Fingolimod is a sphingosine-1-phosphate receptor modulator, primarily indicated for the treatment of relapsing multiple sclerosis in patients aged 10 years and older, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

How to Use Fingolimod (Fingolimod)

Indications, Dosage and Administration

Fingolimod is indicated for the treatment of various types of relapsing multiple sclerosis.

The recommended dosage for adults and pediatric patients aged 10 years and older with a body weight exceeding 40 kg is 0.5 mg orally once daily, which can be taken with food or on an empty stomach.

For pediatric patients aged 10 years and older with a body weight of 40 kg or less, the recommended dosage is 0.25 mg orally once daily.

Essential Evaluations Before Medication Administration

Cardiac evaluation: Required for patients with specific underlying heart diseases.

Complete Blood Count (CBC) test.

Detection of serum transaminase (ALT and AST) and total bilirubin levels.

Ophthalmic examination, including macular assessment.

Skin examination to monitor for suspicious skin lesions.

Monitoring During the First Dose Administration

Initiation of Fingolimod treatment may cause a decrease in heart rate, requiring close monitoring.

The first dose of Fingolimod for patients should be administered in a medical setting equipped with resources to manage symptomatic bradycardia. All patients must be monitored for at least 6 hours after the first dose, with pulse and blood pressure measured every hour.

Electrocardiogram (ECG) is mandatory: All patients need to undergo an ECG before drug administration and at the end of the observation period.

Dose Adjustment of Fingolimod (Fingolimod)

Reinitiation After Treatment Interruption

When restarting Fingolimod after a treatment interruption of more than 14 days, first-dose monitoring is required, as the effects of Fingolimod on heart rate and atrioventricular conduction may recur upon re-administration.

Specific Criteria for Interruption Duration

If treatment is interrupted for 1 day or more within the first two weeks of the initial treatment phase, the first-dose monitoring procedure is recommended.

During the 3rd to 4th weeks of treatment, if the treatment interruption exceeds 7 days, first-dose monitoring is also required.

Monitoring During Dose Escalation

If dose escalation is needed for a patient during treatment (especially for pediatric patients), first-dose monitoring is similarly recommended.

Medication for Special Populations of Fingolimod (Fingolimod)

Pediatric Patients

The efficacy of Fingolimod in pediatric patients aged 10 to under 18 years has been confirmed.

For pediatric patients aged 10 years and older with a body weight exceeding 40 kg, the dosage is 0.5 mg; for those with a body weight of 40 kg or less, the dosage is 0.25 mg.

It is strongly recommended that pediatric patients complete all immunizations in accordance with current immunization guidelines before initiating Fingolimod treatment.

Patients with Hepatic Impairment

Patients with mild or moderate hepatic impairment: No dose adjustment is required.

Patients with severe hepatic impairment: Close monitoring is necessary, as drug exposure is doubled, increasing the risk of adverse reactions.

Pregnant Women and Women of Childbearing Age

Fingolimod may cause fetal harm. Women of childbearing age must use effective contraceptive measures during treatment and for two months after discontinuing the drug.