|Frequency:||Week 0, 1, 2, 4 then monthly|
|TGA approval date:||Mar 2021|
|PBS listed:||No, but to be submitted for consideration with outcome to be announced on 23 April 2021.|
|Mechanism of action||Ofatumumab is a type of protein called a monoclonal antibody designed to recognize 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, ofatumumab helps to reduce their activity and thereby reduces the chance of having a relapse, relieves symptoms and slows down the progression of MS.
|Clinical trial results||In clinical trials named ASCLEPIOS I and II, ofatumumab was compared against teriflunomide (Aubagio). The trials randomly assigned 946 patients to receive ofatumumab and 936 to receive teriflunomide. Results showed that average yearly rates of relapses for patients with MS were reduced by 51% for those who received ofatumumab, and by 58% for those who received teriflunomide. A larger number in the ofatumumab group had no evidence of MS activity during the trial, measured via number of relapses, disability worsening, and MRI activity. No evidence of disease activity is widely recognised as the optimal treatment goal in MS.
Ofatumumab-treated patients also experienced less worsening of disability, as well as dramatically lower numbers of lesions on MRI. While there were no significant effects on brain volume, people treated with ofatumumab exhibited lower levels of a marker of neurodegeneration in the blood called serum neurofilament light.
|Safe in Pregnancy||There are no studies of ofatumumab 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 ofatumumab and for 6 months after you stop using it.
If you become pregnant or think you are pregnant, tell your doctor right away.
Ofatumumab should be used in pregnancy only if the potential benefit justifies the potential risk to the mother or fetus.
|Breastfeeding||The use of ofatumumab in women during lactation has not been studied.
It is unknown whether ofatumumab is transferred into human milk; however, other human antibodies of the same type as ofatumumab (IgG) are present in human milk.
There are no data on the effects of ofatumumab on the breastfed infant or on milk production.
Published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ofatumumab and any potential adverse effects on the breastfed infant from ofatumumab.
|Monitoring requirements||This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.|
|Potential side effects (not a comprehensive list)||Ofatumumab may have unwanted side effects in some people. All medicines can have side effects. Tell your doctor 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 multiple sclerosis symptoms such as muscle weakness, muscle stiffness, muscle spasms, eye changes such as blurred vision or double vision, tremor and general weakness. In the clinical trial, 2.5% of ofatumumab-treated patients experiencing serious infections compared to 1.8% in the teriflunomide-treated patients.
Some side effects (for example decrease in specific proteins in the blood such as immunoglobulin M which help protect against infection) can only be found when your doctor does tests from time to time to check your progress.
|Manufacturer||Novartis Pharmaceuticals Australia|