Treatment:

Briumvi® (ublituximab)

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The active ingredient in Briumvi® is ublituximab. It is used to treat adults with relapsing forms of MS, to reduce the number of relapses, disability progression and the number of new magnetic imaging lesions.

Briumvi® is a monoclonal antibody that selectively targets B cells that express the CD20 molecule. B cells play a role in the disease process of MS. By targeting cells with the CD20 molecule, Briumvi® reduces the number of B cells circulating on the body.

In clinical trials, people with MS who received Briumvi® had fewer relapses and fewer new lesions compared to people taking the oral medication teriflunomide.

Briumvi® should not be used in people:

  • who are allergic to ublituximab, or any of the ingredients in the infusion.
  • who are suffering from a severe infection
  • who have severe problems with their immune system
  • who have cancer.

Briumvi® is infused intravenously through a drip at a hospital infusion unit. You will be monitored by trained staff before, during and after your infusion.

  • When first starting Briumvi®, 150 mg is given as an infusion over 4 hours.
  • The second dose is 450 mg and given over 1 h, 2 weeks after the first dose.
  • Subsequent doses are also 450 mg, given 24 weeks after the first dose and then every 24 weeks thereafter. These infusions will last 1 hour.

There should be at least 5 months between each Briumvi® dose.

Tell your doctor or nurse right away if you experience any signs or symptoms of an infusion-related reaction. Infusion-related reactions can occur during the infusion or up to 24 hours afterwards. Symptoms can include itchy skin, hives, redness of the face or skin, throat irritation, trouble breathing, swelling of tongue or throat, wheezing, chills, fever, headache, dizziness, feeling faint, nausea, belly pain and rapid heartbeat.

You should also tell your doctor or nurse straight away if you notice any signs of infection or liver problems. Signs of infection include fever or chills, coughs that do not go away or herpes infection such as cold sores or shingles. Signs of liver problems include dark coloured urine or yellowing of your skin and eyes.

Other possible side effects of Briumvi® include neutropenia (low levels of neutrophils, a type of white blood cell cell), insomnia, infection of the nose, throat or airways, pain in the arms and legs and fatigue.

Check with your doctor if you are pregnant, think that you might be pregnant or intend to become pregnant. This is because Briumvi® may cross the placenta and affect your baby.

Do not use Briumvi® if you are pregnant unless you have discussed this with your doctor. Your doctor will consider the benefit of you taking Briumvi® against the risk to your baby.

Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known whether Briumvi® passes into your breast milk or whether there would be risks to your baby.

Briumvi® was registered by the Therapeutic Goods Administration (TGA) on 11 June 2025 for the treatment of adults with relapsing forms of MS in Australia. Briumvi® is available through the Pharmaceutical Benefits Scheme (PBS) for relapsing remitting MS from 1 January 2026. Your neurologist will need to obtain a special authority to prescribe the medication for you.

For details of the criteria required to receive a prescription for Briumvi® treatment through the PBS, please visit the official PBS website at https://www.pbs.gov.au/medicine/item/15175Q-15176R-15187H-15197W. You will need to click on the red “Authority Required (STREAMLINED)” link.

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 Briumvi® 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.

Forms of MS used for:
Relapsing forms of MS
Administration route:
Intravenous infusion (into vein)
Dosage and frequency:
The first two doses are infused 2 weeks apart. The third dose is given 24 weeks after the first dose and then subsequent doses are given every 24 weeks.
Storage:
Stored at 2 to 8 degrees Celsius in the pharmacy or clinic, in the medicine’s outer carton to protect it from light.
TGA approval date:
11 June 2025
Available on PBS:
Yes, for relapsing remitting MS
Manufacturer:
Accelagen Pty Ltd
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Briumvi® (ublituximab)