What is Fingolimod used for?

1 INDICATIONS AND USAGE Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod capsules are a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active s

How does Fingolimod work?

11 DESCRIPTION Fingolimod is a sphingosine 1-phosphate receptor modulator.

What pharmaceutical form is Fingolimod available in?

Fingolimod: Kapsułki twarde 0,5 mg (doustna)

What are the side effects of Fingolimod?

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.3 )] Macular Edema [see Warnings and Precautions ( 5.4 )] Liver Injury [see Warnings and Precautions ( 5.5 )] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.6 )]

Who should NOT take Fingolimod?

4 CONTRAINDICATIONS Fingolimod is contraindicated in patients who have: in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure a history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker [see Warnings and Precautions ( 5.1 )] a baseline QTc interval ≥500 msec cardiac arr

Does Fingolimod interact with other medications?

7 DRUG INTERACTIONS Systemic Ketoconazole: Monitor during concomitant use. ( 7.2 , 12.3 ) Vaccines : Avoid live attenuated vaccines during, and for 2 months after stopping fingolimod treatment. ( 5.2 , 7.3 ) 7.1 QT Prolonging Drugs Fingolimod has not been studied in patients treated with drugs that prolong the QT interval. Drugs that prolong the QT interval have been associated with cases of torsades de pointes in patients with bradycardia. Since initiation of fingolimod treatment results in dec

Can Fingolimod be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. In rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m 2 ) basis. The most

What precautions should be taken with Fingolimod?

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures Fingolimod?

Mylan Pharmaceuticals Ltd (Niemcy)

What ATC class does Fingolimod belong to?

Fingolimod: ATC L04AA27. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

Fingolimod

0,5 mg, Kapsułki twarde

INN: Fingolimodum

Data updated: 2026-04-13

Available in:

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Form

Kapsułki twarde

Dosage

0,5 mg

Route

doustna

Storage

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About This Product

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