KESIMPTA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

OFATUMUMAB

Available from:

NOVARTIS ISRAEL LTD

ATC code:

L01XC10

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

OFATUMUMAB 50 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Therapeutic area:

OFATUMUMAB

Therapeutic indications:

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

Authorization date:

2021-07-21

Patient Information leaflet

Based on EU PIL March22
KES APL FEB23 V1.1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
KESIMPTA
SOLUTION FOR INJECTION IN PRE-FILLED PEN
FOR SUBCUTANEOUS INJECTION
ACTIVE INGREDIENT:
ofatumumab 50 mg/ml
Each ml of solution for injection contains 50 mg ofatumumab.
Each pre-filled pen contains 20 mg ofatumumab in 0.4 ml solution.
INACTIVE INGREDIENTS AND ALLERGENS: See section 2 under ‘Important
information about some of this
medicine’s ingredients’, and section 6 ‘Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor of
pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them even
if it seems to you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Kesimpta is intended for treating adults with relapsing forms of
multiple sclerosis (RMS) who have
an active disease as defined by clinical or imaging characteristics.
THERAPEUTIC GROUP: selective immunosuppressive medicines
How Kesimpta works
Kesimpta works by attaching to a receptor called CD20 on the surface
of B cells. B cells are a type
of white blood cell which are part of the immune system (the body’s
defences). In multiple sclerosis,
the immune system attacks the protective layer around nerve cells. B
cells are involved in this
process. Kesimpta targets and removes the B cells and thereby reduces
the chance of a relapse,
relieves symptoms, and slows down the progression of the disease.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to ofatumumab or any of the other
ingredients of this medicine
(listed in section 6).
•
you have been told that you have severe problems with your immune
system.
•
you are suffering from a severe infection.
•
you have cancer.
S

Summary of Product characteristics

KES API FEB23 V3
Page 1 of 14
EU SmPC 01/2023
1.
NAME OF THE MEDICINAL PRODUCT
Kesimpta
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kesimpta 20 mg solution for injection in pre-filled pen
Each pre-filled pen contains 20 mg ofatumumab in 0.4 ml solution (50
mg/ml).
Ofatumumab is a fully human monoclonal antibody produced in a murine
cell line (NS0) by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection) in pre-filled pen (Sensoready Pen)
The solution is clear to slightly opalescent, and colourless to
slightly brownish-yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
management of neurological
conditions.
Posology
The recommended dose is 20 mg ofatumumab administered by subcutaneous
injection with:
•
initial dosing at weeks 0, 1 and 2, followed by
•
subsequent monthly dosing, starting at week 4.
_Missed doses_
If an injection is missed, it should be administered as soon as
possible without waiting until
the next scheduled dose. Subsequent doses should be administered at
the recommended
intervals.
_Special populations _
_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 (see
section 5.2).
KES API FEB23 V3
Page 2 of 14
EU SmPC 01/2023
_Renal impairment_
Patients with renal impairment are not expected to require dose
modification (see section 5.2).
_Hepatic impairment_
Patients with hepatic impairment are not expected to require dose
modification (see
section 5.2).
_Paediatric population_
Kesimpta is not indicated for children and adolescents under 18 years
old.
The safety and efficacy o