Product Information for the User

Plegridy 125 micrograms Injectable Solution in Pre-filled Syringe

Peginterferon beta-1a

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

• Keep this product information, as you may need to refer to it again.

• Consult your doctor, pharmacist, or nurse if you have any questions.
• This medication has been prescribed only for you, and you should not give it to others who 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 product information. See section 4.

1. How to Use Plegridy
2. Possible Adverse Effects

1. Storage of Plegridy
2. Contents of the Package and Additional Information
3. 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 occurring substances produced 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 (MS) in adults 18 years of age or older.

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 relapsing-remitting MS 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 conditionsas they may worsen while using Plegridy:

1. severe kidney or liver problems;

1. skin irritation at the injection site,which may cause skin and tissue damage

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

1. epilepsyor other uncontrolled convulsive disorders;
2. 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);

1. thyroid problems;
2. 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 perform checks on 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 old. The safety and efficacy of Plegridy in this age group are unknown.

Other medications and Plegridy

Plegridy should be used with caution when administered with other medications that are processed in the body by a group of proteins called “cytochrome P450” (e.g., some medications 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 medication, especially those used to treat epilepsy or depression. This includes any medication obtained without a prescription.

On occasion, you may need to remind other healthcare professionals that you are being treated with Plegridy, for example, if they prescribe other medications or perform a blood test. Plegridy may interact with other medications 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 medication.

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

Follow exactly the administration instructions of this medication 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 by intramuscular route

If it is the first time you use Plegridy, your doctor may advise you to gradually increase the dose during the first month of treatment so that you can get used to the effects of Plegridy before administering the full dose.

The full dose with the pre-filled intramuscular syringe of Plegridy is 125 micrograms. You can attach dose adjustment clips to the syringe so that you can gradually increase the dose:

Dose 1 on day 0:

Half dose (63 micrograms) with a YELLOW dose adjustment clip

Dose 2 on day 14:

Three-quarters dose (94 micrograms) with a PURPLE dose adjustment clip

Dose 3 on day 28 and subsequently every 2 weeks:

Full dose (125 micrograms), WITHOUT the need for a dose adjustment clip

The medication Plegridy supplied in this package is designed to be injected into the muscle of the thigh.

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

If you have any doubts about how to inject the medication, consult your doctor, pharmacist, or nurse.

Intramuscular is abbreviated as IM on the syringe label.

Self-injection

Plegridy is injected into the muscle of the thigh (intramuscular 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 of section 7 “Instructions for injecting the pre-filled syringe of Plegridy” before starting.

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

Duration of treatment with Plegridy

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

If you use more Plegridy than you should

You should only inject Plegridy once every 2 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 2 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);
• bruising that appears easily on the skin.
• • Consult 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.

• Consult 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.
• Consult a doctor immediately.

• Seizures

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

If you experience a seizure or an epileptic attack.

• Consult 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.

• Consult a doctor for 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.
• • Consult 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 bruising, bleeding, fever, extreme weakness, headache, dizziness, or confusion. Your doctor may find changes in your blood and kidney function.

If you experience any of the following symptoms:

• increase in bruising or bleeding;
• extreme weakness;
• headache, dizziness, or confusion.

• Consult 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, consult a doctor.

Flu-like symptoms

Flu-like symptoms are more frequent when you first start using Plegridy. As you continue to use the injections, the symptoms 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 30 minutes before the Plegridy injection and continue taking it during the time that the 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, bruising, heat, rash, or change in color;
• changes in the blood 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, consult a doctor.

Rare side effects

(may affect up to 1 in 100 people)

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

• If you are concerned about any of these side effects, consult 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 reporting 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 reach and sight 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 at room temperature (up to 25°C) for a maximum of 30 days, but it must be protected from light.
• • The containers can be removed and reinserted into the refrigerator as needed.
  • Ensure that the period the syringes are out of the refrigeratordoes not exceed30 days in total.
  • Discard any syringe that has been out of the refrigerator for more than 30 days.

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

• Medicines should not be disposed of 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.

Plegridy Composition

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, 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 needle.

Pack sizes:

• The syringes are supplied in a pack containing two or six pre-filled syringes with sterile needles of calibre 23 and 3.175 cm in length.

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 consult the representative of the marketing authorisation holder in your country.

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

Other sources of information

Further 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 for use before starting to use the pre-filled syringe of Plegridy. There may be new information. This information does not replace any conversation with your healthcare professional about your medical condition or your treatment.

Materials needed for the injection of Plegridy:

• 1 pack containing the dose for administration of Plegridy which includes:

• container for sharp objects to dispose of used syringes and needles
• Additional materials not included in the pack:
• 1. moist towelette soaked in alcohol

• gauze

• bandage

If you are using Plegridy for the first time, the dose can be adjusted in 2 injections using the pre-filled syringe with the dose adjustment kit of Plegridy.

Dose 1:

½ dose (yellow clip for dose adjustment) (not supplied in the pack)

Dose 2:

¾ dose (purple clip for dose adjustment) (not supplied in the pack)

Dose 3:

full dose (no clip required)

• The dose adjustment clips of Plegridy are exclusively for single use with the pre-filled syringe of Plegridy. Do not re-use the syringe or the dose adjustment clips.

• You must prepare the pre-filled syringe of Plegridy and the needle before placing them in the dose adjustment clip of Plegridy.

Preparing the dose of Plegridy:

• Use a flat, clean, and well-lit surface, for example a table. Gather all the materials needed for administration or for the healthcare professional to administer the injection.
• Take a pre-filled syringe of Plegridy out of the refrigerator at least 30 minutes before the scheduled time for the injection of the dose of Plegridy to reach room temperature.Do notuse external heat sources, such as hot water, to warm the pre-filled syringe of Plegridy.
• Check the expiry date printed on the label of the syringe, on the double cap, and on the outside of the pack.Do notuse the pre-filled syringe of Plegridy after the expiry date.

• Wash your hands with water and soap.

Preparing the injection of Plegridy:

Administration of the injection of Plegridy:

1. Your healthcare professional will teach you or your caregiver how to prepare and inject the dose of Plegridy before you use the syringe for the first time. Your healthcare professional will observe you administering the dose of Plegridy for the first time.
2. Inject Plegridy as your healthcare professional has taught you.

1. Plegridy is injected into the muscle (intramuscularly).
2. Plegridy must be injected into the thigh (see Figure G).

1. Alternate the injection sites with each dose.Do notuse the same injection site for each injection.
2. Do notadminister the injection in an area of the body where the skin is irritated, red, swollen, infected, or has any type of scar.

After the injection of Plegridy:

• Do notput the protective cover back on the needle. If you put the protective cover back on the needle, you may prick yourself with the needle.

• Dispose of the used syringes and needles in a container for sharp objects or in a rigid plastic container, or a metal container with a screw-top; for example, a detergent bottle or a coffee can. Consult your healthcare professional to find out the correct way to dispose of the container. There may be local or national regulations on how to dispose of used syringes and needles.Do notthrow the used syringes or needles in household waste or in recycling bins.

• Plegridy may cause frequent redness, pain, or swelling at the injection site.
• Contact your healthcare professional immediately if the injection site becomes inflamed and painful or if the area appears to be infected and does not heal in a few days.

General information on the safety and efficacy of Plegridy

• Always use a new syringe and needle for each injection.Do notre-use the syringe or needles of Plegridy.

• Do notshare the syringe or needles.