Liver problems or worsening of liver problems, including liver failure or death. Symptoms may include: yellowing of your skin or the white part of your eye, nausea, loss of appetite, tiredness, bleeding more easily than normal, confusion, sleepiness, dark colored urine, and pale stools. During your treatment with PLEGRIDY you will need to see your healthcare provider and have regular blood tests to check for these possible side effects
Instructions For Use
Why PLEGRIDY?
Could PLEGRIDY be right for you?
Whether you’re considering a change in therapies or are starting treatment for the first time, we’re pleased you’ve decided to learn more about PLEGRIDY.
PLEGRIDY (pronounced plegg-rih-dee) is an injectable treatment for relapsing forms of multiple sclerosis (MS) that offers low dosing frequency. That means you inject PLEGRIDY once every 2 weeks—a total of 26 times a year.
We know that relapsing MS is a journey, but it’s not one you are facing alone. Biogen—along with your healthcare team, care partner, and loved ones—is committed to supporting you and helping you throughout your journey with relapsing MS.
Explore PLEGRIDY Efficacy
In a clinical study, PLEGRIDY was proven to treat relapsing MS in 3 important ways
Based on a 1-year study against placebo, people taking PLEGRIDY had fewer relapses, delayed physical disability progression, and had fewer brain lesions on magnetic resonance imaging (MRI).
Fewer relapses
In a 1-year study, 512 people with relapsing MS taking PLEGRIDY had fewer relapses compared with 500 people in the placebo group. People taking PLEGRIDY experienced 0.26 relapses per year compared with 0.40 in the placebo group.
Delayed physical disability progression
In the same 1-year study, people with relapsing MS taking PLEGRIDY had a 38% lower risk of physical disability progression as compared to placebo. 7% of people taking PLEGRIDY experienced disability progression compared with 11% of those taking placebo.
3.6 T2 lesions with PLEGRIDY
vs
10.9 T2 lesions with placebo
T2 LESIONS: Lesions that show the long-term impact of inflammation on your brain.
0.2 Gd-enhanced lesions with PLEGRIDY
vs
1.4 Gd-enhanced lesions with placebo
GADOLINIUM (Gd)-ENHANCED LESIONS: Lesions that show active inflammation using a dye containing gadolinium.
Fewer brain lesions on MRI
One way to monitor relapsing MS is by observing lesions, or areas of damage, in your brain. It’s important to monitor lesions because they can occur with or without any visible symptoms.
PLEGRIDY reduced the number of new or newly enlarging T2 lesions and gadolinium (Gd)-enhanced lesions compared with people taking placebo.*
*Data measured at 48 weeks among 457 people with relapsing MS taking PLEGRIDY and 476 people in the placebo group.
Explore PLEGRIDY Safety
Understanding side effects seen with PLEGRIDY
It is important to talk to your healthcare provider about the potential side effects of PLEGRIDY. See below for what to tell your healthcare provider before starting PLEGRIDY and to learn about potential serious side effects.
These are not all of the possible side effects of PLEGRIDY. Remember, your healthcare team is always your best source of information.
What to tell your healthcare provider before starting PLEGRIDY
It’s important to communicate regularly with your healthcare provider and your entire healthcare team throughout your journey with relapsing MS. Before beginning treatment with PLEGRIDY, tell your healthcare provider if you:
- Are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior
- Have or had liver problems, low blood cell counts, bleeding problems, heart problems, seizures (epilepsy), thyroid problems, or any kind of autoimmune disease
- Take prescription and over-the-counter medicines, vitamins, and herbal supplements
- Have or had an allergic reaction to rubber or latex. The tip of the cap of the PLEGRIDY prefilled syringe for intramuscular use is made of natural rubber latex
- Are pregnant or plan to become pregnant. It is not known if PLEGRIDY can harm your unborn baby
- Are breastfeeding or plan to breastfeed. PLEGRIDY may pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take PLEGRIDY
Tell your healthcare provider about all the medicines you take, including prescription and over the counter medicines, vitamins, and herbal supplements.
Serious side effects
PLEGRIDY can cause serious side effects, including:
Depression or suicidal thoughts. Symptoms may include: new or worsening depression (feeling hopeless or bad about yourself), thoughts of hurting yourself or suicide, irritability (getting upset easily), nervousness, or new or worsening anxiety
Call your healthcare provider right away if you have any of the symptoms listed above.
PLEGRIDY may cause additional serious side effects, including:
Serious allergic reactions. Serious allergic reactions can happen quickly. Symptoms may include: itching, swelling of the face, eyes, lips, tongue, or throat, trouble breathing, feeling faint, anxiousness, skin rash, hives, skin bumps. Get emergency help right away if you have any of these symptoms
Injection site reactions. PLEGRIDY may commonly cause redness, pain, itching or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected and it does not heal within a few days. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by your healthcare provider
Heart problems, including congestive heart failure. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using PLEGRIDY
- Some people using PLEGRIDY may have other heart problems, including low blood pressure, fast or abnormal heartbeat, chest pain, heart attack, or a heart muscle problem (cardiomyopathy)
Blood problems and changes in your blood tests. PLEGRIDY can decrease your white blood cells or platelets, which can cause an increased risk of infection, bleeding, or anemia and can cause changes in your liver function tests. Your healthcare provider will do blood tests to monitor for side effects while you use PLEGRIDY
Thrombotic microangiopathy (TMA). TMA is a condition that involves injury to the smallest blood vessels in your body. TMA can also cause injury to your red blood cells (the cells that carry oxygen to your organs and tissues) and your platelets (cells that help your blood clot) and can sometimes lead to death. Your healthcare provider may tell you to stop taking PLEGRIDY if you develop TMA
Autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use interferon beta
Seizures. Some people have had seizures while taking PLEGRIDY, including people who have never had seizures before
Tell your healthcare provider right away if you have any of the symptoms listed above.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Most common side effects
In a 1-year study of subcutaneous PLEGRIDY, the most common side effects experienced by ≥10% of people taking PLEGRIDY and at least 2% more than placebo were redness around the injection site, flu-like symptoms, fever, headache, muscle pain, chills, injection site pain, weakness or loss of strength, itching at the injection site, and joint pain.
Flu-like symptoms
- In a 1-year study of subcutaneous PLEGRIDY, 47% of people taking PLEGRIDY experienced flu-like symptoms, compared with 13% of people taking placebo
- Fewer than 1% of people taking PLEGRIDY stopped treatment due to flu-like symptoms
Injection site reactions
- In clinical studies of subcutaneous PLEGRIDY, injection site reactions occurred in 66% of people taking PLEGRIDY, compared with 11% of those taking placebo
- Severe injection site reactions occurred in 3% of the PLEGRIDY group and 0% of the placebo group
- 1 out of 1468 people who took PLEGRIDY experienced injection site necrosis. Necrosis is an area of severe skin damage that would require treatment by your healthcare provider
- In a separate clinical study comparing intramuscular and subcutaneous PLEGRIDY in 130 healthy volunteers, injection site reactions occurred in 14% of people taking intramuscular PLEGRIDY and 32% of people taking subcutaneous PLEGRIDY
Want to know more?
Download a list of questions to help start a conversation with your healthcare provider about your relapsing MS treatment.
Download questions
Biogen Support Services
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actual patients who have taken PLEGRIDY