|Frequency:||At the beginning of treatment, there is a titration period, where for 7 days the dose starts off at a lower level and is increased. After the first 7 days, a daily standard dose is taken.|
|TGA approval date:||Jul 2020|
|Mechanism of action||Ozanimod is a selective immunosuppressant that targets specific proteins on immune cells (called S1P receptors). The mechanism of action is believed to involve preventing immune cells from moving into the areas of inflammation in MS (the brain and spinal cord), but research is ongoing.|
|Clinical trial results||The clinical trial results here were from a “Phase III clinical trial” meaning that ozanimod was compared to a standard MS treatment, in this case, interferon beta.
When compared to interferon beta, there was a reduction in relapses per year of 48% (after 1 year) and 38% (after 2 years).
On ozanimod, 78% of people were relapse-free at Year 1 and 76% in Year 2. These were significantly higher than percent of people relapse-free for interferon beta (66% at Year 1, 68% at Year 2)
There was no significant difference in disability progression detected with ozanimod treatment compared to interferon beta.
Magnetic resonance imaging (MRI) showed significantly fewer MS lesions at both Year 1 and Year 2 than for interferon beta (for both T1 and T2 lesions).
|Safe in Pregnancy||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.
|Breastfeeding (information predominatly from LACTMED database)||Women receiving ozanimod 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 ozanimod should not breastfeed.
|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 https://www.tga.gov.au/ reporting-problems.|
|Potential side effects (not a comprehensive list)||The most common side effects of ozanimod were nose and throat inflammation, headache, and upper respiratory tract infection. Potential serious side effects may include allergic reaction (swelling of the face, lips, mouth, tongue or throat, shortness of breath, wheezing or difficulty breathing, shortness of breath), significant changes in vision, or a rash of small fluid-filled blisters, appearing on reddened skin, signs of viral infection that can be potentially severe (herpes zoster or shingles). Further information can be obtained from the TGA product information and consumer medicine information.|
|Manufacturer||Bristol Myers Squibb|