Rotigotine

Contraindications

Hypersensitivity

Cautions

May cause sudden onset of sleep while engaging in activities of daily living, compulsive disorders (eg, pathologic gambling, hypersexuality, increased libido, repetitive meaningless actions), hallucinations, and psychotic-like behavior

Contains sodium metabisulfite that may cause allergic-type reactions Somnolence is common; falling asleep during activities of daily living observed

May cause symptomatic hypotension and syncope

May increase blood pressure and heart rate

Dose dependent increases in weight and fluid retention observed

May potentiate dopaminergic side effects of levodopa and cause or exacerbate dyskinesia

Avoid abrupt withdrawal; symptoms resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, rhabdomyolysis, and/or autonomic instability) with no other obvious etiology, has been reported in association with rapid dose reduction

Application site reactions are frequent and dose related

Restless leg syndrome rebound/augmentation may occur as dose wears off

Remove patch before MRI; backing layer of patch contains aluminum

Heat may increase absorption; avoid exposure to external heat sources (eg, heating pads, electric blankets, sauna)

Fibrotic complication reported (eg, retroperitoneal fibrosis, pleural effusion, pericarditis)

Binding to melanin-pigmented tissues reported

Hallucinations/psychotic -like behavior and dyskinesia may occur

Monitor for melanoma; increased risk reported for patients receiving therapy

• 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.

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

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.)

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 rotigotine 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 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.

Although not studied, exposures in older subjects (older than 80 years of age) may be higher because of skin changes with aging.

Parkinson disease: Topical: Transdermal:

Early-stage: Initial: Apply 2 mg/24 hours patch once daily; may increase by 2 mg/24 hours weekly, based on clinical response and tolerability; lowest effective dose: 4 mg/24 hours (manufacturer recommends a maximum dose of 6 mg/24 hours; higher doses [eg, 8 mg/24 hours] have been studied in clinical trials [Giladi 2007]).

Advanced-stage: Initial: Apply 4 mg/24 hours patch once daily; may increase by 2 mg/24 hours weekly, based on clinical response and tolerability. Recommended dose: 8 mg/24 hours; in clinical trials maximum doses up to 16 mg/24 hours were used.

Discontinuation of treatment in Parkinson’s disease: Decrease by ≤2 mg/24 hours preferably every other day until withdrawal complete

Restless legs syndrome (RLS): Topical: Transdermal: Initial: Apply 1 mg/24 hours patch once daily; may increase by 1 mg/24 hours weekly, based on clinical response and tolerability; lowest effective dose: 1 mg/24 hours (maximum dose: 3 mg/24 hours)

Discontinuation of treatment for RLS: Decrease by 1 mg/24 hours preferably every other day until withdrawal complete

>10%:

Cardiovascular: Systolic hypotension (13% to 32%), peripheral edema (dose related; 3% to 14%)

Central nervous system: Drowsiness (dose related; 5% to 32%), orthostatic hypotension (8% to 29%), dizziness (5% to 23%), headache (10% to 21%), fatigue (6% to 18%), sleep disorder (disturbance in initiating/maintaining sleep; dose related; 2% to 14%), malaise (≤14%), hallucination (dose related; 3% to 13%), insomnia (7% to 11%)

Dermatologic: Hyperhidrosis (dose related; 1% to 11%)

Endocrine & metabolic: Decreased serum glucose (1% to 15%)

Gastrointestinal: Nausea (dose related; 15% to 48%), vomiting (dose related; 2% to 20%)

Hematologic & oncologic: Decreased hematocrit (8% to 17%), decreased hemoglobin (8% to 15%)

Local: Application site reaction (dose related; 21% to 46%)

Neuromuscular & skeletal: Dyskinesia (dose related; 14% to 17%), weakness (≤14%), arthralgia (8% to 11%)

1% to 10%:

Cardiovascular: Increased diastolic blood pressure (4% to 8%), systolic hypertension (5%), hypertension (dose related; 1% to 5%), atrioventricular block (3%), abnormal T waves on ECG (≤3%), syncope

Central nervous system: Abnormal dreams (dose related; 1% to 7%), nightmares (dose related; 3% to 5%), depression (2% to 5%), paresthesia (dose related; 4%), vertigo (3% to 4%), equilibrium disturbance (2% to 3%), irritability (1% to 3%), narcolepsy (1% to 2%)

Dermatologic: Pruritus (4% to 9%), erythema (dose related; 2% to 6%)

Endocrine & metabolic: Weight gain (2% to 9%), change in libido (4% to 6%), hot flash (3% to 4%), low serum ferritin (dose related; 2%), menstrual disorder (1% to 2%)

Gastrointestinal: Constipation (5% to 9%), anorexia (2% to 9%), xerostomia (dose related; 7%), diarrhea (5% to 7%), dyspepsia (dose related; 2% to 3%), viral gastroenteritis (1% to 2%)

Genitourinary: Change in WBC count (urine, ≤3%)

Hematologic & oncologic: Basal cell carcinoma (3%), leukocyturia (3%)

Infection: Herpes simplex infection (3%)

Neuromuscular & skeletal: Tremor (4%), muscle spasm (dose related; 3% to 4%)

Ophthalmic: Visual disturbance (3% to 5%)

Otic: Tinnitus (2% to 3%)

Renal: Increased blood urea nitrogen (3% to 11%)

Respiratory: Nasopharyngitis (8% to 10%), cough (3%), nasal congestion (3%), sinus congestion (2% to 3%), sinusitis (dose related; 2% to 3%)

Miscellaneous: Hiccups (dose related; 2% to 3%)

<1% (Limited to important or life-threatening): Confusion, delirium, delusions, impulse control disorder, increased creatine phosphokinase, neuroleptic malignant syndrome, paranoia, psychotic symptoms

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, constipation, lack of appetite, nightmares, diarrhea, fatigue, dry mouth, sweating a lot, loss of strength and energy, insomnia, application site irritation, or joint pain. Have patient report immediately to prescriber uncontrollable urges, severe dizziness, passing out, confusion, skin growths, mole changes, severe headache, angina, tachycardia, abnormal heartbeat, mood changes, hallucinations, behavioral changes, muscle pain, muscle rigidity, abnormal movements, decreased libido, severe skin irritation, weight gain, swelling of arms or legs, vision changes, or narcolepsy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.