MAVENCLAD® (Cladribine Tablets) Approved As The First Short-Course Oral Treatment for Relapsing Remitting Multiple Sclerosis in Switzerland - Seite 3

assignment scheme for years 3 and 4.
- The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase
III placebo-controlled study designed to evaluate the efficacy and
safety of cladribine tablets as a monotherapy in patients at risk
of developing MS (patients who have experienced a first clinical
event suggestive of MS).
- The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in
Patients With Active Relapsing Disease) study: a Phase II
placebo-controlled study designed primarily to evaluate the safety
and tolerability of adding cladribine tablets treatment to patients
with relapsing forms of MS, who have experienced breakthrough
disease while on established interferon-beta therapy.
- PREMIERE (Prospective Observational Long-term Safety Registry of
Multiple Sclerosis) study: a long-term observational follow-up
safety registry of MS patients who participated in cladribine
tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse
event (AE) in patients treated with cladribine tablets was
lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The
incidence of infections was 48.3% with cladribine tablets and 42.5%
with placebo, with 99.1% and 99.0% respectively rated
mild-to-moderate by investigators. Adverse Events reported in other
clinical studies were similar.2

Swiss Indication and Important Safety Information

Mavenclad® (10 mg cladribine)

I: Adult patients with highly active relapsing-remitting multiple
sclerosis (MS), as defined by clinical or imaging findings. PO: Dose
of 3.5 mg/kg body weight over 2 years, administered as 1 treatment
phase of 1.75 mg/kg per year. CI: Hypersensitivity to cladribine or
any of the excipients. Infection with the human immunodeficiency
virus (HIV). Severe active infections, active chronic infection (e.g.
tuberculosis or hepatitis). Initiation of treatment in
immunocompromised patients. Existing active malignant disease.
History of progressive multifocal leukoencephalopathy. Moderate or
severe impairment of renal function. Children and adolescents under
18 years. Pregnancy and breast-feeding. W: General: Not recommended
in patients with inactive disease or stabilised on established
therapy. No more than 2 annual treatment phases within 4 years.
Haematological monitoring: The lymphocyte count must be determined
before the start of treatment with Mavenclad in year 1 and year 2, as
well as 2 and 6 months after initiation of treatment in each year of
treatment. Infections: Cladribine can weaken the body's immune system
and potentially increase the likelihood of infection. Patients with