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.
Some of the possible side effects of APOKYN include:
- Nausea and vomiting
- 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.
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.
- 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.