WHAT IS APOKYN?
APOKYN (apomorphine hydrochloride injection) is used as needed to treat off-episode motor symptoms, such as muscle stiffness, slow movements, and difficulty starting movements, in people with advanced Parkinson’s disease (PD). It is used in addition to oral PD medicines.
Off episodes are one of the most frustrating and challenging complications of advancing Parkinson’s disease. They can make movement very difficult and interfere with your ability to walk, stand, and even speak.
*Standards for approvals in other countries may differ from those of the FDA.
Indication and Usage of APOKYN
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
You should 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.
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 this type of drug with apomorphine had severely low blood pressure and lost consciousness or “blacked out.”
APOKYN has not been studied in children.
Before taking APOKYN, make sure to 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, are allergic to sulfites, have had a stroke or other brain problems, or drink alcohol.
Tell your doctor if you are pregnant or plan to become pregnant or if you are breast-feeding or planning to breast-feed. It is not known if APOKYN can harm your unborn baby, and it is not known if APOKYN passes into breast milk.
Also tell your doctors about all medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. APOKYN may interact with other medicines to cause serious side effects.
APOKYN must be injected just under the skin and not into a vein. Patients and caregivers must receive detailed instructions in the preparation and injection of doses, with particular attention paid to the correct use of the dosing pen. Never reuse needles with your APOKYN Injections.
Your healthcare provider may prescribe a medicine called Tigan® to help prevent the severe nausea and vomiting that may occur when taking APOKYN. Some patients can stop taking Tigan after using APOKYN for some time. Some patients may need to continue taking Tigan to help prevent nausea and vomiting. Talk to your healthcare provider before you stop taking Tigan.
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.
If you experience shortness of breath, fast heartbeat, or chest pain while taking APOKYN, you should call your healthcare provider right away.
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.
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.
Some people with PD may get sudden, uncontrolled movements after treatment with some PD medicines. APOKYN can cause or worsen this effect.
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 get depression while taking APOKYN. Call your healthcare provider right away if you get depression with APOKYN.
APOKYN can cause headaches. If these become severe or do not go away, call your healthcare provider.
Some patients may notice soreness, redness, bruising, or itching at the injection site. Changing the injection site with each injection and putting ice on the site before and after the injection may help lessen these effects.
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.
The most common side effects seen in clinical studies with APOKYN were: yawning; sudden uncontrolled movements; nausea and/or vomiting; sleepiness; dizziness; runny nose; seeing and hearing things that are not real; swelling of hands, arms, legs, and feet; increased sweating; flushing; and unusually pale complexion.
Studies of people with Parkinson’s disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson’s disease. It is not known if this problem is associated with Parkinson’s disease or the medicines used to treat Parkinson’s disease. APOKYN is one of the medicines used to treat Parkinson’s disease. Therefore, patients being treated with APOKYN should have periodic skin examinations.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-877-727-6596 (877-7APOKYN). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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