What is Mavenclad (cladribine) | Mavenclad price for?

Buy Mavenclad (cladribine) | Mavenclad price 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^[1].

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) | Mavenclad price 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^[3].

The immune cells called lymphocytes play a key role in this process.^[1]

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^[1].

Where has Mavenclad (cladribine) | Mavenclad price been approved?

Mavenclad (cladribine) was approved for relapsing forms of multiple sclerosis by:

• European Medical Agency (EMA), European Union, August 22, 2017^[1]
• Therapeutic Goods Administration (TGA), Australia, July 17, 2017^[5]
• Health Canada on November 29, 2017^[8]
• Food and Drug Administration (FDA), US, March 29, 2019^[7]
• Medsafe, New Zealand, August 1, 2019^[9]

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^[2,6]:

• 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) | Mavenclad price dosage and administration can be found in the official prescribing information listed in our resources section^[2,6].

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Mavenclad (cladribine) | Mavenclad price?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include^[2]:

• 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^[2]:

• lymphopenia: low lymphocytes count.

Use in a specific population

As Mavenclad (cladribine) | Mavenclad price 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^[2,6] .

References

1. Human Medicines: Mavenclad (cladribine)
EMA, cited Oct 2017

2. Summary of Product Characteristics [EMA]: Mavenclad (cladribine) [PDF]
Merck Serono, Sep. 2017

3. MS Society. About MS
cited Oct 2017

4. MS Society. Types of MS
cited Oct 2017

5. TGA. Public Summary: Mavenclad (cladribine)
July 2017

6. Summary of Product Characteristics [TGA]: Mavenclad (cladribine) [PDF]
Merck Serono, Dec 2017.

7. Summary of Product Characteristics [FDA]: Mavenclad (cladribine) [PDF]
Merck Serono, Mar 2019.

8. Summary of Product Characteristics [Health Canada]: Mavenclad (cladribine) [PDF]
Merck Serono, Nov 2017.

9. Product detail [Medsafe]: Mavenclad (cladribine)
Cilag AG, Mar 2020.

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^[2].

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^[2]:

• 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^[2]:

• 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^[2]:

• 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^[2].

References

2. Summary of Product Characteristics [EMA]: Mavenclad (cladribine) [PDF]
Merck Serono, Sep. 2017

Mavenclad (cladribine) | Mavenclad price 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) | Mavenclad price and additional costs

The price of 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.

Our Named Patient support fee

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.

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 Mavenclad (cladribine)

When you buy Mavenclad (cladribine) | Mavenclad price, 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) | Mavenclad price reimbursement

It might be possible for you to claim the cost of Mavenclad (cladribine) | Mavenclad price 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.