Plegridy 125 micrograms solution for injection in pre-filled syringe IM

Patient Information Leaflet

Introduction

Patient Information Leaflet

Plegridy 125 micrograms solution for injection in pre-filled syringe

peginterferon beta-1a

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

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

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. 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 from the Plegridy 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, long-acting form of interferon. Interferons are natural substances produced in the body that help protect against infections and diseases.

What Plegridy is used for

This medicine is used to treat relapsing-remitting multiple sclerosis (MS) in adults 18 years of age or older.

MS 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 the nerves in the brain and spinal cord. This disrupts the signals between the brain and other parts of the body, causing the symptoms of MS.

Patients with relapsing-remitting MS have periods when the disease is not active (remission) between symptom flare-ups (relapses).

Each patient has specific MS symptoms. These may include:

• feelings of unsteadiness or dizziness, difficulty walking, muscle stiffness and spasms, fatigue, numbness in the face, arms, or legs;
• acute or chronic pain, bladder and bowel problems, sexual dysfunction, and vision problems;
• difficulty thinking and concentrating, depression.

How Plegridy works

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 experience and slow the disabling effects of MS. Treatment with Plegridy may help prevent worsening of the disease, although it will not cure MS.

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 symptoms of an allergic reaction in section 4;
• if you have severe depression or suicidal thoughts.

Warnings and precautions

Talk to your doctor if you have ever had:

• depression or other mood-related problems;

• suicidal thoughts.

• Your doctor may still prescribe Plegridy, but it is important that they know if you have had depression or any other mood-related condition in the past.

Talk to your doctor, pharmacist, or nurse before injecting Plegridy if you have any of the following conditions, as they may worsen while using Plegridy:

• severe kidney or liver problems;
• injection site reactions, which may cause skin and tissue damage (necrosis at the injection site). When you are ready to administer the injection, carefully follow the instructions described in section 7 “Instructions for using the Plegridy pre-filled syringe” at the end of this leaflet. This will reduce the risk of injection site reactions;
• epilepsy or other seizure disorders not controlled by medication;

heart problems that may cause symptoms such as chest pain (angina), especially after physical activity; swollen ankles, shortness of breath (congestive heart failure), or irregular heartbeat (arrhythmias);

thyroid problems;

• low white blood cell or platelet counts, which may increase the risk of infection or bleeding.

Other considerations when using Plegridy

• You will need blood tests to monitor your blood cell counts, blood chemistry, and liver enzyme levels. These tests will be performed before starting Plegridy, periodically after beginning treatment, and regularly during treatment—even if you do not have specific symptoms. These blood tests are in addition to the routine tests normally performed to monitor your MS.
• Your thyroid gland function will be checked regularly or at any time your doctor considers necessary.
• Blood clots may form in small blood vessels during treatment. These clots could affect your kidneys. This may occur several weeks or years after starting treatment with Plegridy. Your doctor may want to monitor your blood pressure, blood (platelet count), and kidney function.

If you or someone else is accidentally pricked with the Plegridy needle, the affected area should be washed immediately with soap and water and you should seek medical advice from a doctor or nurse as soon as possible.

Children and adolescents

Plegridy should not be used in children and adolescents, as its effectiveness and safety have not yet been established in this population.

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., certain medicines used for epilepsy or depression).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially those used to treat epilepsy or depression. This includes any medicines obtained without a prescription.

On occasion, you may need to remind other healthcare professionals that you are being treated with Plegridy, for example, if other medicines are prescribed or if you undergo blood testing. Plegridy may interact with other medicines or affect test results.

Pregnancy and breastfeeding

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

Harmful effects on the breastfed infant are not expected. Plegridy may be used during breastfeeding.

Driving and using machines

The effect of Plegridy on the ability to drive and use machines is negligible or none.

Plegridy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg), i.e., essentially “sodium-free”.

3. How to use Plegridy

Follow exactly the instructions for administering this medicine given 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.

Starting Plegridy by intramuscular route

If this is the first time you are using 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 Plegridy prefilled syringe is 125 micrograms. Dose-adjusting clips can be attached to the syringe to allow gradual dose escalation:

Dose 1 on Day 0:

1/2 dose (63 micrograms) with a YELLOW dose-adjusting clip

Dose 2 on Day 14:

3/4 dose (94 micrograms) with a VIOLET dose-adjusting clip

Dose 3 on Day 28 and every 2 weeks thereafter:

full dose (125 micrograms), WITHOUT the need for a dose-adjusting clip

The Plegridy medicine supplied in this package is intended to be injected into the thigh muscle.

Read the instructions described in section 7 "Instructions for injection of the Plegridy prefilled syringe" at the end of this leaflet before starting to use Plegridy.

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

Intramuscular is abbreviated as IM on the syringe label.

Self-injection

Plegridy is injected into the thigh muscle (intramuscular injection). Alternate the injection site. Do not use the same injection site for every injection.

You may self-inject Plegridy without help from your doctor if you have been trained to do so.

• Read and follow the instructions provided in section 7 "Instructions for injection of the Plegridy prefilled syringe" before starting.

• If you have difficulty handling the syringe, speak to your doctor or nurse who can assist you.

Duration of treatment with Plegridy

Your doctor will inform you how long you should use Plegridy. It is important that you use Plegridy regularly. Do not make any changes not specifically instructed by your doctor.

If you use more Plegridy than you should

You should inject Plegridy only once every 2 weeks.

• If you have administered more than one injection of Plegridy within a 7-day period, contact your doctor or nurse immediately.

If you forget to use Plegridy

You should inject Plegridy once every 2 weeks. This regular schedule helps ensure consistent treatment.

If you miss your scheduled dose, inject the dose as soon as possible and then continue as usual. However, do not inject more than once within a 7-day period. Do not administer two injections to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Serious adverse effects

• Liver problems

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

If you experience any of the following symptoms:

• yellowing of the skin or the white part of the eyes;

• widespread itching;

• feeling unwell (nausea and vomiting);

• bruises appearing easily on the skin.

• Contact a doctor immediately, as these may be signs of a possible liver problem.

• Depression

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

If you experience:

• unusual feelings of sadness, anxiety, or hopelessness; or

• suicidal thoughts.

• Contact a doctor immediately.

• Severe allergic reactions

(uncommon: 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);

• skin rash or redness.

• Contact a doctor immediately.

• Seizures

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

If you experience a seizure or epileptic attack.

• Contact a doctor immediately.

• Injection site damage

(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 fluid discharge around the injection site.

• Contact a doctor for advice.

• Kidney problems, including scarring that may reduce kidney function

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

If you experience one or all of the following symptoms:

• foamy urine;

• fatigue;

• swelling, especially in the ankles and eyelids, and weight gain.

• Contact a doctor, as these may be signs 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 can affect the kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness, or lightheadedness. Your doctor may detect abnormalities in your blood and kidney function.

If you experience one or all of the following symptoms:

• increased bruising or bleeding;

• extreme weakness;

• headache, dizziness, or lightheadedness.

• Contact a doctor immediately.

Other adverse effects

Very common adverse effects

(may affect more than 1 in 10 people)

• flu-like symptoms. These symptoms are not actually due to influenza—see below. They cannot be transmitted to others;

• headache;

• muscle pain (myalgia);

• joint, arm, leg, or neck pain (arthralgia);

• chills;

• fever;

• weakness and fatigue (asthenia);

• redness, itching, or pain around the injection site.

• If you are concerned about any of these effects, contact a doctor.

Flu-like symptoms

Flu-like symptoms are more common when you first start using Plegridy. As you continue with the injections, these symptoms gradually diminish over time. Below are some simple ways to help manage flu-like symptoms if you experience them.

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

1. 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 begin approximately 10 hours after injection and last between 12 and 24 hours.
2. Take paracetamol or ibuprofen half an hour before your Plegridy injection and continue taking it for as long as the flu-like symptoms last. Ask your doctor or pharmacist how much to take and for how long.
3. If you have a fever, drink plenty of water to stay hydrated.

Common adverse effects

(may affect up to 1 in 10 people)

• feeling unwell (nausea or vomiting);

• hair loss (alopecia);

• itchy skin (pruritus);

• increased body temperature;

• changes around the injection site such as swelling, inflammation, bruising, warmth, rash, or discoloration;

• blood changes that may cause fatigue or reduced ability to fight infections;

• increased liver enzymes in the blood (detected in blood tests).

• If you are concerned about any of these effects, contact a doctor.

Uncommon adverse effects

(may affect up to 1 in 100 people)

• hives;

• blood changes that may cause unexplained bruising or bleeding.

• If you are concerned about any of these effects, contact a doctor.

Frequency not known

(cannot be estimated from available data)

• Pulmonary arterial hypertension: A condition in which the blood vessels in the lungs become severely narrowed, 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, even several years after starting treatment with medicines containing interferon beta.

Children (aged 10 years and older) and adolescents

In clinical trials, certain adverse effects were reported very commonly in both adults and children, such as redness at the injection site, flu-like symptoms, headache, and fever.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you 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 administered to you in your medical record. You may also wish to note this information down in case you are asked for it in the future.

5. Storage of Plegridy

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

Do not use this medicine after the expiry date stated on the label and carton after CAD/EXP. The expiry date refers to 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 (between 2°C and 8°C).

• Do not freeze. Discard any 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 protected from light.

• The containers may be removed from and returned to the refrigerator more than once if necessary.

• Ensure that the total time the syringes are kept outside the refrigerator does not exceed 30 days.

• Discard any syringe that has been outside the refrigerator for more than 30 days.

• If it is uncertain how many days a syringe has been kept outside the refrigerator, discard the syringe.

• Do not use this medicine if you notice that:

• the syringe is broken.

• the solution has changed colour, is cloudy, or if you see particles in it.

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Plegridy

The active substance is peginterferon beta-1a.

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”).

Nature and contents of the container

Plegridy is a clear, colourless injectable solution in a pre-filled glass syringe accompanied by a needle.

Pack sizes:

• The syringes are supplied in a pack containing either two or six pre-filled syringes with sterile 23-gauge, 3.175 cm long needles.

Only certain pack sizes may be marketed.

Marketing Authorization 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 12/2025

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

1. Instructions for injecting from the Plegridy pre-filled syringe

How to inject Plegridy

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

Materials you will need for the Plegridy injection:

• 1 package containing the administration dose of Plegridy, including:

• 1 Plegridy pre-filled syringe

• One sterile 23-gauge needle, 3.175 cm in length

• A sharps container for the disposal of used syringes and needles

• Additional materials not included in the package:

• Alcohol wipe

• Gauze

• Plaster (adhesive bandage)

If you are using Plegridy for the first time, the dose may be adjusted over 2 injections using the syringe with the Plegridy dose-adjustment kit.

o Dose 1:

½ dose (yellow dose-adjustment clip) (not supplied in the package)

o Dose 2:

¾ dose (violet dose-adjustment clip) (not supplied in the package)

o Dose 3:

Full dose (no clip required)

• Plegridy dose-adjustment clips are intended for single use only with the Plegridy pre-filled syringe. Do not reuse the syringe or the dose-adjustment clips.

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

Preparing the Plegridy dose:

• Use a clean, flat, well-lit surface, such as a table. Gather all necessary materials for administering or receiving the injection.
• Remove one Plegridy pre-filled syringe from the refrigerator at least 30 minutes before the scheduled injection time to allow it to reach room temperature. Do not use external heat sources, such as warm water, to warm the pre-filled syringe.
• Check the expiry date printed on the syringe label, the dual cap, and the outer carton. Do not use the Plegridy pre-filled syringe after the expiry date.
• Wash your hands thoroughly with soap and water.

Preparing the Plegridy injection:

Administration of Plegridy injection:

1. Your doctor or nurse 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 doctor or nurse will observe you injecting the dose of Plegridy the first time you use the syringe.

2. Inject Plegridy exactly as your doctor or nurse has instructed you.

3. Plegridy is injected into the muscle (intramuscular route).

4. Plegridy should be injected into the thigh (see Figure G).

5. Change (alternate) injection sites with each dose. Do not use the same injection site for each injection.

6. Do not administer the injection in an area of skin that is irritated, red, bruised, infected, or scarred in any way.

After injecting Plegridy:

• Do not recap the needle. If you put the protective cover back over the needle, you could accidentally prick yourself with the needle.
• Dispose of used syringes and needles in a sharps container or in a hard plastic container, or in a metal container with a screw-on lid; for example, a laundry detergent bottle or a coffee can. Ask your healthcare professional how to properly dispose of the container. There may be local or state regulations regarding the proper disposal of used syringes and needles. Do not throw used syringes or needles into household trash or recycling bins.
• Plegridy may commonly cause redness, pain, or swelling of the skin at the injection site.
• Contact your healthcare professional immediately if the injection site becomes swollen and painful, or if the area appears infected and does not heal within a few days.

General information about the safety and efficacy of Plegridy

• Always use a new syringe and needle for each injection. Do not reuse the syringe or needles from Plegridy.
• Do not share your syringes or needles.