Prescribing information

   

KESIMPTA is the first and only self-administered once-monthly (20 mg), subcutaneous (SC) B-cell therapy for relapsing forms of MS (RMS)*1

KESIMPTA is intended for patient self-administration with initial guidance from a healthcare professional (HCP).

KESIMPTA provides flexibility for your patients and your practice

B cell therapy that is easy to manage: simple, once-monthly dosing after the initial dosing period1

 

The first injection of KESIMPTA should be performed under
the guidance of an appropriately trained HCP.

 

Self-administered subcutaneously with the Sensoready® pen

No drug monitoring, hospitalisation or premedication requirement

 
 

Additional dosing information1

Dose modifications

  • No dose modifications expected for patients with renal or hepatic impairment

Missed doses

  • If a dose is missed, administer as soon as possible without waiting until the next scheduled dose; subsequent dose should be administered at the recommended intervals

Adults over 55 years old 

  • No studies have been performed in MS patients over 55 years old. Based on the limited data available, no dose adjustment is considered necessary in patients over 55 years old.

Paediatric population 

  • The safety and efficacy of KESIMPTA in children aged 0 to 18 years have not yet been established. No data are available.

 

HCP=healthcare professional; MS=multiple sclerosis.


KESIMPTA storage guidance1

 

  • Keep KESIMPTA in its outer carton in order to protect from light
  • Store in the refrigerator between 2°C and 8°C. Do not freeze
 

The Sensoready® pen is easy-to-use and preferred by MS patients and nurses over their current device*†‡2

Nurse and patient preferences for using the Sensoready® pen vs other MS disease-modifying therapy (DMT) autoinjectors were investigated in a multicentre survey*§2

 

 
 

Please reach out to your Novartis Key Account Manager or hit the ‘contact’ button on the right-hand side to request a KESIMPTA demonstration kit.

DMT=disease-modifying therapy; MS=multiple sclerosis.
*Based on a survey of 80 MS patients and 50 MS nurses. Comparison autoinjector pens included Rebismart®, Rebidose®, Avonex Pen®, Autoject® 2, YpsoMate®and Plegridy Pen®.
84% of participants preferred the Sensoready® autoinjector over other MS DMT autoinjectors*, 79% of patients stated ‘easy to perform self-injection’ with the Sensoready® autoinjector.
KESIMPTA is intended for patient self-administration with initial guidance from a healthcare professional.
§The survey was conducted in two phases – central location pilots (Germany) followed by face-to-face semi-structured in-field interviews across the USA, Germany, France, and Italy.


HCP=healthcare professional; RMS=relapsing forms of MS; SC=subcutaneous.

References

  1. KESIMPTA [Summary of Product Characteristics]. Basel, Switzerland: Novartis AG; April 2021.
  2. Perrin Ross A, Besser C, Naval S, et al. Patient and Nurse Preferences for the Sensoready® Autoinjector Pen Versus Other Autoinjectors in Multiple Sclerosis: Results From a Multicenter Survey [Poster P210]. Poster presented at: ACTRIMS Forum 2021; 25–27 February 2021.

 

UK | March 2021 | 108318
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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.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]