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Before Initiation of Therapy :
- CBC,ALT, AST,GGT, LD, total bilirubin, Mg, K, lipid assessment, creatinine, hepatitis B, HBsAg, anti-HBc, hepatitis C, HIV, VZV serology, Measles IgG
- ECG, pregnancy test, chest X-ray or quantiferon
- Immunization status of VZV must be confirmed with serology levels prior to starting therapy. If negative then vaccination must be completed at least 4 to 6 weeks prior to starting the treatment.
- Immunization should be brought to date and vaccination for pneumococcus and haemophilus influenza type B done.
- Resting blood pressure.
- Patients with diabetes mellitus or a history of uveitis are at increased risk of macular edema and should undergo an ophthalmic evaluation prior to initiating therapy.
- No washout period is necessary when switching from interferons or glatiramer acetate.
- The washout period should be less than 2 months when switching from natalizumab.
- Cholestyramine should be used to fully eliminate teriflunomide when switching from it to Zeposia.
- Negative pregnancy test and counseling with regards to contraception
First Dose :
- The first dose must be administered at a first dose clinic where ECG, and vital signs monitoring will be done prior and for least 6 hours immediately after the first dose.
- Overnight monitoring should occur in patients with pre-existing cardiac conditions ,prolonged QTc interval, those that require pharmacological intervention for bradyarrythmia during the monitoring period or at the end of the 6 hrs period the QTc is >500ms
- First dose monitoring should be repeated if the therapy is interrupted for more than 1 day during the first 2 weeks, more than 7 days during the weeks 3 and 4 and more than 2 weeks any time after 1 month of therapy.
Monitoring During Therapy :
- CBC,ALT, LD, total bilirubin Q1 months X6 then Q4 months
- Regular blood pressure monitoring
- All patients should undergo an ophthalmological examination at month 3 or 4 for possible macular edema
- Diabetic patients should undergo regular ophthalmological examinations while on therapy
- Annual influenza vaccination of patient and his/her family members
- Ophthalmological examination if there is visual symptoms
- Spirometric evaluation if there is respiratory symptoms (can occur within 1 month of initiation)
Discontinue Therapy :
- There is evidence of a serious infection such as disseminated VZV or herpetic infection or cryptococcal meningitis
- PML is suspected
- There is a sustained 5X ULN increase in the transaminases level
- Evidence of PRES, macular edema
- There is a reduction in spirometric values
(Some studies only include abstracts)
→Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial