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.
(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
(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.
(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.
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.
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 MS ActiveSource®.
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 MS ActiveSource®.
For more information on PLEGRIDY,
including prescribing information and medication guide, go to PLEGRIDY.com.
including prescribing information and medication guide, go to PLEGRIDY.com.
INDICATION AND
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Indication
PLEGRIDYTM
(peginterferon beta-1a) is a prescription medicine used to treat people
with relapsing forms of multiple sclerosis (MS).
(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.
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.
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
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
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.
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:
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
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
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
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
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
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:
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
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
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
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)
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
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
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
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:
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
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
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.
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.
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.
Street, Cambridge, MA 02142. All rights reserved.
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