Neupro

>10% (Early-stage Parkinson Disease)

Nausea (34-48%)

Application site reactions (including erythema, pruritus, irritation, burning, dermatitis, inflammation, papulae, vesicle, pain) (21-46%)

Dizziness (14-22%)

Somnolence (12-20%)

Vomiting (10-20%)

Fatigue (6-18%)

Insomnia (5-11%)

Hyperhidrosis (3-11%)

1-10% (Advanced-stage Parkinson Disease)

Application site reactions (36-46%)

Somnolence (32%)

Nausea (22-28%)

Dizziness (14-23%)

Dyskinesia (14-17%)

Edema peripheral (9-14%)

Insomnia (9-14%)

Hallucinations (7-14%)

Arthralgia (8-11%)

1-10% (Restless Legs Syndrome)

Application site reactions (23-43%)

Nausea (15-23%)

Headache (15-21%)

Asthenia (7-14%)

1-10% (Early-stage Parkinson Disease)

Abnormal dreams (2-7%)

Erythema (3-6%)

Anorexia (2-6%)

Depression (2-5%)

Edema peripheral (2-4%)

Dyspepsia (2-3%)

EKG, T- ave abnormal (2-3%)

Weight loss (2-3%)

Balance disorder (2-3%)

Tinnitus (2-3%)

Hiccups (2-3%)

Pruritic rash (2-3%)

Erectile dysfunction (2-3%)

Lethargy (1-2%)

Orthostatic hypotension (1-2%)

1-10% (Advanced-stage Parkinson Disease)

Vomiting (8-10%)

Headache (8-10%)

Constipation (5-9%)

Diarrhea (5-7%)

Hypertension (3-5%)

Nightmares (3-5%)

Paraesthesias/Dysesthesias (3-4%)

Tremor (3-4%)

Asthenia (3-4%)

Cough (3%)

Nasal Congestion (3%)

Sinus congestion (2-3%)

Erythema (2-3%)

Hyperhidrosis (1-3%)

Musculoskeletal pain (2%)

1-10% (Restless Legs Syndrome)

Nasopharyngitis (5-10%)

Somnolence (5-10%)

Insomnia (2-10%)

Dizziness (5-9%)

Pruritus (3-9%)

Xerostomia (3-7%)

Constipation (2-6%)

Hyperhidrosis (1-5%)

Vomiting (2-4%)

Muscle spasms (1-4%)

Hypertension (1-4%)

Hot flushes (1-4%)

Dyspepsia (1-3%)

Vertigo (1-3%)

Sinusitis (1-3%)

Abnormal dreams (1-3%)

Sleep attacks (1-2%)

Erythema (1-2%)

Neupro 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, 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.
• hallucinations and other psychotic-like behavior. Neupro 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. 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 does of Neupro. If you have hallucinations or any of these other psychotic-like changes, talk with your doctor.
• 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 or increased sexual urges and behaviors. 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.
• increased weight and fluid retention can occur in patients using Neupro. Neupro can cause your body to keep extra fluid which leads to swelling and weight gain. Tell your doctor if you have swelling or fluid retention, especially in the ankles or legs or have an unusually fast increase in weight.
• uncontrolled sudden movements. Neupro may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. Tell your doctor if this happens. The doses of your anti-Parkinson's medicine may need to be changed.
• 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 .
• skin cancer. Some people with Parkinson's disease may have an increased chance of getting a skin cancer called melanoma. People with Parkinson's disease should have a doctor check their skin for skin cancer regularly.

The most common side effects of Neupro for Parkinson's disease are application site reactions, nausea, vomiting, sleepiness, dizziness, loss of appetite, increased sweating, difficulty sleeping, leg swelling, and uncontrolled, sudden movements of arms or legs.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Administration

Transdermal Administration

Administer percutaneously by topical application of a transdermal system (Neupro).1 Apply transdermal system (or “patch”) once daily at a convenient time (day or night) and at approximately the same time each day.1 May apply without regard to meals.1

Instruct patients in the proper use and disposal of the transdermal system and advise patients to read the patient information, including the instructions for use, before beginning therapy and each time drug is refilled.1

Apply transdermal system immediately after removal from its pouch and removal of the protective liner.1

Apply to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm by firmly pressing the system with the palm of the hand for 30 seconds with the adhesive side touching the skin to ensure good contact, particularly around the edges.1

Avoid application sites that are oily, irritated, or damaged; also avoid sites where the patch may be rubbed by tight clothing, under a waistband, and skin folds.1

If application to a hairy area is necessary, shave hair at the application site at least 3 days prior to application;1 do not use creams, lotions, oils, ointments, or powders on skin where patch will be placed.1

Move application site on a daily basis (i.e., from the right side to the left side, from the upper body to the lower body).1 Do not apply transdermal system to the same application site more than once every 14 days.1 (See Application Site Reactions under Cautions.)

Wear each transdermal system continuously for 24 hours.1 If a system becomes dislodged during period of use or if a patient forgets to change the system, apply a new system for the remainder of the day; on the following day, change the patch according to regular time schedule.1 May tape edges of the transdermal system in place with bandage tape if patient experiences difficulty with patch adhesion.1

After handling a transdermal system, wash hands to remove any drug; avoid touching eyes or other objects prior to handwashing.1

Because the backing layer of the rotigotine transdermal system contains aluminum, remove patch prior to magnetic resonance imaging (MRI) or cardioversion to avoid skin burns.1

Dosage

The rotigotine transdermal system (Neupro) is labeled in terms of the approximate rate of drug delivery per 24 hours.1

May use either single or multiple patches of rotigotine to achieve prescribed dosage.1

Adults

Early parkinsonian syndrome: Initially, 2 mg/24 hours;1 may increase dosage weekly by 2 mg/24 hours if tolerated and additional therapeutic effect is needed.1 Lowest effective dosage in clinical studies was 4 mg/24 hours.1 Maximum recommended dosage is 6 mg/24 hours.1

Advanced parkinsonian syndrome: Initially 4 mg/24 hours;1 may increase dosage weekly by 2 mg/24 hours if tolerated and additional therapeutic effect needed.1 Recommended dosage is 8 mg/24 hours.1

When discontinuing treatment in patients with parkinsonian syndrome, reduce daily dosage by a maximum of 2 mg/24 hours with a dosage reduction preferably every other day, until complete withdrawal is achieved.1 (See Withdrawal-emergent Hyperpyrexia and Confusion under Cautions.)

Initially, 1 mg/24 hours; increase dosage weekly by 1 mg/24 hours if tolerated and if additional therapeutic effect is needed, up to a maximum dosage of 3 mg/24 hours.1

When discontinuing treatment, reduce daily dosage by 1 mg/24 hours preferably every other day, until complete withdrawal is achieved.1 (See Augmentation and Rebound in Restless Legs Syndrome and also see Withdrawal-emergent Hyperpyrexia and Confusion under Cautions.)

Prescribing Limits

Adults

Early parkinsonian syndrome: 6 mg/24 hours.1

3 mg/24 hours.1

Special Populations

Hepatic Impairment

Moderate hepatic impairment: Dosage adjustment not necessary.1

Severe hepatic impairment: Not studied; manufacturer does not provide specific dosage recommendations.1 (See Hepatic Impairment under Cautions.)

Renal Impairment

No dosage adjustment necessary in patients with mild to severe renal impairment, including those receiving hemodialysis.1 17 (See Renal Impairment under Cautions.)

Geriatric Patients

Manufacturer makes no specific recommendations for dosage adjustment.1 (See Geriatric Use under Cautions.)

• Importance of reading the manufacturer's patient information before beginning transdermal rotigotine therapy and each time the drug is dispensed.1

• Importance of using the rotigotine transdermal system (patch) as prescribed.1 Importance of instructing patients to wear system continuously for 24 hours, then to remove the patch and immediately apply a new one.1 If a patient forgets to change a patch, they should be advised to apply a new patch as soon as possible and then replace it at the usual time the following day.1

• Risk of severe allergic reactions, including allergic-type reactions in patients with sulfite sensitivity.1 Importance of advising patients to immediately remove the patch and seek immediate medical attention if they experience swelling of the lips or tongue, chest pain, and/or difficulty breathing or swallowing.1

• Importance of advising and alerting patients of the potential for sedating effects, including somnolence and particularly the possibility of falling asleep without feeling drowsy or without warning while engaged in activities of daily living.1 Patients should avoid driving or engaging in other potentially dangerous activities until effects on the individual are known.1

• Importance of informing patients that hallucinations or other psychotic-like behavior can occur during therapy, particularly in geriatric patients with parkinsonian syndrome.1

• Risk of symptomatic (e.g., dizziness, nausea, sweating) or asymptomatic orthostatic hypotension and syncope during therapy, particularly during initial therapy and following an increase in dosage.1 Advise patients to avoid rising rapidly after sitting or lying down, especially if they have been in a seated or recumbent position for prolonged periods and/or if they are just beginning transdermal rotigotine therapy.1 Advise patients to contact their clinician if they experience any signs or symptoms of lowered BP during therapy.1

• Risk of increased BP or exacerbation of hypertension and increased heart rate.1

• Importance of asking patients whether they have developed any new or increased urges or compulsive behaviors (e.g., gambling urges, sexual urges, uncontrolled spending, binge eating) while receiving transdermal rotigotine and of advising them of the importance of reporting such urges.1 21

• Risk of weight gain and fluid retention, which may manifest as peripheral edema.1 Patients should contact their clinician if they experience swelling or fluid retention, especially in the ankles or legs, or have an unusually fast increase in weight.1

• Risk of new onset or exacerbation of dyskinesia.1

• Importance of informing patients that application site reactions can occur with transdermal rotigotine and that the application site should be rotated on a daily basis.1 The patch should not be applied to the same application site more often than once every 14 days.1 Patients should report persistent application site reactions (lasting more than a few days), increases in severity, or skin reactions that spread outside the application site.1 If there is a skin rash or irritation from the transdermal system, direct sunlight on the area should be avoided until the skin heals; such exposure may lead to changes in skin color.1

• Importance of advising patients with parkinsonian syndrome that they are at higher risk of developing melanoma.1 Advise patients to monitor for melanoma frequently and on a regular basis when using transdermal rotigotine for any indication.1

• Importance of informing patients that transdermal rotigotine may cause restless legs symptoms to have an earlier onset during the day or become worse.1

• Importance of informing patients to remove the rotigotine patch before undergoing MRI or cardioversion to avoid possible skin burns.1

• Importance of advising patients about the potential for heat application to increase rotigotine absorption from the patch.1 Instruct patients to avoid applying external heat sources to the transdermal system and to avoid direct sun exposure of the transdermal system.1

• Importance of informing patients that transdermal rotigotine may cause nausea, vomiting, and general GI distress (i.e., dyspepsia, abdominal discomfort).

• Importance of following recommended procedure for administration, removal, and disposal of rotigotine transdermal systems and of reviewing the instruction sheet provided by the manufacturer.1

• Importance of patient (or individual assisting the patient) thoroughly washing hands with soap and water after handling the rotigotine transdermal system (e.g., initial application, removal) and to wash the application site thoroughly after removing the system.1

• Importance of proper transdermal system disposal, including keeping it out of the reach of children or pets.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., CNS depressants including sedatives, antidepressants, and antipsychotics) and OTC drugs and herbal supplements, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rotigotine transdermal patch in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rotigotine transdermal patch in the elderly.

Pregnancy

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sulpiride

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Congestive heart failure or
• Dyskinesia (abnormal muscle movements) or
• Edema (fluid in the hands, lower legs, or feet) or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Kidney disease, severe or
• Lung disease or
• Melanoma (skin cancer), history of or
• Mental illness (e.g., psychosis)—Use with caution. May make these conditions worse.

• Sleep disorders—May worsen sleepiness or episodes of falling asleep during an activity.

• Sulfite allergy—Use with caution. This medicine contains sodium metabisulfite.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
• Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
• A skin lump or growth.
• Change in color or size of a mole.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Dizziness or passing out.
• Mood changes.
• Hallucinations (seeing or hearing things that are not there).
• Change in how you act.
• Feeling confused.
• Fever.
• Muscle pain.
• Muscle stiffness.
• Trouble controlling body movements that is new or worse.
• Weight gain.
• Swelling in the arms or legs.
• Change in eyesight.
• Lowered interest in sex.
• Very bad irritation where this medicine is used.
• Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after Neupro was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take this medicine. Call your doctor right away if this happens or you feel very sleepy.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Neupro or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Neupro. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Neupro is used to treat Parkinson’s disease and restless legs syndrome.

Neupro is a brand name for the drug rotigotine. It isn’t available as a generic drug.

Neupro comes in the form of a patch that you apply to your skin.

The more common side effects of Neupro include nausea, sleepiness, sleep problems, and skin reactions where you applied the patch.

In some cases, Neupro can cause serious side effects. These include hallucinations (seeing or hearing something that isn’t real) and other psychiatric problems. They also include worsening muscle movements, low or high blood pressure, increased heart rate, and increased urges to gamble or act on other impulsive behaviors.

• Stopping the drug suddenly See Details

• Falling asleep See Details

• Compulsive behavior See Details

What is Neupro?

This drug is a prescription drug. It comes as a transdermal (skin) patch.

This drug is available as the brand-name drug Neupro. It isn’t available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

This drug is used to treat Parkinson’s disease and restless legs syndrome.

How it works

This drug belongs to a class of drugs called dopamine agonists.

See Details

More common side effects

Some of the more common side effects of Neupro include:

• nausea

• vomiting

• sleepiness

• headache

• skin redness where you applied the patch

• sleep problems, such as:

  • waking up early in the morning
  • trouble falling asleep
  • trouble staying asleep
  • nightmares
  • strange dreams

• increased sweating

• blurry or double vision

• problems with muscle movements

• leg swelling

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Severe allergic reaction. Symptoms can include:

  • swelling of your lips or tongue
  • chest pain
  • trouble breathing
  • trouble swallowing

• Excessive sleepiness. Symptoms can include:

  • getting sleepy during the day
  • falling asleep without warning while doing daily activities such as talking, eating, or driving a car

• Psychiatric problems. Symptoms can include:

  • hallucinations (seeing or hearing things that aren’t real)
  • delusions (believing things that aren’t real)
  • confusion
  • paranoia (excessive suspicion)
  • aggressive behavior
  • agitation

• A sudden drop in blood pressure when you stand up. This may be more likely to happen after dosage increases.

• High blood pressure

• Faster heart rate

• Unusual urges or increased desires. Examples include:

  • new or increased urges to gamble
  • increased sexual urges
  • impulsive shopping sprees
  • binge eating

• Skin cancer or skin that has an abnormal growth or appearance. Symptoms can include:

  • blue or blue-black lesions (sores)
  • lesions or spots with more than one color or flecks of a different color
  • a mole or spot that changes in color or size over time
  • lesions with irregular borders

• Fast weight gain or swelling

• Problems with muscle movements

• Worse or more frequent symptoms of restless legs syndrome. These can include:

  • leg twitching
  • abnormal itching or a crawling feeling in your legs
  • moving your legs to provide relief

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Brand: Neupro

• 1 mg/24 hours
• 2 mg/24 hours
• 3 mg/24 hours
• 4 mg/24 hours
• 6 mg/24 hours
• 8 mg/24 hours

• Typical starting dosages:
  • Early-stage disease: 2 mg/24 hours
  • Advanced-stage disease: 4 mg/24 hours
• Dosage increases: Your doctor may increase your dosage by 2 mg/24 hours every week.
• Maximum dosages:
  • Early-stage disease: 6 mg/24 hours
  • Advanced-stage disease: 8 mg/24 hours

Neupro hasn’t been studied in children. It shouldn’t be used in people younger than 18 years of age.

Warnings

Don’t stop using your patch suddenly. Doing so can cause you to develop a high fever and confusion. If you need to stop taking Neupro, your doctor will slowly decrease your dosage over time.

Brand: Neupro

• 1 mg/24 hours
• 2 mg/24 hours
• 3 mg/24 hours
• 4 mg/24 hours
• 6 mg/24 hours
• 8 mg/24 hours

• Typical starting dosage: 1 mg/24 hours
• Dosage increases: Your doctor may increase your dosage by 1 mg/24 hours each week.
• Maximum dosage: 3 mg/24 hours

Neupro hasn’t been studied in children. It shouldn’t be used in people younger than 18 years of age.

Warnings

Don’t stop using your patch suddenly. Doing so can cause you to develop a high fever and confusion. If you need to stop taking Neupro, your doctor will slowly decrease your dosage over time.

Apply your patch at the same time each day

Don’t cut the patch into smaller pieces

Store this drug carefully

A prescription for this medication is refillable

Travel

Self-management

Clinical monitoring

Sun sensitivity

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead

Insurance

Are there any alternatives?