Indication: APOKYN is used by injection, as needed, to treat loss of control of body movements in people with advanced Parkinson’s disease (PD). This condition is also called hypomobility or off episodes. An off episode may include symptoms such as muscle stiffness, slow movements, and difficulty starting movements. APOKYN may improve your ability to control your movements when it is used during an off episode. This may help you walk, talk, or move around easier. APOKYN is not used to prevent off episodes. APOKYN does not take the place of your other medicines for PD.
Important Safety Information for Patients
Do not take APOKYN if you are being treated with certain drugs called 5HT3 antagonists (including Anzemet®, Kytril®, Zofran®, Lotronex®, and Aloxi®) that are used for nausea and vomiting or irritable bowel syndrome. People taking these types of drugs with APOKYN experienced severely low blood pressure and lost consciousness or “blacked out.”
Do not take APOKYN if you are allergic to APOKYN or its ingredients, notably sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people, especially in people with asthma.
Before taking APOKYN, tell your healthcare provider about all your medical conditions, including if you have dizziness, fainting spells, low blood pressure, asthma, liver problems, kidney problems, heart problems, a mental disorder called major psychotic disorder, have had a stroke or other brain problems, or drink alcohol.
Tell your healthcare provider about all medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements, because APOKYN may interact with other medicines causing serious side effects.
APOKYN must be injected just under the skin and not into a vein. Injecting APOKYN into a vein could cause a blood clot.
Your healthcare provider may prescribe a medicine called Tigan® (trimethobenzamide hydrochloride) to help prevent the severe nausea and vomiting that may occur when taking APOKYN. If Tigan is prescribed, your healthcare provider will determine how long you should remain on this medicine.
Some patients taking APOKYN may get sleepy during the day or fall asleep without warning doing everyday activities. Do not take medicines that make you sleepy while you are taking APOKYN. Until it is known how APOKYN affects your ability to stay alert, you should not drive a car or operate heavy machinery.
APOKYN may lower blood pressure and cause dizziness and fainting, especially when starting treatment or if the dose is increased. Alcohol, antihypertensives, and nitrates may increase this risk. Patients should not get up too fast from sitting or after lying down to minimize these problems. Do not drink alcohol while you are using APOKYN.
If you take nitroglycerin under your tongue while using APOKYN, your blood pressure may decrease and cause dizziness. Lie down and try to avoid standing for at least 45 minutes after taking nitroglycerin.
The changes that occur with PD and the effects of some PD medicines can increase the risk of falling. APOKYN can also increase this risk.
APOKYN can cause or worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. Call your healthcare provider right away if you experience any of these symptoms.
Some people with PD may get sudden, uncontrolled movements (dyskinesias) after treatment with some PD medicines. APOKYN can cause or worsen this effect.
Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including APOKYN. If you experience new or increased urges, tell your healthcare provider.
If you experience shortness of breath, fast heartbeat, chest pain, a change in your heartbeat, or faint while taking APOKYN, you should call your healthcare provider right away.
The most common side effects seen in clinical studies with APOKYN were: yawning; sleepiness; dyskinesias; dizziness; runny nose; nausea and/or vomiting; hallucinations/confusion; and swelling of hands, arms, legs, and feet.
Some patients may notice soreness, redness, bruising, or itching at the injection site. Change the site with each injection.
APOKYN may cause prolonged, painful erections in some people. If you have an erection that lasts more than 4 hours, you should call your healthcare provider right away.
Tell your healthcare provider if you are pregnant, plan to become pregnant, if you are breast-feeding or planning to breast-feed. It is not known if APOKYN can harm your unborn baby or if APOKYN passes into breast milk.
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.
Patients and care partners must receive complete instructions on the proper use of APOKYN. Please see full Prescribing Information and Pen Instructions for Use/Patient Information.