CLADRITAB

What it is

CLADRITAB contains 10 mg cladribine per tablet. Cladribine is a nucleoside analogue of deoxyadenosine. CLADRITAB tablets are uncoated, white, round and biconvex, and engraved with 'C' on one side and '10' on the other side.

Approved indications

— Relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability.

Dosing overview

The recommended cumulative dose of CLADRITAB 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 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.

Key safety warnings

Cladribine can reduce the body's immune defence and may increase the likelihood of infections. Serious, severe, and opportunistic infections—including events with fatal outcome—have been observed with CLADRITAB treatment. Particular attention is recommended for patients who have no history of exposure to varicella zoster virus (VZV). Vaccination of antibody-negative patients is recommended prior to initiation of CLADRITAB. Initiation of treatment with CLADRITAB must be postponed for 4 to 6 weeks to allow for the full effect of vaccination to occur. Liver injury, including serious cases, has been reported uncommonly in patients treated with CLADRITAB, especially in patients with a medical history of abnormal liver tests. Patients should have their serum aminotransferase, alkaline phosphatase, and total bilirubin levels assessed prior to initiation of each treatment course. In clinical studies, 20% to 25% of the patients treated with a cumulative dose of cladribine 3.5 mg/kg over 2 years as monotherapy developed transient grade 3 or 4 lymphopenia. Grade 4 lymphopenia was seen in less than 1% of the patients. The largest proportion of patients with grade 3 or 4 lymphopenia was seen 2 months after the first cladribine dose in each year. Events of malignancies were observed more frequently in cladribine-treated patients (10 events in 3414 patient-years [0.29 events per 100 patient-years]) compared to patients who received placebo (3 events in 2022 patient-years [0.15 events per 100 patient-years]).

Contraindications

CLADRITAB therapy must not be initiated in patients with hypersensitivity to cladribine or to any of the tablet excipients. CLADRITAB must not be initiated in patients who are infected with the human immunodeficiency virus (HIV). CLADRITAB must not be initiated in patients with active chronic infections (tuberculosis, hepatitis). CLADRITAB must not be initiated in immunocompromised patients, including patients receiving immunosuppressive or myelosuppressive therapy with agents such as cyclosporin, methotrexate, mitoxantrone, azathioprine, natalizumab, or chronic use of corticosteroids. CLADRITAB must not be initiated in patients with moderate or severe renal impairment (creatinine clearance < 60 mL/min). CLADRITAB is contraindicated in pregnancy and breastfeeding.

PBS listing

Information regarding PBS listing, strength, item count, restriction type, and ex-manufacturer price is not available in the provided source documents.

Regulatory history

CLADRITAB cladribine 10 mg tablet was first listed on the ARTG on 22 September 2025. In March 2022, PBAC reviewed CLADRITAB for relapsing-remitting multiple sclerosis. PBAC noted an increasing total number of patients supplied medicines for RRMS, with stable prescription numbers, and that oral therapies are now preferred, shifting away from older generation RRMS medicines. PBAC noted recent PBS listings of siponimod (November 2020) and ozanimod (October 2021). The submission for cladribine assumed it would displace fingolimod, and while some patients switching to cladribine were previously on fingolimod, not all were. Clinical input highlighted the benefits of cladribine's oral administration and dosing for younger, newly diagnosed patients.