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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

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