Plegridy 125 micrograms injectable solution in pre-filled pen

Introduction

Package Leaflet: Information for the User

Plegridy 63 micrograms solution for injection in pre-filled pen

Plegridy 94 micrograms solution for injection in pre-filled pen

Plegridy 125 micrograms solution for injection in pre-filled pen

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, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Plegridy and what is it used for
2. What you need to know before you use Plegridy

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

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

1. What is Plegridy and what is it used for

What is Plegridy

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

What is Plegridy used for

This medicine is used to treat Relapsing-Remitting Multiple Sclerosis (MS) in adults aged 18 years or over.

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 (its natural defenses) damages the protective covering (myelin) that surrounds the nerves in the brain and spinal cord. This disrupts the messages between the brain and the rest of the body, causing the symptoms of MS.

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

Each patient has specific MS symptoms.These can be:

• feeling unsteady or dizzy, problems with walking, stiffness and muscle spasms, tiredness, numbness in the face, arms, or legs;
• sharp or chronic pain, bladder and bowel problems, sexual problems, and vision problems;
• difficulty thinking and concentrating, depression.

How does Plegridy work?

Plegridy is thought 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 down the disabling effects of MS. Treatment with Plegridy may help prevent MS from getting worse, although it will not cure MS.

2. What you need to know before you use Plegridy

Do not use Plegridy

• to peginterferon beta-1a, interferon beta-1a, or any of the other ingredients of this medicine (listed in section 6). See the symptoms of an allergic reaction in section 4;

• or suicidal thoughts.

Warnings and precautions

Tell your doctor if you have ever had:

• depressionor mood problems;
• suicidal thoughts.

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

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

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

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

• epilepsyor other seizure disorders, not controlled with medication;

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

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

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

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 you start using Plegridy, at regular intervals after starting treatment with Plegridy, and periodically during treatment, even if you have no specific symptoms. These blood tests will be in addition to the tests normally performed to monitor your MS.

• Your thyroid function will be regularly reviewed or at any time your doctor considers it necessary for other reasons.
• Blood clots may form in small blood vessels during treatment. These blood clots could affect your kidneys. This can occur after several weeks or several years after 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 soap and water immediatelyand contact a doctor or nurse as soon as possible.

Children and adolescents

Plegridy must not be usedin children and adolescents under 18 years of age. The safety and efficacy of Plegridy in this age group are not known.

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 for epilepsy or depression).

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, especially those used to treat epilepsy or depression. This includes any medicine 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 medicines for you or if they perform a blood test. Plegridy may interact with other medicines or with the test result.

Pregnancy and breastfeeding

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

No harmful effects on the breastfed child are expected. Plegridy can be used during breastfeeding.

Driving and using machines

Plegridy has no or negligible influence on the ability to drive and use machines.

Plegridy contains sodium

This medicine contains less than 1 mmol of sodium (23 mg); this is, essentially "sodium-free).

3. How to use Plegridy

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Usual dose

One injection of Plegridy 125 micrograms every 14 days (every 2 weeks). Try to use Plegridy at the same time on the same day each time you inject.

Starting Plegridy

If you are using Plegridy for the first time, your doctor may advise you to gradually increase the dose so you can get used to the effects of Plegridy before administering the full dose. You will be provided with a starter pack containing the first 2 injections: an orange pen with Plegridy 63 micrograms (for day 0) and a blue pen with Plegridy 94 micrograms (for day 14).

Then you will be provided with a maintenance pack containing grey pens with Plegridy 125 micrograms (for day 28 and then every 2 weeks).

Read the instructions in section 7 "Instructions for injecting Plegridy pre-filled pen" at the end of this leaflet before you start using Plegridy.

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

Self-injection

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

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

• Read and follow the advice given in the instructions in section 7 "Instructions for injecting Plegridy pre-filled pen" before you start.

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

Duration of treatment with Plegridy

Your doctor will tell you how long you should use Plegridy. It is important that you use Plegridy regularly. Do not make any changes that your doctor has not told you to make.

If you use more Plegridy than you should

You should only inject Plegridy 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 to keep the treatment as uniform as possible.

If you forget to administer on your usual day, inject a dose as soon as possible and continue as usual. However, do not inject more than once in a 7-day period. Do not administer two injections to make up for the forgotten injection.

If you have any further questions on the use of this medicine, ask 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 have any of the following symptoms:

• yellowing of the skin or the white of the eyes;
• widespread itching;
• feeling sick (nausea and vomiting);
• bruises that appear easily on the skin.
• • Contact a doctor immediatelyas these may be signs of a possible liver problem.

• Depression

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

If you have:

• 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 have 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 have a seizure or an epileptic fit.

• Contact a doctor immediately.

• Injection site damage

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

If you have any of the following symptoms:

• any open sores on the skin along with swelling, inflammation, or fluid leakage around the injection site.

• Contact a doctor for advice.

• Kidney problems including scarring that can reduce kidney function

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

If you have any or all of these symptoms:

• foamy urine;
• fatigue;
• swelling, especially of 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 your kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome). The symptoms may include an increase in bruising, bleeding, fever, extreme weakness, headache, dizziness, or fainting. Your doctor may find changes in your blood and kidney function.

If you have any or all of these symptoms:

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

• Contact a doctor immediately.

Other side effects

Very common side effects

(may affect more than 1 in 10 people)

• flu-like symptoms. These symptoms are not actually flu, see below. You cannot pass them on to anyone;
• headache;
• muscle pain (myalgia);
• joint pain, arm, leg, or neck pain (arthralgia);
• chills;
• fever;
• weakness and tiredness (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 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. Be aware of the time of administration of the Plegridy injection. The start and end of flu-like symptoms are different for each patient. On average, flu-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 to take it for as long as the flu-like symptoms last. Ask your doctor or pharmacist how much to take and for how long.
2. If you have a fever, drink plenty of water to stay hydrated.

Common side effects

(may affect up to 1 in 10 people)

• feeling sick (nausea or vomiting);
• hair loss (alopecia);
• itching of the skin (pruritus);
• increase in body temperature;
• changes around the injection site such as swelling, inflammation, bruising, warmth, rash, or change in color;
• changes in the blood can cause tiredness or reduced ability to fight infections;
• increase in liver enzymes in the blood (will appear in blood tests).
• If you are concerned about any of these effects, contact a doctor.

Uncommon side effects

(may affect up to 1 in 100 people)

• hives;
• changes in the blood that can cause unexplained bruising or bleeding.

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

Frequency not known

(cannot be estimated from the available data)

• Pulmonary arterial hypertension: A disease in which there is a significant narrowing of the blood vessels in the lungs, which causes an increase in blood pressure in the blood vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension was observed at different times, even several years after the start of treatment with interferon beta-containing medicines.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

In order to improve the traceability of this medicine, your doctor or pharmacist should record the name and batch number of the medicine administered to you in your medical history. You may also want to make a note of this information in case you are asked for it in the future.

5. Storage of Plegridy

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after CAD/EXP. The expiry date is the last day of the month indicated.

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

• Store in a refrigerator(between 2°C and 8°C).
• • Do not freeze. Discard any Plegridy that has been frozen by accident.

• Plegridy can be stored outside of the refrigerator at room temperature (up to 25°C) for a maximum of 30 days, but must be protected from light.
• • The packs can be taken out and put back in the refrigerator on more than one occasion if necessary.
  • Make sure that the time the pens spend outside of the refrigerator does not exceed30 days in total.

• Discard any pen that has been out of the refrigerator for more than 30 days.
• If it is not certain how many days a pen has been out of the refrigerator, discard the pen.

• Do not use this medicine if you notice that:

• the pen is broken.
• the solution has changed color, is cloudy, or you can see particles in suspension.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packs and any medicine that you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Plegridy Composition

The active ingredient is peginterferon beta-1a.

Each 63-microgram prefilled syringe contains 63 micrograms of peginterferon beta-1a in 0.5 mL of injectable solution.

Each 94-microgram prefilled syringe contains 94 micrograms of peginterferon beta-1a in 0.5 mL of injectable solution.

Each 125-microgram prefilled 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 injectable preparations (see section 2 "Plegridy contains sodium").

Product Appearance and Container Contents

Plegridy is a clear and colorless injectable solution in a prefilled glass syringe with an attached needle.

Package sizes:

• The Plegridy starter package contains one orange 63-microgram prefilled syringe and one blue 94-microgram prefilled syringe.
• The gray 125-microgram syringes are supplied in a package containing 2 or 6 prefilled syringes.

Not all package sizes may be marketed.

Marketing Authorization 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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:01/2025

Other Sources of Information

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

1. Instructions for Injecting the Plegridy Prefilled Syringe

Warning: do notremove the cap until you are ready to inject.

How to Inject Plegridy

Read the instructions before you start using Plegridy and each time you get a new prescription. There may be new information. This information does not replace talking to your doctor or nurse about your condition or treatment.

Note:

• Before using the syringe for the first time,your doctor or nurse should teach you or your caregiver how to prepare and inject the syringe.
• The syringe is for subcutaneous use only.
• Each syringe can only be used once.

Do not sharethe syringe with anyone else to avoid spreading infections.

Do not use more than onesyringe every 14 days (every 2 weeks).

Do not usethe syringe if it has fallen or is visibly damaged.

Dosing Schedule

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

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

Materials Needed for Injecting the Plegridy Syringe:

• 1 Plegridy syringe (see Figure A)

Before Use – Parts of the Plegridy Syringe (Figure A)

Warning: do not remove the cap until you are ready to inject. If you remove the cap, do not put it back on the syringe. The cap may block the syringe.

Additional Materials Not Included in the Package (see Figure B):

Preparation for Injection

Step 1: Remove the Syringe from the Refrigerator.

1. Remove a Plegridy package from the refrigerator and choose the correct syringe (dose) from the package.
2. Close the package and store 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 warm water, to warm up the syringe.

Step 2: Gather Materials and Wash Your Hands.

1. Use a flat, clean, and well-lit surface, such as a table. Gather all the materials needed to administer or have the injection administered.

1. Wash your hands with water and soap.

After the Injection

After Use – Parts of the Plegridy Syringe (see Figure K):

Note: Once the syringe is removed from the injection site, the needle guard will lock to protect against needlestick injuries. Do not put the cap back on the syringe.

Step 9: Disposal of the Used Plegridy Syringe

• Ask your doctor, pharmacist, or nurse about the correct way to dispose of the used syringe.

Do not put the cap back on the syringe.

Step 10: Care of the Injection Site

• If necessary, apply the gauze or cold compress to the injection site.

Step 11: Check the Injection Site

• After 2 hours, check the injection site for redness, swelling, or pain to the touch.
• If you have a skin reaction that does not go away in a few days, contact your doctor or nurse.

Record the Date and Site

• Record the date and site of each injection.
• For starter package injections, you can use the recording box printed on the inside of the starter package lid.

General Warnings

Do not reusethe Plegridy syringe.

Do not sharethe Plegridy syringe.

• Keep the Plegridy syringe and all medications out of the reach of children.

Storage

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

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

• 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 NOTfreeze or expose to high temperatures.