Mayzent (Siponimod)
Mayzent (siponimod) is a medication used for the treatment of multiple sclerosis (MS).
- Disease Indications : Multiple Sclerosis
- Manufacturer: Novartis
- Usage : Oral
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Therapeutic Goods Administration (TGA)
Details
What is Mayzent (siponimod)?
Mayzent (siponimod) is a sphingosine 1-phosphate receptor modulator and is used for the treatment of adults with multiple sclerosis, and specifically active secondary progressive multiple sclerosis (SPMS). This is the first oral treatment specifically for active SPMS, which encompasses about 80% of relapsing remitting multiple sclerosis (RRMS) cases.
How does Mayzent (siponimod) work?
Mayzent (siponimod) is a sphingosine 1-phosphate receptor modulator indicated specifically for the treatment of patients with active secondary progressive multiple sclerosis (SPMS).
It works by lowering the number of lymphocytes in peripheral blood with the aim to minimise lymphocyte migration into the central nervous system.
Where has Mayzent (siponimod) been approved?
Mayzent (siponimod) was approved for multiple sclerosis by:
- Food and Drug Administration (FDA), US, March 26, 2019.
- Therapeutic Goods Administration (TGA), Australia, November 1, 2019.
- European Medical Agency (EMA), European Union, January 13, 2020.
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 Mayzent (siponimod) taken?
Prior to initiating Mayzent (siponimod), assessments are required.
Do NOT take Mayzent (siponimod) if:
- your genotype is CYP2C9 *3*3. Check with your healthcare provider before you start treatment with Mayzent if you are not sure. Your CYP2C9 genotype should be determined by your healthcare provider.
- you have had a heart attack, unstable angina (chest pain), certain types of heart failure in the last 6 months, stroke or transient ischemic attack (mini-stroke).
- you have arrhythmia (abnormal heartbeat), certain types of heart block, unless you have a pacemaker.
Please refer to the official prescribing information listed in our references section for a full list of precautions before taking Mayzent (siponimod).
Titration is required for treatment initiation. Please see the official prescribing information listed in our references section for the titration schedule at initiation.
The recommended maintenance dosage is:
- 2 mg taken orally daily.
The recommended maintenance dosage in patients with a CYP2C9 *1/*3 or *2/*3 genotype is:
- 1 mg taken orally daily.
First-dose monitoring is recommended for patients with:
- sinus
- bradycardia
- first- or second-degree [Mobitz type I] atrioventricular (AV) block
- a history of myocardial infarction
- heart failure.
Adjustment in dose may be required based on symptoms and experienced side effects.
Complete information about Mayzent (siponimod) 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 side effects or adverse reactions of Mayzent (siponimod)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include:
- headache
- hypertension
- increased transaminase
- falls.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- increased risk of infections
- macular oedema
- bradyarrhythmia and atrioventricular (AV) conduction delays
- respiratory effects
- liver injury
- increased blood pressure
- foetal risk.
References
- Summary of Product Characteristics [FDA]: Mayzent (siponimod) [PDF], Novartis, March 2019.
- Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease. 26 March, 2019.
- TGA Public Summary: Mayzent (siponimod) [PDF], Novartis, November 2019.
- Summary of Product Characteristics [EMA]: Mayzent (siponimod) [PDF], Novartis, January 2020.
Clinical trials
EXPAND Study
The FDA approval of Mayzent (siponimod) is based on the phase 3 EXPAND study, which was randomised, double-blind and placebo-controlled. It compared the efficacy and safety of Mayzent (siponimod) versus placebo in people with secondary progressive multiple sclerosis (SPMS). The study consisted of 1,651 people from 31 countries, which was representative of a typical population of patients with SPMS and having the following characteristics:
- patients’ mean age of 48 years
- patients have been living with multiple sclerosis (MS) for about 16 years
- more than 50% have a median Expanded Disability Status Scale (EDSS) score of 6.0
- more than 50% depend on a walking aid.
Results
Mayzent (siponimod) significantly reduced the risk of three-month confirmed disability progression (CDP) at primary endpoint.
The proportion of patients with confirmed disability progression (CDP) was:
- 26% with Mayzent (siponimod)
- 32% with placebo.
This indicates a 21% relative risk reduction in patients with Mayzent (siponimod) versus placebo.
The annualised relapse rate was:
- 0.071 with Mayzent (siponimod)
- 0.160 with placebo.
This indicates a 55% relative reduction rate in patients with Mayzent (siponimod) versus placebo.
Change from baseline in T2 lesion volume (mm3) (95% CI):
- 184 with Mayzent (siponimod)
- 879 with placebo.
This indicates a 79% relative reduction rate in patients with Mayzent (siponimod) versus placebo.
Please refer to the summary of product characteristics below and in the references section for comprehensive information about the safety and effectiveness of Mayzent (siponimod) for the approved indication.
References
Price & Costs
Mayzent (Siponimod) treatment costs
The cost for a monthly or yearly treatment of Mayzent (Siponimod) 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 Mayzent (Siponimod) 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.
Mayzent (Siponimod) price and additional costs
- The price of Mayzent (Siponimod)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Mayzent (Siponimod)
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 Mayzent (Siponimod) 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 Mayzent (Siponimod), 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.
Mayzent (Siponimod) reimbursement
It might be possible for you to claim the cost of Mayzent (Siponimod) 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 Mayzent: You can access Mayzent 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
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