As the first oral sphingosine-1-phosphate receptor modulator for the treatment of multiple sclerosis, fingolimod provides patients with a convenient treatment option. However, both doctors and patients need to be alert to its potential safety risks.

What Are the Side Effects of Fingolimod (Fingolimod)?

Common Side Effects

The most common side effects of fingolimod include headache, elevated liver transaminases, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and limb pain.

The incidence of these reactions is usually above 10%.

Patients may also experience hematological changes such as nausea, alopecia (hair loss), elevated triglycerides, leukopenia (reduced white blood cell count), and lymphopenia (reduced lymphocyte count).

Most common side effects are mild in severity and may gradually diminish as treatment continues.

Severe Side Effects of Fingolimod (Fingolimod) That Require Alertness

Side Effects Related to the Cardiovascular System

A decrease in heart rate may occur within 6 hours after the first dose, typically starting within 1 hour of administration and reaching the maximum decrease within 6 hours.

Among adult patients, the incidence of symptomatic bradycardia is 0.6%, mainly presenting with symptoms such as dizziness, fatigue, palpitations, and chest pain. These symptoms usually resolve within 24 hours after the start of treatment.

In very rare cases, cardiac arrest and unexplained death may occur.

Side Effects Related to the Immune System

Fingolimod may increase the risk of infections, including bronchitis, herpes zoster, influenza, sinusitis, and pneumonia.

The incidence of severe infections is 2.3%.

Risk of Opportunistic Infections

Progressive multifocal leukoencephalopathy (PML) is one of the most serious adverse reactions of fingolimod.

PML is a rare brain infection caused by the JC virus, which usually leads to death or severe disability.

Its symptoms are diverse and may progress over days to weeks.

Ocular Side Effects

Macular edema is a significant risk of fingolimod, with an incidence of approximately 0.5%.

Symptoms include blurred vision and decreased visual acuity.

Patients with diabetes and those with a history of uveitis are at a higher risk.

Precautions for the Administration of Fingolimod (Fingolimod)

Monitoring Requirements for the First Dose

All patients must be monitored for at least 6 hours after the first dose, with pulse and blood pressure measured every hour.

An electrocardiogram (ECG) is required before administration and at the end of the observation period.

Administration in Special Populations

For pregnant women and women of childbearing age, fingolimod may cause fetal harm.

It is recommended to use effective contraceptive measures during treatment and for 2 months after discontinuing the drug.

Women planning to become pregnant should stop taking the drug 2 months before planning pregnancy.

The use of fingolimod in pediatric patients requires special caution.

Key Points for Patient Education

Patients should fully understand the potential risks of fingolimod, especially the requirements for heart rate monitoring after the first dose.

Patients should not discontinue the drug without authorization; they must consult a doctor before stopping the medication.