MAYZENT initiation, administration, and ongoing monitoring.
CBC, complete blood count; LFT, liver function test; VZV, varicella zoster virus.
Women of childbearing potential
Due to risk for the foetus, siponimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception. Before initiation of treatment, women of childbearing potential must be informed of this risk to the foetus, must have a negative pregnancy test and must use effective contraception during treatment and for at least 10 days after treatment discontinuation. MAYZENT should not be used during breast-feeding.
*CYP2C9*1*1/*1*2/*2*2 require a maintenance dose of 2 mg. CYP2C9*1*3/*2*3 require a maintenance dose of 1 mg.
For women of childbearing potential
MAYZENT is contraindicated during pregnancy. Consequently, MAYZENT should be stopped at least 10 days before a pregnancy is planned. If a woman becomes pregnant while on treatment, MAYZENT must be discontinued.
Missed dose after day 6
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Re-initiation of maintenance therapy after treatment interruption
If maintenance treatment is interrupted for 4 or more consecutive daily doses, MAYZENT needs to be re-initiated with a new titration pack.
Patients should be instructed to report symptoms of infection to their physician promptly. Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while on therapy. Suspension of treatment with siponimod should be considered if a patient develops a serious infection.
Women of childbearing potential
Women of childbearing potential must continue to use effective contraception for at least 10 days after discontinuation of MAYZENT.
S1P, sphingosine-1-phosphate.
Indication: MAYZENT is indicated for the treatment of adult patients with SPMS with active disease evidenced by relapses or imaging features of inflammatory activity.1
SPMS, secondary progressive multiple sclerosis.
Reference
- MAYZENT (siponimod) Summary of Product Characteristics.
