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Important Safety Information

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

  • GOCOVRI is contraindicated in patients with end-stage renal disease (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 not to drive and to avoid other 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. Concomitant use of alcohol when using GOCOVRI is not recommended.
  • 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.
  • Corneal Edema: Has been reported and onset can occur within a few weeks to several years. Symptoms include sudden onset blurry vision, or progressive vision loss, with or without eye pain. Corneal involvement is usually bilateral. Corneal grafts have been required when not recognized. Permanent damage can occur if amantadine is continued. Ask patients if their vision has changed and obtain ophthalmologic exams to rule out corneal edema if changes occur. If corneal edema occurs, taper and discontinue GOCOVRI. Resolution typically begins within weeks of cessation.
  • Impulse Control/Compulsive Behaviors: Patients can experience intense 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 GOCOVRI.

ADVERSE REACTIONS

  • The most common adverse reactions (>10% and greater than placebo) were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.

INDICATIONS

GOCOVRI® 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

Please see full Prescribing Information.

Important Safety Information

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

  • GOCOVRI is contraindicated in patients with end-stage renal disease (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 not to drive and to avoid other 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. Concomitant use of alcohol when using GOCOVRI is not recommended.
  • 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.
  • Corneal Edema: Has been reported and onset can occur within a few weeks to several years. Symptoms include sudden onset blurry vision, or progressive vision loss, with or without eye pain. Corneal involvement is usually bilateral. Corneal grafts have been required when not recognized. Permanent damage can occur if amantadine is continued. Ask patients if their vision has changed and obtain ophthalmologic exams to rule out corneal edema if changes occur. If corneal edema occurs, taper and discontinue GOCOVRI. Resolution typically begins within weeks of cessation.
  • Impulse Control/Compulsive Behaviors: Patients can experience intense 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 GOCOVRI.

ADVERSE REACTIONS

  • The most common adverse reactions (>10% and greater than placebo) were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension.

INDICATIONS

GOCOVRI® 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

Please see full Prescribing Information.