Gilenya Side Effects

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Gilenya® commonly causes side effects such as weakness, back pain, numbness, burning or tingling of the appendages, headache, depression, balding, and skin problems. It may slow the heart rate when the first dosage is administered; therefore, new patients are monitored in a professional setting for safety. More serious side effects can also occur, and patients have an increased risk of infection.[1]

Gilenya® (fingolimod) is an oral prescription medicine approved by the FDA on September 22, 2010, for the treatment of relapsing forms of multiple sclerosis (MS) in adults.[2] Gilenya® treats symptoms but does not cure multiple sclerosis. It can slow the physical problems MS causes and decrease the number of MS flare-ups (relapses).

With MS, white blood cells attack the myelin sheaths protecting nerve cells. Gilenya® prevents the white blood cells from leaving the lymph nodes. Fewer white blood cells means there will be a reduced risk of MS relapses. This new MS drug was not tested for safety or efficacy in children under the age of 18.[3]


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Wheelchair.jpg
Flickr: Marcel Oosterwijk
Brand name for Fingolimod[4]
Manufacturer Novartis[2]
Uses Treatment of relapsing forms of multiple sclerosis (MS)[3]
Side effects Headache, flu, diarrhea, back pain, cough, slow heart rate, infections, macular edema, shortness of breath, liver problems[5]
Who should not take Gilenya® Those with a history of arrhythmia, slow heart rate or heart problems, fainting, fever, infection, weakened immune system, eye problems, diabetes, breathing problems, liver problems, high blood pressure, pregnant women or those who plan to become pregnant[5]
Disclaimer The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.
Author Susan MacDowell
 
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Contents

Common Gilenya Side Effects

The most common side effects associated with Gilenya® include headache, flu, diarrhea, back pain, abnormal liver tests, and a persistent cough. In Gilenya® clinical trials, more serious side effects included:

  • Bradycardia (slowing of the heartbeat) during the first Gilenya® treatment. Consequently, the first dose must be taken under medical supervision.
  • Increased risk of serious infections due to a decrease in the number of white blood cells (lymphocytes) in the blood.
  • Macular edema (swelling of the central portion of the retina) that causes distorted vision.
  • Shortness of breath
  • Liver problems, which may be indicated by nausea, vomiting, stomach pain, loss of appetite, fatigue, jaundice, dark urine
  • Elevated blood pressure
  • Bronchitis
  • Diarrhea[3] [5] [1]

Side Effects of Gilenya

Overview of Gilenya's side effects

Gilenya Allergic Reactions

Few patients will experience severe allergic reactions to Gilenya®. However, it is possible to be allergic to fingolimod, or to any of the inactive ingredients contained in the medicine. Symptoms of an allergic reaction include swollen facial areas or throat, itchy breakouts, trouble breathing or feelings of dizziness.[3] [5]

Gilenya Precautions and Warnings

  • Gilenya® may not be suitable for patients with a history of asthma, emphysema or other conditions that affect the breathing, as well as diabetes, any chronic infection such as hepatitis, or heart issues.[3]
  • Patients with a heart rate of less than 55 beats per minutes may not be good candidates for this drug.[4]
  • Some patients will need to be tested or vaccinated for chicken pox before beginning treatment, as Gilenya® decreases immune function and thus make this type of infection more dangerous.[4]
  • Gilenya® can cause severe side effects if mixed with blood pressure medications.[4]

FDA Review of Gilenya Death

The FDA is investigating a case where a multiple sclerosis patient died within 24 hours of taking the first dose of Gilenya®. It is currently unknown if Gilenya® caused or contributed to the patient's death. When Gilenya® was released, Novartis warned doctors that patients taking beta blockers and calcium channel blockers are at increased risk of bradycardia. This patient was taking both types of medications.[6]

The London-based European Medicines Agency (EMA) has reported an additional 10 deaths of patients who were taking Gilenya®. It is not known if Gilenya® caused those deaths. EMA and Novartis are investigating. One patient who was taking both Gilenya® and Tysabri® developed a potentially-fatal brain infection called progressive multifocal leukoencephalopathy. This virus typically causes disability or death. While experts believe that the Tysabri® most likely led to the infection, the Gilenya® could have also played a part.[7]

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Gilenya and Pregnancy

There are no clinical studies of Gilenya® in pregnant women, and there is a chance that it can cause birth defects. Novartis advises that women use effective birth control during the course of Gilenya® treatment and for two months after treatment with Gilenya® has ended. It is also not yet determined if Gilenya® passes into breast milk. Novartis advises that pregnant women discuss with their doctors if they will take Gilenya® or breastfeed. Novartis does not advise that both are done simultaneously.[5]

There is a registry for women who become pregnant while exposed to Gilenya® or within two months after stopping Gilenya® treatment. The registry was established to collect information about both the mother's and baby's health. Pregnant women may enroll in the Gilenya® pregnancy registry by calling (877) 598-7237.[8]

Also See: Drug Side Effects, Gilenya, Gilenya Coupons, Gilenya Patient Assistance Programs, Gilenya Free Samples, Tysabri Side Effects, Betaseron Side Effects, Rebif Side Effects, Cymbalta Side Effects

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References

  1. 1.0 1.1 http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004968/
  2. 2.0 2.1 http://www.novartis.com/newsroom/media-releases/en/2010/1445917.shtml
  3. 3.0 3.1 3.2 3.3 3.4 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022527s002lbl.pdf
  4. 4.0 4.1 4.2 4.3 http://www.gilenya.com
  5. 5.0 5.1 5.2 5.3 5.4 http://www.pharma.us.novartis.com/product/pi/pdf/gilenya_pmg.pdf
  6. http://www.fda.gov/Drugs/DrugSafety/ucm284240.htm
  7. http://mobile.bloomberg.com/news/2012-04-13/novartis-gilenya-patient-has-infection-after-taking-tysabri-2-
  8. http://www.pharma.us.novartis.com/assets/pdf/REM/Gilenya_HCP_Safety_Information_Guide.pdf