THERAPY

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

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