Does GILENYA have a black box warning?

Does GILENYA have a black box warning?

FDA is warning that when Gilenya is discontinued, symptoms of disability and other effects of multiple sclerosis (MS) can become worse than they were before or during Gilenya treatment. This severe disease worsening is rare but can result in permanent disability.

Does GILENYA raise blood pressure?

Increases in blood pressure and hypertension (high blood pressure) were reported with Gilenya use. In clinical studies of people with MS, 8% of people who took Gilenya had hypertension during treatment. This was compared to 4% of people who took a placebo (no treatment).

Does GILENYA cause elevated liver enzymes?

Post-market cases of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have been reported in multiple sclerosis (MS) patients treated with GILENYA. Some of these cases have resulted in acute liver failure requiring liver transplant.

What happens if you take too much GILENYA?

Gilenya can increase your risk of serious infections. Gilenya lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 2 months of stopping treatment.

How many people have died from Gilenya?

Thirty-one reported deaths have occurred among the roughly 30,000 patients who have ever taken fingolimod (brand name Gilenya).

Is Gilenya a high risk medication?

Gilenya is generally safe and well tolerated. One of the possible side effects from this medication is macular edema (fluid swelling of the retina in the back of the eye) that causes blurred vision. This rarely occurs and usually it develops within 3-6 months after starting Gilenya.

Does gilenya cause heart problems?

GILENYA may cause serious side effects, including: 1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking GILENYA. GILENYA can cause your heart rate to slow down, especially after you take your first dose.

Does gilenya weaken immune system?

Official Answer. Yes, Gilenya does suppress the immune system. Gilenya will reduce a person’s ability to fight an infection. This ability will be further compromised if the person is also taking other drugs that suppress the immune system.

Can gilenya cause high cholesterol?

Cholesterol: Treatment with fingolimod may result in increased levels of total cholesterol, LDL cholesterol and triglycerides.

What is the washout period for Gilenya?

Shortening the washout period to four weeks when switching from Biogen’s Tysabri (natalizumab) to Novartis’ Gilenya (fingolimod) is safe and reduces the chances of experiencing a disease flare in patients with relapsing-remitting multiple sclerosis (RRMS), a small Swiss study found.

How long can you stay on Gilenya?

Continuous Use of Gilenya for Up to 3 Years Can Lead to 50% Drop in Annual Relapse Rates, Real-world Study Says.

Can Gilenya cause vision problems?

In clinical studies of people with multiple sclerosis (MS), 4% of people who took Gilenya reported blurry vision as a side effect. This was compared to 2% of people who took a placebo (no treatment). Eye problems may also be a symptom of rare but serious side effects related to Gilenya use.

Is there a generic version of Gilenya?

Gilenya is available only as a brand-name medication. It’s not currently available in generic form. Gilenya contains the active drug fingolimod. Gilenya can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Gilenya. These lists do not include all possible side effects.

What are the side effects of Fingolimod (Gilenya)?

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. Common side effects of Gilenya include: infection, back pain, diarrhea, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, and increased liver enzymes.

When is first-dose monitoring of Gilenya indicated?

Patients who initiate Gilenya, and those who reinitiate treatment after discontinuation for longer than 14 days, require first-dose monitoring. This monitoring is also recommended when the dose is increased in pediatric patients [see Dosage and Administration (2.4, 2.5)].