Enspryng (satralizumab)
Enspryng (satralizumab) is a medication used for treatment of neuromyelitis optica spectrum disorder in aquaporin-4 antibody (AQP4-IgG) seropositive adults and children.
- Disease Indications : Chugai Pharmaceutical
- Manufacturer : Roche Registration Limited
- Usage : Subcutaneous
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Health Canada
- Pharmaceuticals and Medical Devices Agency (PMDA)
- Swissmedic (CH)
Details
What is Enspryng (satralizumab) for?
Enspryng (satralizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults and children who are anti-aquaporin-4 (AQP4) antibody positive.
It is available in single-dose syringe form containing 120 mg/mL satralizumab.
How does Enspryng (satralizumab) work?
Enspryng (satralizumab) is a monoclonal antibody, a type of protein, that can bind to and inhibit the interleukin-6 (IL-6) receptor. IL-6 is a cell signalling molecule, also called cytokine, that can trigger inflammation, which leads to damage and the symptoms of the disease.
NMOSD is a rare autoimmune condition of the central nervous system that mainly affects the optic nerve and spinal cord. IL-6 levels are increased in NMOSD patients. It triggers the production of pathological autoantibodies against aquaporin-4 (AQP4) in two thirds of patients. These antibodies bind to and damage a specific cell type, called astrocytes, which results in inflammation of the optic nerve(s), spinal cord and brain.
Where has Enspryng (satralizumab) been approved?
Enspryng (satralizumab) was approved for the intermittent treatment of people with NMOSD who are AQP4 antibody positive by:
- The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on June 29, 2020.
- Swissmedic, Switzerland, on July 14, 2020.
- The Food and Drug Administration (FDA), USA, on August 14, 2020.
- Health Canada, Canada, on August 31, 2020.
- The European Medicines Agency (EMA) on April 23, 2021.
Enspryng (satralizumab) has been designated as an orphan drug in the US, Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA.
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 Enspryng (satralizumab) taken?
The standard dosage is:
- 120 mg by under-the-skin (subcutaneous) injection for the first three administrations in weeks 0, 2, and 4.
- Followed by a maintenance dosage of 120 mg every 4 weeks.
Before starting the first dose of Enspryng (satralizumab), patients should be screened for Hepatitis B Virus (HBV), tuberculosis (TBC). Additionally, liver transaminases and serum bilirubin should be measured before the start of therapy.
Enspryng (satralizumab) can be administered at home by the patient or patient’s caregiver following training from a healthcare provider.
Warning: Patients liver enzymes and neutrophils should be monitored during treatment and every 4 weeks after start of treatment, in case of any reaction.
Complete information about Enspryng (satralizumab) 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 Enspryng (satralizumab)?
Common adverse reactions
The most common adverse reactions (≥15% of patients) listed in the prescribing information include:
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Gastritis
- Rash
- Arthralgia
- Extremity pain
- Fatigue
- Nausea
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:[
- Serious allergic reactions
- Increased risk of infections
- Increased liver enzymes
- Decreased neutrophil counts
- Hypersensitivity reactions
Use in a specific population
Enspryng (satralizumab) 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]: Enspryng (satralizumab) [PDF] Roche, Aug 2020
- Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder Roche press release, June 29, 2020
- ENSPRYNG® (Satralizumab) de Roche homologué en Suisse pour le traitement des Troubles du Spectre de la Neuromyélite Optique (Neuromyelitis Optica Spectrum Disorder, NMOSD) [French] Swissmedic, July 14, 2020
- FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD) Roche press release, Aug 17, 2020
- Health Canada Authorizes ENSPRYNG for Canadians Living with Neuromyelitis Optica Spectrum Disorder Biospace news article, Aug 31, 2020
- New treatment for rare autoimmune disease of nerve cells EMA, Apr 2021
Clinical trials
The Pharmaceuticals and Medical Devices Agency (PMDA), Japan approval of Enspryng (satralizumab) for of neuromyelitis optica spectrum disorder (NMOSD) in adults and children who are anti-aquaporin-4 (AQP4) antibody positive was based on the data of studies SAkuraStar (NCT02073279) and SAkuraSky (NCT02028884).
SAkuraStar and SAkuraSky were multicenter, randomized, double-blind, placebo-controlled, phase 3 studies that evaluated the efficacy and safety of satralizumab as a monotherapy and as an add-on therapy to baseline standard treatment with immunosuppressant therapy (ISV), respectively. The studies involved a total of 64 NMOSD patients who are AQP4 antibody positive that were treated with satralizumab or placebo, with or without additional ISV, on weeks 0, 2, and 4, followed by a maintenance dose every 4 weeks.
Results
The main efficacy outcome was the risk of relapse, which was calculated from the time from the start of treatment until the occurrence of the first relapse. In both studies, satralizumab reduced the risk of relapse compared to placebo.
The risk of relapse was:
- Reduced by 79% [95% CI: 0.06, 0.75] with satralizumab, compared to placebo in SAkuraSky. (both treatment arms as an add-on therapy to baseline IST).
- Reduced by 74% [95% CI: 011, 0.63] with satralizumab monotherapy, compared to placebo In SAkuraStar.
Overall, satralizumab did not increase the risk of serious adverse events, percentages were similar as in the placebo group. However, there were more injection-site reactions and injection-related reactions in the satralizumab group.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Enspryng (satralizumab) for the approved indication.
References
- Full prescribing information [FDA]: Enspryng (satralizumab) [PDF] Roche, Aug 2020
- Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder Roche press release, June 29, 2020
- ENSPRYNG® (Satralizumab) de Roche homologué en Suisse pour le traitement des Troubles du Spectre de la Neuromyélite Optique (Neuromyelitis Optica Spectrum Disorder, NMOSD) [French] Swissmedic, July 14, 2020
- FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD) Roche press release, Aug 17, 2020
- Health Canada Authorizes ENSPRYNG for Canadians Living with Neuromyelitis Optica Spectrum Disorder Biospace news article, Aug 31, 2020
- New treatment for rare autoimmune disease of nerve cells EMA, Apr 2021
Price & Costs
Wakix (pitolisant) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| Pre-filled syringe of 120 mg/ml | 9802 EUR | 16183 AUD | 14627 CAD | 17805 NZD | 16284981 NGN | 13847 SGD | 8081 GBP | 10324 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.
Enspryng (satralizumab) treatment costs
The cost for a monthly or yearly treatment of Enspryng (satralizumab) depends on your prescription requirements which includes the dosage in mg/ml and medicine type (One single-dose syringe).
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 Enspryng (satralizumab) 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.
Enspryng (satralizumab) price and additional costs
- The price of Enspryng (satralizumab)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Enspryng (satralizumab)
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.
We provides access to Enspryng (satralizumab) 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 Enspryng (satralizumab), 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.
Enspryng (satralizumab) reimbursement
It might be possible for you to claim the cost of Enspryng (satralizumab) 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
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping.
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 Enspryng: You can access Enspryng 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
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