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What is Gilenya?

Gilenya (previously known as Gilenia) was approved by the FDA in 2010 to treat relapsing forms of MS. It is administered as a once-per-day 0.5 mg capsule.

Gilenya is the first approved oral disease modifying treatment for MS. Data from clinical trials showed that Gilenya reduces MS relapses, disability progression, lesion activity as seen on MRI, and loss of brain tissue.

While Gilenya is generally safe and well-tolerated by patients, there are health issues the clinical team will watch for, including:

  • Slowing of heart rate — A slowing heart rate can occur with the first dose of Gilenya, usually without other symptoms. Patients are monitored for six hours in the clinic after the first dose of Gilenya is administered to treat symptoms if needed.
  • Infections — The action of Gilenya lowers white blood cell counts, increasing the risk of serious infections.
  • Macular edema — This swelling of the retina occurs rarely, but can cause blurred vision and other vision disturbances. Symptoms usually resolve by discontinuing Gilenya. Patients will undergo an eye test before starting Gilenya and within three to four months after beginning treatment.
  • Increased blood pressure — There can be a mild increase in blood pressure during the first six months of treatment which typically resolves.
  • Other possible side effects include abnormal liver function, shortness of breath, cough, headache, diarrhea and back pain.

Questions and Answers about Gilenya

Are there restrictions for taking Gilenya?
While there are no absolute restrictions, patients who will be further evaluated before taking Gilenya include those with certain heart conditions, a history of fainting, recurrent infections, no prior chicken pox, certain eye problems, diabetes, breathing problems, liver problems, high blood pressure, and women planning to become pregnant. There are also certain medications that should not be taken with Gilenya.

Should I switch from my current MS medication to Gilenya?
Due to the possibility of rare but serious side effects, Gilenya is generally recommended for patients who either can't tolerate other MS medications or are having difficulty controlling their disease. It's helpful to discuss choosing Gilenya with your clinical care team.

Can Gilenya be combined with MS symptom medications?
A thorough medical history, including a detailed medication list, will be required from all patients before starting Gilenya. However, Gilenya can be safely combined with most MS symptom medications. Drugs that require extra caution with Gilenya include certain anti-arrhythmics, beta-blockers, and the anti-fungal ketoconazole (Nizoral).

What about pregnancy and taking Gilenya?
Women taking Gilenya should not get pregnant. Based on animal studies, Gilenya may harm the fetus. Patients should tell their doctor right away if they become pregnant while taking Gilenya or within two months after stopping the drug. It is not known if Gilenya passes into breast milk, so women should not take Gilenya while breastfeeding.

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