20/08/2024 | Press release | Distributed by Public on 20/08/2024 15:11
Key takeaways:
Fingolimod (Gilenya) is an oral medication used to treat multiple sclerosis (MS) in adults and children.
Common fingolimod side effects include slow heart rate, headache, and diarrhea. Temporary elevations in liver enzymes are also possible. Some fingolimod side effects may be from the medication, while others may be related to MS.
Serious fingolimod side effects include an increased risk of infections, severe liver injury, and macular edema. While rare, a serious viral brain infection called progressive multifocal leukoencephalopathy has also been reported.
Prior to 2010, the only treatment options for multiple sclerosis (MS) were injections and infusions. This changed when the FDA approved fingolimod (Gilenya), the first oral MS medication. It's used for relapsing forms of MS in adults and children ages 10 and older.
Fingolimod can be a convenient option for you or your child to help manage MS symptoms. But along with its potential benefits, it's good to know what fingolimod side effects are possible.
Fingolimod works well to slow down the progression of MS. But some people experience side effects while taking it. These can range from mild to serious.
Oral options: There are many oral medications available for multiple sclerosis (MS). Here's how options like Aubagio, Tecfidera, and Gilenya compare.
Injections and infusions for MS: Some injectable MS medications can be given at home, while others are administered in an infusion center. Learn more about injections and infusions available for MS.
Real stories: Hear one woman's firsthand account of how she manages MS, from diet and exercise to mindfulness practices.
Here is a summary of side effects that were reported during clinical trials.
Common fingolimod side effects (reported by at least 8% of people) include:
Headache
Changes in liver tests
Nausea
Diarrhea
Cough
Respiratory infections such as influenza, sinusitis, and bronchitis
Back pain
Stomach pain
Pain in extremities (hands and feet)
Increased blood pressure
Less common but potentially serious side effects include:
Slow heart rate
Shortness of breath
Macular edema (eye problems)
Liver injury
Serious infections
Posterior reversible encephalopathy syndrome
Progressive multifocal leukoencephalopathy
Below, we cover what you should know about 10 fingolimod side effects.
In clinical trials, headache was one of the most commonly reported fingolimod side effects. But a similar percentage of people who didn't take fingolimod also reported headaches. Headaches are common in people living with MS, so it's possible that they may not have been from fingolimod.
If you experience mild headaches while taking fingolimod, contact your care team. They can suggest an over-the-counter (OTC) medication to help manage them.
But if you experience a sudden and severe headache, go to the ER immediately. It could be a sign of a rare but serious condition called posterior reversible encephalopathy syndrome (PRES). Other symptoms can include sudden confusion, vision loss, and seizures. PRES usually goes away when you stop taking fingolimod. But if left untreated, it can result in a stroke.
Nausea is another common fingolimod side effect. Fingolimod can be taken with or without food. But if you experience nausea after your dose, try taking it with food to see if that makes a difference.
Nausea from fingolimod may improve over time as your body gets used to it. But in the meantime, it may be helpful to eat smaller meals and avoid high-fat foods if you're feeling nauseated. Be sure to stay hydrated by drinking enough fluids throughout the day. Dehydration can increase feelings of nausea.
If your nausea is persistent or interfering with your daily activities, contact your care team. They may recommend OTC or prescription medications that can help manage your symptoms.
Some people taking fingolimod experience diarrhea. But keep in mind that bowel problems, including diarrhea, are common in people living with MS.
If you experience diarrhea while taking fingolimod, dietary changes can help make a difference. Increasing your fiber intake, for example, can help add bulk to your stools. It's also a good idea to avoid or minimize foods and drinks that can worsen diarrhea, such as greasy or spicy foods, dairy products, and caffeinated or alcoholic beverages. Be sure to drink enough fluids to avoid dehydration.
If your diarrhea is persistent or severe, contact your prescriber. They may recommend an OTC medication that can help provide relief.
Your immune cell counts can decrease after starting fingolimod. This can increase your risk of infections, ranging from mild to serious. During clinical trials, certain infections were more commonly reported in people taking fingolimod. Examples of these include:
Bronchitis
Shingles
Influenza
Sinus infections
Pneumonia
Serious viral, bacterial, and fungal infections have also been reported in people taking fingolimod. If you develop a serious infection during treatment, your MS care team may have you stop taking the medication for a short period of time.
Tell your prescriber if you have an ongoing infection before starting fingolimod. And notify them right away if you think you're getting sick while taking it. It's also a good idea to share your current medication list with your care team. This is because certain other treatments may suppress your immune system even more when combined with fingolimod.
Good to know: Receiving certain vaccines before starting fingolimod can help lower your risk of certain infections. Ask your care team about which vaccines you should receive and when to get them.
Fingolimod may slow your heart rate after your first dose. Sometimes, your heart rate may slow down too much (bradycardia), causing symptoms such as dizziness, a fast or irregular heartbeat, or chest pain. This usually happens within the first 6 hours, but symptoms can show up later - within 24 hours.
Because of this risk, you'll take your first fingolimod dose in a medical setting. This allows a healthcare professional to monitor you for at least 6 hours after your dose. During this time, they'll check your pulse and blood pressure every hour. Some people, such as those with heart problems or taking certain medications, may need to stay overnight for observation.
Your heart rate should be back to normal after a month of taking fingolimod. But you should seek emergency care if you develop severe slowed heart rate symptoms at any point. And if you miss one or more fingolimod doses, contact your care team. They may need to check your heart rate again once you restart your medication.
Fingolimod can cause a temporary increase in liver enzymes, which can be a sign of inflammation or damage. These changes usually show up on liver function tests without causing noticeable symptoms. But rare cases of liver damage have been reported, resulting in symptoms such as jaundice (yellowing of the skin or eyes).
Your MS care team may check your liver enzymes before starting fingolimod and periodically while you're taking it. Tell them right away if you notice symptoms of liver damage, such as dark urine, jaundice, and right upper abdominal pain.
Fingolimod may increase the risk of macular edema, especially with higher doses. This is when fluid accumulates in an area of the eye called the macula, leading to swelling. If this happens, you may notice vision changes, such as blurry vision. Macular edema usually happens within the first 6 months of treatment.
In addition to higher doses, other factors may also increase your risk of macular edema from fingolimod. Older age, diabetes, and eye conditions such as retinal vascular disease and uveitis are a few examples.
Your MS care team may recommend having your eyes checked shortly after starting fingolimod, as well as during treatment. If you develop macular edema, your prescriber may have you stop the medication. Macular edema usually resolves within 6 months after stopping fingolimod.
If left untreated, macular edema can lead to permanent vision loss. So be sure to tell your healthcare team right away if you notice any changes in your vision after starting fingolimod. Catching it early can help prevent vision loss.
Some people experience shortness of breath while taking fingolimod, especially with higher doses. This side effect can happen as early as 1 month after you start fingolimod. And it seems to resolve after stopping the medication.
Before starting fingolimod, tell your care team if you have any breathing conditions, including in your sleep (like sleep apnea). They may recommend some breathing tests before you start the medication. Tell them right away if you have new or worsening breathing problems.
Small increases in blood pressure have been reported in people taking fingolimod, usually after about 1 month of starting it. Tell your care team if you have high blood pressure, since they may want to monitor your blood pressure regularly during treatment. Let them know if your readings are higher than usual after starting fingolimod.
While rare, there have been cases of progressive multifocal leukoencephalopathy (PML) reported in people taking fingolimod. PML is a life-threatening viral infection of the brain that can happen when a person's immune system becomes weakened. It can result in severe disability or even death.
Taking fingolimod for longer periods of time may increase the risk of PML. Most cases have been reported in people taking it for at least 1.5 years (18 months). Symptoms include changes in thinking or memory, vision problems, and clumsiness or one-sided weakness. Contact your prescriber right away if you develop any of these symptoms.
Common fingolimod (Gilenya) side effects include headaches, diarrhea, and nausea. A slowed heart rate, shortness of breath, and temporary elevations in liver enzymes are also possible. Fingolimod can also increase the risk of infections, ranging from mild to severe.
Serious fingolimod side effects are less common. But they include macular edema, severe liver damage, and progressive multifocal leukoencephalopathy.
Most fingolimod side effects can be managed at home or may just require more frequent follow-up with your care team. Contact your team if you have concerns about possible side effects. They can help you figure out how to prevent or manage them.
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