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:

Liver Icon

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

Head Icon

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:

Allergic Reactions Icon

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

ISR Icon

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 Icon

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 Icon

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

TMA Icon

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 Icon

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

Brain Seizures Icon

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

FLS Icon
  • 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

ISR Icon
  • 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
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What is PLEGRIDY?

PLEGRIDY is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if PLEGRIDY is safe and effective in people under 18 or over 65 years of age.

Important Safety Information

Who should not take PLEGRIDY?

  • Do not take PLEGRIDY if you are allergic to interferon beta or peginterferon, or any of the other ingredients in PLEGRIDY

What is the most important information I should know about PLEGRIDY?

PLEGRIDY can cause serious side effects, including:

  • Liver problems, or worsening of liver problems, including liver failure and 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 regularly. You will have regular blood tests to check for these possible side effects

  • 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.

Before taking PLEGRIDY, tell your healthcare provider about all of your medical conditions, including 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 (where the body’s immune system attacks the body’s own cells)

  • 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.

What are the possible side effects of PLEGRIDY?

PLEGRIDY may cause serious side effects, including:

  • serious allergic reactions. Serious allergic reactions can happen if you take PLEGRIDY. Symptoms may include itching, swelling of the face, eyes, lips, tongue, or throat, trouble breathing, feeling faint, anxiousness, skin rash, hives, or skin bumps. Talk to your healthcare provider before taking another dose of PLEGRIDY

  • injection site reactions. PLEGRIDY may commonly cause redness, pain, itching or swelling at the place where the 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 a 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 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

The most common side effects of PLEGRIDY include:

  • flu-like symptoms. Many people who take PLEGRIDY have flu-like symptoms especially early in the course of therapy. These symptoms are not really the flu. You cannot pass it on to anyone else

    • You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers and drinking plenty of water

Flu-like symptoms or other common side effects of PLEGRIDY may include: headache, muscle and joint aches, fever, chills, or tiredness.

These are not all of the possible side effects of PLEGRIDY.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Why PLEGRIDY?
Additional Considerations
Taking PLEGRIDY
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