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EMA approved (EU); TGA approved (AUS)
Who is cladribine for?
Mavenclad (cladribine) is indicated for the treatment of relapsing forms of multiple sclerosis. It is used in patients whose disease is highly active . The active ingredient, cladribine is approved in the EU, USA, and TGA, among others, as intravenous infusion for the treatment of certain leukaemias (cancers affecting lymphocytes).
Complete information about dosage and administration can be found here . The recommended cumulative dose of cladribine is:
3.5 mg/kg body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
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, 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.
Consult your treating doctor for personalised dosing.
What is cladribine and how does it work?
Mavenclad (cladribine) is an oral nucleoside analog of deoxyadenosine indicated for the treatment of relapsing forms of multiple sclerosis. Cladribine is used in patients whose disease is highly active . MS is a chronic, inflammatory, autoimmune disease that affects the central nervous system, and in particular the communication between the brain and other parts of the body . 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)  thus impairing the communication between neurons, which ultimately results in the death of neurons . The immune cells called lymphocytes play a key role in this process . In its relapsing form, MS is characterised by episodes of worsening function (relapses) which are initially followed by recovery periods (remissions) . The active substance in Mavenclad, cladribine, is a nucleoside analog of deoxyadenosine, meaning that it has a similar chemical structure to purine, one of the substances needed to make up the DNA. In the body, cladribine is taken up by cells such as lymphocytes and interferes with the production of new DNA. This leads to the death of the lymphocytes, slowing down the progression of multiple sclerosis . The active ingredient, cladribine is approved in the EU, USA, and TGA, among others, as intravenous infusion for the treatment of certain leukaemias (cancers affecting lymphocytes).
for the treatment of adults with the relapsing forms of multiple sclerosis. The approval of Mavenclad (cladribine) for relapsing forms of multiple sclerosis (RMS) was based on randomised, double-blind, placebo controlled clinical study (CLARITY) involving1,326 patients with relapsing-remitting MS who had at least one relapse in the previous 12 months. Patients received either placebo (n = 437), or a cumulative dose of cladribine of 3.5 mg/kg (n = 433) or 5.25 mg/kg body weight (n = 456) over the 96-week (2-year) study period divided in 2 treatment courses . Patients with relapsing-remitting MS receiving cladribine 3.5 mg/kg showed statistically significant improvements compared to patients on placebo. The annualised relapse rate (rate of relapses per year) was 0.14 (95 % CI : 0.12, 0.17) in patients in the 3.5 mg/kg treatment plan, 0.15 (95 % CI : 0.12, 0.17) and 0.33 (95 % CI : 0.29, 0.38) in patients taking placebo. Over the 96 weeks 79.7 % of the patients in the 3.5 mg/kg cladribine treatment plan were relapse-free vs. 60.9 % of those on placebo . In addition, cladribine had a significant effect on the reduction of brain lesions: the cladribine 3.5 mg/kg treatment group had 74 % relative reduction in the mean number of lesions per patient per scan . 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 DMDs, or 2 or more relapses in the previous year, whether on DMD treatment or not .
The most common side effects with Mavenclad are the reduction in white blood cells (lymphocytes and neutrophils), infections with herpes zoster virus, rashes and hair loss. Effects on lymphocytes reduce the body’s immune defence against infections and cancer: cladribine must not be given to patients with active long-term infections such as tuberculosis or hepatitis, nor to patients with HIV infection or whose immune defences are weakened for other reasons such as treatment with medicines that suppress the immune system. It must not be given to patients with active cancers. Treatment must also be avoided in patients whose kidney function is moderately or severely reduced, and in women who are pregnant or breastfeeding .
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