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Friday, August 15, 2014
Biogen Idec’s PLEGRIDYTM (peginterferon beta-1a) Approved for Relapsing Forms of MS - detailed information is found here
Below is a brief on the FDA approval of PLEGRIDY™ (peginterferon beta-1a), which can be used as background to educate your staff and internal team on the approval of PLEGRIDY, a treatment for relapsing forms of MS that is dosed once every 14 days, along with a link to the U.S. Prescribing Information and Medication Guide. Please let me know if you have specific questions.
Biogen Idec’s PLEGRIDYTM (peginterferon beta-1a) Approved for Relapsing Forms of MS
The U.S. Food and Drug Administration (FDA) has approved Biogen Idec’s PLEGRIDY™ (peginterferon beta-1a) as a new treatment for people living with relapsing forms of multiple sclerosis (RMS). The approval of PLEGRIDY, the pegylated interferon beta approved for use in relapsing MS, is based off of pivotal Phase 3 data that demonstrated the safety and efficacy of PLEGRIDY complimented by an every two week dosing schedule.
PLEGRIDY is administered subcutaneously just under the skin once every two weeks. It is available via PLEGRIDY PEN, a single-dose autoinjector, or prefilled syringe. Detailed instructions on how to use PLEGRIDY will be available at PLEGRIDY.com.
The FDA approval of PLEGRIDY is based on one year results from ADVANCE, a placebo-controlled clinical trial which involved more than 1,500 people living with MS. In the study, PLEGRIDY was shown to significantly reduce important clinical and imaging measures, including slowing the progression of disability and decreasing the number of relapses and brain lesions.
Biogen Idec plans to make PLEGRIDY available through U.S. specialty pharmacies in the coming weeks. The company is committed to providing access to PLEGRIDY and provides a variety of support services for patients and caregivers, including financial assistance programs, through
For more information on PLEGRIDY, including prescribing information and medication guide, go to PLEGRIDY.com.
INDICATION AND IMPORTANT SAFETY INFORMATION
PLEGRIDYTM (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
o 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
o 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
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 for additional important safety information. This information is not intended to replace discussions with your healthcare provider.
©2014 Biogen Idec Inc. 225 Binney Street, Cambridge, MA 02142. All rights reserved.