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MAYZENT is a brand name for Siponimod, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
, General). 3 Pharmacokinetics, Special Populations and Conditions – Genetic Polymorphism). , immunodeficiency syndrome). , hepatitis, tuberculosis), until resolution of the infection (see 7 WARNINGS AND PRECAUTIONS, Immune). • Patients with known active malignancies, except localized basal cell carcinoma of the skin (see 7 WARNINGS AND PRECAUTIONS, Neoplasm).
• Patients who in the last 6 months had myocardial infarction (MI), unstable angina pectoris, stroke/transient ischemic attack (TIA), decompensated heart failure (requiring inpatient MAYZENT® (siponimod) Page 5 of 56 treatment), or New York Heart Association Class III/IV heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
• Patients with second degree Mobitz type II atrioventricular (AV) block, third degree AV block, or sick sinus syndrome, if they do not have a pacemaker (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). • Women (including female adolescents) who are pregnant or of childbearing potential not using effective contraception.
1 Pregnancy). 1 Dosing Considerations Prior to initiating treatment with MAYZENT the following assessments should be done to guide patient selection and treatment: CYP2C9 genotype The CYP2C9 genotype has a significant impact on siponimod metabolism.
• Determine the CYP2C9 genotype of the patient to establish CYP2C9 metabolizer status. CYP2C9 genotyping prior to initiating treatment with siponimod will be offered by the manufacturer through its Patient Support Program. 3 Pharmacokinetics, Special Population and Conditions – Genetic Polymorphism).
4 Drug-Drug Interactions). Immune system effects MAYZENT causes a reduction in circulating lymphocyte counts to approximately 20% to 30% of baseline values via reversible retention in lymphoid organs and may increase the risk of infections.
, within the last 6 months or after discontinuation of prior therapy) (see 7 WARNINGS AND PRECAUTIONS, Immune – Risk of Infections). • Check varicella zoster virus (VZV) antibody status if there is no health professional confirmed history of chicken pox or vaccination with varicella vaccine; VZV vaccination of antibody-negative patients is recommended, with a delay in treatment initiation for 1 month after vaccination to allow the full effect of vaccination to occur (see 7 WARNINGS AND PRECAUTIONS, Immune – Vaccination).
• Delay the start of MAYZENT in patients with severe active infection until resolved (see 2 CONTRAINDICATIONS). • Vaccination against human papilloma virus (HPV) should be considered before initiating treatment with MAYZENT (see 7 WARNINGS AND PRECAUTIONS, Immune – Risk of Infections).
MAYZENT® (siponimod) Page 6 of 56 Cardiac effects Initiation of treatment with MAYZENT causes a transient decrease in heart rate and atrioventricular conduction delays. Prescribers should: • Obtain an electrocardiogram (ECG) for all patients to determine whether pre-existing conduction abnormalities are present.
3 Pharmacokinetics, Special Population and Conditions – Genetic Polymorphism). 4 Drug-Drug Interactions). Immune system effects MAYZENT causes a reduction in circulating lymphocyte counts to approximately 20% to 30% of baseline values via reversible retention in lymphoid organs and may increase the risk of infections.
, within the last 6 months or after discontinuation of prior therapy) (see 7 WARNINGS AND PRECAUTIONS, Immune – Risk of Infections). • Check varicella zoster virus (VZV) antibody status if there is no health professional confirmed history of chicken pox or vaccination with varicella vaccine; VZV vaccination of antibody-negative patients is recommended, with a delay in treatment initiation for 1 month after vaccination to allow the full effect of vaccination to occur (see 7 WARNINGS AND PRECAUTIONS, Immune – Vaccination).
• Delay the start of MAYZENT in patients with severe active infection until resolved (see 2 CONTRAINDICATIONS). • Vaccination against human papilloma virus (HPV) should be considered before initiating treatment with MAYZENT (see 7 WARNINGS AND PRECAUTIONS, Immune – Risk of Infections).
MAYZENT® (siponimod) Page 6 of 56 Cardiac effects Initiation of treatment with MAYZENT causes a transient decrease in heart rate and atrioventricular conduction delays. Prescribers should: • Obtain an electrocardiogram (ECG) for all patients to determine whether pre-existing conduction abnormalities are present.
2 Drug Interactions Overview, Pharmacodynamic interactions). 4 Administration). • For patients with certain other pre-existing cardiac conditions, seek an evaluation from a cardiologist prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular – Treatment initiation recommendations in patients with certain cardiovascular conditions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Drug Interactions Overview, Pharmacodynamic interactions). 4 Administration). • For patients with certain other pre-existing cardiac conditions, seek an evaluation from a cardiologist prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular – Treatment initiation recommendations in patients with certain cardiovascular conditions).
2 Clinical Trial Adverse Reactions, Bradyarrhythmia). See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Cardiovascular for more complete information regarding patients with certain cardiovascular conditions in which MAYZENT should not be used or may require additional monitoring.
Ophthalmologic evaluation Patients with a history of diabetes mellitus, uveitis and underlying/co-existing retinal diseases are at increased risk of macular edema. It is recommended that patients with diabetes mellitus, uveitis or a history of retinal disorders undergo an […]
2 Clinical Trial Adverse Reactions, Bradyarrhythmia). See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Cardiovascular for more complete information regarding patients with certain cardiovascular conditions in which MAYZENT should not be used or may require additional monitoring.
Ophthalmologic evaluation Patients with a history of diabetes mellitus, uveitis and underlying/co-existing retinal diseases are at increased risk of macular edema. 2 Clinical Trial Adverse Reactions, Macular edema). , within last 6 months) liver function test including transaminase and bilirubin levels prior to initiating treatment with MAYZENT (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Skin cancer Skin cancers have been reported in patients treated with S1P modulators, including MAYZENT. Monitor for suspicious skin lesions before initiating treatment with MAYZENT, particularly in patients with risk factors for skin cancer (see 7 WARNINGS AND PRECAUTIONS, Neoplasm).
1 Pregnancy). A negative pregnancy test must be obtained before initiation of treatment in women of childbearing potential. Current or prior medications For patients taking antineoplastic, immunosuppressive, or immune-modulating therapies, including other disease modifying treatments for multiple sclerosis and corticosteroids, or if there is a history of prior use of such drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with MAYZENT (see 7 WARNINGS AND PRECAUTIONS, Immune – Risk of Infections; and 7 WARNINGS AND PRECAUTIONS, Immune - Prior and concomitant treatment with immunosuppressive or immune-modulating therapies).
2 Pharmacodynamics, Heart rate and rhythm). 25 mg), to reach the maintenance dose of 2 mg* MAYZENT starting on day 6. Table 1 - Dose titration regimen to reach MAYZENT maintenance dosage Titration […]