NEUPRO safety and side effects

NEUPRO® (rotigotine transdermal system) can cause serious side effects, including:

  • Severe allergic reactions. 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. An allergy to sulfites is not the same as an allergy to sulfa. People with asthma are more likely to be allergic to sulfites. Remove your NEUPRO Patch right away and call your doctor if you have swelling of the lips or tongue, chest pain, or trouble breathing or swallowing.
  • Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking NEUPRO. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while using NEUPRO are greater if you take other medicines that cause drowsiness. Tell your doctor right away if this happens. Before starting NEUPRO, be sure to tell your doctor if you take any medicines that make you drowsy.

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  • Hallucinations and other psychosis. NEUPRO can cause 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. If you have hallucinations or any of these other psychotic‐like changes, talk with your doctor right away. 
  • Changes in blood pressure. NEUPRO can decrease or increase your blood pressure. Lowering of your blood pressure is of special concern. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, this may mean that your blood pressure is decreased. If you notice this, you should contact your doctor. Also, when changing position from lying down or sitting to standing up, you should do it carefully and slowly. Lowering of your blood pressure can happen, especially when you start taking NEUPRO or when your dose is increased.
  • Fainting. Fainting can occur, and sometimes your heart rate may be decreased. This can happen especially when you start using NEUPRO or your dose is increased. Tell your doctor if you faint or feel dizzy.
  • Unusual urges. Some patients using NEUPRO get urges to behave in a way unusual for them. Examples of this are an unusual urge 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 notice or your family notices that you are developing any unusual behaviors, talk to your doctor.
  • Changes in heart rate. NEUPRO can increase your heart rate.
  • Skin site reactions. 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 at the skin site where you have applied NEUPRO.
  • Changes in Restless Legs Syndrome symptoms. NEUPRO may cause Restless Legs Syndrome symptoms to come back (rebound), or become worse or start earlier in the day.
  • Withdrawal symptoms. NEUPRO is a dopamine agonist medicine. Dopamine agonist medicines,
    including NEUPRO, can cause withdrawal symptoms as your dose is slowly lowered (tapered) or when
    treatment with NEUPRO is stopped. Tell your doctor right away if you get any of the following withdrawal
    symptoms:
    • fever
    • confusion
    • severe muscle stiffness
    • feeling like you do not care about the things you usually care about (apathy)
    • anxiety
    • depression
    • fatigue
    • insomnia
    • sweating
    • pain
     

Common side effects

The most common side effects of NEUPRO for Restless Legs Syndrome (RLS) are:

  • Application site reactions
  • Nausea
  • Difficulty falling asleep and staying asleep
  • Sleepiness
  • Headache

In some cases, patients using the NEUPRO Patch experienced localized redness, swelling, or itching where the patch was applied. Rotating the application site daily can reduce the chance of skin reactions. For more details, see Using the NEUPRO Patch.

Patients should report application site reactions that do not go away after a few days, that get worse, or that spread outside the patch site. If there is a skin rash or irritation from the patch, direct sunlight on the area should be avoided until the skin heals. Exposure could lead to changes in skin color.

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).

Important information to tell your doctor

Before you start using NEUPRO, tell your doctor if you:

  • have breathing problems, including asthma.
  • have daytime sleepiness from a sleep disorder or have unexpected or unpredictable sleepiness or periods of sleep.
  • have mental problems such as schizophrenia, bipolar disorder, or psychosis.
  • feel dizzy, nauseated, sweaty, or faint when you stand up from sitting or lying down.
  • drink alcoholic beverages. This may increase your chances of becoming drowsy or sleepy while using NEUPRO.
  • have high or low blood pressure.
  • have or have had heart problems.
  • are pregnant or plan to become pregnant. It is not known if NEUPRO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if NEUPRO passes into your breast milk. You and your doctor should decide if you will use NEUPRO or breastfeed. You should not do both.

Is RLS affecting your life?

Some people have to live their lives around their RLS symptoms. Do you?

See “How Is RLS Affecting You?” to find out >

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NEUPRO and other medicines may affect each other, causing side effects. NEUPRO may affect the way other medicines work, and other medicines may affect how NEUPRO works.

Especially tell your doctor if you take other medicines that can make you sleepy, such as sleep medicines, antidepressants, or antipsychotics.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Prepare for your next doctor's appointment

It's not always easy to pinpoint your feelings and communicate them to your doctor. This tool will help you get started.

Build a conversation by selecting key points from the items below. Any items you selected while using the site have already been added to your list. When you are finished, you can print or email your custom list using the buttons below.

This website does not save items added to My Doctor Conversation Builder. Be sure to print or email your list of questions before leaving this website.

Prepare for your next doctor's appointment

Build a list of key points to discuss with your doctor by selecting items from the list below. Click the "Items to ask my doctor" icon at the top of the screen to view, edit, and print your list at any time.

Assess your RLS

If you think you may have RLS, it's important to understand how much of an effect the condition has on your life. It may have a bigger impact than you realize. Below are some statements that describe how people with RLS can feel. Check the ones that apply to you. This does not take the place of a doctor visit. Only your doctor can diagnose you with RLS.

NEUPRO has been approved by the FDA to treat moderate-to-severe primary RLS and the approval was based on improvements in overall symptom scores in clinical trials. The efficacy of NEUPRO for individual symptoms has not been demonstrated. The following information is provided for your education and to help you understand your disease.

Because of my RLS:

Here's a list of common terms that people with RLS use to describe what's happening in their limbs. Do any of these describe how you're feeling? Check off the descriptions that apply to add them to My Doctor Conversation Builder.

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Please select the statements that apply to you and click "submit" again.

  • Your checked items are now reflected in My Doctor Conversation Builder.

    It looks like symptoms from RLS affect you when you are trying to rest, relax, or sit still.

    NEUPRO may help.

INDICATION

NEUPRO is a prescription medicine used to treat moderate-to-severe primary Restless Legs Syndrome.

NEUPRO is indicated for the treatment of moderate‐to‐severe primary Restless Legs Syndrome.

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 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. If you have hallucinations or any of these other psychotic‐like changes, talk with your doctor right away.

NEUPRO can cause decreases in blood pressure, especially when you start or increase your dose. Increases in blood pressure and heart rate, and fainting, also can occur. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, 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 Restless Legs Syndrome symptoms to come back (rebound), become worse, or start earlier in the day.

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 Restless Legs Syndrome are application site reactions, nausea, difficulty falling asleep and staying asleep, sleepiness, and headache.

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.

NEUPRO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people and is seen more frequently in people with asthma.

Patients treated with NEUPRO have reported somnolence and falling asleep without warning signs during activities of daily living, including driving, which sometimes resulted in accidents. Some patients believed they were alert immediately prior to the event. Patients may not recognize or acknowledge increased drowsiness or sleepiness. Therefore, prescribers should directly question patients about these possible occurrences and continually reassess patients, as some events have been reported well after the start of treatment. Patients should be advised to exercise caution while driving, operating heavy machinery, or working at heights during treatment with NEUPRO. If patients develop daytime sleepiness or episodes of falling asleep during activities of daily living, NEUPRO should be discontinued.

Patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic behavior during NEUPRO treatment or after starting or increasing the dose of NEUPRO.

NEUPRO may cause symptomatic postural/orthostatic hypotension. Patients treated with dopamine agonists require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and should be informed of this risk. NEUPRO may also cause syncope, elevated blood pressure, and elevated heart rate. These events should be considered when treating patients with cardiovascular disease or concomitant illness.

Patients may experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and other intense urges, and the inability to control these urges while taking medications, including NEUPRO, that increase central dopaminergic tone. Dopamine dysregulation syndrome, the repeated use of more NEUPRO than as prescribed to manage symptoms, was observed in some patients during treatment with NEUPRO. Because patients may not recognize these behaviors as abnormal, prescribers should specifically ask patients and their caregivers about the development of new or increased urges while being treated with NEUPRO. Dose reduction or discontinuation of NEUPRO should be considered if such urges develop.

NEUPRO can cause application site reactions, and some may be severe. In clinical trials, most reactions were mild or moderate in intensity and were limited to the patch area.

Use of dopaminergic medications, including NEUPRO, may cause augmentation and rebound.

NEUPRO should be removed before magnetic resonance imaging or cardioversion, because the aluminum backing layer in the patch could cause skin burns. Heat application has been shown to increase absorption several fold with other transdermal products. Therefore, patients should be advised to avoid exposing the application site to sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.

Withdrawal symptoms such as apathy, anxiety, depression, fatigue, insomnia, sweating and pain may occur during taper or after discontinuation of NEUPRO. Patients who have been prescribed a lower dose or who have been withdrawn from the drug should be informed about potential withdrawal symptoms and monitored during and after discontinuation.

The most common adverse reactions (at least 5% greater than placebo) for NEUPRO in the treatment of Restless Legs Syndrome are application site reactions, nausea, disturbances in initiating and maintaining sleep, somnolence, and headache.

Please see full Prescribing Information.