Mavenclad (cladribine)

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Mavenclad (cladribine)

Mavenclad (cladribine) is a medication used for the treatment of relapsing forms of multiple sclerosis (MS).

Neurology Multiple Sclerosis
Marketing Authorisation Holder Merck Serono Europe Limited
Mode of Action Nucleoside analogue
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia
Strength 10 milligram

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 active1.

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)1impairing the communication between neurons which ultimately results in the neurons' death3. The immune cells called lymphocytes play a key role in this process1.

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 sclerosis1.

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, 20171

  • Therapeutic Goods Administration (TGA), Australia, July 17, 20175

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 is2,6:

  • 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) dosage and administration can be found in the official prescribing information listed in our resources section2,6.

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

Are there any known side effects of Mavenclad (cladribine)?

Common side effects

The most common side effects listed in the prescribing information include2:

  • herpes

  • lymphopenia: low lymphocytes count

  • neutropenia: decrease in neutrophil count

  • rash

  • alopecia.

Serious side effects

The serious side effects listed in the prescribing information include2:

  • 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 dose2.

Avoid use in patients with a compromised immune system2 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 information2,6.

More Information
Working ingredient cladribine
Shipping method Standard (not temperature controlled)
Therapeutic Area Neurology
Neurology Multiple Sclerosis
Indication Relapsing MS
Administration Oral
Mode of Action Nucleoside analogue
Regulatory agency approval European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Merck Serono Europe Limited
HS Code N/A
CAS Number N/A

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 courses2.

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 was2:

  • 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) was2:

  • 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) was2:

  • 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 not2.

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.

Shipping Type Standard
Shipping method Standard (not temperature controlled)
Dynamic Weight No
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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.