Package leaflet: Information for the user

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
Please read all of 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 further 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform 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 using 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 substance in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a modified form of interferon with prolonged duration of action. Interferons are natural substances produced by the body to help protect it from infections and diseases.

What Plegridy is used for
This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in adults aged 18 years and older.
Multiple sclerosis is a long-term disease affecting the central nervous system (CNS), including the brain and spinal cord, in which the body's immune system (its natural defences) damages the protective layer (myelin) surrounding the nerves in the brain and spinal cord. This disrupts the transmission of messages between the brain and other parts of the body, causing the symptoms of multiple sclerosis. Patients with relapsing-remitting MS experience periods when the disease is not active (remission) between symptom flare-ups (relapses).

Each person experiences a different combination of multiple sclerosis symptoms. Possible symptoms include:

Loss of balance or dizziness, walking difficulties, muscle stiffness and spasms, fatigue, numbness in the face, arms, or legs
Acute or chronic pain, bladder or bowel problems, sexual dysfunction, and vision disturbances
Problems with thinking and concentration, 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 worsening of the disease, although it cannot cure multiple sclerosis.

2. What you need to know before using Plegridy

Do not use Plegridy

if you are allergic to peginterferon beta-1a, interferon beta-1a, or to any of the other ingredients of this medicine (listed in section 6). See section 4 for symptoms of an allergic reaction.
if you have severe depression or are thinking about suicide.

Warnings and precautions

Talk to your doctor if you have ever had:
Depression or mood problems.
Thoughts of suicide.
Your doctor may still prescribe Plegridy, but it is important to inform your doctor if you have previously had depression or any similar mood-related problems.

Talk to your doctor, pharmacist, or nurse before injecting yourself with Plegridy if any of the following conditions occur. These problems may worsen during treatment with
Plegridy:

Severe liver or kidney problems
Irritation at the injection site, which may cause damage to the skin and tissues ( necrosis at the injection site ). When you are ready to inject yourself, carefully follow the instructions provided in section 7 “ Instructions for injecting Plegridy from a pre-filled syringe ” at the end of this leaflet. This will help reduce the risk of injection site reactions.
Epilepsy or other seizure disorders not controlled by medication
Heart problems, which may cause symptoms such as chest pain ( angina ), particularly after physical activity; swollen ankles, shortness of breath ( congestive heart failure ) or irregular heartbeat ( arrhythmia ).
Thyroid problems
Low levels of white blood cells or platelets in the blood, which may increase the risk of infection or bleeding

Other considerations when using Plegridy

Blood tests will be required to monitor blood cell counts, blood chemistry, and liver enzyme levels. These tests will be performed before starting Plegridy, regularly after starting treatment, and periodically throughout treatment, even in the absence of specific symptoms. These blood tests are in addition to the tests routinely performed for monitoring MS.
Your thyroid gland function will be monitored regularly or whenever your doctor considers it necessary.
During treatment, blood clots may form in small blood vessels. These blood clots may affect the kidneys. This may occur from several weeks to several years after starting treatment with Plegridy. Your doctor may decide to monitor your blood pressure, blood (platelet count), and kidney function.

If you accidentally prick yourself or someone else with the needle of Plegridy, the affected area must
be washed immediately with soap and water and a doctor or nurse must be contacted as soon as
possible.
Children and adolescents
Plegridy must not be used in 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 should be used with caution with medicines that are metabolized in the body by a group of proteins called “cytochrome P450” (e.g., certain medicines used for epilepsy or depression).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those used to treat epilepsy or depression. This applies to all medicines, including those obtained without a prescription.
Sometimes you may need to remind other healthcare professionals that you are currently being treated with Plegridy, for example, if other medicines are prescribed for you, or if you undergo blood tests. Plegridy may affect other medicines or test results.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
No harmful effects on the newborn/infant who is breastfed are expected. Plegridy may be used during breastfeeding.
Driving and using machines
Plegridy has no or negligible influence on the ability to drive or use machines.
Plegridy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium, i.e., essentially ‘sodium-free’.

3. How to use Plegridy

Use this medicine exactly as instructed by your doctor or pharmacist. 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 treatment with Plegridy
If you have never used Plegridy before, your doctor may advise you to gradually increase the dose
to allow your body to get used to the effects of Plegridy before taking the full dose. You will be provided with a
Starting 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).
Afterwards, you will be supplied 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 from a pre-filled syringe” at the end
of this leaflet before starting to use Plegridy.
Use the printed record chart inside the lid of the Starting pack
to record the dates of your injections.
Self-injecting
Plegridy must be injected under the skin (subcutaneous injection). Alternate the injection sites. Do not use the same injection site for consecutive injections.
You may self-inject Plegridy without the help of a doctor, if you have been properly trained to do so.

Read and follow the instructions provided in section 7 “Instructions for injecting Plegridy from a pre-filled syringe” before starting.
If you have difficulty handling the syringe, consult your doctor or nurse who can assist you.

How long to use Plegridy
Your doctor will tell you how long you should continue using Plegridy. It is important to continue using Plegridy regularly. Do not change your treatment regimen 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, contact your doctor or pharmacist immediately.

If you forget to use Plegridy
You should inject Plegridy once every 2 weeks. This regular schedule helps ensure the treatment is administered as consistently as possible.
If you miss your usual day, inject a dose as soon as possible and then continue your regular schedule. However, do not inject more than once within a 7-day period. Do not use two injections to make up for a missed dose.
If you have any doubts about how to use this medicine, consult 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 whites of the eyes
- Widespread itching
- Feeling unwell or malaise (nausea and vomiting)
- Easy bruising
- Contact your doctor 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 worthless, or
- You have thoughts of suicide
- Contact your doctor immediately.
Severe allergic reaction (uncommon – may affect up to 1 in 100 people) If you experience any of the following symptoms:
- Difficulty breathing
- Swelling of the face (lips, tongue, or throat)
- Skin rash or redness
- Contact your doctor immediately.
Seizures (uncommon – may affect up to 1 in 100 people) If you have a seizure or epileptic fit
- Contact your doctor 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 accompanied by swelling, inflammation, or fluid leakage at the injection site
- Contact your doctor for advice.
Kidney problems including scarring which may 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 in the ankles and eyelids, and weight gain
- Contact 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 in 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
Contact your doctor immediately.

Other side effects

Very common side effects
(may affect more than 1 in 10 people)

Flu-like symptoms. These symptoms do not result from a true influenza (see below). You cannot pass them on to other people.
Headache
Muscle pain (mialgia)
Joint, arm, leg, or neck pain (artralgia)
Chills
Fever
Feeling weak and tired (astenia)
Redness, itching, or pain around the injection site
If any of these side effects occur, contact your doctor.

Flu-like symptoms
Flu-like symptoms are more common at the beginning of treatment with Plegridy. They tend to gradually decrease as you continue with your 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:

Consider the timing of your Plegridy injection. The onset and duration of flu-like symptoms vary from patient to patient. On average, flu-like symptoms start about 10 hours after injection and last between 12 and 24 hours.
Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue taking paracetamol or ibuprofen for as long as the flu-like symptoms last. Consult your doctor or pharmacist to determine the appropriate dose and duration.
If you develop a fever, drink plenty of fluids to stay hydrated.

Common side effects
(may affect up to 1 in 10 people)

Feeling unwell or malaise (nausea or vomiting)
Hair loss (alopecia)
Itchy skin (pruritus)
Increased body temperature
Changes at the injection site such as swelling, inflammation, bruising, warmth, rash, or skin discoloration
Changes in blood that may cause tiredness or reduce the ability to fight infections
Increased liver enzymes in the blood (detected in blood tests)
If any of these side effects occur, contact your doctor.

Uncommon side effects
(may affect up to 1 in 100 people)

Hives (urticaria)
Changes in blood that may cause unexplained bruising or bleeding
If any of these side effects occur, contact your doctor.

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

Pulmonary arterial hypertension: A condition causing severe narrowing of the blood vessels in the lungs, leading to increased pressure in the blood vessels carrying blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at various times during treatment, including several years after starting treatment with interferon-beta products.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

To improve traceability of this medicine, your doctor or pharmacist should record the name and batch number of the medicine you are taking in your medical records. You are advised to note down this information in case you are asked for it 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 stated on the carton and label after "Exp./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 a new syringe is needed.
Store in a refrigerator at 2°C–8°C.
Do not freeze. Discard Plegridy that has been accidentally frozen.
Plegridy may be stored outside the refrigerator at room temperature (up to 25°C) for a maximum of 30 days, but must be kept away from light.
The packs may be removed from and returned to the refrigerator more than once, if necessary.
Make sure that the total time the syringes are kept outside the refrigerator does not exceed 30 days in total.
Discard any syringe that has been kept outside the refrigerator for more than 30 days.
If you are uncertain 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 discoloured, cloudy, or if particles are visible.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Plegridy contains
The active substance is peginterferon beta-1a.
Each 63 microgram pre-filled syringe contains 63 micrograms of peginterferon beta-1a in 0.5 mL of injectable solution.
Each 94 microgram pre-filled syringe contains 94 micrograms of peginterferon beta-1a in 0.5 mL of injectable solution.
Each 125 microgram pre-filled syringe 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 the appearance of Plegridy and contents of the pack
Plegridy is a clear, colourless injectable solution in a pre-filled glass syringe with an attached needle.

Pack sizes:

The Plegridy starter pack contains one orange pre-filled syringe with 63 micrograms and one blue pre-filled syringe with 94 micrograms.
The grey 125 microgram syringes are supplied in packs containing either 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
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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Biogen Belgium NV/SA Biogen Lithuania UAB
 +32 2 2191218  +370 5 259 6176

България Luxembourg/Luxemburg
TP EVOPHARMA Biogen Belgium NV/SA
 +359 2 962 12 00  +32 2 2191218

Česká republika Magyarország
Biogen (Czech Republic) s.r.o. Biogen Hungary Kft.
 +420 255 706 200  +36 1 899 9883

Danmark Malta
Biogen Denmark A/S Pharma. MT Ltd.
 +45 77 41 57 57  +356 21337008

Deutschland Nederland
Biogen GmbH Biogen Netherlands B.V.
 +49 (0) 89 99 6170  +31 20 542 2000

Eesti Norge
Biogen Estonia OÜ Biogen Norway AS
 +372 618 9551  +47 23 40 01 00

Ελλάδα Österreich
Genesis Pharma SA Biogen Austria GmbH
 +30 210 8771500  +43 1 484 46 13

España Polska
Biogen Spain S.L. Biogen Poland Sp. z o.o.
 +34 91 310 7110  +48 22 351 51 00

France Portugal
Biogen France SAS Biogen Portugal
 +33 (0)1 41 37 9595 Sociedade Farmacêutica, Unipessoal Lda.
 +351 21 318 8450

Hrvatska România
Biogen Pharma d.o.o. Johnson & Johnson Romania S.R.L.
 +385 1 775 73 22  +40 21 207 18 00

Ireland Slovenija
Biogen Idec (Ireland) Ltd. Biogen Pharma d.o.o.
 +353 (0)1 463 7799  +386 1 511 02 90

Ísland Slovenská republika
Icepharma hf Biogen Slovakia s.r.o.
 +354 540 8000  +421 2 323 34008

Italia Suomi/Finland
Biogen Italia s.r.l. Biogen Finland Oy
 +39 02 584 9901  +358 207 401 200

Κύπρος Sverige
Genesis Pharma Cyprus Ltd Biogen Sweden AB
 +357 22 76 57 15  +46 8 594 113 60

Latvija United Kingdom (Northern Ireland)
Biogen Latvia SIA Biogen Idec (Ireland) Limited
 +371 68 688 158  +44 (0) 1628 50 1000

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

7. Instructions for injecting Plegridy in a pre-filled 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. These instructions do not replace consultation with your doctor or nurse regarding your medical condition or treatment.
Note:

Before using Plegridy in a pre-filled syringe for the first time, your doctor or nurse must show you or the person assisting you how to prepare and inject Plegridy using the pre-filled syringe.
Plegridy in a pre-filled syringe is intended only for injecting the medicine under the skin (subcutaneously).
Each pre-filled syringe of Plegridy must be used only once.

Do not share Plegridy in a pre-filled syringe with others to avoid transmission of infections.

Do not use more than one pre-filled syringe every 14 days (every 2 weeks).
Do not use the syringe if it has been dropped or is visibly damaged.
Dosing schedule
The starter pack contains the first two injections to gradually adjust the dose.
Select the correct syringe from a package.

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

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

Materials needed for Plegridy injection
Pre-filled syringe of Plegridy (see Figure A)
Before use – Components of the pre-filled syringe of Plegridy (see Figure A)

Horizontal syringe with labels indicating needle cap, medication, syringe barrel, and plunger on a white background

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

Alcohol wipe
Gauze
Adhesive plaster

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

Drawing of an alcohol wipe, a folded gauze pad, and an adhesive bandage with descriptive labels under each item

Preparation for injection
Step 1: Remove the pre-filled syringe from the refrigerator

Remove one Plegridy pack from the refrigerator and select the appropriate pre-filled syringe from the pack.
Close the pack and return it to the refrigerator after removing one pre-filled syringe.
Allow the Plegridy pre-filled syringe to warm to room temperature for at least 30 minutes.

Do not use external heat sources, such as hot water, to warm the Plegridy pre-filled syringe.
Step 2: Gather materials and wash your hands

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

Step 3: Check the Plegridy pre-filled syringe
Check the expiration date on the Plegridy pre-filled syringe (see Figure C). Do not use Plegridy in the pre-filled syringe after the expiration date. •Check that the Plegridy medicine is clear and colorless (see Figure D). Do not use Plegridy in the pre-filled syringe if the liquid is colored, cloudy, or contains particles in suspension. oYou may see some air bubbles in the Plegridy medicine. This is normal and it is not necessary to expel the air before injection.
Performing the injection
Step 4: Select and clean the injection site
Plegridy in the pre-filled syringe is intended for subcutaneous injection (injection under the skin). •Plegridy in the pre-filled syringe must be injected into the abdomen, thigh, or back of the upper arm (see Figure E). Do not inject directly into the navel. Do not inject into an area of skin that is irritated, tender, red, bruised, tattooed, infected, or scarred. •Select an injection site and clean the skin with an alcohol wipe. •Allow the injection site to dry before injecting the dose. Do not touch or blow on this area before performing the injection.
Step 5: Remove the needle cap
With one hand, hold the syringe by the glass barrel. With the other, firmly grasp and remove the needle cap (see Figure F). Be careful when removing the needle cap to avoid accidental needle stick injury. Do not touch the needle. Caution – Do not recap the Plegridy pre-filled syringe. You may injure yourself with the needle.
Step 6: Gently pinch the injection site
Using your thumb and index finger, gently pinch the skin around the cleaned injection site to create a small skin fold (see Figure G).


Step 7: Inject the medicine
Hold the Plegridy pre-filled syringe at a 90° angle to the injection site. Insert the needle quickly into the skin fold until it is completely under the skin (see Figure H). •Once the needle is inserted, you may release the skin. Do not pull back the plunger.
Slowly push the plunger all the way down until the syringe is empty (see Figure I). Do not remove the Plegridy pre-filled syringe from the injection site until you have pushed the plunger completely down.
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 recap the prefilled syringe of Plegridy. You could get injured by the needle. Do not reuse the prefilled syringe of Plegridy.

After the injection
Step 9: Disposal of the used Plegridy pre-filled syringe

Consult your doctor, pharmacist, or nurse about how to properly dispose of the used syringe.

Step 10: Care of the injection site

If necessary, apply a gauze pad or adhesive plaster over the injection site.

Step 11: Checking the injection site

After 2 hours, check the injection site for possible redness, swelling, or tenderness.
If you experience a skin reaction that does not go away within a few days, contact your doctor or nurse.

Recording the date and injection site

Record the date and location of each injection.
For the first injections, you may use the table provided printed on the inside of the lid of the Starter Pack.

General warnings
Do not reuse the Plegridy pre-filled syringe.

Do not share the Plegridy pre-filled syringe.

Keep the Plegridy pre-filled syringe and all medicines out of the reach of children.

Storage

It is recommended to store in the refrigerator at a controlled temperature between 2 °C and 8 °C, in the original packaging, closed, to protect the medicine from light.
If necessary, Plegridy may be stored in the closed original packaging outside the refrigerator, at a temperature not exceeding 25 °C, for up to 30 days.
Plegridy may be removed from and returned to the refrigerator, if necessary. The total storage time outside the refrigerator, at temperatures up to 25 °C, must not exceed 30 days. Do not freeze or expose to high temperatures.

Package leaflet: information for the user

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

peginterferon beta-1a
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

1. What Plegridy is and what it is used for

What Plegridy is
The active substance in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a modified form of interferon with prolonged action. Interferons are natural substances produced by the body to help protect it from infections and diseases.

What Plegridy is used for
This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in adults aged 18 years and older.
Multiple sclerosis is a long-term disease affecting the central nervous system (CNS), including the brain and spinal cord, in which the body's immune system (its natural defenses) damages the protective layer (myelin) surrounding nerves in the brain and spinal cord. This disrupts the transmission of signals between the brain and other parts of the body, causing the symptoms of multiple sclerosis. Patients with relapsing-remitting MS experience periods when the disease is not active (remission) between symptom flare-ups (relapses).

Each person experiences a different combination of multiple sclerosis symptoms. Possible symptoms include:

Sense of imbalance or dizziness, walking difficulties, muscle stiffness and spasms, fatigue, numbness in the face, arms, or legs
Acute or chronic pain, bladder or bowel problems, sexual dysfunction, and vision disturbances
Thinking and concentration difficulties, 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 the disabling effects of multiple sclerosis. Treatment with Plegridy may help prevent worsening of the condition, although it cannot cure multiple sclerosis.

2. What you need to know before using Plegridy

Do not use Plegridy

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

Warnings and precautions

Talk to your doctor if you have ever had:
Depression or mood problems
Thoughts about suicide
Your doctor may still prescribe Plegridy, but it is important to inform your doctor if you have previously had depression or any similar mood-related problems.

Talk to your doctor, pharmacist, or nurse before injecting Plegridy if any
of the following conditions occur. These problems may worsen during treatment with
Plegridy:

Severe liver or kidney problems
Irritation at the injection site, which may cause skin and tissue damage ( necrosis at the injection site ). When you are ready to inject yourself, carefully follow the instructions provided in section 7 “ Instructions for injecting Plegridy with the prefilled pen ” at the end of this leaflet. This will help reduce the risk of injection site reactions.
Epilepsy or other seizure disorders not controlled by medication
Heart problems, which may cause symptoms such as chest pain ( angina ), especially after physical 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 may increase the risk of infection or bleeding

Other considerations when using Plegridy

Blood tests will be required to monitor blood cell counts, blood chemistry, and liver enzyme levels. These tests will be performed before starting Plegridy, regularly after beginning treatment with Plegridy, and periodically during treatment, even in the absence of specific symptoms. These blood tests are in addition to the routine tests normally performed for monitoring MS.
Thyroid gland function will be monitored regularly or whenever deemed necessary by your doctor for other reasons.
During treatment, blood clots may form in small blood vessels. These blood clots may affect the kidneys. This may occur from several weeks to several years after starting treatment with Plegridy. Your doctor may decide to monitor your blood pressure, blood (platelet count), and kidney function.

If you accidentally prick yourself or someone else with the needle of Plegridy, the affected area must
be washed immediately with soap and water and a doctor or nurse must be contacted as soon as
possible.
Children and adolescents
Plegridy must not be used in 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 should be used with caution together with medicines that are metabolized in the body by a group of proteins called “cytochrome P450” (for example, certain medicines used for epilepsy or depression).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those used to treat epilepsy or depression. This applies to all medicines, including those obtained without a prescription.
Sometimes you may need to remind other healthcare professionals that you are currently being treated with Plegridy, for example, if other medicines are prescribed for you, or if you undergo a blood test. Plegridy may affect other medicines or the results of blood tests.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
No harmful effects on the newborn/breastfed infant are expected. Plegridy may be used during breastfeeding.
Driving and using machines
Plegridy does not affect or has negligible effect on the ability to drive and use machines.
Plegridy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium, i.e. essentially ‘sodium-free’.