TM Owner Novartis
Kesimpta 20mg/0.4ml Solution for injection, prefilled pen/syringe (SC)
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Indications & Clinical Uses
- Kesimpta 20 mg/0.4 mL is a single-dose subcutaneous injection of ofatumumab, an anti-CD20 monoclonal antibody that depletes B cells.
- It is approved for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease; the European authorisation covers adults with active relapsing MS.
- After training, patients give it themselves at home using a Sensoready prefilled pen or a prefilled syringe: 20 mg at weeks 0, 1 and 2, then 20 mg once a month from week 4 onwards.
- A critical safety point: Kesimpta must never be confused with Arzerra, which contains the same active substance, ofatumumab, but is a 100 mg/5 mL concentrate given by intravenous infusion in far higher doses for chronic lymphocytic leukaemia.
- The dose, strength, route and disease are all different and the two products are not interchangeable.
Side Effects
- Upper respiratory tract infections are very common, reported by 39% of people using Kesimpta.
- Systemic injection-related reactions such as fever, headache, muscle ache, chills and tiredness affected 21%, were mostly mild to moderate and usually occurred within 24 hours of the first injection.
- Local injection-site redness, pain, itching or swelling occurred in 11%, headache in 13%, and urinary tract infections are also common.
- The label carries no boxed warning, but serious bacterial, fungal and new or reactivated viral infections have been reported, including hepatitis B reactivation and progressive multifocal leukoencephalopathy.
- Get urgent help for fever, a persistent cough, painful urination, yellowing of the skin or eyes, or new confusion, weakness, vision changes or clumsiness.
- Rotate injection sites and never inject into tender, bruised, red or broken skin.
Precautions & Warnings
- Kesimpta is contraindicated in people with active hepatitis B infection, and everyone must be screened for hepatitis B before the first dose.
- Immunoglobulin levels are checked before starting and during treatment, because IgM fell in 7.7% of patients, and a dose is delayed if you have an active infection until it has cleared.
- Complete all required immunisations before starting: live or live-attenuated vaccines are not recommended during treatment or after stopping until B cells recover, and non-live vaccines should ideally be given at least two weeks beforehand.
- Ofatumumab may harm an unborn baby, so effective contraception is advised during treatment and for six months after the last dose.
- Store in a refrigerator at 2 degrees C to 8 degrees C in the original carton; a single period of up to seven days at room temperature, not above 30 degrees C, is permitted.
- Never freeze it and never shake it.
Avoid Interactions
- Things that increase risk: other immunosuppressant or immune-modifying medicines, including other multiple sclerosis disease-modifying therapies, corticosteroids and chemotherapy, add to the effect on the immune system and raise the chance of serious infection; tell your healthcare provider if you have recently used any, because their effects can overlap for months.
- Things that reduce benefit or cause harm: live and live-attenuated vaccines such as measles-mumps-rubella, yellow fever, live nasal influenza and varicella must not be given during Kesimpta treatment or after stopping until B cells return.
- Non-live vaccines work less well while B cells are depleted, so complete them before treatment starts.
- Do not mix Kesimpta with any other medicine in the same syringe.
- Tell your healthcare provider about every medicine, vaccine and supplement you use.
References
Frequently Asked Questions
Kesimpta (ofatumumab) treats relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS. It is an anti-CD20 antibody that depletes B cells, reducing relapses and new lesions. The dose is 20 mg injected under the skin.
Kesimpta (ofatumumab) 20 mg is injected under the skin at weeks 0, 1 and 2, then once a month from week 4 onwards. You give it yourself at home with a Sensoready pen or prefilled syringe after training, into the thigh, abdomen or upper arm, rotating sites each time.
Colds and other upper respiratory infections affect 39% of people on Kesimpta (ofatumumab). Injection-related reactions such as fever, headache, chills and muscle ache occurred in 21%, usually after the first dose. Report fever, persistent cough, yellowing skin, or new confusion, weakness or vision changes urgently.
Avoid live and live-attenuated vaccines, including MMR, yellow fever, varicella and live nasal flu, during Kesimpta (ofatumumab) treatment and until B cells recover after stopping. Other immunosuppressants add to infection risk. Kesimpta is contraindicated if you have active hepatitis B infection.
Keep Kesimpta (ofatumumab) in the refrigerator at 2°C to 8°C in its original carton; one spell of up to 7 days at room temperature below 30°C is allowed. Never freeze or shake it. If a dose is missed, inject it as soon as possible, then resume the monthly schedule.
No, and the two must never be swapped. Kesimpta (ofatumumab) is 20 mg/0.4 mL injected under the skin monthly for multiple sclerosis. Arzerra contains the same ofatumumab but is a 100 mg/5 mL concentrate infused into a vein in far higher doses for chronic lymphocytic leukaemia.
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