2nd Abu Dhabi Brain Conference 2022 Program Book

Novartis Middle East FZE P.O.Box: 23510, Dubai- United Arab Emirates Tel: +97144357094- Fax :+971144357701 www.novartis.com 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 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 relapsing forms of multiple sclerosis (MS). Dosage and administration: Treatment should be initiated by a physician experienced in the management of neurological conditions, including multiple sclerosis. 1.1 Usual dosage The recommended dose is 20 mg Kesimpta administered by subcutaneous injection at the following intervals: • initial dosing at weeks 0, 1 and 2 followed by • subsequent monthly dosing starting at week 4. To ensure traceability of medicinal products produced using biotechnology, it is recommended that the trade name and batch number be documented at every treatment. Missed doses If an injection of Kesimpta 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 dosage instructions Elderly patients No studies have been performed in elderly MS patients. Ofatumumab was studied in patients with relapsing MS (RMS) aged 18 to 55 years. Results from population pharmacokinetics suggest that dose adjustment is not required in elderly patients (see “Pharmacokinetics”). Patients with renal impairment No specific studies of ofatumumab in patients with renal impairment have been performed. Patients with mild renal impairment were included in the clinical studies. There is no experience in patients with moderate and severe renal impairment. However, as ofatumumab is not excreted via urine, patients with renal impairment are not expected to require dose modification (see “Pharmacokinetics”). Patients with hepatic impairment No specific studies of ofatumumab in patients with hepatic impairment have been performed. Since hepatic metabolism of monoclonal antibodies such as ofatumumab is negligible, hepatic impairment is not expected to impact the pharmacokinetics of this medicinal product. Therefore, patients with hepatic impairment are not expected to require dose modification (see “Pharmacokinetics”). Children and adolescents The safety and efficacy of Kesimpta in children aged 0 to 18 years have not yet been studied. No data are available. 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. 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. ♦ Kesimpta must not be administered to patients with severe immunosuppression (e.g. significant neutropenia or lymphopenia). Severely immunocompromised patients must not be treated until the relevant condition resolves 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. ♦ Patients with existing active malignancies (including patients actively monitored for relapse of a malignancy) must not be treated with ofatumumab. In patients with known risk factors for malignancies the benefit-risk ratio of ofatumumab should be carefully considered and relevant tumour monitoring performed before and during treatment. ♦ In rare cases severe cardiovascular events and severe mucocutaneous reactions have occurred during treatment with other anti-CD20 antibodies. Patients exhibiting a severe mucocutaneous reaction during treatment with Kesimpta should discontinue treatment and seek prompt medical evaluation. 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, urinary tract infection, Headache, injection site reactions (local) injection-related reactions (systemic) • Common: Oral herpes, Decreased serum immunoglobulin M (IgM) 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: Jan 2021. BSS Version: 1.0 2021\Sep\GC2109137392