NEUPRO® (rotigotine transdermal system) is a prescription medicine used to treat Parkinson’s disease.

Understanding Parkinson’s Disease

What is Parkinson’s disease?

Parkinson's disease (PD) is a chronic and progressive disease of the central nervous system, meaning the symptoms will continue and worsen over time. Approximately 1 million people in the United States currently have PD. It is estimated that approximately 60,000 Americans are diagnosed with PD each year.

The disease is sometimes called idiopathic Parkinson's, because the exact cause is not known. However, many Parkinson's symptoms are believed to result from a lack of dopamine, one of the brain's chemical messengers. Without enough dopamine, the neurons (nerve cells in the brain) that control movement can't function properly. This makes it difficult for people with Parkinson's to move normally. Symptoms may vary from person to person.

NEUPRO has been approved by the FDA to treat Parkinson's disease and the approval was based on improvements in symptoms measured by a combination of motor function and activities of daily living. NEUPRO is not approved for the treatment of non-motor symptoms. The following information is provided for your education and to help you understand your disease.

Movement symptoms of Parkinson's disease

There are no specific laboratory tests for Parkinson's, so doctors make the diagnosis based on the presence of typical signs and symptoms.

The primary movement symptoms, or motor symptoms, of Parkinson's can include:

  • Slowness of movements (bradykinesia)
  • Muscle rigidity (stiffness)
  • Resting tremor (shaking)
  • Impaired balance and posture
  • Loss of fine motor control (such as writing or buttoning a shirt)
  • Decreased arm swing, shuffling gait, or decreased facial expression

Parkinson's symptoms typically start on one side of the body and spread to the other side later as the disease progresses.

Underlying non-motor Parkinson’s symptoms

Not all Parkinson's symptoms involve movement. There are many underlying non-motor symptoms that can be part of PD, including:

  • Sleep disturbances (trouble falling asleep, night waking, vivid dreams or nightmares)
  • Mood changes (depression, anxiety, fear)
  • Digestive changes (constipation, diarrhea, trouble swallowing, drooling, nausea, upset stomach)
  • Fatigue/daytime sleepiness
  • Tingling ("pins and needles") in the hands and feet
  • Sexual or urinary problems
  • Low blood pressure when changing position (fainting or dizziness on standing)
  • Excessive sweating
  • Changes in your sense of smell or taste
  • Problems with thinking (forgetfulness, lack of concentration)
  • Pain

It is estimated that 60% of people with Parkinson's have 2 or more of these underlying non-motor symptoms and that 25% may have 4 or more.

Make sure you talk to your doctor about all your PD symptoms. It's important to understand that these changes can be directly related to Parkinson's. And for some people, these underlying non-motor symptoms can have just as much impact as movement-related symptoms.

A word about depression

It's important to recognize the signs of depression so you can get the help you need. Depression is a real illness and may or may not be related to your Parkinson's. It won't go away without treatment, so talk to your doctor if you notice any changes in your mood or your behavior.

Important: If you or someone you know is in crisis or emotional distress, please call the Lifeline Network at 1-800-273-TALK (8255). When you dial 1-800-273-TALK, you are calling the crisis center in the Lifeline Network closest to your location. To find out what center is closest to you, search the Crisis Center Locator at https://suicidepreventionlifeline.org/our-network. If you need immediate assistance, please dial 911 for help.

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Indication

NEUPRO is a prescription medicine used to treat Parkinson's disease.

Important Safety Information

NEUPRO contains a sulfite called sodium metabisulfite. Sulfites can cause severe allergic reactions that are life threatening to some people who are sensitive to sulfites. People with asthma are more sensitive to sulfites. Remove the patch right away and call your doctor if you have swelling of the lips or tongue, chest pain, or trouble breathing or swallowing.

NEUPRO may make you fall asleep suddenly or without warning while doing normal activities, such as driving, which may result in accidents. Tell your doctor right away if this happens. Drinking alcohol or taking other medicines that cause drowsiness may increase your chances of becoming sleepy while using NEUPRO. Do not drive, use hazardous machinery, or do other dangerous activities until you know how NEUPRO affects you.

NEUPRO can cause or worsen psychotic symptoms 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. The chances of having hallucinations or these other psychotic-like changes are higher in people with Parkinson's disease who are elderly, taking NEUPRO, or taking higher doses of NEUPRO. If you have any of these problems, talk to your doctor.

NEUPRO can cause decreases in blood pressure, especially when you start or increase your dose. Increases in blood pressure and heart rate, fainting, weight gain, and fluid retention also can occur. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, or have an unusually fast increase in weight, swelling, or fluid retention, especially in the ankles or legs, tell your doctor.

Some patients using NEUPRO get urges to behave in a way that is unusual for them, such as unusual urges to gamble, strong urges to spend money, binge eating, or increased sexual urges and behaviors. Some patients may want to use more NEUPRO than prescribed for their symptoms (dopamine dysregulation syndrome). If you or your family notices you are developing any unusual behaviors, talk to your doctor.

NEUPRO may cause uncontrolled, sudden movements or make such movements you already have worse or more frequent if you have Parkinson's disease, which may mean that your anti-Parkinson's medicine needs to be changed.

Skin reactions may occur at the site where you apply NEUPRO. Tell your doctor if you get a rash, redness, swelling, or itching that will not go away.

Avoid exposing the NEUPRO patch you are wearing to heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and direct sunlight. Too much medicine could be absorbed into your body. Also, do not wear NEUPRO during medical procedures called magnetic resonance imaging (MRI) or cardioversion because this could cause skin burns.

Do not stop using NEUPRO without talking to your doctor first. If your doctor tells you to stop using NEUPRO, you should ask your doctor for specific instructions on how to slowly and safely discontinue using NEUPRO. If you stop using NEUPRO, you may have withdrawal symptoms such as fever, confusion, severe muscle stiffness, feeling like you do not care about the things you usually care about (apathy), anxiety, depression, fatigue, insomnia, sweating and pain.

Tell your doctor if you have breathing problems, a sleep disorder, mental problems, high or low blood pressure, or heart problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. NEUPRO may not be right for you.

The most common side effects in people taking NEUPRO for Parkinson's disease are nausea, vomiting, sleepiness, application site reactions, dizziness, loss of appetite, difficulty falling asleep and staying asleep, increased sweating, vision problems, leg swelling, and uncontrolled, sudden movements of the arms or legs.

These are not all the possible side effects of NEUPRO. For more information, ask your doctor or pharmacist.

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. You may also report side effects to UCB, Inc. at ucbCARES® (1-844-599-2273).

Please see additional Patient Information about the NEUPRO Patch. This information does not take the place of talking with your healthcare provider about your condition or treatment.