KESIMPTA™ BSS - Qatar
KESIMPTA™ BSS - Qatar
Regulatory Affairs
KESIMPTA™ (ofatumumab)
20 mg Solution for injection in a pre-filled pen
National Succinct Statement (NSS)
Version 2.0
CDS Effective date:20-Jan-2022
Safety Label Change (SLC) N/A
Tracking number:
Document status: Final
Property of Novartis
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis
⮟This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can also report side effects directly via www.report.novartis.com
Kesimpta™ 20 mg/0.4 mL solution for injection
Important note:
Before prescribing, consult full prescribing information: AIPS Single Query (swissmedicinfo.ch)
Disclaimer: This link will contain the most updated product information approved by SwissMedic.
Presentation:
20 mg/0.4 mL Solution for subcutaneous injection in a pre-filled pen
Each pre-filled pen contains 20 mg ofatumumab solution for subcutaneous injection (0.4 mL of 50 mg/mL solution).
Indications:
Kesimpta is indicated for the treatment of adult patients with active relapsing forms of multiple sclerosis (MS).
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:
Hypersensitivity to the active substance or any of the excipients
Severely immunocompromised patients
Presence of an active infection
Known active malignancies.
Treatment initiation during pregnancy.
Warnings and precautions:
♦Injection site reaction (local) symptoms observed in clinical studies include erythema, swelling, itching and pain. ♦Systemic injection-related reactions 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. Inform patients that injection-related reactions generally occur within 24 hours and predominantly following the first injection. ♦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 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: The use of ofatumumab in women during breast-feeding has not been studied. It is unknown whether ofatumumab is transferred into human milk. 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: upper respiratory tract infections, injection site reactions (local) injection- related reactions (systemic).
Common: immunoglobulin M decreased.
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.