Fingolimod
فینگولیمود
🎗️ Antineoplastic And Immunomodulating AgentsS1P receptor modulator (MS)
Market / country: 🇺🇸 USA
Gilenya (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Gilenya · 2.3
- • First dose with 6-hour monitoring (hourly pulse and BP, ECG before and after) for bradycardia; same when restarting after >14 days off. CBC, liver enzymes and fundus exam. FDA Gilenya · 2.4FDA Gilenya · 2.1FDA Gilenya · 2.5
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Within 6 months: MI, unstable angina, stroke, TIA or decompensated heart failure; Mobitz II/3rd-degree AV block or sick sinus without pacemaker; baseline QTc ≥500 ms; class Ia or III antiarrhythmics; hypersensitivity. FDA Gilenya · 4
Warnings
- • First-dose bradycardia; infections and PML; macular oedema; liver injury. FDA Gilenya · 5FDA Gilenya · 2.4
Formulations
- 0.25 mg capsule — capsule 🇺🇸 USA FDA Gilenya · 3
- 0.5 mg capsule — capsule 🇺🇸 USA FDA Gilenya · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Gilenya · 8.1
“Based on findings from animal studies, GILENYA may cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Gilenya · 8.2
“Risk Summary There are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Gilenya · 8.4
“Safety and effectiveness of GILENYA in pediatric patients below the age of 10 years 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 Gilenya · 8.5
“GILENYA should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, 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 Gilenya · 8.3
“Contraception Before initiation of GILENYA treatment, females of reproductive potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with GILENYA [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)] .”
🔗 Reference links
- FDA (approval record)NDA022527
- DailyMed (FDA label)FDA Gilenya
- MedlinePlus (NIH)Fingolimod
- WHO ATC/DDDL04AE01
- Darooyab (Iran)Fingolimod
🇮🇷 Registered in Iran Darooyab · G-4753/Fingolimod
Dosage forms with Iranian generic codes, per Darooyab.
- 18099 · FINGOLIMOD 0.5MG CAP · کپسول فینگولیمود ۰٫۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Gilenya · 3FDA Gilenya · 2.3FDA Gilenya · 2.4FDA Gilenya · 2.1FDA Gilenya · 2.5FDA Gilenya · 4FDA Gilenya · 5FDA Gilenya · SPL approval / marketing categoryFDA Gilenya · 8.1FDA Gilenya · 8.2FDA Gilenya · 8.4FDA Gilenya · 8.5FDA Gilenya · 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-4753/Fingolimod
- Clinical review⚠ Unverified