PLEGRIDY 63 MCG Roztwór do wstrzykiwań

Treść ulotki

1. Plegridy 63 micrograms injectable solution in pre-filled syringe, 94 micrograms injectable solution in pre-filled syringe, 125 micrograms injectable solution in pre-filled syringe
   1. What you need to know before using Plegridy
   2. How to use Plegridy
   3. Possible side effects
   4. How to store Plegridy
   5. Contents of the pack and other information
   6. Instructions for injecting Plegridy in a prefilled syringe
2. Plegridy 63 micrograms injectable solution in pre-filled pen, 94 micrograms injectable solution in pre-filled pen, 125 micrograms injectable solution in pre-filled pen
   1. What you need to know before using Plegridy
   2. How to use Plegridy
   3. Possible side effects
   4. How to store Plegridy
   5. Contents of the pack and other information
   6. Instructions for injecting Plegridy in a prefilled pen
3. Plegridy 125 micrograms injectable solution in pre-filled syringe
   1. What you need to know before you use Plegridy
   2. How to use Plegridy
   3. Possible side effects
   4. How to store Plegridy
   5. Contents of the pack and other information
   6. Instructions for injecting Plegridy in prefilled syringe

Plegridy 63 micrograms injectable solution in pre-filled syringe, 94 micrograms injectable solution in pre-filled syringe, 125 micrograms injectable solution in pre-filled syringe

peginterferon beta-1a

Read this leaflet carefully before you use this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Plegridy is and what it is used for

2. What you need to know before you use Plegridy

3. How to use Plegridy

4. Possible side effects

5. How to store Plegridy

6. Contents of the pack and other information

7. Instructions for injecting Plegridy in pre-filled syringe

1. What Plegridy is and what it is used for

What is Plegridy
The active ingredient contained in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a
modified form of interferon with a long duration of action. Interferons are natural substances that
the body produces to help protect it from infections and diseases.

What is Plegridy used for
This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in
adults aged 18 years and over.
Multiple sclerosis is a long-term disease that affects the central nervous system (CNS),
including the brain and spinal cord, in which the body's immune system (its natural defenses
) damages the protective coating (myelin) around the nerves in the brain and spinal
cord. This disrupts messages between the brain and other parts of the body, causing the
symptoms of multiple sclerosis. Patients with relapsing-remitting MS experience phases where the
disease is not active (remission) between flare-ups of symptoms (relapses).

Each person experiences an individual variety of multiple sclerosis symptoms.Among the possible
symptoms are:

• Sense of imbalance or dizziness, problems with walking, stiffness and muscle spasms, fatigue, numbness in the face, arms or legs
• Sharp or chronic pain, bladder or bowel problems, sexual problems and vision disturbances
• Difficulty thinking and concentrating, depression.

How Plegridy works
Plegridy appears to work by preventing the body's immune system from damaging the
brain and spinal cord.This may help reduce the number of relapses and slow down the
disabling effects of multiple sclerosis. Treatment with Plegridy may help prevent you from
getting worse, although it cannot cure multiple sclerosis.

2. What you need to know before using Plegridy

Do not use Plegridy

• if you are allergicto peginterferon beta-1a, interferon beta-1a or any of the other ingredients of this medicine (listed in section 6). See section 4 for the symptoms of an allergic reaction.
• If you suffer from severe depressionor think about committing suicide.

Warnings and precautions

• Talk to your doctor if you have ever had:
• Depressionor mood problems.
• Thoughts of committing suicide.
• The doctor may still be able to prescribe Plegridy, but it is important to inform the doctor if you have had depression or any similar mood problems in the past.

Talk to your doctor, pharmacist or nursebefore injecting Plegridy if any of the conditions listed below occur.These problems may worsen during the use of
Plegridy:

• Serious problems with the liver or kidneys
• Irritation at the injection site,which can cause damage to the skin and tissues ( necrosis at the injection site). When you are ready to inject, carefully follow the instructions provided in section 7

to reduce the risk of reactions at the injection site.

• Epilepsyor other uncontrolled convulsive disorders, not controlled by medication
• Heart problems, which can cause symptoms such as chest pain ( angina), especially after any activity; swollen ankles, shortness of breath ( congestive heart failure) or an irregular heartbeat ( arrhythmia).
• Thyroid problems
• A low number of white blood cells or platelets in the blood, which can increase the risk of infection or bleeding

Other things to consider when using Plegridy

• Blood tests will be needed to determine the number of blood cells, blood chemistry and liver enzyme levels. These tests will be performed before starting to use Plegridy, regularly after starting treatment with Plegridy and then periodically during treatment, even if there are no particular symptoms. These blood tests will be in addition to the tests performed normally for monitoring MS.
• The function of the thyroid gland will be checked regularly or whenever deemed necessary by the doctor.
• Blood clots may form in the small blood vessels during treatment. These blood clots can have an effect on the kidneys. This can happen from several weeks to several years after starting treatment with Plegridy. The doctor may decide to check blood pressure, blood (platelet count) and kidney function.

If you accidentally prick or puncture another person with the Plegridy needle, the affected area must be
washed immediatelywith soap and water and a doctor ora nurse must be
contacted as soon as possible.
Children and adolescents
Plegridy must notbe usedin children and adolescents under 18 years of age. The
safety and efficacy of Plegridy in this age group have not been established.

Other medicines and Plegridy
Plegridy must be used with caution with medicines that are metabolized in the body
by a group of proteins called “cytochrome P450” (e.g. some medicines used for
epilepsy or depression).
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, particularly those used for the treatment of epilepsy or
depression. This applies to any medicine, including those obtained without a prescription.
Sometimes you will need to remind other healthcare professionals that you are currently being treated with Plegridy, for
example, if you are prescribed other medicines, or if you undergo a blood test. Plegridy
can affect other medicines or the result of tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
No harmful effects on the newborn/breastfed infant are expected. Plegridy can be used
during breastfeeding.

Driving and using machines
Plegridy does not alter or negligibly alters the ability to drive and use machines.

Plegridy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium, which is essentially ‘sodium-free’.

3. How to use Plegridy

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

Usual dose
One injection of Plegridy 125 micrograms every 14 days (every two weeks). Each time you
administer Plegridy, try to do it at the same time and on the same day.

Starting therapy with Plegridy
If you have never used Plegridy before, your doctor may advise you to gradually increase the dose,
to get used to the effects of Plegridy before taking the full dose. You will be provided with a Starter
Pack containing the first 2 injections: one orange syringe with Plegridy 63 micrograms
(for day 0) and one blue syringe with Plegridy 94 micrograms (for day 14).
Subsequently you will be provided with a maintenance pack containing grey syringes with
Plegridy 125 micrograms (for day 28 and then every two weeks).
Read the instructions in section 7 “ Instructions for injecting Plegridy in a prefilled syringe” at the end
Use the registration table printed inside the lid of the Starter Pack
to record the dates of your injections.

Self-administration of the injection
Plegridy must be injected under the skin ( subcutaneous injection). Alternate the sites you use for
injections. Do not use the same injection site for consecutive injections.
You can inject Plegridy without the help of a doctor, if you have been shown how to do it.

• Read and follow the advice provided in the instructions in section 7 “ Instructions for injecting Plegridyin a prefilled syringe” before starting.
• If you have problemshandling the syringe, contact your doctor or nurse who can help you.

How long to use Plegridy
Your doctor will tell you how long you should continue to use Plegridy. It is important to continue to
use Plegridy regularly. Do not change the therapy in any way, unless instructed by your
doctor.

If you use more Plegridy than you should
You should inject Plegridy only once every 2 weeks.

• If you have used more than one injection of Plegridy within a 7-day period, consultyour doctor or pharmacist immediately.

If you forget to use Plegridy
You should inject Plegridy once every 2 weeks. This regular schedule helps to administer the
treatment as evenly as possible.
If you miss your usual day, inject a dose as soon as possible and continue normally. However, do not inject
more than once within a 7-day period. Do not use two injections to make up for forgetting
an injection.
If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

• Liver problems(common - may affect up to 1 in 10 people)If you experience any of the following symptoms:
• Yellowing of the skin or the whites of the eyes
• Widespread itching
• Feeling unwell or sick (nausea and vomiting)
• Easy bruising
• Seek medical attention immediately.These may be signs of a potential liver problem.
• Depression(common - may affect up to 1 in 10 people)If:
• You feel unusually sad, anxious or hopeless or
• You have thoughts of committing suicide
• Seek medical attention immediately.
• Severe allergic reaction(uncommon - may affect up to 1 in 100 people)If you experience any of the following symptoms:
• Difficulty breathing
• Swelling around the face (lips, tongue or throat)
• Skin rash or redness
• Seek medical attention immediately.
• Convulsions(uncommon - may affect up to 1 in 100 people)If you have a convulsion or fit
• Seek medical attention immediately.
• Damage at the injection site(rare - may affect up to 1 in 1,000 people)If you experience any of the following symptoms:
• Any skin lesion together with swelling, inflammation or leakage of fluid around the injection site
• See a doctor for advice.
• Kidney problems including scarring that can reduce kidney function(rare - may affect up to 1 in 1,000 people)If you experience some or all of the following symptoms:
• Foamy urine
• Fatigue
• Swelling, particularly around the ankles and eyelids, and weight gain.
• See a doctor as these may be signs of a potential problem with yourkidneys.
• Blood problems(rare - may affect up to 1 in 1,000 people)The following may occur: blood clots inside small blood vessels, which can affect the kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or lightheadedness. Your doctor is likely to find changes in your blood and kidney function.

If you experience some or all of the following symptoms:

• Increased bruising or bleeding
• Extreme weakness
• Headache, dizziness or lightheadedness
• Seek medical attention immediately.

Other side effects
Very common side effects

(may affect more than 1 in 10 people)

• Flu-like symptoms. These symptoms are not due to a real flu (see below). You cannot infect other people.
• Headache
• Muscle pain (myalgia)
• Joint pain, arm, leg or neck pain (arthralgia)
• Chills
• Fever
• Feeling weak and tired (asthenia)
• Redness, itching or pain around the area where you had the injection
• If any of these side effects occur, see a doctor.

Flu-like symptoms
Flu-like symptoms are more common at the beginning of treatment with Plegridy. They tend to decrease
gradually as you continue with the injections. See below for simple ways to manage
these flu-like symptoms, if they occur.
Three simple ways to reduce the intensity of flu-like symptoms:

• 1. Consider the timing of your Plegridy injection. The start and end of flu-like symptoms are different for each patient. On average, flu-like symptoms start about 10 hours after the injection and last between 12 and 24 hours.
• 2. Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue to take paracetamol or ibuprofen for the duration of the flu-like symptoms. Ask your doctor or pharmacist which dose to take and for how long.
• 3. If you develop a fever, drink plenty of water to keep your body hydrated.

Common side effects

(may affect up to 1 in 10 people)

• Feeling unwell or sick (nausea or vomiting)
• Hair loss (alopecia)
• Itchy skin (pruritus)
• Increased body temperature
• Changes around the injection site, such as swelling, inflammation, bruising, warmth, rash or change in colour
• Changes in the blood that may cause fatigue or reduce your ability to fight infections
• Increased liver enzymes in the blood (will show up in blood tests)
• If any of these side effects occur, see a doctor.

Uncommon side effects

(may affect up to 1 in 100 people)

• Hives
• Changes in the blood that may cause unexplained bruising or bleeding.
• If any of these side effects occur, see a doctor.

Frequency not known
(the frequency cannot be estimated from the available data)

• Pulmonary arterial hypertension: A disease that causes severe narrowing of the blood vessels in the lungs, leading to increased pressure in the vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at various times during treatment, even years after starting treatment with interferon-beta products.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.
In order to improve the traceability of this medicine, the doctor or pharmacist must record the
name and batch number of the medicine you are taking in your medical record. It is advisable
to also make a note of these details in case you are asked for this information in the future.

5. How to store Plegridy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and label after
“Expiry/EXP”. The expiry date refers to the last day of that month.

• Store in the original packaging to protect the medicine from light. Only open the packaging when you need the new syringe.
• Store in a refrigerator2º-8ºC.
• Do not freeze. Discard Plegridy that has been accidentally frozen.
• Plegridy can be stored outside the refrigerator at room temperature (up to 25 °C) for a maximum of 30 days, but must be stored away from light.
• The packs can be removed from the refrigerator and then returned to the refrigerator more than once, if necessary.
• Ensure that the time the syringes spend outside the refrigerator is notgreater than atotal of 30 days.
• Discard any syringe kept outside the refrigerator for more than 30 days.
• If you are unsure about the number of days a syringe has been kept outside the refrigerator, discard the syringe.
• Do not use this medicine if you notice any of the following:
• If the syringe is broken.
• If the solution is coloured, cloudy or particles are visible in suspension.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Plegridy contains
The active ingredient is peginterferon beta-1a.
Each pre-filled syringe of 63 micrograms contains 63 micrograms of peginterferon beta-1a
in 0.5 mL of injectable solution.
Each pre-filled syringe of 94 micrograms contains 94 micrograms of peginterferon beta-1a
in 0.5 mL of injectable solution.
Each pre-filled syringe of 125 micrograms contains 125 micrograms of peginterferon
beta-1a in 0.5 mL of injectable solution.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride,
polysorbate 20 and water for injections (see section 2 “Plegridy contains sodium”).

Description of Plegridy and contents of the pack
Plegridy is a clear and colourless injectable solution in a pre-filled glass syringe with a needle
inserted.
Pack size:

• The Plegridy starter pack contains one orange pre-filled syringe of 63 micrograms and one blue pre-filled syringe of 94 micrograms.
• The 125 microgram grey syringes are supplied in a pack containing two or six pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands

Manufacturer
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
DK-3400 Hillerød
Denmark
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/SA
 +32 2 2191218

Lietuva
Biogen Lithuania UAB
 +370 5 259 6176

България
ТП ЕВОФАРМА
 +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium NV/SA
 +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
 +420 255 706 200

Magyarország
Biogen Hungary Kft.
 +36 1 899 9883

Danmark
Biogen Denmark A/S
 +45 77 41 57 57

Malta
Pharma. MT Ltd.
 +356 21337008

Nederland
Biogen Netherlands B.V.
 +31 20 542 2000

Eesti
Biogen Estonia OÜ
 +372 618 9551

Deutschland
Biogen GmbH
 +49 (0) 89 99 6170

Norge
Biogen Norway AS
 +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
 +30 210 8771500

Österreich
Biogen Austria GmbH
 +43 1 484 46 13

España
Biogen Spain S.L.
 +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
 +48 22 351 51 00

France
Biogen France SAS
 +33 (0)1 41 37 9595

Portugal
Biogen Portugal
Sociedade Farmacêutica, Unipessoal Lda.
 +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
 +385 1 775 73 22

România
Johnson & Johnson Romania S.R.L.
 +40 21 207 18 00

Ireland
Biogen Idec (Ireland) Ltd.
 +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
 +386 1 511 02 90

Ísland
Icepharma hf
 +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
 +421 2 323 34008

Italia
Biogen Italia s.r.l.
 +39 02 584 9901

Suomi/Finland
Biogen Finland Oy
 +358 207 401 200

Κύπρος
Genesis Pharma Cyprus Ltd
 +357 22 76 57 15

Sverige
Biogen Sweden AB
 +46 8 594 113 60

United Kingdom (Northern Ireland)
Biogen Idec (Ireland) Limited
 +44 (0) 1628 50 1000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

7. Instructions for injecting Plegridy in a prefilled syringe

BEFORE YOU START
How to inject Plegridy
Read the instructions for use before starting to use Plegridy and each time your prescription is renewed. There may be new information. This information does not replace consultation with your doctor or nurse regarding your medical condition or treatment.

Note:

• Before using Plegridy in a prefilled syringe for the first time, your doctor or nurse must show you or the person assisting you how to prepare and inject Plegridy in a prefilled syringe.
• Plegridy in a prefilled syringe is used only for injecting the medicine under the skin (subcutaneously).
• Each prefilled syringe of Plegridy can be used only once.LatvijaBiogen Latvia SIA  +371 68 688 158

Do notshare Plegridy in a prefilled syringe with others to avoid the transmission of infections.

Do notuse more than one prefilled syringe every 14 days (every 2 weeks).

Do notuse the syringe if it has been dropped or is visibly damaged.

Dosage regimen
The starter pack contains the first two injections to gradually adjust the dose.
Select the correct syringe from a pack.

When	Which dose	Which pack
Day 0 (63 micrograms)	First injection: 63 micrograms, select the orange syringe			c o
Day 14 (94 micrograms)	Second injection: 94 micrograms, select the blue syringe
Day 28 and then subsequently every two weeks (125 micrograms)	Full dose injection: 125 micrograms, select the grey syringe		m a

Do notuse more than one prefilled syringe for each 14-day period (every 2 weeks).

Materials needed for injecting Plegridy

Plegridy prefilled syringe (see Figure A)

Before use - Components of the Plegridy prefilled syringe (see Figure A)

Additional materials not included in the pack (see Figure B):

• Alcohol swab
• Gauze
• Adhesive bandage

Ask your doctor, pharmacist or nurse for instructions on how to dispose of used syringes.

Preparing for the injection
Step 1: Remove the prefilled syringe from the refrigerator

• Remove a pack of Plegridy from the refrigerator and choose the appropriate prefilled syringe from the pack.
• Close the pack and return it to the refrigerator after removing a prefilled syringe.
• Allow the Plegridy prefilled syringe to warm to room temperature for at least30 minutes.

Do notuse external heat sources, such as warm water, to warm Plegridy in a prefilled syringe.

Step 2: Gather the materials and wash your hands

• Find a well-lit, clean and flat surface, such as a table. Gather all the materials needed to self-inject or receive the injection.
• Wash your hands with soap and water.

m Step 3: Check the Plegridy prefilled syringe

Check the expiration date on the Plegridy prefilled syringe (see Figure C). Do not use Plegridy in a prefilled syringe after the expiration date. Check that the Plegridy medicine is clear and colorless (see Figure D). Do not use Plegridy in a prefilled syringe if the liquid is colored, cloudy or contains particles in suspension. o You may see some air bubbles in the Plegridy medicine. This is normal and it is not necessary to expel the air before injection.

i a n a d e l F a r

Performing the injection
Step 4: Select and clean the injection site
Plegridy in a prefilled syringe is used for subcutaneous injection (injection into the skin). Plegridy in a prefilled syringe must be injected into the abdomen, thigh or the back of the arm (see Figure E). Do not inject directly into the navel. Do not inject into an area of the body where the skin is irritated, sensitive, reddened, bruised, tattooed, infected or has scars. Select an injection site and clean the skin with an alcohol swab. Allow the injection site to dry before injecting the dose. Do not touch or blow on this area again before performing the injection	n a d e l F a r m a c o
a Step 5: Remove the needle cap
i With one hand, hold the syringe by the body of the glass. With the other, firmly grasp the needle cap and remove it from the needle (see Figure F). Be careful when removing the needle cap to avoid injuring yourself with the needle. Do not touch the needle. Caution - Do not put the needle cap back on the Plegridy prefilled syringe. You could injure yourself with the needle.

		m a		c o
Step 7: Inject the medicine
Hold the Plegridy prefilled syringe at a 90° angle to the injection site. Quickly insert the needle into the skin fold until it is fully penetrated under the skin (see Figure H). Once the needle is inserted, the skin can be released. Do not pull back the plunger.	d e l F a r
Slowly press the plunger all the way down to empty the syringe (see Figure I). Do not remove the Plegridy prefilled syringe from the injection site until you have pressed the plunger all the way down.	a i
Keep the needle inserted for 5 seconds (see Figure J).

Step 8: Remove the prefilled syringe from the injection site
Completely remove the needle from the skin (see Figure K). Caution - Do not put the needle cap back on the Plegridy prefilled syringe. You could injure yourself with the needle. Do not reuse the Plegridy prefilled syringe.		r m	a c o

After the injection
Step 9: Disposal of the used Plegridy prefilled syringe

• Ask your doctor, pharmacist or nurse how to properly dispose of the used syringe.

Step 10: Care of the injection site

• If necessary, apply a gauze or adhesive bandage to the injection site.

Step 11: Check the injection site

• After 2 hours, check the injection site for possible redness, swelling or soreness.
• If you have a skin reaction that does not disappear within a few days, contact your doctor or nurse.

Record the date and location

• Record the date and location of each injection.
• For the first injections, you can use the appropriate table printed inside the lid of the Starter Pack.

General warnings
Do notreuse the Plegridy prefilled syringe.

Do notshare the Plegridy prefilled syringe.

• Keep the Plegridy prefilled syringe and all medicines out of the reach ofchildren.

Storage

• Refrigerated storage is recommended, at a controlled temperature between 2 °C and 8 °C, in the original closed pack, to protect the medicine from light.
• If necessary, Plegridy can be stored in the original closed pack, out of the refrigerator, at a temperature of up to 25 °C for a maximum of 30 days.
• Plegridy can be removed from the refrigerator and returned to the refrigerator, if necessary. The totalstorage time outside the refrigerator, at a temperature of up to 25 °C, must notexceed 30 days.Do notfreeze or expose to high temperatures.

Plegridy 63 micrograms injectable solution in pre-filled pen, 94 micrograms injectable solution in pre-filled pen, 125 micrograms injectable solution in pre-filled pen

peginterferon beta-1a

Read this leaflet carefully before you start using this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Plegridy is and what it is used for

2. What you need to know before you use Plegridy

3. How to use Plegridy

4. Possible side effects

5. How to store Plegridy

6. Contents of the pack and other information

7. Instructions for injecting Plegridy in pre-filled pen

1. What Plegridy is and what it is used for

What is Plegridy
The active ingredient contained in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a
modified form of interferon with a long-lasting action. Interferons are natural substances that
the body produces to help protect it from infections and diseases.

What is Plegridy used for
This medicine is used to treat relapsing-remitting multiple sclerosis (RRMS) in
adults aged 18 years and over.
Multiple sclerosis is a long-term disease that affects the central nervous system (CNS),
including the brain and spinal cord, in which the body’s immune system (its natural defences
) damages the protective coating (myelin) around the nerves in the brain and spinal
cord. This disrupts messages between the brain and other parts of the body, causing the
symptoms of multiple sclerosis. Patients with RRMS experience phases where the
disease is not active (remission) between flare-ups of symptoms (relapses).

Each person experiences an individual variety of multiple sclerosis symptoms.Among the possible
symptoms are:

• A sense of imbalance or dizziness, problems with walking, stiffness and muscle spasms, fatigue, numbness in the face, arms or legs
• Sharp or chronic pain, bladder or bowel problems, sexual problems and vision disturbances
• Difficulty thinking and concentrating, depression.

How Plegridy works
Plegridy appears to work by preventing the body’s immune system from damaging the
brain and spinal cord.This may help to reduce the number of relapses and slow down the
disabling effects of multiple sclerosis. Treatment with Plegridy may help to prevent
worsening, although it cannot cure multiple sclerosis.

2. What you need to know before using Plegridy

Do not use Plegridy

• If you are allergicto peginterferon beta-1a, interferon beta-1a or any of the other ingredients of this medicine (listed in section 6). See section 4 for the symptoms of an allergic reaction.
• If you suffer from severe depressionor are thinking about committing suicide.

Warnings and precautions

• Talk to your doctor if you have ever had:
• Depressionor mood problems
• Thoughts of committing suicide
• The doctor may still prescribe Plegridy, but it is important to inform your doctor if you have had depression or any similar mood problems in the past.

Talk to your doctor, pharmacist or nursebefore injecting Plegridy if any of the conditions listed below occur.These problems may worsen during the use of
Plegridy:

• Serious problems with the liver or kidneys
• Irritation at the injection site,which can cause damage to the skin and tissues (injection site necrosis). When you are ready to inject, carefully follow the instructions provided in section 7

to reduce the risk of reactions at the injection site.

• Epilepsyor other uncontrolled seizure disorders treated with medication
• Heart problems, which can cause symptoms such as chest pain (angina), especially after any activity; swollen ankles, shortness of breath (congestive heart failure) or an irregular heartbeat (arrhythmia).
• Thyroid problems
• A low number of white blood cells or platelets in the blood, which can increase the risk of infection or bleeding

Other things to consider when using Plegridy

• Blood tests will be needed to determine the number of blood cells, blood chemistry and liver enzyme levels. These tests will be performed before starting to use Plegridy, regularly after starting treatment with Plegridy and then periodically during treatment, even if you have no particular symptoms. These blood tests will be in addition to the tests performed normally for monitoring MS.
• The function of the thyroid gland will be checked regularly or whenever deemed necessary by the doctor for other reasons.
• Blood clots may form in the small blood vessels during treatment. These blood clots can have an effect on the kidneys. This can occur from several weeks to several years after starting treatment with Plegridy. The doctor may decide to check blood pressure, blood (platelet count) and kidney function.

If you accidentally prick or puncture another person with the Plegridy needle, the affected area must be
washed immediatelywith soap and water and a doctor ora nurse must be
contacted as soon as possible.
Children and adolescents
Plegridy must notbe usedin children and adolescents under 18 years of age. The
safety and efficacy of Plegridy in this age group are unknown.

Other medicines and Plegridy
Plegridy must be used with caution with medicines that are metabolized in the body
by a group of proteins called “cytochrome P450” (e.g. some medicines used for
epilepsy or depression).
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, particularly those used for the treatment of epilepsy or
depression. This applies to any medicines, including those obtained without a prescription.
Sometimes you will need to remind other healthcare professionals that you are currently being treated with Plegridy, for
example, if you are prescribed other medicines, or if you undergo a blood test. Plegridy
can affect other medicines or the result of tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
No harmful effects on the breastfed infant are expected. Plegridy can be used
during breastfeeding.

Driving and using machines
Plegridy does not alter or alters negligibly the ability to drive and use machines.

Plegridy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium, which is essentially ‘sodium-free’.

3. How to use Plegridy

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

Usual dose
One injection of Plegridy 125 micrograms every 14 days (every two weeks). Each time you
administer Plegridy, try to do it at the same time and on the same day.

Starting therapy with Plegridy
If you have never used Plegridy before, your doctor may advise you to gradually increase the dose,
to get used to the effects of Plegridy before taking the full dose. You will be provided with a Starter
Pack containing the first 2 injections: an orange pen with Plegridy 63 micrograms
(for day 0) and a blue pen with Plegridy 94 micrograms (for day 14).
Subsequently you will be provided with a maintenance pack containing grey pens with
Plegridy 125 micrograms (for day 28 and then every two weeks).
Read the instructions in section 7 “ Instructions for injecting Plegridy in a prefilled pen” at the end of
Use the registration table printed inside the lid of the Starter Pack
to record the dates of your injections.

Self-administration of the injection
Plegridy must be injected under the skin ( subcutaneous injection). Alternate the sites you use for
injections. Do not use the same injection site for consecutive injections.
You can inject Plegridy without the help of a doctor, if you have been shown how to do it.

• Read and follow the advice provided in the instructions in section 7 “ Instructions for injecting Plegridyin a prefilled pen” before starting.
• If you have problemshandling the pen, contact your doctor or nurse who can help you.

How long to use Plegridy
Your doctor will tell you how long you need to continue using Plegridy. It is important to continue to
use Plegridy regularly. Do not modify the therapy in any way unless instructed by
your doctor.

If you use more Plegridy than you should
You must inject Plegridy only once every 2 weeks.

• If you have used more than one injection of Plegridy in a period of 7 days, consultimmediately your doctor or pharmacist.

If you forget to use Plegridy
You must inject Plegridy once every 2 weeks. This regular schedule helps to administer the
treatment as evenly as possible.
If you miss your usual day, inject a dose as soon as possible and continue normally. Do not inject
more than once in a period of 7 days. Do not use two injections to make up for forgetting
an injection.
If you have any doubts about using this medicine, contact your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

• Liver problems(common - may affect up to 1 in 10 people)If you experience any of the following symptoms:
• Yellowing of the skin or the whites of the eyes
• Widespread itching
• Feeling unwell or sick (nausea and vomiting)
• Easy bruising
• Seek medical attention immediately.These may be signs of a potential liver problem.
• Depression(common - may affect up to 1 in 10 people)If:
• You feel unusually sad, anxious or hopeless or
• You have thoughts of harming yourself
• Seek medical attention immediately.
• Serious allergic reaction(uncommon - may affect up to 1 in 100 people)If you experience any of the following symptoms:
• Difficulty breathing
• Swelling in the area of the face (lips, tongue or throat)
• Skin rash or redness
• Seek medical attention immediately.
• Convulsions(uncommon - may affect up to 1 in 100 people)

If you have a convulsion or seizure

• Seek medical attention immediately.
• Injection site damage(rare - may affect up to 1 in 1,000 people)If you experience any of the following symptoms:
• Any skin lesion together with swelling, inflammation or fluid leakage around the injection site
• Seek medical advice.
• Kidney problems including scarring that can reduce kidney function(rare - may affect up to 1 in 1,000 people)If you experience some or all of the following symptoms:
• Foamy urine
• Fatigue
• Swelling, particularly around the ankles and eyelids, and weight gain.
• Tell your doctor as these may be signs of a potential kidney problem.
• Blood problems(rare - may affect up to 1 in 1,000 people)The following may occur: blood clots inside small blood vessels which can affect the kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or lightheadedness. Your doctor is likely to find changes in your blood and kidney function.

If you experience some or all of the following symptoms:

• Increased bruising or bleeding
• Extreme weakness
• Headache, dizziness or lightheadedness
• Seek medical attention immediately.

Other side effects
Very common side effects

(may affect more than 1 in 10 people)

• Flu-like symptoms. These symptoms are not due to a real flu (see below). You cannot infect other people.
• Headache
• Muscle pain (myalgia)
• Joint pain, arm, leg or neck pain (arthralgia)
• Chills
• Fever
• Feeling weak and tired (asthenia)
• Redness, itching or pain around the area where you had the injection
• If any of these side effects occur, tell your doctor.

Flu-like symptoms
Flu-like symptoms are more common at the beginning of treatment with Plegridy. They tend to decrease
gradually as you continue with the injections. See below for simple ways to manage
these flu-like symptoms, if they occur.
Three simple ways to reduce the intensity of flu-like symptoms:

• 1. Consider the timing of your Plegridy injection. The start and end of flu-like symptoms are different for each patient. On average, flu-like symptoms start about 10 hours after the injection and last between 12 and 24 hours.

• 2. Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue to take paracetamol or ibuprofen for the duration of the flu-like symptoms. Ask your doctor or pharmacist which dose to take and for how long.
• 3. If you develop a fever, drink plenty of water to keep your body hydrated.

Common side effects

(may affect up to 1 in 10 people)

• Nausea or vomiting
• Hair loss (alopecia)
• Itchy skin (pruritus)
• Increased body temperature
• Changes around the injection site, such as swelling, inflammation, bruising, warmth, rash or change in colour
• Changes in the blood that may cause fatigue or reduce your ability to fight infections
• Increased liver enzymes in the blood (will show up in blood tests)
• If any of these side effects occur, tell your doctor.

Uncommon side effects

(may affect up to 1 in 100 people)

• Hives
• Changes in the blood that may cause unexplained bruising or bleeding.
• If any of these side effects occur, tell your doctor.

Frequency not known

(the frequency cannot be estimated from the available data)

• Pulmonary arterial hypertension: A disease that causes severe narrowing of the blood vessels in the lungs, leading to increased pressure in the vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at various times during treatment, even years after starting treatment with interferon-beta products.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
In order to improve the traceability of this medicine, the doctor or pharmacist must record the
name and batch number of the medicine you are using in your medical record. It is advisable
to also make a note of these details in case you are asked for them in the future.

5. How to store Plegridy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and the label after
“Expiry Date/EXP”. The expiry date refers to the last day of that month.

• Store in the original packaging to protect the medicine from light. Only open the packaging when you need the new pen.
• Store in a refrigerator(2 °-8 °C).
• Do not freeze. Discard Plegridy that has been accidentally frozen.
• Plegridy can be stored outside the refrigerator at room temperature (up to 25 °C) for a maximum of 30 days, but it must be stored away from light.
• The packs can be removed from the refrigerator and then returned to the refrigerator more than once, if necessary.
• Ensure that the time spent by the pens outside the refrigerator is notgreater than atotal of 30 days.
• Discard any pen kept outside the refrigerator for more than 30 days.
• If you are unsure about the number of days a pen has been kept outside the refrigerator, discard the pen.
• Do not use this medicine if you notice any of the following:
• If the pen is broken.
• If the solution is coloured, cloudy or particles are visible in suspension.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Plegridy contains
The active ingredient is peginterferon beta-1a.
Each pre-filled pen containing 63 micrograms contains 63 micrograms of peginterferon beta-1a in
0.5 mL of injectable solution.
Each pre-filled pen containing 94 micrograms contains 94 micrograms of peginterferon beta-1a in
0.5 mL of injectable solution.
Each pre-filled pen containing 125 micrograms contains 125 micrograms of peginterferon beta-1a
in 0.5 mL of injectable solution.
The other ingredients are: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride,
polysorbate 20 and water for injections (see section 2 “Plegridy contains sodium”).

Description of Plegridy and contents of the pack
Plegridy is a clear and colourless injectable solution in a pre-filled pen, made of glass, with a needle
attached.
Pack size:

• The Plegridy starter pack contains one orange pre-filled pen of 63 micrograms and one blue pre-filled pen of 94 micrograms.
• The grey 125 microgram pens are supplied in a pack containing two or six pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Manufacturer
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
DK-3400 Hillerød
Denmark
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/SA
 +32 2 2191218

Lietuva
Biogen Lithuania UAB
 +370 5 259 6176

България
ТП ЕВОФАРМА
 +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium NV/SA
 +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
 +420 255 706 200

Magyarország
Biogen Hungary Kft.
 +36 1 899 9883

Danmark
Biogen Denmark A/S
 +45 77 41 57 57

Malta
Pharma. MT Ltd.
 +356 21337008

Nederland
Biogen Netherlands B.V.
 +31 20 542 2000

Eesti
Biogen Estonia OÜ
 +372 618 9551

Deutschland
Biogen GmbH
 +49 (0) 89 99 6170

Norge
Biogen Norway AS
 +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
 +30 210 8771500

Österreich
Biogen Austria GmbH
 +43 1 484 46 13

España
Biogen Spain S.L.
 +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
 +48 22 351 51 00

France
Biogen France SAS
 +33 (0)1 41 37 9595

Portugal
Biogen Portugal
Sociedade Farmacêutica, Unipessoal Lda.
 +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
 +385 1 775 73 22

România
Johnson & Johnson Romania S.R.L.
 +40 21 207 18 00

Ireland
Biogen Idec (Ireland) Ltd.
 +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
 +386 1 511 02 90

Ísland
Icepharma hf
 +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
 +421 2 323 34008

Italia
Biogen Italia s.r.l.
 +39 02 584 9901

Suomi/Finland
Biogen Finland Oy
 +358 207 401 200

Κύπρος
Genesis Pharma Cyprus Ltd
 +357 22 76 57 15

Sverige
Biogen Sweden AB
 +46 8 594 113 60

United Kingdom (Northern Ireland)
Biogen Idec (Ireland) Limited
 +44 (0) 1628 50 1000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu .

7. Instructions for injecting Plegridy in a prefilled pen

• Caution! Do notremove the cap until you are ready to administer the injection.

How to inject Plegridy
Read the instructions for use before starting to use Plegridy and each time your prescription is renewed. There may be new information. This information does not replace consultation with your doctor or nurse regarding your medical condition or treatment.

Note:

• Before using the pen for the first time, the doctor or nurse must show you or the person assisting you how to prepare and inject the pen.
• The pen is used only for injecting the medicine under the skin (subcutaneously).
• Each pen can be used only once. LatvijaBiogen Latvia SIA  +371 68 688 158

Do not sharethe pen with others to avoid the transmission of infections.

Do not use more than 1pen every 14 days (every 2 weeks).

Do notuse the pen if it has been dropped or is visibly damaged.

Dosage regimen
The starter pack contains the first two injections to gradually adjust the dose.
Select the correct pen from a pack.

Do not usemore than one pen for each 14-day period (every 2 weeks).

When	Which dose	Which pack
Day 0 (63 micrograms)	First injection: 63 micrograms, select the orange pen	m a c
Day 14 (94 micrograms)	Second injection: 94 micrograms, select the blue pen
Day 28 and then subsequently every two weeks (125 micrograms)	Full dose injection: 125 micrograms, select the F grey pen	a r

Materials needed for injecting Plegridy Pen:
1 Plegridy Pen (see Figure A)

Before use - Components of Plegridy Pen (Figure A)

Caution! Do not remove the capuntil you are ready to administer the injection. If you remove the cap, do not put it back on the pen. Reapplying the cap may cause the pen to lock.

Additional materials not included in the package (see Figure B):

Preparation for the injection
Step 1: Remove the pen from the refrigerator.

• a. Remove a pack of Plegridy from the refrigerator and choose the appropriate pen (dose) from the pack.
• b. Close the pack and return it to the refrigerator after removing one pen.
• c. Allow the pen to warm to room temperature for at least 30 minutes.Do not use external heat sources, such as warm water, to heat the pen.

Step 2: Gather materials and wash your hands.

• a. Find a well-lit, clean, and flat surface, such as a table. Gather all the materials needed to self-inject or receive the injection.
• b. Wash your hands with soap and water.

Step 3: Check Plegridy Pen (see Figure C)

a. Check the injection status display window. Green stripes should be visible. b. Check the expiration date. c. Check the medicine window and make sure the Plegridy medicine is clear and colorless. Do not use the pen if: Green stripes are not visible in the injection status display window. It is expired. The liquid is colored, cloudy, or contains particles in suspension. Note: You may see air bubbles in the medicine window. This is normal and does not affect the dose. Do not use the pen if it has been dropped or is visibly damaged.

a d e l F a r m a c o

n Step 4: Select and clean the injection site

a a. Select an injection site on the thigh, abdomen, or back of the arm (see highlighted areas in Figure D). i If some areas are too difficult to reach, ask for help from a person assisting you who has received adequate training. Do not inject into an area of the body where the skin is irritated, reddened, bruised, tattooed, infected, or has scars. Do not inject directly into the navel. z b. Clean the skin with an alcohol wipe.

Performing the injection
Step 5: Remove the cap from Plegridy Pen
a. Completely remove the cap and set it aside (see Figure E). The pen is now ready for injection. Warning! Do not touch, clean or manipulate the needle cover. You could injure yourself with the needle or the pen may lock. Caution! Do not put the cap back on the pen. This could cause it to lock.		a r m a c o
Step 6: Perform the injection
a. Hold the pen over the injection site. Make sure the green stripes are visible in the injection status display window (see Figure F). You must hold the pen over the injection site at a 90° angle. Warning! Do not lean the pen on the injection site until you are ready to inject. This could cause accidental locking of the pen. n	a d e l F
i b. Press firmly and hold the pen on the injection site. You will feel “clicks”. This indicates that the pen is injecting the medicine (see Figure G). t I a i z

c. Continue to hold the pen firmly pressed on the injection site until you no longer hear the “clicks” (see Figure H). Do not lift the pen from the injection site until you no longer hear the “clicks” and a green check mark appears in the injection status display window. Warning! If you do not hear the “clicks” or do not see the green check marks in the injection status display window after attempting to inject, it is possible that the pen has locked and you have not received the injection. In this case, contact your doctor, nurse or pharmacist.	F a r m a c o
Fase 7: Remove Plegridy Pen from the injection site
a. When you no longer hear the “clicks”, lift the pen from the injection site. The needle cover extends covering the needle and locks (see Figure I). If you see blood at the injection site, clean it with gauze and apply a bandage or adhesive bandage n a i l	a d e

Step 8: Verify that you have received the complete dose of Plegridy (see Figure J)
a. Check the injection status display window. Green check marks should be visible. b. Check the medicine window. You should see a yellow plunger.	e l F a r m a c o

After the injection
After use - Components of Plegridy Pen (see Figure K):

Note: Once the pen is removed from the injection site, the needle cover locks to protect against injury.

Do not put the cap back on the pen.
Step 9: Disposal of the used Plegridy pen

• Consult your doctor, pharmacist or nurse on how to properly dispose of the used pen. Do not put the cap back on the pen.

Step 10: Care of the injection site

• If necessary, apply gauze or a bandage or adhesive bandage to the injection site.

Step 11: Check the injection site

• After 2 hours, check the injection site for possible redness, swelling or soreness.
• If you have a skin reaction that does not disappear within a few days, consult your doctor or nurse.

Recording the date and location

• Record the date and location of each injection.
• For the Starter Pack injections, you can use the appropriate table printed inside the lid of that pack.

General warnings
Do not reuse Plegridy Pen.

Do not share Plegridy Pen.

• Keep Plegridy Pen and all medicines out of the reach of children.

Storage

• Recommended storage in a refrigerator, at a controlled temperature between 2 °C and 8 °C, in the original closed packaging, to protect the medicine from light.
• If necessary, Plegridy can be stored in the original closed packaging, outside the refrigerator, at a temperature of up to 25 °C for a maximum of 30 days.
• Plegridy can be removed from the refrigerator and returned to the refrigerator, if necessary. The total storage time outside the refrigerator, at a temperature of up to 25 °C, must not exceed 30 days.Do notfreeze or expose to high temperatures.

Plegridy 125 micrograms injectable solution in pre-filled syringe

peginterferon beta-1a

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Plegridy is and what it is used for

2. What you need to know before you use Plegridy

3. How to use Plegridy

4. Possible side effects

5. How to store Plegridy

6. Contents of the pack and other information

7. Instructions for injecting Plegridy from a pre-filled syringe

1. What Plegridy is and what it is used for

What Plegridy is
The active ingredient in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a
modified form of interferon with a long-lasting action. Interferons are natural substances that
the body produces to help protect it from infections and diseases.

What Plegridy is used for
This medicine is used to treat relapsing-remitting multiple sclerosis (RRMS) in
adults aged 18 years and over.
Multiple sclerosis is a long-term disease that affects the central nervous system (CNS),
including the brain and spinal cord, in which the body’s immune system (its natural defences
) damages the protective coating (myelin) around the nerves in the brain and spinal
cord. This disrupts messages between the brain and other parts of the body, causing the
symptoms of multiple sclerosis. Patients with RRMS experience phases where the
disease is not active (remission) between flare-ups of symptoms (relapses).

Each person experiences an individual variety of multiple sclerosis symptoms.Among the possible
symptoms are:

• A feeling of imbalance or dizziness, problems with walking, muscle stiffness and spasms, fatigue, numbness in the face, arms or legs
• Sharp or chronic pain, bladder or bowel problems, sexual problems and vision disturbances
• Difficulty thinking and concentrating, depression.

How Plegridy works
Plegridy appears to work by preventing the body’s immune system from damaging the
brain and spinal cord.This may help to reduce the number of relapses and slow down the
disabling effects of multiple sclerosis. Treatment with Plegridy may help to prevent
worsening, although it cannot cure multiple sclerosis.

2. What you need to know before you use Plegridy

Do not use Plegridy

• If you are allergicto peginterferon beta-1a, interferon beta-1a or any of the other ingredients of this medicine (listed in section 6). See section 4 for the symptoms of an allergic reaction.
• If you suffer from severe depressionor think about committing suicide.

Warnings and precautions

• Talk to your doctor if you have ever had:
• Depressionor mood problems
• Thoughts of committing suicide
• The doctor may still prescribe Plegridy, but it is important to inform the doctor if you have had depression or any similar mood problems in the past.

Talk to your doctor, pharmacist or nursebefore injecting Plegridy if any of the conditions listed below occur.These problems may worsen during the use of
Plegridy:

• Serious problems with the liver or kidneys
• Irritation at the injection site,which can cause damage to the skin and tissues ( injection site necrosis). When you are ready to inject, carefully follow the instructions provided in section 7

to reduce the risk of reactions at the injection site.

• Epilepsyor other uncontrolled seizure disorders, not controlled by medication
• Heart problems, which can cause symptoms such as chest pain ( angina), especially after any activity; swollen ankles, shortness of breath ( congestive heart failure) or an irregular heartbeat ( arrhythmia).
• Thyroid problems
• A low number of white blood cells or platelets in the blood, which can increase the risk of infection or bleeding

Other things to consider when using Plegridy

• Blood tests will be needed to determine the number of blood cells, blood chemistry and liver enzyme levels. These tests will be performed before starting to use Plegridy, regularly after starting treatment with Plegridy and then periodically during treatment, even if you have no particular symptoms. These blood tests will be in addition to the tests performed normally for monitoring MS.
• The function of the thyroid gland will be checked regularly or whenever deemed necessary by the doctor.
• Blood clots may form in the small blood vessels during treatment. These blood clots can have an effect on the kidneys. This can happen from several weeks to several years after starting treatment with Plegridy. The doctor may decide to check blood pressure, blood (platelet count) and kidney function.

If you accidentally prick or puncture another person with the Plegridy needle, the affected area must be washed immediatelywith soap and water and a doctor or nurse must be contacted as soon as possible.
Children and adolescents
Plegridy must not be usedin children and adolescents under the age of 18. The
safety and efficacy of Plegridy in this age group have not been established.

Other medicines and Plegridy
Plegridy must be used with caution with medicines that are metabolized in the body
by a group of proteins called “cytochrome P450” (for example, some medicines used for
epilepsy or depression).
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines, especially those used for the treatment of epilepsy or
depression. This applies to any medicine, including those obtained without a prescription.
Sometimes you will need to remind other healthcare professionals that you are currently being treated with Plegridy, for
example, if you are prescribed other medicines, or if you undergo a blood test. Plegridy
can affect other medicines or the result of the tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
No harmful effects on the newborn/breastfed infant are expected. Plegridy can be used
during breastfeeding.

Driving and using machines
Plegridy does not alter or negligibly alters the ability to drive vehicles and use machinery.

Plegridy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium, which is essentially ‘sodium-free’.

3. How to use Plegridy

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

Usual dose
One injection of Plegridy 125 micrograms every 14 days (every two weeks). Each time you
administer Plegridy, try to do it at the same time and on the same day.

Starting therapy with Plegridy for intramuscular use
If you have never used Plegridy before, your doctor may advise you to gradually increase the
doseduring the first month of treatment. This means that your body needs to get used to the effects of
Plegridy before you can receive the full dose.
The full dose of a prefilled Plegridy syringe for intramuscular administration is
125 micrograms. You can attach the Plegridy titration clips to the syringe so that you can
gradually increase the dose:
Dose 1 on day 0:
1/2 dose (63 micrograms) with YELLOW titration clip
Dose 2 on day 14:
3/4 dose (94 micrograms) with PURPLE titration clip
Dose 3 on day 28 and then every 2 weeks:
full dose (125 micrograms) - no titration clip is needed
Plegridy supplied in this package is intended to be injected into a thigh muscle.
Read the instructions in section 7 “ Instructions for injecting Plegridy in a prefilled syringe” at the end
Consult your doctor, nurse or pharmacist if you do not know how to inject the medicine.
On the syringe label, intramuscular is abbreviated as IM.

Self-administer the injection
Plegridy must be injected into a thigh muscle ( intramuscular injection). Alternate the sites you
use for injections. Do not use the same injection site for consecutive injections.
You can inject Plegridy without the help of a doctor, if you have been shown how to do it.

• Read and follow the advice provided in the instructions in section 7 “ Instructions for injecting Plegridyin a prefilled syringe” before starting.
• If you have problemshandling the syringe, contact your doctor or nurse who can help you.

How long to use Plegridy
Your doctor will tell you how long you should continue to use Plegridy. It is important to continue to
use Plegridy regularly. Do not change the therapy in any way unless instructed by your
doctor.

If you use more Plegridy than you should
You should inject Plegridy only once every 2 weeks.

• If you have used more than one Plegridy injection in a 7-day period, consultyour doctor or pharmacist immediately.

If you forget to use Plegridy
You should inject Plegridy once every 2 weeks. This regular schedule helps to administer the
treatment as evenly as possible.
If you miss your usual day, inject a dose as soon as possible and continue normally. However, do not inject
more than once in a 7-day period. Do not use two injections to make up for forgetting an
injection.
If you have any questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
li manifestino.

Serious side effects

• Liver problems(common - may affect up to 1 in 10 people)If you experience any of the following symptoms:
• Yellowing of the skin or the whites of the eyes
• Widespread itching
• Feeling unwell or sick (nausea and vomiting)
• Easy bruising
• Seek medical attention immediately.These may be signs of a potential liver problem.
• Depression(common - may affect up to 1 in 10 people)If:
• You feel unusually sad, anxious or hopeless or
• You have thoughts of harming yourself
• Seek medical attention immediately.
• Severe allergic reaction(uncommon - may affect up to 1 in 100 people)If you experience any of the following symptoms:
• Difficulty breathing
• Swelling in the area of the face (lips, tongue or throat)
• Skin rash or redness
• Seek medical attention immediately.
• Convulsions(uncommon - may affect up to 1 in 100 people)If you have a convulsion or fit
• Seek medical attention immediately.
• Damage at the injection site(rare - may affect up to 1 in 1,000 people)If you experience any of the following symptoms:
• Any skin lesion together with swelling, inflammation or fluid leakage around the injection site
• See a doctor for advice.
• Kidney problems including scarring that can reduce kidney function(rare - may affect up to 1 in 1,000 people)If you experience some or all of the following symptoms:
• Foamy urine
• Fatigue
• Swelling, particularly around the ankles and eyelids, and weight gain.
• Tell your doctor as these may be signs of a potential kidney problem.
• Blood problems(rare - may affect up to 1 in 1,000 people)The following may occur: blood clots inside small blood vessels which can affect the kidneys (thrombotic thrombocytopenic purpura or haemolytic uraemic syndrome). Symptoms may include increased bruising, bleeding, fever, severe weakness, headache, dizziness or lightheadedness. Your doctor is likely to find changes in your blood and kidney function.

If you experience some or all of the following symptoms:

• Increased bruising or bleeding
• Severe weakness
• Headache, dizziness or lightheadedness
• Seek medical attention immediately.

Other side effects
Very common side effects

(may affect more than 1 in 10 people)

• Flu-like symptoms. These symptoms are not caused by real influenza (see below). You cannot infect other people.
• Headache
• Muscle pain (myalgia)
• Joint pain, arm, leg or neck pain (arthralgia)
• Chills
• Fever
• Feeling weak and tired (asthenia)
• Redness, itching or pain around the area where you had the injection
• If any of these side effects occur, see your doctor.

Flu-like symptoms
Flu-like symptoms are more common at the beginning of treatment with Plegridy. They tend to decrease
gradually as you continue with the injections. See below for simple ways to manage
these flu-like symptoms, if they occur.
Three simple ways to reduce the intensity of flu-like symptoms:

• 1. Consider the timing of your Plegridy injection. The start and end of flu-like symptoms are different for each patient. On average, flu-like symptoms start about 10 hours after the injection and last between 12 and 24 hours.
• 2. Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue to take paracetamol or ibuprofen for the duration of the flu-like symptoms. Ask your doctor or pharmacist which dose to take and for how long.
• 3. If you develop a fever, drink plenty of water to stay hydrated.

Common side effects

(may affect up to 1 in 10 people)

• Feeling unwell or sick (nausea or vomiting)
• Hair loss (alopecia)
• Itchy skin (pruritus)
• Increased body temperature
• Changes around the injection site, such as swelling, inflammation, bruising, warmth, rash or change in colour
• Changes in the blood that may cause fatigue or reduce the ability to fight infections
• Increased liver enzymes in the blood (will show up in blood tests)
• If any of these side effects occur, see your doctor.

Uncommon side effects

(may affect up to 1 in 100 people)

• Hives
• Changes in the blood that may cause unexplained bruising or bleeding.
• If any of these side effects occur, see your doctor.

Frequency not known

(the frequency cannot be estimated from the available data)

• Pulmonary arterial hypertension: A disease that causes severe narrowing of the blood vessels in the lungs, leading to increased pressure in the vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at various times during treatment, even years after starting treatment with interferon-beta products.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By
reporting side effects you can help provide more information on the safety of this medicine.
In order to improve the traceability of this medicine, the doctor or pharmacist must record the
name and batch number of the medicine you are taking in your medical record. It is advisable
to keep a note of these details should you be asked for them in the future.

5. How to store Plegridy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and label after
“Expiry Date/EXP”. The expiry date refers to the last day of that month.

• Store in the original packaging to protect the medicine from light. Only open the packaging when you need the new syringe.
• Store in a refrigerator(2 °-8 °C).
• Do not freeze. Discard Plegridy that has been accidentally frozen.
• Plegridy can be stored outside the refrigerator at room temperature (up to 25 °C) for a maximum of 30 days, but must be stored away from light.
• The packs can be removed from the refrigerator and then returned to the refrigerator more than once, if necessary.
• Ensure that the time the syringes spend outside the refrigerator is notgreater than atotal of 30 days.
• Discard any syringe kept outside the refrigerator for more than 30 days.
• If you are unsure about the number of days a syringe has been kept outside the refrigerator, discard the syringe.
• Do not use this medicine if you notice any of the following:
• If the syringe is broken.
• If the solution is coloured, cloudy or particles are visible in suspension.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Plegridy contains
The active ingredient is peginterferon beta-1a.
Each pre-filled syringe of 125 micrograms contains 125 micrograms of peginterferon
beta-1a in 0.5 mL of injectable solution.
The other components are: sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride,
polysorbate 20 and water for injections (see section 2 “Plegridy contains sodium”).

Description of Plegridy and contents of the pack
Plegridy is a clear and colourless injectable solution in a pre-filled glass syringe with a needle
inserted.
Pack size:

• The syringes are supplied in a pack containing two or six pre-filled syringes with sterile 23 gauge needles, 3.2 cm long.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands

Manufacturer
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
DK-3400 Hillerød
Denmark
Biogen Netherlands B.V.
Prins Mauritslaan 13
1171 LP Badhoevedorp
The Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biogen Belgium NV/SA
 +32 2 2191218

Lietuva
Biogen Lithuania UAB
 +370 5 259 6176

България
ТП ЕВОФАРМА
 +359 2 962 12 00

Luxembourg/Luxemburg
Biogen Belgium NV/SA
 +32 2 2191218

Česká republika
Biogen (Czech Republic) s.r.o.
 +420 255 706 200

Magyarország
Biogen Hungary Kft.
 +36 1 899 9883

Danmark
Biogen Denmark A/S
 +45 77 41 57 57

Malta
Pharma. MT Ltd.
 +356 21337008

Nederland
Biogen Netherlands B.V.
 +31 20 542 2000

Eesti
Biogen Estonia OÜ
 +372 618 9551

Deutschland
Biogen GmbH
 +49 (0) 89 99 6170

Norge
Biogen Norway AS
 +47 23 40 01 00

Ελλάδα
Genesis Pharma SA
 +30 210 8771500

Österreich
Biogen Austria GmbH
 +43 1 484 46 13

España
Biogen Spain S.L.
 +34 91 310 7110

Polska
Biogen Poland Sp. z o.o.
 +48 22 351 51 00

France
Biogen France SAS
 +33 (0)1 41 37 9595

Portugal
Biogen Portugal
Sociedade Farmacêutica, Unipessoal Lda.
 +351 21 318 8450

Hrvatska
Biogen Pharma d.o.o.
 +385 1 775 73 22

România
Johnson & Johnson Romania S.R.L.
 +40 21 207 18 00

Ireland
Biogen Idec (Ireland) Ltd.
 +353 (0)1 463 7799

Slovenija
Biogen Pharma d.o.o.
 +386 1 511 02 90

Ísland
Icepharma hf
 +354 540 8000

Slovenská republika
Biogen Slovakia s.r.o.
 +421 2 323 34008

Italia
Biogen Italia s.r.l.
 +39 02 584 9901

Suomi/Finland
Biogen Finland Oy
 +358 207 401 200

Κύπρος
Genesis Pharma Cyprus Ltd
 +357 22 76 57 15

Sverige
Biogen Sweden AB
 +46 8 594 113 60

United Kingdom (Northern Ireland)
Biogen Idec (Ireland) Limited
 +44 (0) 1628 50 1000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .

7. Instructions for injecting Plegridy in prefilled syringe

How to inject Plegridy
Read the instructions for use before starting to use the Plegridy prefilled syringe. There may
be new information. This information does not replace consultation with your
healthcare provider regarding your medical condition or treatment.

Materials needed for Plegridy injection:

• 1 single-dose pack of Plegridy containing:
• 1 Plegridy prefilled syringe
• 1 sterile 23 gauge needle, 3.2 cm long
• a puncture-resistant container for disposal of used syringes and needles
• Additional materials not included in the package:
• Alcohol swab
• Gauze
• Adhesive bandage LatvijaBiogen Latvia SIA  +371 68 688 158

If this is the first time you are using Plegridy, your dose may be titrated in 2 injections using the
syringe with the Plegridy titration kit.
o Dose 1:
½ dose (yellow titration clip) ( not included in the package)
o Dose 2:
¾ dose (purple titration clip) ( not included in the package)
o Dose 3:
Full dose (clip not needed)

• Plegridy titration clips are for exclusive use with Plegridy prefilled syringe and are single-use. Do not reuse the syringe or titration clips.
• Prepare the Plegridy prefilled syringe and the needle before inserting it into the Plegridytitration clip

Preparing the Plegridy dose:

• Find a well-lit, clean, and flat surface, such as a table, and gather all the materials needed to self-inject or receive the injection.
• Remove 1 Plegridy prefilled syringe from the refrigerator about 30 minutes before the injection to allow the Plegridy dose to reach room temperature. Do notuse external heat sources, such as hot water, to warm the Plegridy prefilled syringe.
• Check the expiration date printed on the syringe label, cap, and outer carton. Do notuse Plegridy in a prefilled syringe after the expiration date.
• Wash your hands with soap and water.

Preparing for the Plegridy injection:
Step 1: check the syringe (see
Figure A):

• The syringe must not be cracked or damaged.
• Check that the cap is intact and has not been removed.

Syringe

• Plegridy must be clear, colorless, and must not contain particles. Protective rubber cover

• Do notuse the Plegridy prefilled syringe if:

Cap

• the syringe is cracked or damaged; Figure A
• the solution is cloudy, colored, or contains clumps or particles;
• the cap has been removed or is not securely in place.

Do notuse the syringe if any of the
conditions occur. Take a new syringe.

Step 2: with 1 hand, hold the Plegridy prefilled
syringe just below the cap, with the
cap facing up (see
Figure B).

• Make sure to hold the syringe with the knurled part, located just below the cap.

Figure B

Step 3: with the other hand, grasp the cap and bend it at a 90° angle until you hear a click (see Figure C). This exposes the glass tip of the syringe (see Figure D). n a i	o c a m r a F Figure C l e d a Figure D
l a Step 4: open the package of the sterile single-use needle and remove the covered needle. Hold the t syringe with the glass tip of the syringe facing I upward. Press the needle onto the glass tip of d the syringe (see Figure E). a i z n e	Figure E

Step 5: gently rotate the needle clockwise until it is firmly and tightly attached (see Figure F). If the needle is not securely attached, the syringe may leak and you may receive an incomplete dose of Plegridy. Do not remove the plastic cover from the needle.

o c a m r a Figure F

Performing the Plegridy injection:

• Your healthcare provider must show you or someone assisting you how to prepare and inject the Plegridy dose before using the syringe for the first time. The healthcare provider or nurse will monitor you while you inject your first dose of Plegridy with the syringe.
• Perform the Plegridy injection exactly as explained by your healthcare provider.
• Plegridy is injected into the muscle (intramuscular administration).
• Plegridy must be injected into the thigh (see Figure G).
• Alternate injection sites with each dose. Do notuse the same injection site for consecutive injections.
• Do notinject into an area of the body where the skin is irritated, red, bruised, infected, or has scars.

i l Step 6: Choose the right or left thigh and a clean the skin with an alcohol swab (see Figure G). Let the injection site dry before injecting the dose. t I Do not touch, rub, or blow on the disinfected area before performing the injection. a	Figure G
i Step 7: Remove the protective cap from the needle z by pulling it off (see Figure H). Do not unscrew n the protective cap. e g	Figure H

Step 8: With 1 hand, tense the skin around the injection site. With the other hand, hold the syringe like a pencil. With a quick, straight motion, insert the needle at a 90° angle through the skin and into the muscle (see Figure I). Once the needle is inserted, the skin can be released.	o c Figure I
Step 9: Slowly push the plunger all the way down, until the syringe is empty (see Figure J).	a m r a Figure J
Step 10: Remove the needle from the skin (see Figure K). Press on the injection site with a gauze pad for a few seconds or gently massage it with a rotary motion. If, after pressing on the injection site for a few seconds, you see blood, remove it with a gauze pad and apply a bandage.	F l e d Figure K a

After the Plegridy injection:

• Do notreattach the needle cover as this could cause an accidental needle stick.
• Dispose of used syringes and needles in a sharps container or in a hard plastic or metal container with a screw-on lid, such as a detergent box or coffee can. Check with your healthcare provider for the correct method of disposing of the container. There may be local or national laws regarding the disposal of used syringes and needles. Do notdispose of used syringes and needles in household or recyclable waste.
• Plegridy may commonly cause redness, pain, or swelling of the skin at the injection site.
• Contact your healthcare provider immediately if the injection site swells and is painful or if the area appears infected and does not heal within a few days.

General information on the safe and effective use of Plegridy

• Always use a new syringe and needle for each injection. Do notreuse the syringe or needles.
• Do notshare the syringe or needles.