Fingolimod

فینگولیمود

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsS1P receptor modulator (MS)

Market / country: 🇺🇸 USA

Gilenya (US)

🧮 Dose calculator

Multiple sclerosis (relapsing) · Regimen source: FDA Gilenya · 2.3

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🛡️ 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

Formulations

👥 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)] .”

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