FINGOLIMOD HYDROCHLORIDE

Electrolyte / Mineral

Brand names: Fingolimod

Oral

Mechanism of Action

12.1 Mechanism of Action Fingolimod is metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate. Fingolimod-phosphate is a sphingosine 1-phosphate receptor modulator, and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.

Indications

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

Contraindications

• 4 CONTRAINDICATIONS Fingolimod capsules are 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

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Infections: Fingolimod may increase the risk
3 ) • Macular Edema : Increases the risk of macular edema
Diabetes mellitus and uveitis increase the risk
7 ) • Fetal Risk: May cause fetal harm

Known Side Effects

7 documented side effects by frequency

Fatigue

>10%

Headache

>10%

Dizziness

1-10%

Falls

1-10%

Nausea

1-10%

Drug Not Working

0.1-1%

General Unwellness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral