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KESIMPTA™ NSS - Kuwait
KESIMPTA™ NSS - Kuwait
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Regulatory Affairs
KESIMPTA® (ofatumumab)
20 mg Solution for injection in a pre-filled syringe
or pre-filled pen
Basic Succinct Statement (BSS)
Version 2.1
Effective date: 09-Aug-2023
Safety Label Change (SLC)
Tracking number: 2023-PSB/GLC-1370-s
Document status: Final
Property of Novartis
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
Kesimpta® 20 mg/0.4 mL solution for injection
Important note: Before prescribing, consult full prescribing information.
Presentation:
20 mg/0.4 mL Solution for injection in a pre-filled syringe
20 mg/0.4 mL Solution for injection in a pre-filled pen
Each pre-filled syringe and pre-filled pen contains 20 mg ofatumumab solution for injection
(0.4 mL of 50 mg/mL solution).
Indications:
Kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple
sclerosis (RMS).
Dosage and administration:
Adults: The recommended dose is 20 mg Kesimpta administered by subcutaneous injections
with initial dosing at weeks 0, 1 and 2, followed by subsequent monthly dosing, starting at
week 4.
Contraindications:
♦History of confirmed hypersensitivity to Kesimpta.
Warnings and precautions:
♦Injection site reaction (local) symptoms observed in clinical studies include erythema,
swelling, itching and pain. ♦Systemic injection-related reactions (SIRRs) occurred
predominantly with the first injection. Symptoms observed include fever, headache, myalgia,
chills and fatigue and were predominantly (99.7%) non-serious and mild to moderate in
severity. ♦Additional SIRRs reported in the post-marketing setting include rash, urticaria,
dyspnea, angioedema (e.g., tongue, pharyngeal or laryngeal swelling), and rare cases which
were reported as anaphylaxis. Most of the cases were non-serious and occurred with first
injection. While there were some cases which were serious and resulted in discontinuation of
Kesimpta treatment, there were also serious cases where patients were able to continue
Kesimpta treatment without further incidents. ♦Some SIRR symptoms may be clinically
indistinguishable from Type 1 acute hypersensitivity reactions (IgE-mediated). ♦Inform
patients that injection-related reactions generally occur within 24 hours and predominantly
following the first injection. SIRRs can be managed with symptomatic treatment, should they
occur. ♦A hypersensitivity reaction may present with any injection, although typically would
not present with the first injection. For subsequent injections, more severe symptoms than
previously experienced, or new severe symptoms, should prompt consideration of a potential
hypersensitivity reaction. Patients with known IgE mediated hypersensitivity to Kesimpta must
not be treated. ♦First injection should be performed under the guidance of an appropriately
trained healthcare professional. ♦It is recommended to evaluate the patient’s immune status
prior to initiating therapy. Kesimpta has the potential for an increased risk of infections.
Kesimpta administration should be delayed in patients with active infection until the infection
is resolved. ♦Vigilance is advised for clinical symptoms or MRI findings that may be suggestive
of progressive multifocal leukoencephalopathy (PML). If PML is suspected, treatment with Novartis
Kesimpta should be suspended. ♦Kesimpta treatment should not be initiated in patients with
active hepatitis B (HBV) infection until the infection has been adequately treated. Perform HBV
screening in all patients before initiation of treatment with Kesimpta. Patients with positive
serology should consult liver disease experts before start of treatment. ♦Vaccinations:
Administer all required immunizations at least 4 weeks prior to initiation of Kesimpta for live
or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of
Kesimpta for inactivated vaccines. Kesimpta may interfere with the effectiveness of inactivated
vaccines. Administering live or live-attenuated vaccines to neonates and infants exposed to
ofatumumab in utero should be avoided until B-cell recovery occurs.
Pregnancy, lactation, females and males of reproductive potential
Pregnancy: There are no or limited amount of data from the use of Kesimpta in pregnant
women. Ofatumumab may cause fetal B-cell depletion.
Lactation: Published data suggest that antibodies in breast milk do not enter the neonatal and
infant circulations in substantial amounts. The potential for absorption of ofatumumab to lead
to B-cell depletion in the infant is unknown. The developmental and health benefits of breast
feeding should be considered along with the mother’s clinical need for Kesimpta and any
potential adverse effects on the breast-fed infant from Kesimpta.
Females and males of reproductive potential: Women of childbearing potential should use
effective contraception while receiving Kesimpta and for 6 months after the last treatment of
Kesimpta.
Adverse drug reactions:
• Very common (≥10%): upper respiratory tract infections, injection site reactions (local)
injection-related reactions (systemic).
• Common (≥1 to <10%): immunoglobulin M decreased.
• Unknown: hypersensitivity reaction.
Interactions:
The risk of additive immune system effects should be considered when coadministering
immune-modulating or immunosuppressive therapies with Kesimpta. When switching from
drugs with prolonged immune effects, such as ocrelizumab, cladribine, fingolimod,
natalizumab, teriflunomide, mitoxantrone or dimethyl fumarate, the duration and mode of
action of these drugs should be considered because of potential additive immunosuppressive
effects when initiating Kesimpta.
Packs and prices: Country-specific.
Legal classification: Country-specific.
Leaflet Date: Feb 2024
Leaflet Presentation Type: R02
NSS Version: 2.1