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.

mayzent

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.