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APOKYN Case Studies


There are many faces of advancing Parkinson’s disease (PD) and off episodes. The following case studies profile APOKYN patients.* Each patient meets one or more of the criteria for APOKYN treatment and each has been able to obtain optimal benefit from the drug.
Case Early morning akinesia
Patient: Ying C.
  • Age: 53
  • Occupation: Accountant
  • Particulars: Married, mother of 2

Clinical profile
  • Diagnosed 5 years ago and began treatment with pramipexole
  • Started concomitant levodopa/carbidopa regimen 2 years later
  • A year ago, began experiencing early morning akinesia accompanied by some loss of facial expression and mild unilateral tremor
APOKYN and Early Morning Akinesia

Case Young-onset Parkinson's disease (YOPD)
Patient: Chuck T.
  • Age: 44
  • Occupation: Corporate attorney
  • Particulars: Married, father of 3

Clinical profile
  • Diagnosed 8 years ago with PD after 2 misdiagnoses
  • Began PD treatment with ropinirole
  • After 3 years, levodopa/carbidopa was added to treatment regimen
  • After 5 years, began experiencing unpredictable off episodes
APOKYN and Young Onset PD
Case Wearing-off
Patient: Dominic G.
  • Age: 76
  • Occupation: Retired police officer; part-time greeter at local home
    improvement center
  • Particulars: Widower with 2 children, 3 grandchildren

Clinical profile
  • Diagnosed with PD at age 64; began levodopa/carbidopa therapy
  • Three years ago, ropinirole was added to regimen
  • Several months ago, began experiencing end-of-dose wearing-off episodes during late afternoon, despite optimal regimen of oral PD medications
APOKYN and wearing-off
Case Difficulty walking
Patient: Virginia R.
  • Age: 58
  • Occupation: Retired schoolteacher
  • Particulars: Married, mother of 1, grandmother of 1

Clinical profile
  • Diagnosed with PD 7 years ago and began treatment with pramipexole
  • Started concomitant levodopa/carbidopa regimen 5 years ago
  • Six months ago, began experiencing off episodes with difficulties walking
APOKYN and difficulty moving
Case Early morning akinesia
Patient: Ying C.
  • Age: 53
  • Occupation: Accountant
  • Particulars: Married, mother of 2

Clinical profile
  • Diagnosed 5 years ago and began treatment with pramipexole
  • Started concomitant levodopa/carbidopa regimen 2 years later
  • A year ago, began experiencing early morning akinesia accompanied by some loss of facial expression and mild unilateral tremor

Case Young-onset Parkinson's disease (YOPD)
Patient: Chuck T.
  • Age: 44
  • Occupation: Corporate attorney
  • Particulars: Married, father of 3

Clinical profile
  • Diagnosed 8 years ago with PD after 2 misdiagnoses
  • Began PD treatment with ropinirole
  • After 3 years, levodopa/carbidopa was added to treatment regimen
  • After 5 years, began experiencing unpredictable off episodes
Case Wearing-off
Patient: Dominic G.
  • Age: 76
  • Occupation: Retired police officer; part-time greeter at local home
    improvement center
  • Particulars: Widower with 2 children, 3 grandchildren

Clinical profile
  • Diagnosed with PD at age 64; began levodopa/carbidopa therapy
  • Three years ago, ropinirole was added to regimen
  • Several months ago, began experiencing end-of-dose wearing-off episodes during late afternoon, despite optimal regimen of oral PD medications
Case Difficulty walking
Patient: Virginia R.
  • Age: 58
  • Occupation: Retired schoolteacher
  • Particulars: Married, mother of 1, grandmother of 1

Clinical profile
  • Diagnosed with PD 7 years ago and began treatment with pramipexole
  • Started concomitant levodopa/carbidopa regimen 5 years ago
  • Six months ago, began experiencing off episodes with difficulties walking

*The individuals described here are not actual APOKYN patients, but represent a composite of the types of patients included in the registration trials.

Learn more about off episodes.


Indication for Healthcare Providers

APOKYN is indicated for the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing-off” and unpredictable “on-off” episodes) in patients with advanced Parkinson’s disease (PD). APOKYN has been studied as an adjunct to other medications.

Important Safety Information for Healthcare Providers

Contraindication: Concomitant use of APOKYN with 5HT3 antagonists is contraindicated based on reports of profound hypotension and loss of consciousness when APOKYN was administered with ondansetron.

Contraindication: APOKYN is contraindicated in patients who have demonstrated hypersensitivity/allergic reaction to the drug or any of its excipients (notably sodium metabisulfite). Angioedema or anaphylaxis may occur.

Subcutaneous injection: APOKYN should be administered by subcutaneous injection, NOT intravenously, because serious adverse events like thrombus formation and pulmonary embolism may occur. Patients and care partners must receive detailed instructions about preparing and injecting doses, with particular attention paid to the correct use of the dosing pen.

Nausea and vomiting: At recommended doses of APOKYN, severe nausea and vomiting can be expected. Therefore, trimethobenzamide hydrochloride should be started 3 days prior to the initial dose of APOKYN and continued as long as necessary to control nausea and vomiting, and generally no longer than two months. In clinical trials, 50% of patients (262/522) discontinued trimethobenzamide hydrochloride after about 2 months of APOKYN.

Falling Asleep During Activities of Daily Living (ADL): There have been reports of patients treated with APOKYN who suddenly fell asleep while engaged in ADL. Patients should be advised not to drive or participate in potentially dangerous activities until it is known how APOKYN affects them. Patients should be continually reassessed for daytime drowsiness or sleepiness.

Symptomatic Hypotension: Dopamine agonists, including APOKYN, can cause hypotension, orthostatic hypotension, and syncope. Alcohol, antihypertensive medications, and vasodilating medications may potentiate the hypotensive effect of apomorphine. Patients should avoid alcohol when using APOKYN. Patients taking APOKYN should lie down before and after taking sublingual nitroglycerin.

Falls: Patients with PD are at risk of falling due to underlying postural instability, possible concomitant autonomic instability, and from syncope caused by the blood pressure lowering effects of the drugs used to treat PD.

Hallucinations/Psychotic-Like Behavior: APOKYN has been associated with new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior. This abnormal thinking and behavior can consist of paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation and delirium.

Dyskinesias: APOKYN may cause dyskinesia or exacerbate pre-existing dyskinesia.

Intense Urges: Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including APOKYN. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their care partners about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with APOKYN. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking APOKYN.

Cardiac Events: Coronary events—APOKYN reduces resting systolic and diastolic blood pressure and has the potential to exacerbate coronary (and cerebral) ischemia. Therefore, exercise caution when prescribing APOKYN for patients with known cardiovascular and cerebrovascular disease.

QT Prolongation—Caution is recommended when administering APOKYN to patients with an increased risk of QT prolongation, such as those with hypokalemia, hypomagnesemia, bradycardia, a genetic predisposition, or who use other drugs that prolong the QT/QTc interval.

Adverse Events: The most common adverse events seen in controlled trials were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucinations/confusion, and edema/swelling of extremities. Injection site reactions, including bruising, granuloma, and pruritus, have been reported.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Supernus Pharmaceuticals, Inc. at 1-877-727-6596 (1-877-7APOKYN). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Pen Instructions for Use/Patient Information.

All trademarks are property of their respective owners.

MDD US Operations, LLC is the exclusive licensee and distributor of APOKYN in the United States and Its territories.

© 2020. APOKYN is a registered trademark of BRITUSWIP. SPN.APO.2020-0002

Terms of Use | Privacy Policy

Important Safety Information and Indication

Indication for Healthcare Providers

APOKYN is indicated for the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing-off” and unpredictable “on-off” episodes) in patients with advanced Parkinson’s disease (PD). APOKYN has been studied as an adjunct to other medications.

Important Safety Information for Healthcare Providers

Contraindication: Concomitant use of APOKYN with 5HT3 antagonists is contraindicated based on reports of profound hypotension and loss of consciousness when APOKYN was administered with ondansetron.

Contraindication: APOKYN is contraindicated in patients who have demonstrated hypersensitivity/allergic reaction to the drug or any of its excipients (notably sodium metabisulfite). Angioedema or anaphylaxis may occur.

Subcutaneous injection: APOKYN should be administered by subcutaneous injection, NOT intravenously, because serious adverse events like thrombus formation and pulmonary embolism may occur. Patients and care partners must receive detailed instructions about preparing and injecting doses, with particular attention paid to the correct use of the dosing pen.

Nausea and vomiting: At recommended doses of APOKYN, severe nausea and vomiting can be expected. Therefore, trimethobenzamide hydrochloride should be started 3 days prior to the initial dose of APOKYN and continued as long as necessary to control nausea and vomiting, and generally no longer than two months. In clinical trials, 50% of patients (262/522) discontinued trimethobenzamide hydrochloride after about 2 months of APOKYN.

Falling Asleep During Activities of Daily Living (ADL): There have been reports of patients treated with APOKYN who suddenly fell asleep while engaged in ADL. Patients should be advised not to drive or participate in potentially dangerous activities until it is known how APOKYN affects them. Patients should be continually reassessed for daytime drowsiness or sleepiness.

Symptomatic Hypotension: Dopamine agonists, including APOKYN, can cause hypotension, orthostatic hypotension, and syncope. Alcohol, antihypertensive medications, and vasodilating medications may potentiate the hypotensive effect of apomorphine. Patients should avoid alcohol when using APOKYN. Patients taking APOKYN should lie down before and after taking sublingual nitroglycerin.

Falls: Patients with PD are at risk of falling due to underlying postural instability, possible concomitant autonomic instability, and from syncope caused by the blood pressure lowering effects of the drugs used to treat PD.

Hallucinations/Psychotic-Like Behavior: APOKYN has been associated with new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior. This abnormal thinking and behavior can consist of paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation and delirium.

Dyskinesias: APOKYN may cause dyskinesia or exacerbate pre-existing dyskinesia.

Intense Urges: Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including APOKYN. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their care partners about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with APOKYN. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking APOKYN.

Cardiac Events: Coronary events—APOKYN reduces resting systolic and diastolic blood pressure and has the potential to exacerbate coronary (and cerebral) ischemia. Therefore, exercise caution when prescribing APOKYN for patients with known cardiovascular and cerebrovascular disease.

QT Prolongation—Caution is recommended when administering APOKYN to patients with an increased risk of QT prolongation, such as those with hypokalemia, hypomagnesemia, bradycardia, a genetic predisposition, or who use other drugs that prolong the QT/QTc interval.

Adverse Events: The most common adverse events seen in controlled trials were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucinations/confusion, and edema/swelling of extremities. Injection site reactions, including bruising, granuloma, and pruritus, have been reported.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Supernus Pharmaceuticals, Inc. at 1-877-727-6596 (1-877-7APOKYN). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Pen Instructions for Use/Patient Information.

All trademarks are property of their respective owners.

MDD US Operations, LLC is the exclusive licensee and distributor of APOKYN in the United States and Its territories.

© 2020. APOKYN is a registered trademark of BRITUSWIP. SPN.APO.2020-0002

Terms of Use | Privacy Policy

 

 

Indication: APOKYN is indicated for the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing-off” and unpredictable “on-off” episodes) in patients with advanced Parkinson’s disease (PD). APOKYN has been studied as an adjunct to other medications.

Important Safety Information for Healthcare Providers

Contraindication: Concomitant use of APOKYN with 5HT3 antagonists is contraindicated based on reports of profound hypotension and loss of consciousness when APOKYN was administered with ondansetron.

Contraindication: APOKYN is contraindicated in patients who have demonstrated hypersensitivity/allergic reaction to the drug or any of its excipients (notably sodium metabisulfite). Angioedema or anaphylaxis may occur.

Subcutaneous injection: APOKYN should be administered by subcutaneous injection, NOT intravenously, because serious adverse events like thrombus formation and pulmonary embolism may occur. Patients and care partners must receive detailed instructions about preparing and injecting doses, with particular attention paid to the correct use of the dosing pen.

Nausea and vomiting: At recommended doses of APOKYN, severe nausea and vomiting can be expected. Therefore, trimethobenzamide hydrochloride should be started 3 days prior to the initial dose of APOKYN and continued as long as necessary to control nausea and vomiting, and generally no longer than two months. In clinical trials, 50% of patients (262/522) discontinued trimethobenzamide hydrochloride after about 2 months of APOKYN.

Falling Asleep During Activities of Daily Living (ADL): There have been reports of patients treated with APOKYN who suddenly fell asleep while engaged in ADL. Patients should be advised not to drive or participate in potentially dangerous activities until it is known how APOKYN affects them. Patients should be continually reassessed for daytime drowsiness or sleepiness.

Symptomatic Hypotension: Dopamine agonists, including APOKYN, can cause hypotension, orthostatic hypotension, and syncope. Alcohol, antihypertensive medications, and vasodilating medications may potentiate the hypotensive effect of apomorphine. Patients should avoid alcohol when using APOKYN. Patients taking APOKYN should lie down before and after taking sublingual nitroglycerin.

Falls: Patients with PD are at risk of falling due to underlying postural instability, possible concomitant autonomic instability, and from syncope caused by the blood pressure lowering effects of the drugs used to treat PD.

Hallucinations/Psychotic-Like Behavior: APOKYN has been associated with new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior. This abnormal thinking and behavior can consist of paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation and delirium.

Dyskinesias: APOKYN may cause dyskinesia or exacerbate pre-existing dyskinesia.

Intense Urges: Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including APOKYN. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their care partners about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with APOKYN. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking APOKYN.

Cardiac Events: Coronary events—APOKYN reduces resting systolic and diastolic blood pressure and has the potential to exacerbate coronary (and cerebral) ischemia. Therefore, exercise caution when prescribing APOKYN for patients with known cardiovascular and cerebrovascular disease.

QT Prolongation—Caution is recommended when administering APOKYN to patients with an increased risk of QT prolongation, such as those with hypokalemia, hypomagnesemia, bradycardia, a genetic predisposition, or who use other drugs that prolong the QT/QTc interval.

Adverse Events: The most common adverse events seen in controlled trials were yawning, drowsiness/somnolence, dyskinesias, dizziness/postural hypotension, rhinorrhea, nausea and/or vomiting, hallucinations/confusion, and edema/swelling of extremities. Injection site reactions, including bruising, granuloma, and pruritus, have been reported.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Supernus Pharmaceuticals, Inc. at 1-877-727-6596 (1-877-7APOKYN). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information and Pen Instructions for Use/Patient Information.

All trademarks are the property of their respective owners.

MDD US Operations, LLC is the exclusive licensee and distributor of APOKYN in the United States and Its territories.
© 2020. APOKYN is a registered trademark of BRITUSWIP. SPN.APO.2020-0002

Terms of Use | Privacy Policy