Mayzent® (siponimod)

Mayzent® is used for the treatment of adults with secondary progressive MS (SPMS), the form of MS that can follow on from relapsing remitting MS. People with SPMS experience a gradual worsening of their condition as disability accumulates.

Mayzent® acts on certain types of white blood cells (lymphocytes) which are involved in the immune attack on myelin seen in MS. Mayzent® targets immune cells and prevents them from moving into the areas of inflammation in MS (the brain and spinal cord), resulting in a reduced immune attack on the nerve cells.

Mayzent® is a film-coated tablet taken orally, once daily.

Before initiation of treatment with Mayzent® a special genotype blood test is required to determine firstly, if it is safe to take Mayzent®, and secondly, the correct dosage. People considered for Mayzent® will not be charged for the costs of this genotype test. Also, before treatment with Mayzent® a blood test may be taken to check the level of white blood cells and liver function.

Treatment with Mayzent® is initiated with a special titration pack that lasts for 5 days to gradually build up the medication dose. The rate of this titration or gradual build up will be determined by your treating doctor depending on the results of the genotype blood test. During the first 6 days of treatment initiation, the recommended daily dose should be taken once daily in the morning with or without food.

Mayzent® 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 Mayzent® are high blood pressure, headaches and abnormal liver tests. Potential serious side effects may include shortness of breath and swelling and narrowing of blood vessels in the brain. 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 Mayzent® prior to starting therapy and over the course of treatment. Your health professional can provide comprehensive information on the use of Mayzent®, including precautions and side effects.

There is no adequate data on the developmental risk associated with the use of Mayzent® in pregnant women. Based on laboratory models and its mechanism of action, Mayzent® can cause foetal harm when administered to a pregnant woman. The use of Mayzent® in women who are or may become pregnant should only be considered if the potential benefit justifies the potential risk to the fetus.

Because it takes approximately 10 days to eliminate Mayzent® from the body, women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping Mayzent® treatment.

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 Mayzent® should not breastfeed. There is no data on the presence of Mayzent® in human milk, the effects of Mayzent® on the breastfed infant, or the effects of the drug on milk production. A study in laboratory models has shown excretion of Mayzent® and/or its metabolites in milk. Since many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Mayzent®, a nursing woman should be advised on the potential risks to the child.

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

Mayzent® has been approved by the Therapeutic Goods Administration (TGA) for the treatment of patients with secondary progressive MS and is available through the Pharmaceutical Benefits Scheme (PBS). 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 Mayzent® treatment through the PBS, please visit the official PBS website at: https://www.pbs.gov.au/medicine/item/12158X-12160B-12172P

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 Mayzent® 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.