|Frequency:||At the beginning of treatment, there is a titration period for 5 days, followed by a daily maintenance dose.|
|TGA approval date:||Nov 2019|
|Mechanism of action||Siponimod is a selective immunosuppressant that acts by targeting immune cells and preventing them from moving into the areas of inflammation in MS (the brain and spinal cord).|
|Clinical trial results||21% reduction in the risk of disability progression
This number is in comparison to a control group given a placebo.
|Safe in Pregnancy||There are no adequate data on the developmental risk associated with the use of siponimod in pregnant women. Based on laboratory models and its mechanism of action, siponimod can cause fetal harm when administered to a pregnant woman. The use of siponimod 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 siponimod from the body, women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping siponimod treatment.
|Breastfeeding (information predominatly from LACTMED database)||Women receiving siponimod should not breastfeed. There are no data on the presence of siponimod in human milk, the effects of siponimod on the breastfed infant, or the effects of the drug on milk production. A study in laboratory models has shown excretion of siponimod 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 siponimod, a nursing woman should be advised on the potential risks to the child.
|Potential side effects (not a comprehensive list)||The most common side effects of siponimod 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.|