Kesimpta® (oftumumab)

Kesimpta® contains the active ingredient ofatumumab. It is a self-administered therapy used for the treatment of adults with the relapsing forms of MS to delay the progression of physical disability and reduce the frequency of relapse.

Kesimpta® uses a type of protein called a monoclonal antibody designed to recognise and attach to a target called CD20 on the surface of certain types of white blood cells which are part of the immune system (called B cells).

By targeting and removing the B cells, Kesimpta® helps to reduce their activity and thereby reduces the chance of having a relapse, relieves symptoms and slows down the progression of MS.

Kesimpta® is intended for self-administration by an injection under the skin (subcutaneous injection). The usual injection sites are the abdomen, the thigh and the upper outer arm.

The first injection of Kesimpta® should be performed under the guidance of a health professional. Comprehensive instructions for administration are provided in the instructions for use and handling, and your neurologist, MS Nurse or GP can help discuss how to use this medication with you.

The recommended dose of Kesimpta® is 20 mg, which lessens in frequency over time. Initial dosing will occur at weeks 0, 1 and 2, followed by subsequent monthly dosing, starting at week 4. This is to build up levels of Kesimpta® in your body gradually.

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.

Kesimpta® helps most people with MS, but may have side effects in some people. All medicines have side effects. It is important to tell your health professional if you notice anything that is making you feel unwell.

Less serious side effects may include upper chest infections such as a sore throat and runny nose, injection site reactions such as redness, pain, itching and swelling at the injection site and/or fever, headache and muscle pain and infections such as a urinary tract infection.

More serious side effects may include worsening of MS symptoms such as muscle weakness, muscle stiffness, muscle spasms, eye changes such as blurred vision or double vision, tremor and general weakness.

Kesimpta® should not be given to patients with severe immunosuppression (e.g. significant neutropenia or lymphopenia). Patients with active hepatitis B disease should not be treated with Kesimpta®. Hepatitis B virus screening should be performed in all patients before initiation of treatment with Kesimpta®.

Kesimpta has not been studied in patients below 18 years. Tell your doctor if you are taking any other medicines, including any that you get without prescription from a pharmacy, supermarket or health food shop.

Your neurologist, MS Nurse, GP or pharmacist can provide comprehensive information on the safe use of Kesimpta®, precautions and a complete list of common and more serious side effects.

There are no studies of Kesimpta® in pregnant women. It is not known whether ofatumumab can cause fetal harm when administered to pregnant women.

You should avoid becoming pregnant while using Kesimpta® and for 6 months after you stop using it. Kesimpta® should be used in pregnancy only if the potential benefit justifies the potential risk to the mother or fetus.

If you are currently pregnant or trying to become pregnant, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

The use of Kesimpta® in women during breastfeeding has not been studied. It is unknown whether Kesimpta® is transferred into human milk; however, other human antibodies of the same type as Kesimpta® are present in human milk.

There are no data on the effects of Kesimpta® on the breastfed infant or on milk production.

Published data suggest that antibodies in breast milk do not enter the newborn and infant circulations in substantial amounts.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Kesimpta® and any potential adverse effects on the breastfed infant from ofatumumab.

If you are currently breastfeeding, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

Kesimpta® was registered by the Therapeutic Goods Administration (TGA) on 5 March 2021 for the treatment of adults with relapsing forms of MS in Australia. Kesimpta® is available through the Pharmaceutical Benefits Scheme (PBS) from 1 October 2021. Your neurologist will need to obtain an authority to prescribe the medication for you.

For details of the criteria required to receive a prescription for Kesimpta® treatment through the PBS, please visit the official PBS website at: https://www.pbs.gov.au/pbs/home

If you are eligible for medications through the PBS, you will need to pay a contribution fee each time your prescription is dispensed. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card. The amount of this fee is set each year by the Federal Government.

Further information about the PBS, your entitlements and details regarding the PBS safety net (which protects patients and their families requiring a large number of PBS items) is available through the Medicare Australia website at: www.medicare.gov.au

If you are not eligible for Kesimpta® through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. In this instance you will have to pay the full cost to the pharmacy that dispenses your medication. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS.