- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Injections of ofatumumab.
Treatment of relapsing-remitting multiple sclerosis
Treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features.
Initial dose: 20mg at weeks 0, 1 and 2.
Maintenance dose: 20mg monthly starting at week 4.
Additional Dosage Information
If a dose is missed, administer the missed dose as soon as possible. Administer subsequent doses at the recommended intervals.
For subcutaneous injection only.
The usual sites for subcutaneous injections are the abdomen, the thigh and the upper outer arm.
The first dose should be administered under guidance of a specialist.
Children under 18 years
Within 2 weeks of inactivated vaccines
Within 4 weeks of live viral or bacterial vaccination
Precautions and Warnings
History of hepatitis B
History of progressive multifocal leukoencephalopathy (PML)
Avoid live vaccines during treatment and until immune recovery
Before initiating screen all patients for hepatitis B infection
Hepatitis B: Refer prior to initiation to liver disease specialist
Treat and control infections prior to commencing therapy
Treatment to be initiated by specialist
Record name and batch number of administered product
Evaluate patient's immune status before initiation
Antibody response to vaccines may be reduced
Risk of developing opportunistic infections
Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
B-cell median time recovery to lower limit of normal or baseline value is 24.6 weeks post treatment discontinuation.
HBV screen will need to include hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb), these can be complemented with other appropriate markers.
Severely immunocompromised patients cannot be treated with ofatumumab until condition resolves. It is not recommend to use other immunosuppressants concomitantly except corticosteroids for the treatment of symptomatic relapses.
Pregnancy and Lactation
Use ofatumumab with caution during pregnancy.
The manufacturer recommends that ofatumumab should be avoided during pregnancy unless the benefit to the mother outweighs the risk of the foetus. Animal studies indicate that ofatumumab may cross the placenta and cause foetal B-cell depletion.
Manufacturer recommends that live vaccinations should be avoided in infants of mothers treated with ofatumumab during pregnancy until immune recovery.
Use ofatumumab with caution during breastfeeding.
The manufacturer states that the use of ofatumumab during breastfeeding has not been studied and it is unknown if ofatumumab is excreted in human milk. A risk to breastfed newborns cannot be excluded due to low concentrations of immunoglobulin G following birth. Breastfeeding can begin immediately if the patient was treated with ofatumumab up to the last few months of pregnancy.
Advise patient that injection-related reactions can occur generally within 24 hours following the first dose.
Advise patient to report signs or symptoms of infection.
Decrease in blood immunoglobulin M
Injection site reactions
Upper respiratory tract infection
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: June 2021
Summary of Product Characteristics: Kesimpta 20 mg solution for injection in pre-filled pen. Novartis Pharmaceuticals UK Ltd. Revised April 2021.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.