Buy Mavenclad (cladribine)

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^[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) 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) 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) 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)?

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) 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.