Zeposia® (ozanimod)

Zeposia® is used to treat adult patients with relapsing forms of MS. Zeposia® contains an active substance called ozanimod, which belongs to a group of medicines called sphingosine-1-phosphate (S1P) receptor modulators. Ozanimod belongs to the same class of drugs as Gilenya® (fingolimod) and Mayzent® (siponimod).

Zeposia® can affect the ability of some white blood cells to move freely within the body and stops them from reaching the central nervous system (the brain, spine and optic nerve), where they can cause inflammation and damage. In doing so, Zeposia® may help protect against attacks on the nerves, reduce inflammation and damage to the nerves’ protective coating and slow down the progression of disability.

Zeposia® is taken as a film-coated capsule, once daily. Before you start taking Zeposia®, your doctor will conduct liver and blood tests. You will also have an electrocardiogram (also called an ECG), which measures and records the heart’s rhythm and activity.

When you first start taking Zeposia®, you will receive an ‘initiation pack’. Your treatment will start at a lower dose and will gradually be increased over the first 7 days of treatment. This is to minimise the risk of heart rate reductions, one of the potential side effects of Zeposia®. On Day 8 and thereafter, once you have completed the ‘initiation pack’, you will move on to a ‘maintenance pack’ with orange capsules each containing the recommended dose of 920mg of Zeposia®.

You will continue regular treatment with one 920mg capsule daily.

Zeposia® helps most people with MS, but may have side effects in some people. All medications have side effects. It is important to notify your health professional if you experience any side effects or are feeling unwell.

The most common side effects of ozanimod were nose and throat inflammation, headache, and upper respiratory tract infection. There is also the potential for the heart rate (pulse) to slow down (known as bradycardia) after the first couple of doses. Other potential side effects include the possibility of a serious infection (such as shingles or meningitis), liver problems and increased blood pressure.

Particularly in the first few months of treatment, there is also the potential for a rare side effect called macula oedema, which is swelling of the macula in the eye. Your neurologist will advise on what to look for and any tests that may be required to detect macula oedema, depending on your medical history.

Your neurologist will assist you to assess the risks and the expected benefit of treatment with Zeposia® prior to starting therapy and over the course of treatment. Your health professional can provide comprehensive information on the use of Zeposia®, including precautions and side effects.

There are no adequate data on the developmental risk associated with the use of Zeposia® in pregnant women.

Based on laboratory models and its mechanism of action, Zeposia® potentially could cause fetal harm when administered to a pregnant woman.

Before initiation of treatment, women of childbearing potential must be informed of the risk to the fetus, should have a negative pregnancy test, and should use effective contraception during treatment and for 3 months after stopping Zeposia®.

If the patient becomes pregnant or plans to become pregnant while taking Zeposia®, she should be informed of the potential hazards and discontinuation of therapy should be considered.

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

Women receiving Zeposia® should not breastfeed.

There are no data on the presence of ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.

A study in laboratory models has shown excretion of ozanimod and/or its metabolites in milk, and that there were detrimental effects on young animals when ozanimod was given by mouth.

Due to the potential for serious adverse reactions to ozanimod/metabolites in nursing infants, women receiving Zeposia® should not breastfeed.

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

Zeposia® has been approved by the Therapeutic Goods Administration (TGA) for the treatment of patients with relapsing remitting MS and is available through the Pharmaceutical Benefits Scheme (PBS).

As Zeposia® has specific patient management requirements, only neurologists are able to initiate treatment. Your neurologist will need to obtain a special authority to prescribe you with the medication. 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 Tysabri® treatment through the PBS, please visit the official PBS website at: https://www.pbs.gov.au/medicine/item/12271W-12278F

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 Zeposia® 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.