Drug Detail:Rotigotine (transdermal) (Rotigotine (transdermal) [ roe-tig-oh-teen ])
Drug Class: Dopaminergic antiparkinsonism agents
Usual Adult Dose for Parkinson's Disease
Initial doses:
Early-stage Parkinson's disease: Apply 2 mg topically once a day
Advanced-stage Parkinson's disease: Apply 4 mg topically once a day
Maintenance dose: Increase weekly in 2 mg/24 hours increments if additional therapeutic effect is needed
Lowest effective dose: 4 mg/24 hours
Maximum dose for Early-stage Parkinson's disease: 6 mg/24 hours
Maximum dose for Advanced-stage Parkinson's disease: 8 mg/24 hours
Comments:
- Upon discontinuation, reduce the daily dose by a maximum of 2 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is complete.
Use: Treatment of Parkinson's disease
Usual Adult Dose for Restless Legs Syndrome
Initial dose: Apply 1 mg topically once a day
Maintenance dose: Increase weekly in 1 mg/24 hours increments if additional therapeutic effect is needed
Lowest effective dose: 1 mg/24 hours
Maximum dose: 3 mg/24 hours
Comments:
- Upon discontinuation, reduce the daily dose by a maximum of 1 mg every 24 hours, if possible; reduce the dose every other day until withdrawal is complete
Use: Treatment of moderate-to-severe primary Restless Legs Syndrome
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
No adjustment recommended.
Dose Adjustments
Nausea and vomiting occur more frequently during initial therapy and may require dose adjustment.
This drug should be tapered before discontinuation:
- Parkinson's disease: The daily dose should be reduced by a maximum of 2 mg/24 hours with a dose reduction preferably every other day, until complete withdrawal is achieved.
- Restless legs syndrome: The daily dose should be reduced by 1 mg/24 hours preferably every other day, until complete withdrawal is achieved.
Precautions
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
No adjustment recommended.
Other Comments
Administration advice:
- Apply topically once a day at approximately the same time every day
- Apply to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm; do not apply to skin that is oily, irritated, or damaged, or where it will be rubbed by tight clothing
- If it is necessary to apply to a hairy area, the area should be shaved at least 3 days prior to application
- Rotate application sites; do not use the same application site more than once every 14 days
- System should be applied immediately after opening pouch and removing protective liner
- Press system firmly on skin and hold in place for 30 seconds
- The prescribed dose may be achieved using single or multiple patches
Missed dose: If a dose is missed, apply a new patch as soon as remembered; may return to normal application time the following day
Storage requirements: Do not store patches outside of their pouch; apply patch immediately after opening pouch.
Preparation techniques:
- To open pouch, grasp the 2 sides and pull apart; holding patch with both hands so that the protective liner is facing up, bend edges up so that the S-shaped cut opens up
- Peel off one-half of the protective liner and apply patch to skin while removing the remaining liner, press and hold patch firmly with palm of hand for 30 seconds to ensure good contact; there should be no bumps or folds in patch
- If the edges of the patch lift, may tape down with bandaging tape; if patch falls off, apply a new patch for the rest of the day; apply a new patch at regular time the following day
- To remove patch, peel off slowly and carefully; fold patch sticky sides together and dispose of properly
- After patch removal, gently wash application area; excess adhesive may be removed with baby or mineral oil if necessary
- Mild redness may be seen at the application site and should resolve over time; if irritation or itchiness persists, patient should be instructed to notify health care provider
General:
- Prescribed dose may be achieved using single or multiple patches; patches should not be cut into pieces.
- This drug contains sodium metabisulfite and may cause allergic-type reactions in those with sulfite sensitivity.
Monitoring:
- Cardiovascular: Monitor for signs and symptoms of orthostatic hypotension, weight gain and fluid retention, particularly during dose escalation; consider blood pressure monitoring at the start of treatment.
- Nervous System: Monitor for somnolence and drowsiness
- Ocular: If vision abnormalities occur, ophthalmologic monitoring is recommended at regular intervals.
- Psychiatric: Question patients about new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges.
Patient advice:
Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- This patch should be removed before undergoing magnetic resonance imaging (MRI) or cardioversion as it may cause a burn at the application site.
- Heat application may increase drug absorption and patients should therefore avoid direct sun exposure, heating pads, saunas, or hot baths.
- This drug frequently causes drowsiness; patients should not drive a car or operate machinery or other potentially dangerous activities until it is determined how this drug affects their mental and/or motor performance.
- Patients should be instructed to report episodes of sudden onset of sleep, new or worsening dyskinesia, new or worsening compulsive behaviors and/or unusual urges, weight gain, fluid retention, or changes in restless legs syndrome symptoms.
- Patients should speak to their physician or health care provider if they become pregnant, intend to become pregnant, or are breastfeeding.