Kesimpta (ofatumumab)
We can help with your prescription. Read the “Prescription Guide”.
You can access this medicine even if it’s not approved in your country. Learn how.
Kesimpta (ofatumumab) is a medication used as a subcutaneous injection for the treatment of relapsing forms of multiple sclerosis.
It is the first B-cell therapy that can be self-administered once per month at home using an autoinjector pen.
Disease Indications
Multiple Sclerosis
Manufacturer
Novartis
Usage
Subcutaneous
Medicine approved by
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European Medical Agency (EMA)
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Food and Drug Administration (FDA)
Patients helped
- Over 1.2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 88 countries
We can help with your import documents
We are experts in import regulations. Scroll below to download the import guide for your country.
FREQUENTLY ASKED QUESTIONS
We help you access approved medicines that are not approved or available in your country of residence.
Legal
Finances
Payment
- Your permanent residence is outside the European Union
- You take the medicines with you, unused within 90 days after purchase
- You have a full original receipt (which we provide you)
Unfortunately, we are unable to help with VAT refunds following delivery or collection from our partner pharmacies outside of the Netherlands.
- If you are residing within the European Union and you are not a company
- If you are coming to Amsterdam, Luxembourg or Dusseldorf to pick up your order
In case of pick up, you may be eligible for a VAT tax refund if you live outside the European Union.
Price
Reimbursement
- That you want to import an approved medicine from abroad
- The lack of reasonable treatment options available in your country (if you can, include a letter from a doctor confirming this) - no alternative to the treatment.
- That the medicine has already been approved in another country (state the name of the country)
- That your treating doctor states that this medicine is the best option for you (include a copy of the prescription in the letter to the healthcare insurance company)
Ordering and shipping
Ordering
- Name of the patient
- Contact details of patient(email and phone number)
- Copy of patient’s ID
- Contact details of the Doctor (name, address, email and phone number)
- Shipping address
- Copy of the doctor's prescription
Shipping: We can deliver to the patient's residence, a pharmacy, or doctor's office / hospital, but this depends on the country. If you’re not sure what the right choice is for you, please get in touch with our Patient Support Team and we can help you work out your exact requirements.
Once we have received this information, one of our Patient Support Team members will then check your prescription and contact you to follow up on your order. Please note that other documents may be needed for import, we will guide you through the ordering process.
Generally not, 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.
As part of our protocols we might reach out to your treating doctor for verification or information updates. By sending us your prescription you allow us to do so.
- Patient's name and date of birth
- Name of the medicine and dosage
- Required quantity
- Doctor's name and signature
- Doctor's registration number and/or stamp
Ideally, the prescription should be issued in English. Alternatively, a translation (unofficial is sufficient) must be provided.
Please be aware that your doctor may be contacted by one of our team members or by the processing pharmacy in order to verify the prescription.
Shipping
Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping.
For EMA approved medicines with prescriptions from within the Schengen zone, you can pick the medicines up from our partner pharmacy in Amsterdam, Luxembourg or Dusseldorf. For non-EMA approved medicines, with prescriptions from within the Schengen zone, you can pick the medicines up in our partner pharmacy in Dusseldorf. If you have requested to collect your medicines, you will receive a notification when the medicines are in the pharmacy and ready for you.
There are also options to deliver the medicines to other countries. Please get in touch with our Patient Support Team to discuss which other pick-up and delivery options may be suitable for you.
- Copy of the ID/passport of the patient
- Copy of the ID/passport of the person who is coming to pick up the medicines
- Letter signed by the patient stating that he/she authorises this person to pick up the medicines on his/her behalf
- Step 1 - Customs may need to check the package to verify its contents. In order to streamline this step, we include a letter for customs with information about the contents. Any additional questions will be answered by TheSocialMedwork as and when we are contacted by customs.
- Step 2 - In some countries, there are additional questions from the medical regulatory agencies (i.e. the FDA, EMA, etc). We provide them with all the necessary information based on the information provided by the patient, such as: the prescription, copy of ID and a letter from the treating doctor to show that the medicines are for personal use.
- Step 3 - Customs fees. In some cases, the recipient will be requested to pay taxes and duties. These should be arranged by the patient or receiver and are not covered by TheSocialMedwork unless stated otherwise.
Please be aware that the import of the medicines always requires customs clearance and active cooperation from the importing party. We will help and guide you but are dependent on your cooperation and responsiveness.
About us
- Complete the enquiry form on our Contact Us page
- Send an email: [email protected]
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- +31 20 808 4414 (EU)
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- +61 28 417 2910 (AUS)
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Available medicines
Medicine approval
The respective national and regional agencies, such as the Food and Drugs Administration (FDA) in the USA or the European Medical Authority (EMA) for the European Union assess these applications and make a decision on whether to approve new medicines. The review process is based on evaluation of the evidence provided by the company. Every agency uses a slightly different process.
- Phase I - performed in a small number of healthy volunteers or very sick patients with lack of treatment options, designed to study the effects of the medicine in the human body.
- Phase II - larger number of patients, designed to evaluate the safety and efficacy of the medicine and to determine if different dosages of the treatment have different effects.
- Phase III - large number of patient groups, designed to confirm the safety and efficacy of the medicine.
- Phase IV - after the medicine has received regulatory approval, designed to evaluate the long-term effects.
Updates
Kesimpta (ofatumumab)
Package
Single-dose prefilled syringe/autoinjector pen
Where can we deliver?
We have delivered medicines to more than 88 countries. Check if we have sent medicines to yours.
We currently can’t ship medicines to - contact us for alternative options.
Make an enquiry to receive information about the different options of obtaining for a patient in .
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Make an enquiry to receive information about the cost, shipping time and import details for .
Yes, we have successfully delivered medicines to .
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PICK-UP IN PERSON FROM A PARTNER PHARMACY
We can arrange for you to pick up this medicine from our partner pharmacy in Luxembourg. Read more.
Pick-up from Luxembourg.
Depending on your particular circumstance, this option can be cheaper and require less paperwork than direct delivery. You can ask someone else to pick up the medicine on your behalf.
In some cases, medicines can be picked up from partner pharmacies in Amsterdam (the Netherlands) or Dusseldorf (Germany).
Tell our Patient Support Team if you’re interested in pick-up options for your order.
Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
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What is Kesimpta (ofatumumab) for?
Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody (immunotherapy) indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.1
It is available as a single-dose prefilled Sensoready autoinjector pen or as a single-dose prefilled syringe, each containing 20 mg/0.4 mL ofatumumab.1
How does Kesimpta (ofatumumab) work?
MS is a chronic inflammatory disease that affects the central nervous system. It is characterized by destruction of myelin that covers nerve endings, and damage of axons in the brain, optic nerves and spinal cord. Immune cell B-cells are thought to be involved in the development of MS, and targeting these cells is a way to treat MS.2
Kesimpta (ofatumumab, formerly OMB157) is an anti-CD20 monoclonal antibody. CD20 is an antigen, a type of protein, expressed on the surface of B-cells. How ofatumumab works in MS exactly is not fully understood yet, but it is thought that it lowers the amount of B-cells by triggering cell death (lysis).3
Because it is administered subcutaneously, ofatumumab can be delivered precisely to the lymph nodes, where lowering of B-cell levels is needed. By giving ofatumumab once monthly, the patient’s body is allowed time to replete B-cells in their system.3
Where has Kesimpta (ofatumumab) been approved?
Kesimpta (ofatumumab) was approved for the treatment of adult patients with relapsing forms of MS by:
- The Food and Drug Administration (FDA), USA on August 20, 2020.4
- The European Medicines Agency (EMA) on January 28, 2021.5
Kesimpta (ofatumumab) is the first treatment option for MS that can be self-administered once monthly at home using an autoinjector pen.4
The active ingredient ofatumumab was previously approved for use in combination with fludarabine and cyclophosphamide for treatment of relapsed chronic lymphocytic leukemia (CLL).6
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 Kesimpta (ofatumumab) taken?
The standard dosage is:1
- Starting dose of 20 mg by subcutaneous injection at weeks 0, 1, and 2.
- Subsequent doses of 20 mg by subcutaneous injection once monthly starting at week 4.
If an injection of Kesimpta is missed, it should be administered as soon as possible without waiting until the next scheduled dose. Subsequent doses should be administered at the recommended intervals.1
Before administering the first dose of Kesimpta, patients should be screened for Hepatitis B virus (HBV) and quantitative serum immunoglobulins.1
Complete information about Kesimpta (ofatumumab) dosage and administration can be found in the official prescribing information listed in our references section.1
Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.
Are there any known adverse reactions or side effects of Kesimpta (ofatumumab)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include:1
- Upper respiratory tract infection (with symptoms such as sore throat, runny nose, headache)
- Infusion reactions
- Low immunoglobulin levels
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- Hepatitis B virus (HBV) reactivation
Use in a specific population
Kesimpta (ofatumumab) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
1. Summary of Product Characteristics [FDA]: Kesimpta (ofatumumab) [PDF]
Novartis, August 2020
2. FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
Novartis press release, Aug 20, 2020
3. Ofatumumab
Zhang B, MAbs, Jul-Aug 2009
4. FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
Novartis press release, Aug 20, 2020
5. Kesimpta (ofatumumab) Medicine summary
EMA, cited on Feb 16, 2021
6. Genmab Announces U.S. FDA Approval of Arzerra® (ofatumumab) in Combination with Fludarabine and Cyclophosphamide for Relapsed CLL
Genmab press release, Aug 31, 2016
The Food and Drug Administration (FDA), USA approval of Kesimpta (ofatumumab) for the treatment of adult patients with relapsed forms of multiple sclerosis (MS) was based on the data from studies ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231).1
ASCLEPIOS I and II were two identically designed, double-blind, randomized, multi-center phase 3 studies to investigate the efficacy and safety of ofatumumab. It involved 1,882 MS patients that were treated with either subcutaneous ofatumumab 20 mg once monthly or oral teriflunomide 14 mg daily. Patients were treated for up to 30 months.2,3
Results
The main efficacy outcome measure was the annualized relapse rate (ARR), which is the number of confirmed relapses in a year. Secondary end points included disability worsening at 3 or 6 months, disability improvement at 6 months, number of brain lesions.2,3
Overall, results of the studies showed that patients treated with ofatumumab had reduced ARR, showed limited disability progession, and had reduced inflammatory brain lesions.4
The ARR was significantly lower among patients treated with ofatumumab, as compared to patients treated with teriflunomide. ARR was:4
- 0.11 and 0.22, respectively, in ASCLEPIOS I (difference, −0.11 [95% CI: −0.16, −0.06])
- 0.10 and 0.25, resp. in ASCLEPIOS II (difference, −0.15 [95% CI: −0.20, −0.09])
Pooled data of both studies showed that after 3 months, the percentage of patients with disability worsening was significantly lower in the ofatumumab group after 3 months (10.9% vs 15%) or after 6 months (8.1% vs 12.0%). Of patients treated with ofatumumab, more experienced a lessening in disability after 6 months; however, this difference did not reach statistical significance.4
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Kesimpta (ofatumumab) for the approved indication.5
References
1. FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
Novartis press release, Aug 20, 2020
2. Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I)
Clinical trial NCT02792218, last updated on Aug 7, 2020
3. Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. (ASCLEPIOS II)
Clinical trial NCT02792231, last updated on Aug 14, 2020
4. Ofatumumab versus Teriflunomide in Multiple Sclerosis
Hauser SL, New England Journal of Medicine, Aug 6, 2020
5. Summary of Product Characteristics [FDA]: Kesimpta (ofatumumab) [PDF]
Novartis, August 2020
Kesimpta (ofatumumab) price in other currencies*
| Package | Euro | Argentine peso | Chilean peso | Colombian peso | Mexican peso | Peruvian sol |
|---|---|---|---|---|---|---|
| 1 prefilled Sensoready pen 20 mg/0.4 mL | 1697 EUR | 211660 ARS | 1525350 CLP | 7231222 COP | 35739 MXN | 6739 PEN |
| 1 prefilled syringe 20 mg/0.4 mL | 1697 EUR | 211660 ARS | 1525350 CLP | 7231222 COP | 35739 MXN | 6739 PEN |
*The prices listed above are based on the cheapest package size and strength TheSocialMedwork has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Kesimpta (ofatumumab) treatment costs
The cost for a monthly or yearly treatment of Kesimpta (ofatumumab) depends on your prescription requirements which includes the dosage in mg/ml and medicine type (Single-dose prefilled syringe/autoinjector pen).
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 Kesimpta (ofatumumab) 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.
Kesimpta (ofatumumab) price and additional costs
The price of Kesimpta (ofatumumab)
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.
Our Named Patient support fee
TheSocialMedwork provides access to Kesimpta (ofatumumab) 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.
Shipping costs
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.
Payment methods when you buy Kesimpta (ofatumumab)
When you buy Kesimpta (ofatumumab), 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.
Kesimpta (ofatumumab) reimbursement
It might be possible for you to claim the cost of Kesimpta (ofatumumab) 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.
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. For more details, please see our article on cold chain delivery.
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.
Four steps to access the medicines you need
How and where to access and buy Kesimpta: You can access Kesimpta from TheSocialMedwork if the drug has not been approved or is not available in your country.
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Step 1
You send a request for your medicine online
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.
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Step 2
We verify your prescription and medical details
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.
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Step 3
We source your medicine
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.
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Step 4
We deliver your medicine
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.
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Disclaimer
Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.
