Neupro (rotigotine)
Neupro (rotigotine transdermal system) is a prescription medicine used to treat Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome.
- Disease Indications : Parkinson's Disease
- Manufacturer : Schwarz Pharma
- Usage : Cutaneous
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Pharmaceuticals and Medical Devices Agency (PMDA)
- Therapeutic Goods Administration (TGA)
- NMPA (China)
Details
What is Neupro (rotigotine transdermal system) for?
Neupro (rotigotine transdermal system) is a dopamine agonist indicated to treat:
- Parkinson’s disease (PD) - it is used on its own in early-stage disease, or in combination with levodopa (another medicine used in PD) at any stage of the disease, including the later stages when levodopa starts becoming less effective
- Moderate to severe restless-legs syndrome (RLS) - it is used when a specific cause for the disorder cannot be identified.
It is available in as a transdermal system (patch) that you stick on your skin that comes in six dosing strengths for PD: 1 mg, 2 mg, 3 mg, 4 mg, 6 mg, and 8 mg.
How does Neupro (rotigotine transdermal system) work?
Parkinson’s disease (PD) is a neurodegenerative condition that affects brain nerve cells that produce dopamine. Dopamine is an important signaling molecule that controls movement. Loss of dopamine-producing cells leads to a lack in dopamine in the brain, which leads to the symptoms of PD, including tremors, stiffness and slowness.
The active ingredient in Neupro, rotigotine, is a dopamine agonist, which means that it mimics the action of dopamine. The patch delivers a constant supply of rotigotine through the skin into the bloodstream.
The patch allows patients to control their movement and to have fewer of the signs and symptoms of PD disease, such as stiffness and slowness of movement. The exact way rotigotine treats PD and RLS is not fully understood. It is believed that rotigotine stimulates dopamine receptors in the brain.
Where has Neupro (rotigotine transdermal system) been approved?
Neupro (rotigotine transdermal system) was approved by:
- The Food and Drug Administration (FDA), USA:
- On May 10, 2007 for the treatment of the signs and symptoms of early-stage idiopathic PD.
- On April 3, 2012 for the treatment of the signs and symptoms of advanced stage idiopathic PD and as a treatment for moderate-to-severe primary RLS.
- The European Medicines Agency (EMA) on April 24, 2008 for the treatment of PD and RLS.
- The Therapeutic Goods Administration (TGA), Australia on January 2011 for the treatment of PD and RLS.
- The Ministry of Health, Labor and Welfare, Japan on December 27, 2012 for the treatment of PD and RLS.
- China Food and Drug Administration on July 10, 2018 for the treatment of PD and RLS.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Neupro (rotigotine transdermal system) taken?
The standard dosage is:
- Parkinson's disease:
- Initially, 2 mg/24 hours for early-stage disease or 4 mg/24 hours for advanced-stage disease.
- The dose may be increased as needed by 2 mg/24 hours at weekly intervals, up to 6 mg /24 hours for early-stage disease and up to 8 mg/24 hours for advanced-stage disease.
- Restless-leg syndrome:
- Initially, 1 mg/24 hours
- The dose may be increased as needed by 1 mg/24 hours at weekly intervals, up to 3 mg/24 hours.
The strength of patch to use at the start of treatment depends on the type and stage of the disease being treated. The dose can then be increased every week until an effective dose is reached. It may take several weeks before you reach the dose that controls your symptoms best.
Apply the patch one time each day at the same time each day on a dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm. Leave the patch on the skin for 24 hours, replace it by a new one in a different place. The same place must not be used again until two weeks later.
Complete information about Neupro (rotigotine transdermal system) dosage and administration can be found in the official prescribing information listed in our references section.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Neupro (rotigotine transdermal system)?
Common adverse reactions
The most common side effects ( ≥5% of patients) for the highest recommended doses for treatment of PD listed in the prescribing information include:
- Nausea
- Vomiting
- Somnolence
- Application site reactions
- Dizziness
- Anorexia
- Hyperhidrosis
- Insomnia
- Peripheral edema
- Dyskinesia
The most common side effects ( ≥5% of patients) for the highest recommended doses for treatment of RLS listed in the prescribing information include:
- Application site reactions
- Nausea
- Somnolence
- Headache
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Severe allergic reactions
- Falling asleep during normal activities
- Hallucinations and other psychotic-like behavior
- Changes in blood pressure or heart rate
- Changes in RLS symptoms: coming back (rebound), or worsening or starting earlier in the day
Use in a specific population
Neupro (rotigotine transdermal system) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- 1. Full prescribing information [FDA]: Neupro (rotigotine transdermal system) [PDF] Schwarz Pharma, May 2007
- 2. Wearing off and motor fluctuations European Parkinson’s Disease Association (EPDA), last checked on Sept 3, 2020
- 3. Neupro EMA, cited Mar 2021
- 4. FDA Approves Schwarz Pharma's Neupro (Rotigotine TransdermalSystem) for the Treatment of Early-Stage Parkinson's Disease in USA Press release, May 2007
- 5. Neupro Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome Press release, Apr 2012
- 6. Committee for medicinal products for human use, post-authorisation summary of positive opinion for Neupro on 24 April 2008 [PDF] EMA, Apr 2008
- 7. Australian Public Assessment Report for Rotigotine [PDF] TGA, Jan 2011
- 8. Japan welcomes Neupro patch for restless legs and Parkinson's Japan, Dec 2012
- 9. China Approves Neupro Patches to Treat Early-Stage Parkinson’s China FDA, Jul 2018
Clinical trials
Parkinson’s Disease
The Food and Drug Administration (FDA) approval of Neupro (rotigotine transdermal system) for treatment of people with Parkinson’s Disease (PD) was based on data of five parallel group, randomized, double-blind placebo-controlled trials.
These studies, which involved a total of 830 patients with early-stage disease and 842 patients with advanced disease compared rotigotine with placebo. Two of these studies also compared Neupro with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Patients underwent a weekly stepwise increase of rotigotine in 2 mg/24 hours steps to either the randomized dose or optimal dose. Stepwise reductions by 2 mg/24 hours of Neupro were permitted for intolerable adverse events.
Results
The main efficacy outcome of the studies in early-stage disease was the number of patients who had at least a 20% improvement in symptoms, as measured with a standard symptom questionnaire, Unified Parkinson's Disease Rating Scale (UPDRS), parts II + III.
Rotigotine was more effective than placebo in treating PD. In early-stage disease, 48 to 52% of the patients using rotigotine had an improvement in symptoms, compared with 19 to 30% of those using placebo.
Rotigotine was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole.3
The main efficacy outcome of the studies in advanced disease was the length of time during the day that the patients recorded as ‘off’ (when they had too many Parkinson’s disease symptoms to be able to live normally).
In advanced Parkinson’s disease, patients using rotigotine had a greater decrease in their ‘off’ time than those taking placebo.
The decrease was 2.1 to 2.7 h with rotigotine compared with 0.9 h with placebo). The decrease seen with rotigotine was similar to that seen with pramipexole (2.8 h).
Two smaller studies comparing rotigotine with ropinirole were completed after the medicine’s authorisation. Data showed that the effectiveness of rotigotine was found to be comparable with ropinirole.
Restless Legs Syndrome
The Food and Drug Administration (FDA) approval of Neupro (rotigotine transdermal system) for treatment of people with restless legs syndrome (RLS) was based on data of two fixed-dose, randomized, double-blind, placebo-controlled trials.
The studies, which involved a total of 963 patients with moderate to severe restless-legs syndrome, compared rotigotine with placebo. Patients were treated for 6 months.
Results
The main efficacy outcome was the change in symptoms after six months of treatment with a stable dose, measured using two standard scales: the International RLS Rating Scale (IRLS Scale) and a Clinical Global Impression - Improvement (CGI-I) assessment.
In restless-legs syndrome, patients using doses of Neupro between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Neupro (rotigotine transdermal system) for the approved indication.
References
- 1. Full prescribing information [FDA]: Neupro (rotigotine transdermal system) [PDF] Schwarz Pharma, May 2007
- 2. Neupro EMA, cited Mar 2021
- 3. Rotigotine results PD Neupro.com, cited Mar 2021
Price & Costs
Neupro (rotigotine) price in other currencies*
Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
---|---|---|---|---|---|---|---|---|
single-dose vial x 350 mg/20 mL (17.5 mg/mL) | 1738 EUR | 2869 AUD | 2593 CAD | 3156 NZD | 2887459 NGN | 2455 SGD | 1432 GBP | 1830 USD |
28 transdermal systems 2 mg/24 h | 324 EUR | 536 AUD | 484 CAD | 590 NZD | 539788 NGN | 458 SGD | 267 GBP | 342 USD |
84 transdermal systems 1 mg/24 h | 630 EUR | 1041 AUD | 941 CAD | 1145 NZD | 1047663 NGN | 890 SGD | 519 GBP | 664 USD |
84 transdermal systems 2 mg/24 h | 743 EUR | 1227 AUD | 1109 CAD | 1350 NZD | 1235284 NGN | 1050 SGD | 613 GBP | 783 USD |
84 transdermal systems 3 mg/24 h | 855 EUR | 1412 AUD | 1276 CAD | 1553 NZD | 1421012 NGN | 1208 SGD | 705 GBP | 900 USD |
84 transdermal systems 4 mg/24 h | 968 EUR | 1598 AUD | 1444 CAD | 1758 NZD | 1608599 NGN | 1367 SGD | 798 GBP | 1019 USD |
84 transdermal systems 6 mg/24 h | 1062 EUR | 1753 AUD | 1584 CAD | 1929 NZD | 1764457 NGN | 1500 SGD | 875 GBP | 1118 USD |
84 transdermal systems 8 mg/24 h | 1201 EUR | 1984 AUD | 1793 CAD | 2183 NZD | 1996699 NGN | 1697 SGD | 990 GBP | 1265 USD |
*The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Neupro (rotigotine) treatment costs
The cost for a monthly or yearly treatment of Neupro (rotigotine) depends on your prescription requirements which includes the dosage in mg and medicine type (Transdermal systems).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Neupro (rotigotine) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Neupro (rotigotine) price and additional costs
- The price of Neupro (rotigotine)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Neupro (rotigotine)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
everyone.org provides access to Neupro (rotigotine) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
When you buy Neupro (rotigotine), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Neupro (rotigotine) reimbursement
It might be possible for you to claim the cost of Neupro (rotigotine) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Shipping
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Our Process
Four steps to access the medicines you need
How and where to access and buy Neupro: You can access Neupro from everyone.org if the drug has not been approved or is not available in your country.
- Step 1: You send a request for your medicine online
- Step 2: We verify your prescription and medical details
- Step 3: We source your medicine
- Step 4: We deliver your medicine
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
Contact Patient Support
If you have any questions or need any help, contact our Patient Support Team. We will get in touch with you within 24 hours from Monday to Friday between 9:00 and 10:00 CET.
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