New Relapsing Multiple Sclerosis Medication Allows For Every Two Weeks Dosing

(BPT) - People living with relapsing forms of multiple sclerosis (RMS) now have an effective new treatment option with an every two weeks dosing schedule. PLEGRIDY™ (peginterferon beta-1a), which was recently approved by the U.S. Food and Drug Administration, significantly decreases the number of relapses and brain lesions on MRI, and slows disability progression.

MS is a chronic disease that attacks the central nervous system, which is made up of the brain, spinal cord and optic nerves. The disease often strikes people in the prime of their lives, may cause symptoms that range from numbness in the limbs to paralysis or vision loss. The progression, severity and specific symptoms of MS are unpredictable and vary from one person to another.ⁱ

An estimated 400,000 Americans are currently living with MS.ⁱⁱ The majority have relapsing forms of the disease, which are characterized by acute flare-ups of symptoms, known as relapses.ⁱⁱⁱ

PLEGRIDY is a pegylated interferon beta-1a recently approved for people with relapsing forms of MS. Pegylation is a process that allows the molecule to stay in the body longer. PLEGRIDY is self-injected just beneath the skin with either the PLEGRIDY PEN, which is a single-dose autoinjector, or a prefilled syringe.

“With relapsing forms of MS, the goal of treatment is to slow the progression of disability and number of relapses,” said Bruce Hughes, M.D., Director of the Ruan Multiple Sclerosis Center at Mercy Ruan Neurology Clinic and Research Center in Des Moines, Iowa. “The approval of PLEGRIDY is significant for the MS community because it has demonstrated efficacy in reducing key measures of disease activity and provides a once every two weeks dosing schedule.”

Patient Dosing Administration:

Your healthcare provider should show you how to inject PLEGRIDY before you use it for the first time. Your healthcare provider may tell you to slowly increase your dose. PLEGRIDY is given by injection under the skin. Rotate the injection site to decrease the chance that you will have an injection site reaction. You may be able to manage flu-like symptoms with premedication.

The most common adverse reactions (incidence ≥10 percent) were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.

Indication

PLEGRIDY™ (peginterferon beta-1a) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS).

Important Safety Information

Before beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with PLEGRIDY.

PLEGRIDY can cause serious side effects. Call your healthcare provider right away if you have any of the symptoms listed below.

• 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

Do not take PLEGRIDY if you are allergic to interferon beta or peginterferon beta-1a, or any of the other ingredients in PLEGRIDY.

Before taking 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
• Are pregnant or plan to become pregnant. It is not known if PLEGRIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with PLEGRIDY
• Are breastfeeding or plan to breastfeed. It is not known if PLEGRIDY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use PLEGRIDY

PLEGRIDY can 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, or skin bumps
• Injection site reactions. PLEGRIDY may commonly cause redness, pain 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. While PLEGRIDY is not known to have any direct effects on the heart, some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking interferon beta. If you already have heart failure, PLEGRIDY may cause your heart failure to get worse. 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 heart beat, chest pain, heart attack, or a heart muscle problem (cardiomyopathy)
• 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
• 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 should do blood tests while you use PLEGRIDY to check for side effects
• 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 early in the course of therapy. These symptoms are not really the flu. You cannot pass it on to anyone else. Symptoms may include headache, muscle and joint aches, fever, chills or tiredness
• You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers and drinking plenty of water. For many people, these symptoms lessen or go away over time

Please see www.Plegridy.com for full Prescribing Information and Medication Guide for additional important safety information.

ⁱ National Multiple Sclerosis Society. Frequently Asked Questions about Multiple Sclerosis. 2012. Accessed July 2014. Available at http://www.nationalmssociety.org/What-is-MS/MS-FAQ-s

ⁱⁱ National Multiple Sclerosis Society. “MS Prevalence.” http://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed July 2014.

ⁱⁱⁱ National Multiple Sclerosis Society. “Types of MS.” http://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed July 2014.