Drugs List

Therapeutic Indications

Uses

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.

Administration

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.

Contraindications

Children under 18 years
Severe immunosuppression
Severe infection
Within 2 weeks of inactivated vaccines
Within 4 weeks of live viral or bacterial vaccination
Malignant neoplasm

Precautions and Warnings

Infection
Breastfeeding
History of hepatitis B
History of progressive multifocal leukoencephalopathy (PML)
Pregnancy

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

Pregnancy

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.

Lactation

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.

Side Effects

Chills
Decrease in blood immunoglobulin M
Erythema
Fatigue
Fever
Headache
Injection site reactions
Itching
Myalgia
Oral herpes
Swelling
Upper respiratory tract infection
Urinary tract infections

Presentation

Injections of ofatumumab.

Drugs List

Therapeutic Indications

Uses

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.

Dosage

Adults

Additional Dosage Information

Administration

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.

Contraindications

Children under 18 years
Severe immunosuppression
Severe infection
Within 2 weeks of inactivated vaccines
Within 4 weeks of live viral or bacterial vaccination
Malignant neoplasm

Precautions and Warnings

Infection
Breastfeeding
History of hepatitis B
History of progressive multifocal leukoencephalopathy (PML)
Pregnancy

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

Pregnancy

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.

Lactation

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.

Counselling

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.

Side Effects

Chills
Decrease in blood immunoglobulin M
Erythema
Fatigue
Fever
Headache
Injection site reactions
Itching
Myalgia
Oral herpes
Swelling
Upper respiratory tract infection
Urinary tract infections

Overdosage

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 ).

Further Information

Last Full Review Date: June 2021

Reference Sources

Summary of Product Characteristics: Kesimpta 20 mg solution for injection in pre-filled pen. Novartis Pharmaceuticals UK Ltd. Revised April 2021.