Siponimod
سیپونیمود
🎗️ Antineoplastic And Immunomodulating AgentsS1P receptor modulator
Market / country: 🇺🇸 USA
Mayzent (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Mayzent · 2.2
- • Genotype CYP2C9 first. *1/*3 or *2/*3: 1 mg from day 5 after a 4-day titration. Swallow whole. Interruption ≥4 days: restart titration. Bradycardia, AV block or prior MI/HF: 6-hour first-dose monitoring. FDA Mayzent · 2.2FDA Mayzent · 2.3FDA Mayzent · 2.5FDA Mayzent · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Within 6 months: MI, unstable angina, stroke, TIA, decompensated or class III/IV heart failure; Mobitz II or third-degree AV block or sick sinus syndrome without a pacemaker; CYP2C9*3/*3 genotype; hypersensitivity to siponimod. FDA Mayzent · 4
Warnings
- • Infections and PML; macular oedema; bradyarrhythmia at initiation; respiratory effects; liver injury; skin cancer; raised blood pressure; fetal risk; severe disability increase after stopping. FDA Mayzent · 5
Formulations
- 2 mg tablet — tablet 🇺🇸 USA FDA Mayzent · 3
- 1 mg tablet — tablet 🇺🇸 USA FDA Mayzent · 3
- 0.25 mg tablet (titration) — tablet 🇺🇸 USA FDA Mayzent · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Mayzent · 8.1
“Based on animal data and its mechanism of action, MAYZENT can cause fetal harm when administered to a pregnant woman ( see Data ).”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Mayzent · 8.2
“Risk Summary There are no data on the presence of siponimod in human milk, the effects of MAYZENT on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Mayzent · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Mayzent · 8.5
“In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Mayzent · 8.3
“Contraception Females Before initiation of MAYZENT treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with MAYZENT [see Use in Specific Populations (8.1)] .”
🔗 Reference links
- FDA (approval record)NDA209884
- DailyMed (FDA label)FDA Mayzent
- MedlinePlus (NIH)Siponimod
- WHO ATC/DDDL04AE03
- Darooyab (Iran)Siponimod
🇮🇷 Registered in Iran Darooyab · G-5546/Siponimod
Dosage forms with Iranian generic codes, per Darooyab.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Mayzent · 3FDA Mayzent · 2.2FDA Mayzent · 2.3FDA Mayzent · 2.5FDA Mayzent · 2.4FDA Mayzent · 4FDA Mayzent · 5FDA Mayzent · SPL approval / marketing categoryFDA Mayzent · 8.1FDA Mayzent · 8.2FDA Mayzent · 8.4FDA Mayzent · 8.5FDA Mayzent · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5546/Siponimod
- Clinical review⚠ Unverified