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OFF EPISODES
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ABOUT APOKYN
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EFFICACY/SAFETY
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PRESCRIBING APOKYN
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In addition, patients with identifiable treatment goals or activities that they are able to engage in when on are good candidates and include:
- Working patients
- Retired but active patients
- More sedentary patients who are able to assist in activities of daily living when on
Visit Identifying APOKYN candidates to learn more.
In the same study, APOKYN delivered efficacy approximately equivalent to optimally dosed levodopa. Patients reported that APOKYN successfully reversed 95% of off episodes in a 4-week clinical study of patients with advancing PD who experienced off episodes despite optimized oral PD therapy.1
- Hypersensitive to APOKYN or to its inactive ingredients (notably sodium metabisulfite)
- Taking 5HT3 antagonists, such as Anzemet® (dolasetron mesylate), Kytril® (granisetron HCl), Zofran® (ondansetron HCl), Lotronex® (alosetron HCl), and Aloxi® (palonosetron HCl) based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.
Please consult the full Prescribing Information and Important Safety Information for details on the contraindications of APOKYN and for general warnings.
- Nausea and vomiting
- Syncope
- QT prolongation
- Symptomatic hypotension
- Falling asleep during activities of daily living
- Coronary events
- Injection site reactions
The most common adverse events seen in controlled trials were yawning, dyskinesias, nausea and/or vomiting, somnolence, dizziness, rhinorrhea, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.
Please consult the full Prescribing Information and Important Safety Information for details on the side effects of APOKYN.
After initial titration, the patient or the patient's care partner can inject APOKYN as needed, up to 5 times per day. For detailed instructions on how to use the APOKYN pen, click here.
Patients in the APOKYN clinical trials required few dose changes once titrated to an optimal dose, even after using APOKYN for an extended period.2 The APOKYN response should be about equivalent to the usual response received with levodopa.
*Standards for approvals in other countries may differ from those of the US Food and Drug Administration.
- Dewey RB, Hutton JT, LeWitt PA, Factor SA. A randomized, double-blind, placebo-controlled trial of subcutaneously injected apomorphine for parkinsonian off-state events. Arch Neurol. 2001;58(9):1385–1392.
- Pfeiffer RF, Gutmann L, Hull KL Jr, Bottini PB, Sherry JH; The APO302 Study Investigators. Continued efficacy and safety of subcutaneous apomorphine in patients with advanced Parkinson's disease. Parkinsonism Relat Disord. 2007;13(2):93–100.
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
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
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.
© 2020. APOKYN is a registered trademark of BRITUSWIP. SPN.APO.2020-0002
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