Prospect: information for the user

Plegridy 63 micrograms injectable solution in pre-filled syringe

Plegridy 94 micrograms injectable solution in pre-filled syringe

Plegridy 125 micrograms injectable solution in pre-filled syringe

peginterferón beta-1a

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

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

• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear 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 syringe 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 (RRMS) in adults 18 years of age or older.

Multiple Sclerosis (MS) 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 covering (myelin) that surrounds the nerves of the brain and spinal cord. This alters the messages between the brain and other parts of the body, causing MS symptoms.

Patients with RRMS have periods in which the disease is not active (remission) between exacerbations of symptoms (relapses).

Each patient has specific MS symptoms.They may include:

• feeling of instability or dizziness, difficulty walking, stiffness and muscle 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 relapses you have and slow the disabling effects of MS. Treatment with Plegridy may help prevent worsening, although it will not cure MS.

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 conditions,as 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 you are ready to administer it, carefully follow the instructions described in section 7 “Instructions for injecting the pre-filled syringe of Plegridy”, at the end of this leaflet. This reduces the risk of injection site reactions;

• epilepsyor other uncontrolled seizure disorders;

• heart problemsthat may cause symptoms such as chest pain(angina),especially after any activity; swelling of the ankles, shortness of breath(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 initiating 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 your doctor considers necessary.
• 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 another person 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 for this medication as indicated by your doctor or pharmacist. If in 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.

Plegridy Start

If you are using 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 syringe with Plegridy 63 micrograms (for day 0) and a blue syringe with Plegridy 94 micrograms (for day 14).

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

Read the instructions in the section 7 “Instructions for Pre-Filled Syringe Injection of Plegridy” at the end of this leaflet before starting to use Plegridy.

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

Self-Administration

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 the section 7 “Instructions for Pre-Filled Syringe Injection of Plegridy” before starting.

• If you have problemshandling the syringe, talk to your doctor or nurse who canhelp 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 advised.

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 forget 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 questions 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.
• • Contact a doctor immediatelyas 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.

• Contact a doctor 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.
• Contact a doctor immediately.

• Seizures

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

If you experience a seizure or an epileptic attack.

• Contact a doctor 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.

• Contact a doctor for advice.

• Kidney problems that include 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.
• • Contact a doctor as they may be manifestations of a possible kidney 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.

• Contact a doctor 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, contact a doctor.

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, contact a doctor.

Rare side effects

(may affect up to 1 in 100 people)

• hives;
• 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, contact a doctor.

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 note this information for future reference.

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 container when a new syringe is needed.

• Store in the refrigerator(refrigerator), between 2°C and 8°C.

• Plegridy can be stored outside the refrigerator at room temperature (up to 25°C) for a maximum of 30 days but must be storedprotected from light.
• • The containers can be removed and reinserted into the refrigerator as needed.
  • Make sure that the time the syringes spend outside the refrigeratoris not more than30 days in total.

• Do not use this medication if you observe that:
• • the syringe is broken.

• 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 you no longer need. 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 injectable preparations (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 grey 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

Responsible Person

FUJIFILM Diosynth Biotechnologies Denmark ApS

Biotek Allé 1

DK-3400 Hillerød

Denmark

Biogen Netherlands B.V.

Prins Mauritslaan 13

1171 LP Badhoevedorp

Netherlands

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet: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.

• Instructions for the injection of the pre-filled syringe of Plegridy 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 your treatment.

Nota:

1. Before using the pre-filled syringe of Plegridy for the first time, your doctor or nursemust teach you or your caregiver how to prepare and inject the pre-filled syringe of Plegridy.

1. The pre-filled syringe of Plegridy is for subcutaneous injection only (under the skin).

1. Each pre-filled syringe of Plegridy can only be used once.

Do not share the pre-filled syringe of Plegridy with anyone else to avoid the transmissionof infections.

Do not use more than one pre-filled syringe every 14 days (every 2 weeks).

Do not use the pre-filled syringe if it has fallen or shows visible damage.

Calendar of administration

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

Do not usemore than one pre-filled syringe in a period of 14 days (every 2 weeks).

Materials needed for the injection of Plegridy

Pre-filled syringe of Plegridy (see Figure A)

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

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

• damp alcohol wipe

• gauze
• bandage

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

Preparation for injection

Step 1: Remove the pre-filled syringe from the refrigerator

• Remove a pack of Plegridy from the refrigerator and choose the correct syringe from the pack.
• Close the pack and put it back in the refrigerator after taking the syringe.
• Allow the pre-filled syringe of Plegridy to reach room temperature for at least 30 minutes.

Do not use external heat sources, such as hot water, to warm the pre-filled syringeof Plegridy.

Step 2: Gather materials and wash hands

• For preparation, use a flat, clean, and well-lit surface, such as a table. Gather all the materials needed for self-administration or for administration by someone else.
• Wash your hands with water and soap.

Administration of the injection

After the injection

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

• Consult your doctor, pharmacist, or nurse for instructions on how to dispose of the used syringe.

Step 10: Care of the injection site

• Apply a gauze or bandage to the injection site if necessary.

Step 11: Check the injection site

1. After 2 hours, check the injection site for signs of redness, swelling, or pain on palpation.

1. If a skin reaction occurs and does not disappear within a few days, contact your doctor or nurse.

Record the date and location

1. Record the date and location of each injection.
2. For the first injections, you can use the injection record printed on the inside of the starter pack lid.

General warnings

Do not reuse the pre-filled syringe of Plegridy.

Do not share the pre-filled syringe of Plegridy.

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

Storage

1. It is recommended to store in the refrigerator at a controlled temperature between 2°C and 8°C in the original packaging to protect it from light.

1. If necessary, Plegridy can be stored in the original packaging outside the refrigerator at a temperature of up to 25°C for a period of up to 30 days.

1. If necessary, Plegridy can be removed from the refrigerator and put back. The total combined time outside the refrigerator at a temperature of up to 25°C should not exceed 30 days.

Do not freeze or expose to high temperatures.