What is APOKYN?
APOKYN is a prescription medicine used to treat acute, intermittent episodes of poor mobility called "off" episodes (end-of-dose wearing "off" or unpredictable "on-off" episodes) in people with advanced Parkinson’s disease (PD). It is not known if APOKYN is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Who should not take APOKYN?
Do not take APOKYN if you are:
- taking certain medicines to treat nausea called 5HT3 antagonists including ondansetron, granisetron, dolasetron, palonosetron, and alosetron. People taking ondansetron together with apomorphine, the active ingredient in APOKYN, have had very low blood pressure and lost consciousness or “blacked out.”
- allergic to APOKYN or its ingredients and experience hives, itching, rash, or swelling (e.g., eyes, tongue, etc.). APOKYN also contains a sulfite called sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people, especially people with asthma.
What should I tell my healthcare provider before taking APOKYN?
Before you start using APOKYN, tell your healthcare provider if you:
- have difficulty staying awake during the daytime
- have dizziness, fainting spells or low blood pressure
- have asthma
- are allergic to any medicines containing sulfites
- have liver, kidney or heart problems
- have had a stroke or other brain problems
- have a mental problem called a major psychotic disorder
- drink alcohol
- are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed. It is not known if APOKYN will harm your unborn baby or if APOKYN passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using APOKYN with certain other medicines may affect each other and can cause serious side effects.
- If you take nitroglycerin under your tongue while using APOKYN, your blood pressure may decrease and cause dizziness. After taking nitroglycerin, lie down for at least 45 minutes.
What should I avoid while using APOKYN?
- Do not drink alcohol while using APOKYN. It can increase your chance of developing serious side effects.
- Do not take medicines that make you sleepy while you are using APOKYN.
- Do not drive, operate machinery, or do other dangerous activities until you know how APOKYN affects you.
- Do not change your body position too fast. Get up slowly from sitting or lying. APOKYN can lower your blood pressure and cause dizziness or fainting.
What are the possible side effects of APOKYN?
Call your healthcare provider right away if you experience any of the following serious side effects:
- allergic reaction. An allergic reaction with side effects of hives, itching, rash, swelling (e.g., eyes, tongue, etc.); trouble breathing and/or swallowing may occur after injecting APOKYN.
- blood clots. Injecting APOKYN into a vein (intravenous) can cause blood clots. Do not inject APOKYN in your vein.
- nausea and vomiting. Nausea and vomiting, which may be severe, can happen with APOKYN. Your healthcare provider may prescribe a medicine to help decrease nausea and vomiting. Follow your healthcare provider’s instructions on how to take and when to stop this medicine.
- sleepiness or falling asleep during the day. Some people treated with APOKYN may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car.
- dizziness. APOKYN can lower your blood pressure and cause dizziness. Dizziness can happen when APOKYN treatment is started or when the dose is increased. Do not get up too fast from sitting or lying down, especially if you have been sitting or lying down for a long period of time.
- falls. The changes that can happen with PD, and the effects of some PD medicines, can increase the risk of falling. APOKYN may also increase your risk of falling.
- hallucinations or psychotic-like behavior. 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.
- sudden uncontrolled movements (dyskinesias). Some people with PD may get sudden, uncontrolled movements after treatment with some PD medicines. APOKYN can cause or make dyskinesias worse.
- low red blood cells (hemolytic anemia). Tell your healthcare provider if you have any of the following signs or symptoms: you become pale, fast heartbeat, feel more tired or weaker than usual, skin or eyes look yellow, chest pain, shortness of breath or trouble breathing, dark-colored urine, fever, dizziness, or confusion.
- 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.
- heart problems. If you have shortness of breath, fast heartbeat, or chest pain while taking APOKYN, call your healthcare provider or get emergency help right away.
- serious heart rhythm changes (QT prolongation). Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat) or if you faint.
- injection site problems. Bruising, swelling, and itching can happen at the injection site.
- fever and confusion. This can happen in some people when their PD medicine is stopped or there is a fast decrease in the dose of their PD medicine.
- tissue changes (fibrotic complications). Some people have had changes in the tissues of their pelvis, lungs, and heart valves when taking medicines called nonergot derived dopamine agonists like APOKYN.
- prolonged painful erections (priapism). 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 or go to the nearest hospital emergency room right away.
- swelling of ankles/legs. APOKYN may cause swelling, especially in the ankles or legs. Tell your healthcare provider if you notice any swelling.
Other common side effects of APOKYN include:
- runny nose
- swelling of your hands, arms, legs, and feet
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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.