Gilenya Oral Capsule 0.5Mg Drug Medication Dosage Information
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Gilenya: Oral capsule (0.5mg)

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Gilenya 0.5mg Capsule

What is this Medicine?

FINGOLIMOD (fin GOL i mod) may help prevent relapses of multiple sclerosis. This medicine is not a cure.

CVS Pharmacy Patient Statistics for Gilenya: Oral capsule(0.5mg)
Generic vs. Brand Name Usage*
*Brand contains same active ingredient but may not represent FDA-approved generic equivalent
Usage By Strength
In-Depth Information

Gilenya 0.5mg Capsule

NDC: 000780607
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Multiple Sclerosis

Storage Information
Protect from moisture
Store at 77 degrees F; excursions permitted to 59-86 degrees F
Gilenya 0.5mg Capsule

Reported Side Effects for Gilenya 0.5mg Capsule

Brain Dysfunction Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Lightheadedness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Scaly And Itchy Rashes Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Macular Edema Incidence:
0.5-1.5%*
Severity: SEVERE
Onset: DELAYED
Secondary Malignancy Incidence:
2.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Weakness Incidence:
2.0%*
Severity: MILD
Onset: DELAYED
Low White Blood Cell Counts Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
Hair Loss Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Slow Heart Beat Incidence:
3.0%*
Severity: SEVERE
Onset: RAPID
Heart Block Incidence:
4.0-4.7%*
Severity: SEVERE
Onset: EARLY
Blurred Vision Incidence:
4.0%*
Severity: MODERATE
Onset: EARLY
Migraine Incidence:
6.0%*
Severity: MODERATE
Onset: EARLY
Low Lymphocytes Incidence:
7.0%*
Severity: MODERATE
Onset: DELAYED
High Blood Pressure Incidence:
8.0%*
Severity: MODERATE
Onset: EARLY
Shortness Of Breath Incidence:
9.0%*
Severity: MODERATE
Onset: EARLY
Back Pain Incidence:
10.0%*
Severity: MILD
Onset: DELAYED
Sinus Infection Incidence:
11.0%*
Severity: MILD
Onset: DELAYED
Stomach Pain Incidence:
11.0%*
Severity: MILD
Onset: EARLY
Flu Incidence:
11.0%*
Severity: MILD
Onset: DELAYED
Cough Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
15.0%*
Severity: MODERATE
Onset: DELAYED
Headache Incidence:
25.0%*
Severity: MILD
Onset: EARLY
Infection Incidence:
72.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


Learning More About
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Patient Experiences with Gilenya

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