Prospecto: information for the user

Plegridy 63 micrograms injectable solution in pre-filled pen

Plegridy 94 micrograms injectable solution in pre-filled pen

Plegridy 125 micrograms injectable solution in pre-filled pen

peginterferón beta-1a

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.

• Consult your doctor, pharmacist, or nurse if you have any doubts.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• Consult your doctor, pharmacist, or nurse if you experience any adverse effects, even if they are not listed in this prospect. See section 4.

1. How to use Plegridy
2. Possible adverse effects
3. Storage of Plegridy

1. Contents of the package and additional information
2. Instructions for injecting the pre-filled pen of Plegridy

What is Plegridy

The active ingredient in Plegridy is peginterferon beta-1a. Peginterferon beta-1a is a long-acting modified form of interferon. Interferons are naturally produced substances in the body that help protect against infections and diseases.

What is Plegridy used for

This medication is used to treat Relapsing-Remitting Multiple Sclerosis (EM) in adults 18 years of age or older.

EM 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 (natural defenses) damages the protective layer (myelin) surrounding the nerves of the brain and spinal cord. This alters the messages between the brain and other parts of the body, causing EM symptoms.

Patients with relapsing-remitting EM have periods in which the disease is not active (remission) between exacerbations of symptoms (flare-ups).

Each patient has specific EM symptoms.They may include:

• feeling of instability or dizziness, walking problems, muscle stiffness and spasms, fatigue, numbness in the face, arms, or legs;
• acute or chronic pain, urinary and intestinal problems, sexual problems, and visual problems;
• difficulty thinking and concentrating, depression.

How does Plegridy work?

Plegridy appears to work by preventing the immune system from damaging the brain and spinal cord.This may help reduce the number of flare-ups you have and slow down the disabling effects of EM. Treatment with Plegridy may help prevent worsening, although it will not cure EM.

Do not use Plegridy

• if you are allergicto peginterferon beta-1a, interferon beta-1a, or any of the other componentsof this medication (listed in section 6). See the symptoms of an allergic reaction in section 4;

• if you have a severe depressionor suicidal thoughts.

Warnings and precautions

Consult your doctor if you have ever had:

• depressionor mood disorders;
• suicidal thoughts.

Consult your doctor, pharmacist, or nursebefore injecting Plegridyif you have any of the following conditionsas they may worsen while using Plegridy:

• severe kidney or liver problems;
• skin irritation at the injection site,which may cause skin and tissue damage

(injection site necrosis). When ready to administer, follow the instructions described in section 7 “Instructions for the injection of the pre-filled pen of Plegridy”, at the end of this leaflet. This reduces the risk of reactions at the injection site;

• epilepsyor other uncontrolled convulsive disorders;

• heart problemsthat may cause symptoms such as chest pain(angina),especially after any activity; swelling of the ankles, difficulty

breathing(congestive heart failure)or an irregular heart rhythm(arrhythmias);

• thyroid problems;
• low white blood cell or platelet counts,which may increase the risk of infection orbleeding.

Other things to consider when using Plegridy

• You will need blood tests to determine your blood cell counts, blood biochemistry, and liver enzyme levels. These tests will be performed before starting Plegridy, at regular intervals after starting treatment with Plegridy, and then periodically during treatment, even if you do not have specific symptoms. These blood tests will be added to the tests that are normally performed to monitor your MS.

• Your thyroid function will be regularly reviewed or at any time that your doctor considers necessary for other reasons.
• Blood clots may form in small blood vessels during treatment. These blood clots could affect your kidneys. This may occur after several weeks or several years of starting treatment with Plegridy. Your doctor may want to monitor your blood pressure, blood (platelet count), and kidney function.

If you accidentally prick or prick someone else with the Plegridy needle, wash the affected area with water and soapimmediatelyandcontact a doctor ornurseas soon as possible.

Children and adolescents

Plegridyshould not be 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 should be used with caution when administered with other medicines that are processed in the body by a group of proteins called “cytochrome P450” (e.g., some medicines used to treat epilepsy or depression).

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, especially those used to treat epilepsy or depression. This includes any medicine obtained without a prescription.

At times, you may need to remind other healthcare professionals that you are being treated with Plegridy, for example, if they prescribe other medicines or perform a blood test. Plegridy may interact with other medicines or the test results.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

No harmful effects are expected in the infant. Plegridy can be used during breastfeeding.

Driving and operating machinery

The influence of Plegridy on the ability to drive and operate machinery is negligible or insignificant.Plegridy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg); it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Usual dose

One injection of Plegridy 125 micrograms every 14 days (every two weeks). Try to use Plegridy at the same time on the same day each time you inject it.

Plegridy initiation

If you are going to use Plegridy for the first time, your doctor may advise you to start gradually increasing the dose so that you can get used to the effects of Plegridy before administering the full dose. You will be provided with a starter pack that contains the first two injections: a yellow pen with Plegridy 63 micrograms (for day 0) and a blue pen with Plegridy 94 micrograms (for day 14).

After that, you will be provided with a maintenance pack that contains grey pens with Plegridy 125 micrograms (for day 28 and then every two weeks).

Read the instructions in section 7 “Instructions for the pre-filled syringe injection of Plegridy” at the end of this leaflet before starting to use Plegridy.

Use the printed record box inside the lid of the starter pack to keep a record of the injection dates.

Self-injection

Plegridy is injected under the skin (subcutaneous injection). Alternate the injection site. Do not use the same injection site for other injections.

You can inject Plegridy without the help of your doctor if you have been taught how to do it.

• Consult and follow the advice given in the instructions in section 7 “Instructions for the injection of the pre-filled syringe of Plegridy” before starting.

• If you have problemshandling the pen, talk to your doctor or nurse who can help you.

Duration of Plegridy treatment

Your doctor will inform you for how long you should use Plegridy. It is essential that you use Plegridy regularly. Do not make any changes that your doctor has not told you.

If you use more Plegridy than you should

You should only inject Plegridy once every two weeks.

• If more than one injection of Plegridy has been administered in a period of 7 days,contact your doctor or nurse immediately.

If you forgot to use Plegridy

You should inject Plegridy once every two weeks. This regular regimen helps to administer the treatment as uniformly as possible.

If you forget to administer it on your usual day, inject a dose as soon as possible and continue as usual. However, do not inject more than once in a period of 7 days. Do not administer two injections to compensate for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

• Liver problems

(frequent: may affect up to 1 in 10 people)

If you experience any of the following symptoms:

• yellowing of the skin or the white part of the eyes;
• generalized itching;
• feeling of discomfort (nausea and vomiting);
• bruises that appear easily on the skin.
• • Seek medical attention immediately, as they may be manifestations of a possible liver problem.

• Depression

(frequent: may affect up to 1 in 10 people)

If you experience:

• unusual feelings of sadness, anxiety, or hopelessness; or
• have suicidal thoughts.

• Seek medical attention immediately.

• Severe allergic reactions

(rare: may affect up to 1 in 100 people)

If you experience any of the following:

• difficulty breathing;
• swelling around the face (lips, tongue, or throat);
• eruption or redness of the skin.
• Seek medical attention immediately.

• Seizures

(rare: may affect up to 1 in 100 people)

If you experience a seizure or an epileptic attack.

• 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 open wound on the skin along with swelling, inflammation, or discharge around the injection site.

• Seek medical advice.

• Renal problems, including scarring that may reduce kidney function

(rare: may affect up to 1 in 1,000 people)

If you experience any of the following symptoms:

• foamy urine;
• fatigue;
• swelling, especially of ankles and eyelids, and weight gain.
• • Seek medical attention, as they may be manifestations of a possible renal problem.

• Blood problems

(rare: may affect up to 1 in 1,000 people)

The following may occur: blood clots in small blood vessels that may affect your kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome). Symptoms may include an increase in bruises, bleeding, fever, extreme weakness, headache, dizziness, or fainting. Your doctor may find changes in your blood and kidney function.

If you experience any of the following symptoms:

• increase in bruises or bleeding;
• extreme weakness;
• headache, dizziness, or fainting.

• Seek medical attention immediately.

Other side effects

Very frequent side effects

(may affect more than 1 in 10 people)

• flu-like symptoms. These symptoms are not actually flu, see below. You cannot transmit them to anyone;
• headache;
• muscle pain (myalgia);
• joint pain, arms, legs, or neck (arthralgia);
• chills;
• fever;
• weakness and fatigue (asthenia);
• redness, itching, or pain around the injection site.
• If you are concerned about any of these side effects, seek medical attention.

Flu-like symptoms

Flu-like symptoms are more common when you first start using Plegridy. As you continue to use the injections, the symptoms will gradually disappear. See below for some simple ways to help reduce the impact of flu-like symptoms if you experience them.

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

1. Take note of the time of administration of the Plegridy injection. The onset and end of flu-like symptoms are different for each patient. On averageflu-like symptoms start, approximately, 10 hours after the injection and last between 12 and 24 hours.

1. Take paracetamol or ibuprofen half an hour before the Plegridy injection and continue taking it during the time that flu-like symptoms last. Ask your doctor or pharmacist what amount to take and for how long.
2. If you have a fever, drink plenty of water to stay hydrated.

Frequent side effects

(may affect up to 1 in 10 people)

• feeling of discomfort (nausea or vomiting);
• hair loss (alopecia);
• skin itching (pruritus);
• increase in body temperature;
• changes around the injection site such as swelling, inflammation, hematoma, heat, rash, or change in color;
• changes in the blood that may cause fatigue or reduced ability to fight off infections;
• increase in liver enzymes in the blood (will appear in blood tests).
• If you are concerned about any of these side effects, seek medical attention.

Rare side effects

(may affect up to 1 in 100 people)

• urticaria;
• changes in the blood that may be the cause of bruises or bleeding without explanation.

• If you are concerned about any of these side effects, seek medical attention.

Unknown frequency

(cannot be estimated from available data)

• Pulmonary arterial hypertension: A disease in which a large narrowing of the blood vessels in the lungs causes an increase in pressure in the blood vessels that transport blood from the heart to the lungs. Pulmonary arterial hypertension was observed at different times, even several years after starting treatment with medications containing interferon beta.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

In order to improve the traceability of this medicine, your doctor or pharmacist must register the name and batch number of the medicine that has been administered to you in your medical history. You may also want to take note of this information in case you are asked for it in the future.

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

Do not use this medication after the expiration date that appears on the label and the box after CAD/EXP. The expiration date is the last day of the month indicated.

• Store in the original packaging to protect from light. Only open the packaging when a new pen is needed.

• Store in the refrigerator(refrigerator), between 2°C and 8°C.
• • Do not freeze. Discard any 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 protected from light.
• • The pens can be removed and reinserted into the refrigerator as needed.
  • Ensure that the time the pens spend outside the refrigeratoris not more than30 days in total.

• Do not use this medication if you observe that:

• Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that are no longer needed. This will help protect the environment.

Composition of Plegridy

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 components are sodium acetate trihydrate, glacial acetic acid, arginine hydrochloride, polisorbate 20, and water for injection (see section 2 “Plegridy contains sodium”).

Appearance of the product and contents of the pack

Plegridy is a transparent and colourless injectable solution in a pre-filled syringe with a attached needle.

Pack sizes:

• The starter pack of Plegridy contains a pre-filled syringe of 63 micrograms in an orange syringe and a pre-filled syringe of 94 micrograms in a blue syringe.
• The 125 micrograms pre-filled syringes are supplied in a pack containing 2 or 6 pre-filled syringes.

Only some 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 more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Last update of the summary of product characteristics:01/2025

Other sources of information

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

1. Instructions for the injection of the pre-filled syringe of Plegridy

Warning: do not remove the cap until you are ready to inject.

How to inject Plegridy

Read the instructions before starting to use Plegridy and each time you receive a new prescription. There may be new information. This information does not replace the conversation with your doctor or nurse about your disease or treatment.

Nota:

• Before using the syringe for the first time,your doctor or nurse must teach you or yourcared how to prepare and inject the syringe.
• The syringe is only for use under the skin (subcutaneous).
• Each syringe can only be used once.

Do not sharethe syringe with anyone else to avoid the transmission of infections.

Do not usemore than one syringe every 14 days (every 2 weeks).

Do not usethe syringe if it hasfallen or shows visible damage.

Administration calendar

The starter pack contains your first two injections to gradually adjust your dose. Choose the correct syringe from the pack.

Do notuse more than one syringe in a period of 14 days (every 2 weeks).

Materials needed for the injection of the Plegridy syringe:

• 1 Plegridy syringe (see Figure A)

Before use – Parts of the Plegridy syringe (Figure A)

Advertencia: do not remove the cap until you are ready to inject. If you remove the cap, do not put the cap back on the syringe. Placing the cap could block the syringe.

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

Preparation for injection

Step 1: Take the syringe out of the refrigerator.

1. Take a Plegridy pack out of the refrigerator and choose the correct syringe (dose) from the pack.
2. Close the pack and put it back in the refrigerator after taking the syringe.

1. Let the syringe reach room temperature for at least 30 minutes.

Do notuse external heat sources, such as hot water, to warm the syringe.

Step 2: Gather materials and wash your hands.

1. Wash your hands with soap and water.