What Plegridy is used for and how to use it
Россия
  • Россия
  • Украина

Plegridy - Consumer Medicine Information

Manufacture: Biogen Inc.
Country: Canada
Condition: Multiple Sclerosis
Class: Interferons
Form: Liquid solution, Subcutaneous (SC)
Ingredients: peginterferon beta 1a, L-arginine hydrochloride, glacial acetic acid, polysorbate 20 in water for injection, sodium acetate trihydrate

PLEGRIDY (pronounced PLEGG-rih-dee)

About this Medication

What the medication is used for

The active substance in PLEGRIDY is peginterferon beta-1a. Peginterferon beta-1a is a long-acting form of interferon. Interferons are natural substances made in your body to help protect you from infections and diseases. PLEGRIDY is intended for use under the guidance and supervision of a physician familiar with the treatment of MS.

Multiple Sclerosis (MS) is a long term illness that affects the central nervous system (CNS), including the brain and spinal cord. In multiple sclerosis, your body's immune system damages the protective covering (myelin) that surrounds the nerves in your brain and spinal cord. This disrupts the messages between the brain and other parts of the body causing the symptoms of MS.

Everyone has their own set of MS symptoms. These can include:

  • feeling off-balance or light headed, walking problems, stiffness and muscle spasms, tiredness, numbness in the face, arms or legs
  • acute or chronic pain, bladder and bowel problems, sexual problems and problems with vision
  • difficulty in thinking and concentrating, depression.

MS symptoms also tend to flare up from time to time: this is called a relapse.

What it does

PLEGRIDY seems to work by stopping the body's immune system from damaging the protective covering (myelin) that surrounds the nerves in your brain and spinal cord. This can help to reduce the number of relapses that you have and slow down the disabling effects of MS. Treatment with PLEGRIDY can help to prevent you from getting worse, although it will not cure MS. Your doctor will advise you for how long you can use PLEGRIDY or when to stop.

When it should not be used

Do not use PLEGRIDY:

  • If you are allergic (hypersensitive) to interferon beta, peginterferon beta-1a or any of the ingredients in PLEGRIDY
  • If you are pregnant
  • If you currently experience severe depression and thoughts about committing suicides

If you notice signs of allergy:

  • Because PLEGRIDY is based on a protein, there is a small chance of an allergic reaction. Signs of an allergic reaction may include:
    • becoming very wheezy or having difficulty breathing
    • swelling around the face (lips, tongue or throat)
    • skin rashes or redness

Usually these symptoms will be signs of less serious side effects. But they may be more serious.

If you know you are allergic or notice any of these symptoms contact a doctor as soon as possible.

What the medicinal ingredient is

The medicinal/active ingredient in PLEGRIDY is peginterferon beta 1a.

What the important nonmedicinal ingredients are:

L-Arginine Hydrochloride, Glacial Acetic Acid, Polysorbate 20 in Water for Injection, and Sodium Acetate Trihydrate.

What dosage forms it comes in

PLEGRIDY is a liquid for subcutaneous injection provided in a pre-filled syringe or pre-filled pen. Three strengths are available, 63 μg, 94 μg and 125 μg.

Warnings and Precautions

BEFORE you use PLEGRIDY talk to your doctor or pharmacist if:

  • you have ever experienced:
    • depression or problems affecting your mood
    • thoughts about committing suicide

Your doctor may still prescribe PLEGRIDY for you, but it's important to let your doctor know if you have had depression or any similar problems affecting your moods in the past.

  • If you have:
    • serious liver problems
    • irritation at your injection site, which can lead to skin and tissue damage, (injection site necrosis). Read carefully and follow the instructions given under "How to inject PLEGRIDY" to reduce the risk of injection site necrosis
    • a low number of white blood cells or platelets, which can cause an increased risk of infection, bleeding or anaemia
    • seizure disorders, not controlled by medication
    • heart problems, which can cause symptoms such as chest pain (angina), particularly after any activity; swollen ankles, shortness of breath (congestive heart failure); or an irregular heartbeat (arrhythmias)

PLEGRIDY may affect your white blood cell counts and your liver function. Your doctor may periodically do a blood test to count the number of your white blood cells or platelets and to check that your liver is working properly.

While you are using PLEGRIDY talk to your doctor or pharmacist if:

  • There are changes to your mood, for example you have thoughts about suicide; feel unusually sad, anxious or worthless.

Pregnancy and breast-feeding

  • If you could get pregnant, you need to use contraception while you use PLEGRIDY.
  • If you are planning a baby or if you do become pregnant while you are using PLEGRIDY, tell your doctor. You and your doctor can discuss if you should carry on with treatment.
  • If you are already pregnant, or think that you might be, talk to a doctor as soon as you can.
  • If you want to breastfeed, talk to your doctor first.

Interactions with this Medication

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines obtained without a prescription. Sometimes you will need to remind other medical staff that you are being treated with PLEGRIDY. For example, if you are prescribed other medicines, or if you have a blood test, PLEGRIDY may affect the other medicines or the test result.

Proper Use of this Medication

Usual dose

PLEGRIDY is only to be injected once every two weeks.
PLEGRIDY is injected under the skin (subcutaneously). Try to use PLEGRIDY at the same time on the same day every time you inject.

Starting PLEGRIDY
If you are new to PLEGRIDY, your doctor may advise you to gradually increase your dose so that you can adjust to the side effects of PLEGRIDY before taking the full dose. You will be provided with a Starter Pack containing your first 2 injections: one orange labelled syringe/pen with PLEGRIDY 63 micrograms (for day 0) and one blue labelled syringe/pen with PLEGRIDY 94 micrograms (for day 14). After that you will be provided with a maintenance pack containing grey pens/syringes with PLEGRIDY 125 micrograms (for day 28 and then every 2 weeks). Read the instructions on how to inject before you start using PLEGRIDY.
Use the record table printed on the inside lid of the Pack to keep a track of your injection dates.

Injecting yourself
Only inject PLEGRIDY by yourself once you have been trained by a healthcare professional. Read and follow the advice given in the instructions on how to inject yourself before you start.

If you have trouble handling the pen or syringe, ask your doctor or nurse who will be able to assist you.

How long to use PLEGRIDY
Your doctor will tell you how long you need to keep using PLEGRIDY. It is important to continue using PLEGRIDY regularly. Do not make changes unless your doctor tells you.

Overdose

You must only inject PLEGRIDY once every 14 days (every 2 weeks). If you have used more than one injection of PLEGRIDY in a 7-day period, contact your doctor or nurse straight away.

Missed dose

You need to inject PLEGRIDY once every 14 days (every 2 weeks). This regular schedule helps to deliver the treatment as evenly as possible.

If you do miss your usual day, inject as soon as you can and carry on as usual. However, never inject more than once in a 7-day period. Do not use two injections to make up for a missed dose. If you have problems with your dosing schedule, talk to your doctor or nurse.

Side Effects and what to do about them

These are the side effects that people reported when PLEGRIDY was being tested. The figures are based on how many people reported these events It gives you an idea how likely you are to get similar side effects.

Very common side effects

(at least 1 in 10 people are affected)

Flu-like symptoms

These symptoms are not really the flu.
You can't pass it on to anyone else. They are more common symptoms when you first start using PLEGRIDY. Using the Starter Pack to gradually increase the amount of PLEGRIDY you inject when you start treatment can help reduce symptoms. As you keep using your injections, the flu-like symptoms gradually get less.

Three simple ways to help reduce the impact of flu-like symptoms:

  1. Use your PLEGRIDY injection just before bedtime. This may allow you to sleep through the effects.
  2. Take acetaminophen or ibuprofen half an hour before your PLEGRIDY injection and continue taking it for up to a day(24 hours). Speak to your doctor or pharmacist about a suitable dose.
  3. If you have a fever, drink plenty of water to keep you hydrated.

Injection site reactions

You may get reactions around the place you inject. These usually get less over time. To reduce injection site reactions;

  • Alternate the sites you use for injections
  • Do not use the same injection site for consecutive injections
  • After injecting, check the site for redness, swelling, or tenderness

If you have a skin reaction and it does not clear up in a few days, contact your doctor or nurse. Read and follow the advice given in the instructions on How to inject PLEGRIDY.

Changes to levels of liver enzymes

These changes will show up in blood tests. You may not experience any symptoms or you may notice:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Itching all over
  • Feeling sick, being sick (nausea and vomiting)
  • Easy bruising of the skin.

Call a doctor immediately if you do get any of these symptoms. They may be signs of a possible liver problem.

If any of the effects trouble you, talk to your doctor.

Serious side effects, how often they happen and what to do about them

Common Talk with your doctor
or pharmacist
Stop
taking
drug and
call your
doctor or
pharmacist
Symptom / Effect Only if
severe
In all
cases
Flu-like
symptoms
headache,
muscle aches,
chills or a
fever
X
Injection site
reactions
redness,
itching or pain
X
swelling,
bruising,
warmth or rash
at injection
site
X
Changes to
levels of liver
enzymes
Yellowing of
your skin or
the whites of
your eyes
(jaundice)
X
Itching all
over
X
Feeling sick,
being sick
(nausea and
vomiting)
X
Easy bruising
of the skin
X
Other headache X
Muscle pain
(myalgia)
X
Pain in your
joints, arms,
legs or neck
(arthralgia)
X
Chills, feeling
cold
X
Feeling weak
and tired
(asthenia)
X
Feeling sick or
being sick
(nausea or
vomiting)
X
Itchy skin
(pruritus)
X
Increase in
body
temperature
X

This is not a complete list of side effects. For any unexpected effects while taking PLEGRIDY, contact your doctor or pharmacist.

How to inject plegridy pre-filled syringe

How to Store it

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date stated on the carton. The expiry refers to the last day of the month.

Keep PLEGRIDY syringes and pens in the outer carton in the refrigerator (between 2 °C and 8 °C). If a refrigerator is not available, PLEGRIDY can be left at room temperature 2 °C to 25 °C for up to 30 days. Keep the outer carton closed to protect PLEGRIDY from light. Do not freeze.

PLEGRIDY does not contain preservatives.

Do NOT use PLEGRIDY if you notice any of the following:

  • If the pre-filled pen or syringe is broken.
  • If the solution is coloured or you can see particles floating in it.

Disposal

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is in your plegridy pack

The PLEGRIDY pre-filled syringe Starter Pack holds 2 ready to use syringes. Each Starter Pack for PLEGRIDY syringe contains clear, colourless liquid (0.5ml) containing one syringe with- 63 and one syringe with 94 micrograms of peginterferon- beta-1a. Every syringe has a pre-attached needle and is ready to inject.

The PLEGRIDY pre-filled syringe Administration Dose Pack holds 2 or 6 ready to use syringes. Each Administration Dose Pack syringe contains a clear, colourless liquid (0.5ml) containing 125 micrograms of peginterferon beta-1a. Every syringe has a pre-attached needle and is ready to inject.

The PLEGRIDY pre-filled pen Starter Pack holds 2 ready to use pens. Each Starter Pack for PLEGRIDY pen contains clear, colourless liquid (0.5ml) containing one pen with 63 and one pen with 94 micrograms of peginterferon- beta-1a. Every pen has a pre-attached needle and is ready to inject.

The PLEGRIDY pre-filled pen Administration Dose Pack holds 2 or 6 ready-to-use pens. Each Administration Dose Pack pen contains clear, colourless liquid (0.5ml) containing 125 micrograms of peginterferon beta-1a. Every pen has a preattached needle and is ready to inject.

BEFORE YOU START
Read the Instructions for Use before you start using PLEGRIDY and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

STORAGE
Once removed from the refrigerator, allow PLEGRIDY to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm.

PLEGRIDY can be removed from and returned to the refrigerator if necessary. The total combined time out of refrigeration should not exceed 30 days, at a temperature that does not exceed 2 °C to 25 °C (36 °F to 77 °F), protected from light.

DOSE SCHEDULE
Choose the correct PLEGRIDY pre-filled syringe from a pack. PLEGRIDY pre-filled syringe Starter Pack contains your first two injections to gradually adjust your dose.

WHEN WHICH
DOSE
WHICH PACK
Day 0* (63
micrograms)
First injection:
63
micrograms,
choose
orange
labelled
syringe


Day 14* (94
micrograms)
Second
injection
94
micrograms,
choose
blue labelled
syringe
Day 28* and
then every 2
weeks after
(125
micrograms)
Full dose
injection:
125
micrograms,
choose
grey labelled
syringe


*Do not use more than one pre-filled syringe per 14-day period (every 2 weeks).

Preparing for Injection

KNOW THE PRE-FILLED SYRINGE FEATURES


PREPARE WORK SURFACE
Find a well-lit, clean, flat surface like a table and collect all the supplies you will need to give yourself or to receive an injection.

Collect supplies. You will need the following supplies to perform the injection:

  • Alcohol wipe
  • Gauze pad
  • Adhesive bandage
  • A puncture resistant container for disposal of used syringes

REMOVE FROM REFRIGERATOR
Remove 1 PLEGRIDY pack out of the refrigerator and select the appropriate pre-filled syringe (dosage) from the pack. Close the pack and put back in the refrigerator after removal of the first injection pre-filled syringe.

CHECK THE PACK AND THE PRE-FILLED SYRINGE
Check the expiration date printed on the PLEGRDY pre-filled syringe, PLEGRIDY pre-filled syringe carton, and the outer carton. Do not use the PLEGRIDY pre-filled syringe past the expiration date.

Let the pre-filled syringe sit for 30 minutes before injecting the PLEGRIDY dose to allow the medication to reach room temperature. A room temperature solution is more comfortable to inject. Do not use external heat sources such as hot water to warm the PLEGRIDY pre-filled syringe.

Check that the medication is
clear and colourless
Do not use PLEGRIDY prefilled
syringe if the liquid is
coloured, cloudy, or contains
floating particles.

PLEGRIDY in pre-filled syringe is for subcutaneous injection. PLEGRIDY should be injected exactly as your healthcare professional has shown you. PLEGRIDY should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way. Do not remove the Needle Cover until ready to inject.

Wash your hands with soap and water

Giving the Injection

1. CHOOSE THE INJECTION SITE
Choose an injection site and
wipe the skin with an
alcohol wipe.
Let the injection site dry
before injecting the dose.
. Do not touch this area
again before giving the
injection.
PLEGRIDY should be
injected into the thigh,
abdomen or upper arm.
2. FIRMLY REMOVE NEEDLE COVER
Pull the Needle Cover
straight off the needle and
dispose of the Needle
Cover. Do not touch the
needle. Do not recap the
PLEGRIDY pre-filled
syringe.
3. PREPARE INJECTION SITE AND POSITION PRE-FILLED
SYRINGE
Pinch the skin around the
cleaned injection site using
thumb and forefinger.
Hold the PLEGRIDY
syringe at a 90° angle to the
injection site.
4. INJECT MEDICATION
Quickly insert the needle
straight into the skin fold
until the needle is fully
under the skin.

The skin fold can be
released after needle
insertion.
Slowly push the Plunger in
one smooth motion until
syringe is empty. This
should take about 5
seconds.

Do not lift the pre-filled
syringe off the injection
site.

5. WAIT 5 SECONDS
Keep the needle inserted for
5 seconds.
6. REMOVE PRE-FILLED SYRINGE FROM SITE
Pull the needle straight out.

Do not recap the
PLEGRIDY pre-filled
syringe.

Do not reuse the
PLEGRIDY pre-filled
syringe.

AFTER THE INJECTION

CARE FOR INJECTION SITE
Apply pressure to the injection site for a few seconds using a sterile gauze pad. If there is blood, wipe it off. Apply an adhesive bandage if needed.

DISPOSE OF PRE-FILLED SYRINGE
Discard the used PLEGRIDY pre-filled syringe in a sharps container or some type of hard plastic or metal container with a screw cap such as a detergent bottle or coffee can. Check with your healthcare professional about the right way to throw away the container. There may be local laws about how dispose of used PLEGRIDY pre-filled syringes. Do discard used PLEGRIDY prefilled syringe in household trash or recycling bins.

RECORD DATE AND INJECTION SITE LOCATION
Record the date and injection site location of each injection and alternate sites between your injections. Do not use the same injection site for consecutive injections.

CHECK INJECTION SITE
After 2 hours, check the injection site for redness, swelling, or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your healthcare professional.

GENERAL WARNINGS
Do not reuse your PLEGRIDY pre-filled syringe. Do not share your PLEGRIDY pre-filled syringe. Keep PLEGRIDY pre-filled syringe out of reach of children.

How to Inject Plegridy Pre-filled Pen

BEFORE YOU START
Read the Instructions for Use before you start using PLEGRIDY and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

STORAGE
Once removed from the refrigerator, allow PLEGRIDY to warm to room temperature (about 30 minutes) prior to injection. Do not use external heat sources such as hot water to warm.

PLEGRIDY can be removed from and returned to the refrigerator if necessary. The total combined time out of refrigeration should not exceed 30 days, at a temperature that does not exceed 2°C to 25°C (36°F to 77°F), protected from light

DOSE SCHEDULE
Choose the correct PLEGRIDY Pen from the pack. PLEGRIDY pre-filled pen Starter Pack contains your first two injections to gradually adjust your dose.

WHEN WHICH DOSE WHICH PACK
Day 0* (63
micrograms)
First injection:
63 micrograms,
choose
orange pen


Day 14* (94
micrograms)
Second injection
94 micrograms,
choose
blue pen
Day 28* and
then every 2
weeks after
(125
micrograms)
Full dose
injection:
125 micrograms,
choose
gray pen


*Do not use more than one pre-filled pen per 14-day period (every 2 weeks).

Preparing for Injection

KNOW THE PEN FEATURES

Before use (Figure A)


After use (Figure B)


PREPARE WORK SURFACE
Find a well-lit, clean, flat surface like a table and collect all the supplies you will need to give yourself or to receive an injection.

Collect supplies. You will need the following supplies to perform the injection:

  • Alcohol wipe
  • Gauze pad
  • Adhesive bandage
  • A puncture resistant container for disposal of used pens

REMOVE FROM REFRIGERATOR
Remove 1 PLEGRIDY pack out of the refrigerator and select the appropriate pen (dosage) from the pack. Close the pack and put back in the refrigerator after removal of the first injection prefilled pen.

CHECK PACK AND PEN
Check the expiration date printed on the PLEGRIDY Pen, PLEGRIDY Pen carton, and the outer carton. Do not use the PLEGRIDY Pen past the expiration date.

Let the pen sit for 30 minutes before injecting the PLEGRIDY dose to allow the medication to reach room temperature. Do not use external heat sources such as hot water to warm the PLEGRIDY Pen. A room temperature solution is more comfortable to inject.

Check your PLEGRIDY Pen

Check injection status. Make sure that green stripes are visible (Figure D).
  • Do not use the pen unless injection status window shows green stripes.
  • Check that the medication is clear and colourless in the medication window (Figure E). Do not use the PLEGRIDY Pen if the liquid is coloured, cloudy, or contains floating particles.
  • You may see a bubble. This is normal

PLEGRIDY in pre-filled Pen is for subcutaneous injection. PLEGRIDY should be injected exactly as your healthcare professional has shown you. PLEGRIDY should not be injected into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way. Do not remove the cap until ready to inject. Wash your hands with soap and water.

Giving the injection

1. CHOOSE THE INJECTION SITE (Figure F)
Choose an injection
site and wipe the skin
with an alcohol wipe.
Let the injection site
dry before injecting the
dose. Do not touch this
area again before
giving the injection.
PLEGRIDY should be
injected into the thigh,
abdomen or upper arm.
2. REMOVE CAP (Figure G)
Pull the Cap off and
dispose of the Cap.
  • Do not recap
    your
    PLEGRIDY
    Pen

  • The needle is
    covered by
    the needle
    cover and will
    not be visible.

  • Do not touch
    or push down
    on the needle
    cover, you
    could get a
    needle stick
    injury.

Your PLEGRIDY Pen
is ready to inject after
the cap is removed.
3. POSITION PEN AND CHECK (Figure H)
Place your
PLEGRIDY Pen
on your chosen
injection site.
You should hold
your
PLEGRIDY Pen
at a 90º angle to
your injection
site so that you
can see the green
stripes in the
injection status
window. Do not
use your
PLEGRIDY pen
unless you see
green stripes in
the injection
status window.
4. INJECT MEDICATION (Figure I)
Press into site
and hold until
clicking stops
and green
checkmarks
appear.
Pressing down
will insert the
needle and
automatically
start the
injection.
Do not lift the
pen off the
injection site.
Do not make any
movements until
injection is
completed.
Continue to
firmly press
down, hold the
Pen at a 90°
angle and keep
your hand steady
until the
injection is completed.

During the
injection
process:
PLEGRIDY Pen
will “click”
several times.
Green stripes
pattern will be
moving in the
injection status
window. The
pen's clicking
sounds will stop
when the
injection is
complete.
Check for
completion.
Make sure the
green check
marks have
appeared in the
injection status
window.
5. REMOVE PEN FROM SITE (Figure K)
Lift the PLEGRIDY
Pen from the
injection site.
The needle cover
will extend covering
the needle
completely.

After the injection

CARE FOR INJECTION SITE
Apply pressure to the injection site for a few seconds using a sterile gauze pad. If there is blood, wipe it off. Apply an adhesive bandage if needed.

VERIFY DOSE DELIVERY
Check the injection
status window. You
should see green
checkmarks in the
injection status window (Figure L).
Check the medication
window. You should
see a yellow plunger in
the medication window
(Figure M)
An extended yellow
plunger indicates that
the entire dose has been
successfully
administered. Do not
reuse the PLEGRIDY
Pen.

DISPOSE OF PEN
Discard the used PLEGRIDY Pen in a sharps container or some type of hard plastic or metal container with a screw cap such as a detergent bottle or coffee can. Check with your healthcare professional about the right way to dispose of the container. There may be local laws about how to discard used Pens. Do not discard used PLEGRIDY Pen in household trash or recycling bins.

RECORD DATE AND INJECTION SITE LOCATION
Record the date and injection site location of each injection and alternate sites between your injections. Do not use the same injection site for consecutive injections.

CHECK INJECTION SITE
After 2 hours, check the injection site for redness, swelling, or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your doctor or nurse.

GENERAL WARNINGS

Do not reuse your PLEGRIDY Pen. Do not share your PLEGRDY Pen. Keep PLEGRIDY Pen out of reach of children.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada web site at
www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Biogen Canada Inc. at: 1-855-MSONE-00 (1-855-676-6300).