized to GOCOVRI (n = 54) or placebo (n = 57).

Pooled safety data on hallucinations1,2

Hallucination was the most common adverse reaction in the GOCOVRI arm (21% [n = 21] vs 3% [n = 3] for placebo)

Hallucinations were generally mild and resolved quickly

  • 62% (13/21) were rated mild, 29% (6/21) moderate, and 10% (2/21) severe
  • 38% (8/21) of patients discontinued therapy due to hallucinations
  • 86% (18/21) of patients experienced resolution of symptoms including all patients who discontinued therapy
    • 57% (12/21) experienced resolution within 2 weeks
  • 31% (16/52) of patients age ≥65 years and 10% (5/48) of patients age <65 years reported hallucinations

In the clinical trials, hallucinations did not result in hospitalization or treatment with an antipsychotic.

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.

ADVERSE REACTIONS (ARs) LEADING TO TREATMENT DISCONTINUATION1

The overall rate of discontinuation due to ARs for patients treated with placebo was 8%, compared to 20% with GOCOVRI.

ARs LEADING TO TREATMENT DISCONTINUATION (≥2% OF PATIENTS)

ADVERSE REACTIONS

Placebo

n = 98, %

Gocovri 274 MG

n = 100, %

Hallucination

0

8

Dry mouth

0

3

Peripheral edema

0

3

Blurred vision

0

3

Postural dizziness and syncope

0

2

Abnormal dreams

1

2

Dysphagia

0

2

Gait disturbance

0

2

GOCOVRI CONTRAINDICATIONS AND WARNINGS AND PRECAUTIONS1

Contraindications

GOCOVRI™ (amantadine) extended release capsules 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.

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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.