FAQs

Find the answers to the most frequently asked questions about APOKYN here. If you have a question that is not answered here, please contact us by email or phone.

APOKYN is indicated for the acute, intermittent treatment of hypomobility, off episodes (end-of-dose wearing-off and unpredictable on-off episodes) associated with advanced Parkinson's disease. In clinical studies, APOKYN has been studied as an adjunct to other medications.

APOKYN, a non-ergot, non-narcotic dopamine agonist with D2 and D3 receptor activity, reverses off episodes by directly stimulating dopamine receptors in the striatum.

An ideal candidate for APOKYN is a patient who responds to levodopa but is experiencing off episodes despite conventional treatments.

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 one clinical study, APOKYN provided patients a full levodopa-equivalent on response within 20 minutes while placebo provided no response.1

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

APOKYN is contraindicated in patients who are:

  • 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.

Some of the possible side effects of APOKYN include:

  • 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.

APOKYN is administered by subcutaneous injection with a very fine (29 gauge) needle similar to that used by patients with diabetes who require insulin injections. APOKYN should never be administered intravenously. Intravenous injection may result in serious adverse events such as thrombus formation and pulmonary embolism.

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.

APOKYN is used as needed, up to 5 times per day. Patients who participated in the clinical studies used APOKYN an average of 3 times per day. Since APOKYN bypasses the stomach, patients do not need to worry about meal times; APOKYN will work just as effectively at any time of the day. The effects of APOKYN typically last no more than 60-90 minutes, so it's important that patients continue to take their usual PD medications as prescribed.2

In clinical studies, APOKYN has been studied as an adjunct to other medications, not in place of them. Patients who use APOKYN should continue to receive their appropriate daily dose of oral PD medications. In clinical trials, the mean dose of APOKYN was .5 mL in patients who had no prior exposure to apomorphine.

Apomorphine hydrochloride injection has been available in Europe since 1993. Studies suggest no tachyphylaxis among patients using apomorphine.

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.

Once the patient begins using an APOKYN cartridge, he or she should not continue using it for more than 7 days. The cartridge should not be used if the solution has turned cloudy or green or has particles in it. APOKYN cartridges should be stored at room temperature, 77°F (25°C). When traveling, the cartridges should be kept at 59° to 86°F (15° to 30°C).

APOKYN was approved for use in the United States in 2004. Patients in Europe have been using apomorphine hydrochloride injection since 1993.*

*Standards for approvals in other countries may differ from those of the US Food and Drug Administration.

References

  1. 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.
  2. 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.

Important Safety Information

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.

 

 

Important Safety Information

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.