Mavenclad (cladribine)
Mavenclad (cladribine) is a medication used for the treatment of relapsing forms of multiple sclerosis (MS).
For this product the estimated delivery time is usually between 5 and 10 working days.
- Disease Indications : Multiple Sclerosis
- Manufacturer: Merck Serono Europe Limited
- Usage : Oral
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Health Canada
- Therapeutic Goods Administration (TGA)
- Medsafe (NZ)
Details
What is Mavenclad (cladribine) for?
Mavenclad (cladribine) is a an oral nucleoside analog of deoxyadenosine indicated for the treatment people with relapsing forms of multiple sclerosis. Cladribine is used in patients whose disease is highly active.
The active ingredient cladribine is approved in the EU, USA, and TGA, among others as an intravenous infusion for the treatment of certain leukemias (cancers affecting lymphocytes).
How does Mavenclad (cladribine) work?
In MS the patient’s immune system attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord)[1], impairing the communication between neurons which ultimately results in the neurons' death.
The immune cells called lymphocytes play a key role in this process.
The active substance in Mavenclad, cladribine, is a nucleoside analog of deoxyadenosine, meaning that it has a similar chemical structure to one of the substances needed to make up the DNA (purine). In the body, cladribine is taken up by cells such as lymphocytes and therein interferes with the production of new DNA. This leads to the death of the lymphocytes, slowing down the progression of multiple sclerosis.
Where has Mavenclad (cladribine) been approved?
Mavenclad (cladribine) was approved for relapsing forms of multiple sclerosis by:
- European Medical Agency (EMA), European Union, August 22, 2017
- Therapeutic Goods Administration (TGA), Australia, July 17, 2017
- Health Canada on November 29, 2017
- Food and Drug Administration (FDA), US, March 29, 2019
- Medsafe, New Zealand, August 1, 2019
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 Mavenclad (cladribine) taken?
The standard dosage is:
- Cumulative dose of 3.5 mg/kg body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
- In year 1 and year 2 each treatment course consists of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year.
- Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight.
- Following completion of the 2 treatment courses (after year 2), no further cladribine treatment is required in years 3 and 4. Re-initiation of therapy after year 4 has not been studied.
It is recommended that administration of any other oral medicinal product be separated from that of cladribine by at least 3 hours during the limited number of days of cladribine administration.
Complete information about Mavenclad (cladribine) dosage and administration can be found in the official prescribing information listed in our resources section.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Mavenclad (cladribine)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include:
- herpes
- lymphopenia: low lymphocytes count
- neutropenia: decrease in neutrophil count
- rash
- alopecia.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- lymphopenia: low lymphocytes count.
Use in a specific population
As Mavenclad (cladribine) can be fatal for a fetus, it is not advised for women who are pregnant or breastfeeding. Breastfeeding is contraindicated during treatment and for 1 week after the last dose[2].
Avoid use in patients with a compromised immune system[2] as effects on lymphocytes reduce the body’s immune defence against infections and cancer. It must not be given to patients with active cancers.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- Human Medicines: Mavenclad (cladribine) EMA, cited Oct 2017
- Summary of Product Characteristics [EMA]: Mavenclad (cladribine) [PDF] Merck Serono, Sep. 2017
- MS Society. About MS cited Oct 2017
- MS Society. Types of MS cited Oct 2017
- TGA. Public Summary: Mavenclad (cladribine) July 2017
- Summary of Product Characteristics [TGA]: Mavenclad (cladribine) [PDF] Merck Serono, Dec 2017.
- Summary of Product Characteristics [FDA]: Mavenclad (cladribine) [PDF] Merck Serono, Mar 2019.
- Summary of Product Characteristics [Health Canada]: Mavenclad (cladribine) [PDF] Merck Serono, Nov 2017.
- Product detail [Medsafe]: Mavenclad (cladribine) Cilag AG, Mar 2020.
Clinical trials
The European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia) approvals of Mavenclad (cladribine) for relapsing forms of multiple sclerosis (RMS) were based on one randomised, double-blind, placebo controlled clinical study (CLARITY). This study involved a total of 1,326 patients with relapsing-remitting MS who had at least one relapse in the previous 12 months. Patients were randomly divided in 3 groups of similar size and received either placebo, or a cumulative dose of cladribine of 3.5 mg/kg or 5.25 mg/kg body weight over the 96-week (2-year) study period divided in 2 treatment courses.
Results
Among the major efficacy outcome measures were the annualised relapse rate (rate of relapses per year), the reduction of brain lesions, and risk of disability progression.
Patients with relapsing-remitting MS receiving cladribine 3.5 mg/kg showed statistically significant improvements compared to patients on placebo, with a relative reduction in relapses of 57.6%.
The annualised relapse rate was:
- 0.14 (95 % CI : 0.12, 0.17) in patients in the 3.5 mg/kg treatment plan
- Proportion of patients relapse-free: 79.7%
- 0.15 (95 % CI : 0.12, 0.17) in patients in the 5.25 mg/kg treatment plan
- Proportion of patients relapse-free: 78.9%
- 0.33 (95 % CI : 0.29, 0.38) in patients taking placebo
- Proportion of patients relapse-free: 60.9%
The relative reduction in brain lesions (cladribine 3.5 mg/kg) was:
- 86% relative reduction in the mean number of T1 Gd+ lesions
- 73% relative reduction in the mean number of active T2 lesions
- 74% relative reduction in the mean number of combined unique lesions per patient per scan
The relative reduction in disability progression (cladribine 3.5 mg/kg) was:
- 47%
Efficacy analysis in patients with high disease activity showed that cladribine reduced the risk of disability progression by 82%. MS was considered highly active if patients experienced 1 relapse in the previous year with occurrence of brain lesions while on therapy with other disease-modifying drugs (DMD), or 2 or more relapses in the previous year, whether on DMD treatment or not.
References
- Summary of Product Characteristics [EMA]: Mavenclad (cladribine) [PDF] Merck Serono, Sep. 2017
Price & Costs
Mavenclad (cladribine) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| 1 tablet of 10 mg | 2253 EUR | 3720 AUD | 3362 CAD | 4093 NZD | 3743814 NGN | 3183 SGD | 1857 GBP | 2373 USD |
| 4 tablets of 10 mg | 8826 EUR | 14571 AUD | 13170 CAD | 16031 NZD | 14662875 NGN | 12468 SGD | 7276 GBP | 9296 USD |
| 6 tablets of 10 mg | 13208 EUR | 21805 AUD | 19708 CAD | 23990 NZD | 21942233 NGN | 18658 SGD | 10889 GBP | 13911 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.
Mavenclad (cladribine) treatment costs
The cost for a monthly or yearly treatment of Mavenclad (cladribine) 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 Mavenclad (cladribine) 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.
Mavenclad (cladribine) price and additional costs
- The price of Mavenclad (cladribine)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Mavenclad (cladribine)
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 Mavenclad (cladribine) 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 Mavenclad (cladribine), 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.
Mavenclad (cladribine) reimbursement
It might be possible for you to claim the cost of Mavenclad (cladribine) 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 Mavenclad: You can access Mavenclad 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.
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