Plegridy 125 micrograms solution for injection in pre-filled pen

Package leaflet: Information for the user

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 the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the 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 injection with the Plegridy pre-filled pen

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 (RRMS) in adults aged 18 years or older.

Multiple sclerosis (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 communication between the brain and other parts of the body, leading to the symptoms of MS.

Patients with relapsing-remitting MS experience 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 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 problems affecting your mood;

• suicidal thoughts.

• Your doctor may still prescribe Plegridy, but it is important that you inform them if you have ever had depression or any other similar condition affecting your mood 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 provided in section 7 “Instructions for using the Plegridy prefilled pen” at the end of this leaflet. This will help 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; ankle swelling, difficulty breathing (congestive heart failure), or an 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, at regular intervals after beginning treatment, and periodically throughout treatment—even if you do not have specific symptoms. These blood tests are in addition to the routine tests performed to monitor your MS.

• Your thyroid gland function will be monitored regularly or at any time your doctor considers it necessary for other reasons.

• 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 contact a doctor or nurse as soon as possible.

Children and adolescents

Plegridy must 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 together with other medicines that are processed in the body by a group of proteins called “cytochrome P450” (e.g., certain medications 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 you are prescribed other medicines or if you undergo blood testing. Plegridy may interact with other medicines or affect test results.

Pregnancy and breastfeeding

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

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

Driving and using machines

The influence 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); essentially, it is “sodium-free”.

3. How to use Plegridy

Follow exactly the administration instructions for 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

If you are using Plegridy for the first time, your doctor may advise you to start with a gradual dose increase so that you can get used to the effects of Plegridy before administering the full dose. You will be supplied 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).

Afterwards, you will be supplied with a maintenance pack containing grey pens with Plegridy 125 micrograms (for day 28 and then every two weeks).

Read the instructions in section 7 "Instructions for injection with the Plegridy pre-filled pen" at the end of this leaflet before starting to use Plegridy.

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

Self-injection

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

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 with the Plegridy pre-filled pen" before starting.

• If you have difficulty handling the pen, 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 the treatment is administered as consistently as possible.

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

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 experiences 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 whites of the eyes;

• widespread itching;

• feeling unwell (nausea and vomiting);

• bruises that appear 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 reactions

(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 any 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 any or all of these 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 these 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 significantly 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 very commonly reported 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 effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 the traceability of this medicine, your doctor or pharmacist should record the name and batch number of the medicine you have been given in your medical record. You may also wish to keep a note of this information 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 EXP. The expiry 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 pen is required.

• Store in the refrigerator at 2°C to 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 pens are kept outside the refrigerator does not exceed 30 days in total.

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

• If the number of days a pen has been kept outside the refrigerator is not known with certainty, discard the pen.

• Do not use this medicine if you observe that:

• the pen is damaged.

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

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Plegridy

The active substance is peginterferon beta-1a.

Each 63-microgram pre-filled pen contains 63 micrograms of peginterferon beta-1a in 0.5 ml of injectable solution.

Each 94-microgram pre-filled pen contains 94 micrograms of peginterferon beta-1a in 0.5 ml of injectable solution.

Each 125-microgram pre-filled pen 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”).

Appearance of the product and contents of the container

Plegridy is a clear, colourless injectable solution in a pre-filled glass pen with an attached needle.

Pack sizes:

• The starter pack of Plegridy contains one orange pre-filled pen of 63 micrograms and one blue pre-filled pen of 94 micrograms.
• The grey 125-microgram pens are supplied in packs containing either 2 or 6 pre-filled pens.

Only some 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

More information about this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Date of the most recent revision of this leaflet:

Other sources of information

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

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

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 get a new prescription. There may be new information. This information does not replace the discussion with your doctor or nurse about your condition or treatment.

Note:

• Before using the pen for the first time, your doctor or nurse should train you or your caregiver on how to prepare and inject the pen.
• The pen is intended for subcutaneous use only (under the skin).
• Each pen can only be used once.

Do not share the pen with anyone else to avoid spreading infections.

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

Do not use the pen if it has been dropped or shows visible damage.

Administration schedule

The starter pack contains your first two injections for gradual dose adjustment. Select the correct pen from the pack.

Do not use more than one pen within a 14-day period (every 2 weeks).

Materials needed for the injection with the Plegridy pen:

• 1 Plegridy pen (see Figure A)

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

Warning: Do not remove the cap until you are ready to inject. If you remove the cap, do not reattach the cap to the pen. Replacing the cap could block the pen.

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

Preparation for injection

Step 1: Take the pen out of the refrigerator.

1. Remove a Plegridy package from the refrigerator and select the appropriate pen (dose) from the package.

2. Close the package and return it to the refrigerator after removing the pen.

3. Allow the pen to reach room temperature for at least 30 minutes.

Do not use external heat sources, such as warm water, to warm the pen.

Step 2: Gather materials and wash your hands.

1. Use a clean, flat, well-lit surface, such as a table. Gather all materials needed to administer the injection to yourself or to have someone else administer it.
2. Wash your hands with soap and water.

After injection

After use – Parts of the Plegridy pen (see Figure K):

Note: Once the pen has been removed from the injection site, the needle safety shield will lock into place to protect against needlestick injury. Do not re-cap the pen.

Step 9: Disposal of the used Plegridy pen

• Consult your doctor, pharmacist, or nurse for instructions on the proper disposal of the used pen.

Do not re-cap the pen.

Step 10: Care of the injection site

• If needed, apply a gauze pad or adhesive bandage to the injection site.

Step 11: Check the injection site

• After 2 hours, check the injection site for redness, swelling, or tenderness upon touch.
• If you experience a skin reaction that does not resolve within a few days, contact your doctor or nurse.

Record the date and injection site

• Record the date and injection site for each injection.
• For injections from the starter pack, you may use the recording box printed on the inside of the starter pack lid.

General warnings

Do not reuse the Plegridy pen.

Do not share the Plegridy pen.

• Keep the Plegridy pen and all medicines out of the reach of children.

Storage

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

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

• If necessary, Plegridy may be removed from the refrigerator and returned. The total cumulative time outside the refrigerator at temperatures up to 25°C must not exceed 30 days.

DO NOT freeze or expose to high temperatures.