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Gilenya

Generic Name: fingolimod (fin GOE li mod)
Brand Names: Gilenya
Gilenya (fingolimod) is used to treat relapsing forms of multiple sclerosis. Includes Gilenya side effects, interactions and indications.
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Drug Information:
Gilenya (fingolimod) is an immunosuppressant. It works by keeping immune cells trapped in your lymph nodes so they can't reach the central nervous system (brain and spinal cord). Gilenya is used to treat relapsing multiple sclerosis (MS) in adults, and children and adolescents aged 10 years and older. Gilenya will not cure MS, it will only decrease the frequency of relapse symptoms. You should not use Gilenya if you have a serious heart condition. This includes severe heart failure, "AV block," sick sinus syndrome (unless you have a pacemaker), taking certain heart rhythm medicines, or a recent heart attack, stroke, chest pain, or other serious heart problem. Learn more

Gilenya Side Effects

Gilenya Side Effects

Note: This document contains side effect information about fingolimod. Some of the dosage forms listed on this page may not apply to the brand name Gilenya.

In Summary

Common side effects of Gilenya include: infection, back pain, diarrhea, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, and increased liver enzymes. Other side effects include: blurred vision, bradycardia, bronchitis, increased gamma-glutamyl transferase, lymphocytopenia, migraine, dizziness, dyspnea, hypertension, increased serum transaminases, and tinea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fingolimod: oral capsule

Along with its needed effects, fingolimod (the active ingredient contained in Gilenya) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fingolimod:

More common

  • Blurred vision
  • chills
  • cough
  • cough-producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • pounding in the ears
  • runny nose
  • seizures
  • shivering
  • slow or fast heartbeat
  • sore throat
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

Less common

  • Black, tarry stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • headache, severe and throbbing
  • hoarseness
  • lightheadedness, dizziness, or fainting
  • lower back or side pain
  • painful or difficult urination
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising

Incidence not known

  • Confusion
  • difficulty in speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • slow speech
  • weight loss
  • yellow skin and eyes

Some side effects of fingolimod may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Back pain
  • pain or tenderness around the eyes and cheekbones
  • stuffy nose

Less common

  • Decreased weight
  • depression
  • eye pain
  • hair loss or thinning of the hair
  • itching in the genitals or other skin areas
  • itching skin
  • lack or loss of strength
  • scaling
  • stomach pain
  • skin rash, encrusted, scaly, and oozing
  • weakness

For Healthcare Professionals

Applies to fingolimod: oral capsule

General

The most common adverse events were headache, influenza, diarrhea, back pain, liver transaminase elevations, and cough.

Cardiovascular

Common (1% to 10%): Hypertension, first degree AV block, bradycardia

Uncommon (0.1% to 1%): Symptomatic bradycardia, second degree AV block

Rare (0.01% to 0.1%): Peripheral arterial occlusive disease

Very rare (less than 0.01%): Hemophagocytic syndrome

Frequency not reported: Heart rate decrease, Mobitz type I (Wenckebach) block, Mobitz type II block

Postmarketing reports: Third degree AV block, AV block with junctional escape, transient asystole, peripheral arterial occlusive disease

Hepatic

In the majority of cases, elevations in liver enzymes occurred within 6 to 9 months and returned to normal within approximately 2 months following discontinuation of fingolimod (the active ingredient contained in Gilenya)

Very common (10% or more): ALT/AST increased (14%)

Common (1% to 10%): Elevation in liver transaminases, GGT increased, hepatic enzyme increased, liver function test abnormal

Immunologic

Infections occurred at a rate similar to placebo.

Very common (10% or more): Influenza viral infection (13%), sinusitis (10.9%), infections

Common (1% to 10%): Herpes viral infection, bronchitis, gastroenteritis, tinea infection

Uncommon (0.1% to 1%): Pneumonia

Frequency not reported: Fatal herpetic infection, fatal varicella zoster virus infection

Nervous system

Symptoms of posterior reversible encephalopathy syndrome included sudden onset of severe headache, altered mental status, visual disturbances, and seizure.

Very common (10% or more): Headache (25%)

Common (1% to 10%): Dizziness, paresthesia, migraine

Rare (less than 0.1%): Posterior reversible encephalopathy syndrome, ischemic and hemorrhagic stroke

Frequency not reported: Neurological atypical disorders

Postmarketing reports: Syncope

Gastrointestinal

Very common (10% or more): Diarrhea (12%)

Hematologic

Common (1% to 10%): Lymphopenia, leukopenia

Uncommon (0.1% to 1%): Neutrophil count decreased

Ocular

Macular edema occurred at a dramatically higher rate in patients with a history of uveitis.

Common (1% to 10%): Vision blurred, eye pain

Uncommon (0.1% to 1%): Macular edema

Respiratory

Very common (10% or more): Cough (10%)

Common (1% to 10%): Dyspnea, reduction in diffusion lung capacity, reduction in FEV1

Musculoskeletal

Very common (10% or more): Back pain (12%)

Dermatologic

Common (1% to 10%): Alopecia, eczema, pruritus

Metabolic

Common (1% to 10%): Weight decreased, blood triglycerides increased

Other

Common (1% to 10%): Asthenia

Postmarketing reports: Unexplained death

Psychiatric

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Depressed mood

Oncologic

Frequency not reported: Lymphoma

Hypersensitivity

Postmarketing reports: Rash, urticaria, angioedema

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Gilenya (www.drugs.com/gilenya.html).