Prescribing information

 

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KESIMPTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.1,2

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KESIMPTA (ofatumumab) is indicated for adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. KESIMPTA is the first and only self-administered once-monthly (20 mg), subcutaneous (SC), B-cell therapy for RMS.1,2 

The first injection should be performed under the guidance of a healthcare professional.1,2

The recommended dose is 20 mg KESIMPTA administered by subcutaneous injection with:1,2

  • initial dosing at Weeks 0, 1 and 2, followed by
  • subsequent monthly dosing, starting at Week 4

It is an anti-CD20 monoclonal antibody which selectively binds to sites on CD20 molecules expressed on B-cells. KESIMPTA mechanism of action results in lysis of CD20 expressing cells leading to a depletion of B cells.1,2

To learn more, review either the KESIMPTA:

  • Efficacy: KESIMPTA’s efficacy and safety profile was assessed in two identically designed Phase III studies (ASCLEPIOS I and II). Both studies compared ofatumumab (ASCLEPIOS I n=465, ASCLEPIOS II n=481) against teriflunomide (ASCLEPIOS I n=462, ASCLEPIOS II n=474) and demonstrated a significant reduction in the annual relapse rate primary endpoint by 51% (0.11 vs 0.22, p<0.001) and 59% (0.10 vs 0.25, p<0.001) respectively.1,2 ALITHIOS is a long-term study designed to assess the benefit-risk profile of KESIMPTA. Patients on the continuous KESIMPTA arm experienced 0.05 ARR* at 5 years, equivalent to 1 relapse every 20 patient years.6 
  • Safety profile: Across the pooled analysis of ASCLEPIOS clinical trials, ofatumumab exhibited a comparable safety profile to teriflunomide.1,2 In the ALITHIOS open-label extension, no new safety risks were identified in cumulative safety data for up to 5 years.7 Please refer to the KESIMPTA safety profile for more information. 
  • Self-administration:  KESIMPTA is intended for self-administration: patients can administer their treatment at home using the KESIMPTA pen1,2, meaning that your patients with relapsing MS have access to a treatment that integrates into their daily lives, leaving them with more time to spend on the things that matter most. The first injection should be performed under the guidance of an appropriately trained healthcare professional.1,2

Patients must not be prescribed KESIMPTA (ofatumumab) if they have:1,2 

  • Hypersensitivity to the active substance or to any of the excipients listed in the SmPC for GB and the SmPC for NI
  • Patients in a severely immunocompromised state 
  • Severe active infection until resolution
  • Known active malignancy 

Key special warnings and precautions:1,2

  • Administration should be delayed in patients with an active infection until the infection is resolved
  • Patients with active hepatitis B disease should not be treated with KESIMPTA

Please refer to KESIMPTA prescribing informationSmPC for GB and SmPC for NI for further special warnings and precautions.

NICE recommendations:8

In England, Wales and Northern Ireland, KESIMPTA is now reimbursed following NICE Technology Appraisal Guidance recommending KESIMPTA as a treatment option for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. This is only if the company provides KESIMPTA according to the commercial arrangement.

This recommendation is not intended to affect treatment with KESIMPTA that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

SMC advice: following a full submission9

KESIMPTA (ofatumumab) is accepted for restricted use within NHSScotland.

Indication under review: treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

SMC restriction: treatment of relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

Two Phase III studies demonstrated superiority of ofatumumab in reducing annualised relapse rate when compared with another disease-modifying treatment (DMT) in adult patients with RMS.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower.

*Data on the ARR were analysed using a negative binomial-regression model, with an offset for time spent in the trial in years to adjust for varying treatment durations among patients. Confirmed relapses are those accompanied by a clinically relevant change in the EDSS.3,6

ARR, annualised relapse rate; CD20, cluster of differentiation 20; DMT, disease-modifying treatment; EDSS, expanded disability status scale; IgG1, immunoglobulin 1; MS, multiple sclerosis; NICE, National Institute for Health and Care Excellence; PAS, patient access scheme; RMS, relapsing forms of multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SC, subcutaneous; SMC, Scottish Medicines Consortium; SmPC, Summary of Product Characteristics.

References:

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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]