Mayzent (Siponimod) – Multiple Sclerosis | DengYueMed

Mayzent Application Scope

Mayzent is an oral sphingosine‑1‑phosphate receptor modulator used to treat relapsing forms of multiple sclerosis, including active secondary progressive MS.

Characteristics

• Ingredients: Siponimod

• Properties:

  • Mechanism: blocks S1P receptors on lymphocytes, reducing their migration to the CNS

  • High oral bioavailability (~84%), >99.9% protein-bound

  • Metabolized mainly by CYP2C9 (and CYP3A4), half‑life ~30 h

• Packaging Specification:

  • Film‑coated tablets in strengths: 0.25 mg, 1 mg, 2 mg

  • Available in blister packs for titration (12 tablets) and maintenance (28, 84, 98, 120 tablets)

• Storage: See FDA/EMA labeling; standard room temperature, protect from moisture and tampering

• Expiry Date: Refer to the printed date on the packaging. Leaflet last revised March 2025

• Executive Standard:

  • Follows EMA/US FDA/Health Canada regulatory standards

  • Specific pharmacopeial references in prescribing info

• Approval Number:

  • US NDA 209884

  • The EU and other regions have marketing authorization per EMA and TGA records

• Date of Revision:

  • EU PI last updated May 6, 2025

  • UK leaflet revised 03/2025; US Medication Guide June 2024

• Manufacturer: Novartis Pharmaceuticals (e.g., UK, US labeling)

Guidelines for the Use of Mayzent

• Dosage and Administration:

  • Genotype CYP2C9 before initiating

  • For *1/*3 or *2/*3 genotypes: 4‑day titration to 1 mg maintenance

  • Tablets swallowed whole, with or without food

• Adverse Reactions:

  • 10%:

    • headache, hypertension, elevated liver enzymes

    • peripheral edema, nausea, dizziness, diarrhea, falls, extremity pain

  • <5%, ≥1% higher than placebo:

    • herpes zoster, lymphopenia, seizure, tremor, macular edema

    • AV block, asthenia, reduced lung function

• Contraindications:

  • Hypersensitivity to siponimod, peanut/soya

  • CYP2C9 *3/*3 genotype

  • Severe active infections or known opportunistic infections

  • Active malignancy (except skin basal cell carcinoma)

  • Recent MI, unstable angina, stroke/TIA, decompensated or advanced heart failure

  • Significant AV block or sick sinus without a pacemaker

  • Pregnancy and women of childbearing potential not using contraception

• Precautions:

  • Monitor for infections, macular edema, hepatic injury, and skin cancer.

  • The first dose requires 6-hour monitoring in patients with cardiac concerns.

  • Lymphocytes and ECG, liver enzymes, VZV antibody, ophthalmic and skin exams before starting

Mayzent Interactions

• Drug Interactions:

  • Avoid CYP3A4/CYP2C9 inducers (e.g., carbamazepine, modafinil)

  • Care with beta‑blockers, calcium-channel blockers, and anti‑arrhythmics

  • QT‑prolonging drugs and other immunosuppressants

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.