Prescribing information

 

   

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

KESIMPTA® (ofatumumab) dosing guidance

Following an initial dosing period, KESIMPTA offers a minute a month*†‡, easy self-administration at home when the patient is ready to administer†1,2 

Initial doses of KESIMPTA are at weeks 0, 1, and 2. The once-monthly dosing schedule begins at week 4. All doses are 20 mg and are administered via subcutaneous injection.

KESIMPTA is intended for patient self-administration with initial guidance of an appropriately trained HCP. After the initial dosing period, KESIMPTA 20 mg is self administered once monthly at home.‡1

 

Infographic of KESIMPTA dosing schedule

 

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No routine drug monitoring, hospital visits or premedication required1,2

 

 
Sensoready pen icon.

Self-administered subcutaneously with the Sensoready® pen1,2

 

To educate your patients about the KESIMPTA dosing schedule, you can direct them to a portal specifically designed for patients. Here, prescribed patients may access resources and support. The first injection of KESIMPTA should be performed under the guidance of a healthcare professional.

* 1 minute a month’ refers to the time it takes for a patient to inject a full dose of KESIMPTA.3
Patient must take the pen out of the refrigerator about 15 to 30 minutes before self-administration to allow it to reach room temperature. Additional time is required to prepare the pen and clean the administration site.1-3
Based on stability data.3

 
 
You can learn more about B cell therapy by reviewing KESIMPTA’s mechanism of action.

Additional KESIMPTA dosing information1,2

Before initiating treatment, KESIMPTA’s safety and KESIMPTA’s prescribing information should be reviewed. 

Syringe icon representing injectable subcutaneous solution

Injectable subcutaneous solution:

  • 20 mg/0.4 mL single-dose prefilled Sensoready® pen.
 

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 Dose modifications

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

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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.
 

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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.
 

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Paediatric population 

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

KESIMPTA®▼(ofatumumab) storage guidance1,2

 

Fridge icon representing Kesimpta's storage information.
  • 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.
  • If necessary, KESIMPTA may be stored unrefrigerated for a single period of up to 7 days at room temperature (not above 30°C). If not used during this period, Kesimpta can then be returned to the refrigerator for a maximum of 7 days.
 

How to use KESIMPTA®▼(ofatumumab)  

Watch this video to learn more about how to use KESIMPTA. This will help you teach your patients how to administer KESIMPTA with the Sensoready® pen after the initial dose. 

Information for patients can be found on our patient resource page.

 

 

 

Infographic showing- The Sensoready® pen is easy-to-use and preferred by MS patients and nurses over their current device

 

The KESIMPTA pen (Sensoready®) is easy to use and preferred by MS patients and nurses over their current device*†‡4

Nurse and patient preferences for using the Sensoready® pen vs other MS disease-modifying therapy (DMT) autoinjectors were investigated in a multicentre survey.*§4

 

 
To request a demonstration kit, please reach out to your Novartis Key Account Manager or click the ‘Contact us’ button on the right-hand side.

 

*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 (84% vs 16%; p <0.5)*, 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.

 KESIMPTA® (ofatumumab) administration

KESIMPTA is the first and only self-administered once-monthly (20 mg), subcutaneous (SC) B cell therapy for relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features1,2

KESIMPTA is intended for patient self-administration with initial guidance from a healthcare professional (HCP). To learn more, review the KESIMPTA:

 

KESIMPTA® (ofatumumab) patient self-administration

Watch this video to discover more about KESIMPTA self-administration from the perspective of a patient with RRMS.  
 

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DMT, disease-modifying therapy; HCP, healthcare professional; MS, multiple sclerosis; RMS, relapsing forms of MS; SC, subcutaneous.

References

  1. KESIMPTA Summary of Product Characteristics. Great Britain: Novartis Pharmaceuticals UK Ltd; July 2022.
  2. KESIMPTA Summary of Product Characteristics. Novartis Ireland Limited; July 2022.
  3. Novartis data on file (OFA 005).
  4. 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. 

 

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UK | November 2022 | 247941

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]