Kesimpta

What it is

Kesimpta contains ofatumumab, a recombinant fully human monoclonal immunoglobulin G1 (IgG1) antibody against human CD20 expressed on B-cells. Each pre-filled syringe and pre-filled pen contains 20 mg ofatumumab solution for injection (0.4 mL of 50 mg/mL solution). The single-use solution for injection is sterile, preservative-free, clear to slightly opalescent, and colourless to slightly brownish-yellow.

Approved indications

— Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse.

Dosing overview

The recommended dose is 20 mg Kesimpta administered by subcutaneous injection with initial dosing of 20 mg by subcutaneous injection at weeks 0, 1 and 2, followed by subsequent monthly dosing of 20 mg by subcutaneous injection, starting at week 4. Treatment with Kesimpta should be initiated by a physician experienced in the management of neurological conditions. Kesimpta is intended for patient self-administration by subcutaneous injection. The first injection of Kesimpta should be performed under the guidance of a healthcare professional.

Key safety warnings

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. Additional systemic injection-related reactions reported in the post-marketing setting include rash, urticaria, dyspnea, angioedema (for example, tongue, pharyngeal or laryngeal swelling), and rare cases which were reported as anaphylaxis. Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies. Based on its mode of action and available clinical experience, ofatumumab has the potential for an increased risk of infections. Administration should be delayed in patients with a severe active infection until the infection is resolved. Since John Cunningham (JC) virus infection resulting in progressive multifocal leukoencephalopathy (PML) has been observed in patients treated with anti-CD20 antibodies (including ofatumumab at higher doses in other indications) and other multiple sclerosis therapies, physicians should be vigilant for any clinical symptoms or magnetic resonance imaging (MRI) findings that may be suggestive of PML. Patients with active hepatitis B disease should not be treated with Kesimpta. Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with Kesimpta. Clinically significant liver injury, without findings of viral hepatitis, has been reported in the post marketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of multiple sclerosis, including Kesimpta. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred weeks to months after administration.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Patients with known IgE mediated hypersensitivity to Kesimpta must not be treated with Kesimpta. Patients with active hepatitis B disease should not be treated with Kesimpta. Patients with existing active malignancies (including patients actively monitored for relapse of a malignancy) must not be treated with ofatumumab.

PBS listing

Kesimpta solution for injection 20 mg in 0.4 mL pre-filled pen is listed on the PBS with 2 items, streamlined restriction, at an ex-manufacturer price of A$2058.29.

Regulatory history

Kesimpta ofatumumab 20 mg/0.4mL solution for injection (pre-filled pen and pre-filled syringe) was first registered on the ARTG on 4 March 2021. The PBAC recommended Kesimpta in November 2014 for the treatment of relapsing-remitting multiple sclerosis in patients who have failed prior treatment with interferon beta or glatiramer acetate. The PBAC recommended Kesimpta in March 2021 for relapsing-remitting multiple sclerosis (RRMS). Kesimpta is subject to additional monitoring in Australia. This will allow quick identification of new safety information.