Zeposia (ozanimod)
Zeposia (ozanimod) is a medication used to treat adults with relapsing-remitting multiple sclerosis (RRMS) and ulcerative colitis (UC).
- Disease Indications : Multiple Sclerosis
- Manufacturer: Bristol-Myers Squibb
- Usage : Intravenous
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Health Canada
- Therapeutic Goods Administration (TGA)
Details
What is Zeposia (ozanimod) for?
Zeposia (ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of:
- adults with relapsing-remitting multiple sclerosis (RRMS), including:
- clinically isolated syndrome
- relapsing-remitting disease, where the patient has flare-ups (relapses) followed by periods with milder or no symptoms (remission)
- active secondary progressive disease
- adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).
It is available in capsule form each containing 0.23 mg or 0.46 mg or 0.92 mg ozanimod.
How does Zeposia (ozanimod) 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.
Ozanimod can block the action of so-called sphingosine 1-phosphate (S1P) receptors, which are found on lymphocytes (immune cells). By binding to the receptors, ozanimod stops lymphocytes from travelling from the lymph nodes towards the brain and spinal cord. This protects nerve tissue from getting damaged.
Where has Zeposia (ozanimod) been approved?
Zeposia (ozanimod) was approved for the treatment of:
- adults with RRMS by:
- The Food and Drug Administration (FDA), USA, on March 26, 2020.
- The European Medicines Agency (EMA), Europe, on May 20, 2020.
- The Therapeutic Goods Administration (TGA), Australia, on July 27, 2020.
- Health Canada, Canada, on October 7, 2020.
- adults with moderately to severely active ulcerative colitis.
It is the first approved S1P receptor modulator that does not require a genetic test or first-dose observation.
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 Zeposia (ozanimod) taken?
The standard dosage is:
- Starting with a 7-day titration:
- Days 1-4: 0.23 mg once daily
- Days 5-7: 0.46 mg once daily
- Day 8 and thereafter: 0.92 mg once daily
- The recommended maintenance dosage is 0.92 mg taken orally once per day starting on Day 8.
Before starting with Zeposia (ozanimod) treatment, patients should be screened by a healthcare professional for: complete blood count, heart function, liver function, current or previous medications and vaccinations.
Complete information about Zeposia (ozanimod) 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 Zeposia (ozanimod)?
Common adverse reactions
The most common side effects (≥5% of patients) listed in the prescribing information include:
- Back pain
- Urination problems
- High or low blood pressure (hyper-/hypotension)
- Abnormal liver function tests
- Cold symptoms such as stuffy nose, sneezing, sore throat
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Infections
- Slow heart rate (bradyarrhythmia)
- Increased blood pressure (hypertension)
- Liver problems
- Breathing problems
- Swelling and narrowing of blood vessels in your brain (Posterior Reversible Encephalopathy Syndrome)
- Severe worsening of MS after stopping with treatment
Use in a specific population
Zeposia (ozanimod) can cause fetal harm when administered to a pregnant woman, 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
- Full prescribing information [FDA]: Zeposia (ozanimod) [PDF] Bristol-Myers Squibb (BMS), March 26, 2020
- Zeposia (ozanimod) - Mechanism of action BMS, cited on Oct 29, 2020
- U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis BMS press release, March 26, 2020
- Zeposia (ozanimod) EMA, May 20, 2020
- Zeposia (ozanimod) TGA, July 27, 2020
- Health Canada Approves ZEPOSIA®, an Oral Treatment for Relapsing Remitting Multiple Sclerosis Press release, Oct 7, 2020
- U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis BMS, May 27, 2021
Clinical trials
Relapsing-Remitting Multiple Sclerosis
The Food and Drugs Administration (FDA) approval of Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) was based on the data of studies SUNBEAM (NCT02294058) and RADIANCE (NCT02047734).
SUNBEAM was a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial that studied the safety and efficacy of ozanimod in RRMS patients over a 12-month period. The study involved 1,346 patients who received either oral ozanimod 0.92 mg or weekly intramuscular interferon beta-1a (IFNb1a) for at least 12 months.
RADIANCE had the same study design as SUNBEAM, but patients were treated over a 24-month period. The study involved 1,320 patients who received either oral ozanimod 0.92 mg or weekly intramuscular interferon beta-1a for at least 24 months.
Results
The main efficacy outcome was the annualized relapse rate (ARR), which is the average number of relapses the patients have in one year.
People had fewer relapses with Zeposia (ozanimod) treatment:
- ARR was 0.18 for ozanimod and 0.35 for IFNb1a after 12 months, which is 48% fewer relapses.
- ARR was 0.17 for ozanimod and 0.28 for IFNb1a after 24 months, which is 38% fewer relapses.
More people were relapse free after treatment with Zeposia (ozanimod):
- After 12 months of treatment, 78% of ozanimod-treated patients were relapse-free, versus 66% of IFNb1a-treated patients.
- After 24 months of treatment, 76% of ozanimod-treated patients were relapse-free, versus 64% of IFNb1a-treated patients.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Zeposia (ozanimod) for the approved indication.
Ulcerative Colitis
The Food and Drugs Administration (FDA) approval of Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) was based on the data of study True North.
True North was Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating Zeposia as an induction and maintenance therapy versus placebo in 457 adult patients with moderately to severely active UC.
Results
During induction at Week 10 (Zeposia N=429 versus placebo N=216) the trial met its primary endpoint of clinical remissiona (18% versus 6%) as well as key secondary endpoints, including clinical responseb (48% versus 26%), endoscopic improvementc (27% versus 12%) and endoscopic-histologic mucosal improvement (13% versus 4%) for Zeposia versus placebo, respectively.
References
- U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis BMS press release, March 26, 2020
- Phase 3 Study of RPC1063 in Relapsing MS Clinical Trial SUNBEAM (NCT02294058), cited on Oct 29, 2020
- Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis (Radiance Study) Clinical Trial RADIANCE (NCT02047734), cited on Oct 29, 2020
- Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial Comi G., The Lancet Neurology, Sept 03, 2019
- Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial Cohen JA, The Lancet Neurology, Sept 03, 2019
- Full prescribing information [FDA]: Zeposia (ozanimod) [PDF] Bristol-Myers Squibb, March 26, 2020
- U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis BMS, May 27, 2021
Price & Costs
Zeposia (ozanimod) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| 7-day starter pack (4 capsules of 0.23 mg + 3 capsules of 0.46 mg) | 562 EUR | 929 AUD | 840 CAD | 1022 NZD | 935197 NGN | 795 SGD | 464 GBP | 592 USD |
| Bottle with 28 capsules of 0.92 mg | 2230 EUR | 3682 AUD | 3327 CAD | 4050 NZD | 3705107 NGN | 3150 SGD | 1838 GBP | 2349 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.
Zeposia (ozanimod) treatment costs
The cost for a monthly or yearly treatment of Zeposia (ozanimod) depends on your prescription requirements which includes the dosage in g/mg/ml/etc and medicine type (Capsules).
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 Zeposia (ozanimod) 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.
Zeposia (ozanimod) price and additional costs
- The price of Zeposia (ozanimod)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Zeposia (ozanimod)
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 Zeposia (ozanimod) 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 Zeposia (ozanimod), 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.
Zeposia (ozanimod) reimbursement
It might be possible for you to claim the cost of Zeposia (ozanimod) 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 Zeposia: You can access Zeposia 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
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079 48916267
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