Rotigotine

Rotigotine is a prescription medication used to treat the symptoms of Parkinson's disease and moderate-to-severe Restless Legs Syndrome. Rotigotine belongs to a group of drugs called dopamine agonists, which help control body movements by stimulating dopamine receptors in the brain.

This medication comes in the form of a patch that is applied on the skin once a day.

Common side effects of rotigotine include nausea, drowsiness, and headache. Do not drive or operate heavy machinery until you know how rotigotine affects you.

Rotigotine is a prescription medicine used to treat the signs and symptoms of idiopathic Parkinson's disease (PD). It is also used for moderate to severe primary Restless Legs Syndrome (RLS).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Rotigotine may be found in some form under the following brand names:

• Neupro

Rotigotine can cause serious side effects, including:

• severe allergic reactions. Rotigotine 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 rotigotine 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 rotigotine. 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 rotigotine are greater if you take other medicines that cause drowsiness. Tell your doctor right away if this happens. Before starting rotigotine, be sure to tell your doctor if you take any medicines that make you drowsy.
• hallucinations and other psychotic-like behavior. Rotigotine 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 rotigotine, or taking higher does of rotigotine. If you have hallucinations or any of these other psychotic-like changes, talk with your doctor.
• changes in blood pressure. Rotigotine 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 rotigotine 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 rotigotine or your dose is increased. Tell your doctor if you faint or feel dizzy.
• unusual urges. Some patients using rotigotine 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. Rotigotine can increase your heart rate.
• increased weight and fluid retention can occur in patients using rotigotine. Rotigotine 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. Rotigotine 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 rotigotine. 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 rotigotine.
• 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 rotigotine 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 rotigotine. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines that make you sleepy like:

• antidepressants
• medications for anxiety
• medications for mental illness
• medications for seizures
• muscle relaxants
• metoclopramide
• sedatives
• sleeping pills
• tranquilizers

This is not a complete list of rotigotine drug interactions. Ask your doctor or pharmacist for more information.

• Do not use rotigotine if you are allergic to rotigotine or any of the ingredients in rotigotine.
• Do not drive, operate machinery, or do other dangerous activities until you know how rotigotine affects you.
• Avoid exposing the site where you have applied your rotigotine patch 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.
• Do not use rotigotine during certain medical procedures called magnetic resonance imaging (MRI) or cardioversion. Using rotigotine during these procedures could cause a burn to the site where you applied your rotigotine patch.
• Avoid direct sunlight if you get a skin rash or irritation from rotigotine until your skin heals. Sun exposure could lead to skin color changes.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of rotigotine there are no specific foods that you must exclude from your diet when receiving rotigotine.

Before you start using rotigotine, 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 rotigotine.
• have high or low blood pressure.
• have or have had heart problems.
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if rotigotine passes into your breastmilk. You and your doctor should decide if you will use rotigotine or breast feed. You should not do both.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if rotigotine passes into your breastmilk. You and your doctor should decide if you will use rotigotine or breastfeed. You should not do both.

• Use rotigotine exactly as your doctor tells you to use it.
• Rotigotine comes in 4 different size (dose) patches for Parkinson's disease. Your doctor should start you on a low dose of rotigotine. Your doctor will change the dose weekly until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach the dose that controls your symptoms best.
• Rotigotine comes in 3 different size (dose) patches for RLS. Your doctor should start you on the lowest dose of rotigotine. Your doctor may change the dose weekly until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach the dose that controls your symptoms best.
• Apply rotigotine 1 time each day at the same time each day.
• You may bathe, shower, or swim while wearing a rotigotine patch. Water may loosen your rotigotine patch.
• If the edges of the patch lift, you may tape them down with bandaging tape.
• If your rotigotine patch falls off, apply a new rotigotine patch for the rest of the day. The next day, apply a new patch at your regular time.
• If you miss a dose or forget to change your rotigotine patch, apply a new rotigotine patch as soon as you remember. Replace the rotigotine patch at your normal time the next day.
• Talk to your doctor often about your condition. Do not stop or change your treatment with rotigotine without talking to your doctor.

Read the Instructions for Use that come with your rotigotine before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

When to apply rotigotine:

Each rotigotine patch is sealed in a pouch that protects it until you are ready to apply it.

• Rotigotine should be applied right away after removing it from the protective pouch. Do not damage or cut your rotigotine patch into smaller pieces.
• Choose the time of day or night that works best for you to apply your rotigotine patch. Apply your rotigotine patch at the same time each day.
• Wear your rotigotine patch for 24 hours.
• After 24 hours, remove your rotigotine patch and apply a new one right away to a different area of your skin.

Where to apply rotigotine:

• Choose an area of clean, dry, and healthy skin on the stomach, thigh, hip, side of the body between the ribs and the pelvis (flank), shoulder, or upper arm.

• Apply your rotigotine patch to a different place on your skin each day, for example, from the right side to the left side and from the upper body to the lower body. Your rotigotine patch should not be applied to the same area of your skin more than 1 time every 14 days. Apply rotigotine to a different area of skin each day to reduce the chance of getting skin irritation.
• If you need to apply your rotigotine patch to a hairy area, the area should be shaved at least 3 days before applying the patch.
• Avoid applying your rotigotine patch to areas where it could be rubbed by tight clothing or under a waistband.
• Avoid applying your rotigotine patch on skin folds.
• Do not apply your rotigotine patch to skin that is red, irritated, or injured.
• Avoid applying creams, lotions, ointments, oils, and powders to the skin area where your rotigotine patch will be placed.

How to apply rotigotine:

• Grasp the two sides of the pouch and pull apart. 
• Remove your rotigotine patch from the pouch.
• Hold your rotigotine patch with both hands, with the protective liner on top.
• Bend the edges of your rotigotine patch away from you so that the S-shaped cut in the liner opens up. 
• Peel off one half of the protective liner. Do not touch the sticky surface of your rotigotine patch because the medicine could come off on your fingers.
• Apply the sticky half of your rotigotine patch to a clean area of your skin and remove the remaining liner. 
• Press your rotigotine patch firmly with the palm of your hand for 30 seconds to make sure there is good contact with your skin, especially around the edges. The warmth of your hand helps the adhesive on the patch to stick to your skin. Make sure that your rotigotine patch is flat against your skin. There should be no bumps or folds in your rotigotine patch.
• Wash your hands with soap and water right after handling your rotigotine patch to remove any medicine that may have gotten on them. Do not touch your eyes until after you have washed your hands.

How to Remove rotigotine:

• Slowly and carefully peel off your used rotigotine patch. Carefully fold it in half (sticky sides together) and throw away the folded patch so that children and pets cannot reach it. Your rotigotine patch still contains some medicine and could harm a child or pet.
• Gently wash the area with warm water and mild soap to remove any sticky material (adhesive) that stays on your skin.
• Baby or mineral oil may also be used to remove any adhesive. Avoid using alcohol or other solvents, such as nail polish remover. They may cause your skin to become irritated.
• Wash your hands with soap and water.
• You may see mild redness at the site when a patch is removed like when you remove an adhesive bandage. This redness should go away over time. If irritation or itchiness continues, tell your doctor.

Parkinson's Disease

Rotigotine comes in 4 different size (dose) patches for Parkinson's disease. Your doctor should start you on a low dose of rotigotine. Your doctor will change the dose weekly until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach the dose that controls your symptoms best. The highest recommended dose for early-stage Parkinson's disease is 6 mg/24 hours. The recommended dose for advanced-stage Parkinson's disease is 8 mg/24 hours.

Restless Legs Syndrome (RLS)

Rotigotine comes in 3 different size (dose) patches for RLS. Your doctor should start you on the lowest dose of rotigotine. Your doctor may change the dose weekly until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach the dose that controls your symptoms best. The highest recommended dose is 3 mg/24 hours.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store rotigotine at 68ºF to 77ºF (20ºC to 25ºC).
• Store rotigotine in its original sealed pouch until use. Do not store rotigotine outside of the pouch.
• Keep rotigotine and all medicines out of reach of children and away from pets.

IMPORTANT: Rotigotine is for use on the skin only.