Prescribing information

 

MAYZENT initiation, administration, and ongoing monitoring.

CBC, complete blood count; LFT, liver function test; VZV, varicella zoster virus.

 

mayzent-metaboliser-table

 

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.


 

Infographic showing the titration schedule

*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.


 

 Infographic showing ongoing monitoring of patients, including complete blood count, ophthalmic evaluation and blood pressure.

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.


 

dosing_admin_tab4_new

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

  1. MAYZENT (siponimod) Summary of Product Characteristics.
     
SIP20-C001d May 2020.
×

Ask Speakers

×

Medical Information Request

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]