Ponvory (ponesimod)
Ponvory (ponesimod) is an oral once-daily prescription medicine used for the treatment of active relapsing forms of Multiple Sclerosis (MS).
- Disease Indications : Multiple Sclerosis
- Manufacturer: Janssen Pharmaceutica
- Usage : Oral
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
Details
What is Ponvory (ponesimod) for?
Ponvory (ponesimod) is a sphingosine 1-phosphate (S1P1) receptor modulator indicated to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
It is available as a 14-day starter packcontaining 2, 3, 4, 5, 6, 7, 8, 9 and 10 mg tabletes, or as tablets of 20 mg ponesimod.
How does Ponvory (ponesimod) work?
Multiple sclerosis is a disease in which the body’s immune system attacks the protective insulation that covers the nerves, which creates damage to the nerves in the brain and spinal cord. Because of this damage, the brain cannot communicate with the rest of the body anymore.
How ponesimod exerts its therapeutic effects is not fully understood, but it is believed that ponesimod works by trapping immune cells called lymphocytes in the lymph nodes. By doing this, the immune cells are kept out of the blood and out of the central nervous system, where they would otherwise cause damage.
Where has Ponvory (ponesimod) been approved?
Ponvory (ponesimod) was approved to treat relapsing forms of multiple sclerosis (MS) in adults with active disease by:
- The Food and Drug Administration (FDA), USA on March 19, 2021.
On March 25, 2021, a branch of the European Medicines Agency (EMA) recommended the approval of this medicine to treat active relapsing MS in adults. This is a scientific recommendation for marketing authorisation, and does not mean that the medicine is approved yet.
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 Ponvory (ponesimod) taken?
Before starting treatment with Ponvory (ponesimod), a medical evaluation should be performed to test for various parameters. You should tell your treating doctor about your medical history and all the medicines you are taking.
The dosage is:
- Start Ponvory (ponesimod) treatment by slowly increasing doses (titrating) over the first 2 weeks with a 14-day starter pack. For the dose schedule, see the official prescribing information. This may reduce the risk of slowing of the heart rate. You will be monitored by a healthcare professional for 4 hours after taking the first dose.
- After dose titration is complete, the recommended maintenance dosage is 20 mg taken orally once daily starting on day 15.
Take Ponvory (ponesimod) orally once daily. Swallow the tablet whole, with or without food.
Do not stop taking Ponvory (ponesimod) without talking with your treating doctor first.
If you miss taking:
- 1, 2, or 3 tablets in a row of the 14-day starter pack, continue treatment by taking the first dose you missed. Take 1 tablet as soon as you remember. Then, take 1 tablet a day to continue with the starter pack dose as planned.
- 4 or more tablets in a row while taking the 14-day starter pack or the 20 mg maintenance dose, you need to restart treatment with a new 14-day starter pack. Do not restart treatment after stopping it for 4 or more days in a row without talking to your treating doctor. If you have certain heart conditions, you may need to be monitored by your treating doctor for at least 4 hours when you take your next dose.
- 1, 2, or 3 tablets in a row while taking the 20 mg maintenance dose, continue treatment with the 20 mg maintenance dose.
Complete information about Ponvory (ponesimod) 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 Ponvory (ponesimod)?
Common adverse reactions
The most common side effects ( ≥10% of patients) listed in the prescribing information include:
- Upper respiratory tract infection
- Abnormal liver tests (hepatic transaminase elevation)
- High blood pressure (hypertension)
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Risk of infections
- Heart problems: bradyarrhythmia and atrioventricular conduction delays
- Breathing problems
- Liver injury
- Skin cancer
- Macular edema
- Posterior reversible encephalopathy syndrome (PRES)
- Severe exacerbation of disease, including disease rebound (rare)
Use in a specific population
Ponvory (ponesimod) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding. Talk with your treating doctor if you are pregnant or plan to become pregnant. If you are a woman who can become pregnant, you should use effective birth control during your treatment, and for 1 week after you stop taking Ponvory (ponesimod).
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- Full prescribing information [FDA]: Ponvory (ponesimod) [PDF] Janssen, Mar 2021
- What is MS National MS Society, cited Mar 2021
- Ponesimod, a selective S1P1 receptor modulator: a potential treatment for multiple sclerosis and other immune-mediated diseases D’Ambrosio, D et al., Ther Adv Chronic Dis., Jan 2016
- Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions Janssen press release
- Ponvory EMA, Mar 25, 2021
Clinical trials
The Food and Drug Administration (FDA) approval of Ponvory (ponesimod) for treatment of adults with active relapsing multiple sclerosis (MS) was based on data of the OPTIMUM study (NCT02425644).
OPTIMUM was a phase 3 randomized, doubleblind, parallel group, active-controlled superiority study to compare ponesimod with teriflunomide (AUBAGIO) in patients with active relapsing MS. The study involved 1133 patients, who received either once daily ponesimod, beginning with a 14-day dose titration or teriflunomide 14 mg for 108 weeks. Neurological evaluations were performed at baseline, every 3 months during the study, and at the time of a suspected relapse. Brain MRI scans were performed at baseline and at weeks 60 and 108.
Results
The main efficacy outcome of OPTIMUM was the annualized relapse rate (ARR), which is the average number of relapses the patients have in one year.
Treatment with Ponvory (ponesimod) led to nearly a third fewer annual relapses than Aubagio (teriflunomide).
Ponesimod significantly reduced annual relapses by 30.5% compared to teriflunomide 14 mg in patients with relapsing MS.
The proportion of patients without relapses was increased, and the number of new inflammatory brain lesions was reduced by 56%, as seen on MRI scans.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Ponvory (ponesimod) for the approved indication.
References
- Full prescribing information [FDA]: Ponvory (ponesimod) [PDF] Janssen, Mar 2021
- Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis Clinical Trial OPTIMUM, cited Mar 2021
- Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions Janssen Press release, Mar 2021
Price & Costs
Ponvory (ponesimod) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| 14-day starter pack | 1070 EUR | 1767 AUD | 1597 CAD | 1944 NZD | 1778777 NGN | 1512 SGD | 882 GBP | 1127 USD |
| 30 tablets of 20 mg | 2118 EUR | 3497 AUD | 3160 CAD | 3847 NZD | 3518997 NGN | 2992 SGD | 1746 GBP | 2231 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.
Ponvory (ponesimod) treatment costs
The cost for a monthly or yearly treatment of Ponvory (ponesimod) depends on your prescription requirements which includes the dosage in mg and medicine type (Tablets).
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 Ponvory (ponesimod) 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.
Ponvory (ponesimod) price and additional costs
- The price of Ponvory (ponesimod)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Ponvory (ponesimod)
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 Ponvory (ponesimod) 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.
You can read a detailed overview of prices and costs here.When you buy Ponvory (ponesimod), 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.
Ponvory (ponesimod) reimbursement
It might be possible for you to claim the cost of Ponvory (ponesimod) 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 Ponvory: You can access Ponvory 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.
Email Address
Sshealthcare1012@gmail.com
+91 7575883015
Landline
079 48916267
Disclaimer
All Trademarks and Brands that appear on the website belong to their respective owners, and S S Healthcare does not lay any claim on them. We only provide information.
