Gilenya Side Effects

Serious Side Effects of Gilenya

pain in chest or decrease in heart rate
trouble breathing or feeling short of breath
feeling extremely drowsy or dizzy
faintness and passing out
flu-like symptoms or signs of an infection such as soreness of the throat, fever, chills and coughing
eye discomfort or pain; vision changes such as blurred vision, change in color perception, seeing spots or loss of vision
unusual sensitivity to light
upset stomach, abdominal pain, nauseousness or throwing up, jaundice (yellowing of the sin or eyes) and dark urine which may be signs of liver damage
hives, rash, swelling of the mouth, tongue, throat, or face and difficulty breathing indicate an allergic reaction

Common Side Effects of Gilenya

Unexplained headache or head pain.
Loss of strength or back pain.
Changes in mood or mentality, which make include feelings of depression.
Numbness, burning, or tingling sensations in the extremities, especially the hands and feet.
Dry, itchy, or peeling skin.
Alopecia, or hair loss.

Warnings & Recalls for Gilenya

FDA Warnings and Gilenya

In December of 2011, U.S. Food and Drug Administration released information about a rare incident in which a patient died 24 hours after taking the initial dose of Gilenya. The FDA warns patients that this medicine can slow the heart rate to dangerous levels and should be used with caution. The FDA recommends that patients be carefully monitored after taking Gilenya.

Gilenya and Pregnancy

Gilenya is listed as an FDA pregnancy Category C medicine. The effect of Gilenya on the fetus when taken by a pregnant woman is not certain. Gilenya may cause harm to a baby that is nursing. Do not breastfeed if you are taing Gilenya. Ask your doctor about the risks and benefits before taking Gilenya if you are pregnant or planning to become pregnant.

General Warnings

Gilenya is not safe for all patients. Gilenya should not be used by anyone with the following conditions:

is allergic to fingolimod
extreme heart failure (the heart is not able to pump blood properly)
"AV block" (impairment between the atria and ventricles)
sick sinus syndrome and does not have a pacemaker
if you use any medications for maintaining your heart rate
if you have had a recent heart problem such as a heart attack, any type of stroke, or pain in the chest

Tell your doctor about all medical conditions you may have or if you are taking any medicines. Let your doctor know if you have:

any illnesses or infections
heart disorders
heart rate or blood pressure irregularities (including high or low blood pressure)
diabetes
any liver or kidney problems
breathing disorders
uveitis (swelling of the eye)
never had chickenpox or have never been given a varicella vaccination

While taking Gilenya, keep all appointments with your doctor, you may need to have your blood, eyes, liver and lung function tested to ensure your safety.

Gilenya Interactions

Gilenya may interact with other drugs or affect the way other medicines work. Let your doctor know about all medications you are taking, especially:

beta blockers
calcium channel blockers
arsenic trioxide or chemotherapy medicines
transplant rejection preventing drugs such as tacroliuus
antibiotics, antifungals and anti-malaria drugs
antidepressant or medicines for mental illnesses
nausea preventing medication
narcotics
pain relievers
any medicine which may decrease the ability of the immune system
migraine headache treatments

Gilenya Treatment and Use

Gilenya | fingolimod is a sphingosine l-phosphate receptor modulator medicine marketed by Novartis for treating and preventing relapsing (deteriorating) multiple sclerosis. Gilenya was approved by the U.S. Food and Drug Administration in September of 2010 and has become a controversial medicine for the serious risks it poses. Gilenya does not cure multiple sclerosis.

Gilenya should only be used in patients over the age of 18.

How Does Gilenya Work?

Multiple sclerosis is caused by abnormally functioning nerve cells. Gilenya treats multiple sclerosis and prevents serious damage to the body by suppressing the immune system and blocking cells from causing further injury to nerves.

How to Use Gilenya

Gilenya is prescribed in capsule form to be taken orally. It is typically recommended to take Gilenya in .5mg doses once each day with a full glass of water, with or without food. Your first dose should be taken under supervision or in a doctor’s office to monitor the effects for 6 hours after taing Gilenya.

Use Gilenya as prescribed by your doctor. Do not use any different dosage amounts.

Other Names for Gilenya

Brand name:

Gilenya

Generic name:

fingolimod