Plegridy 63 94 micrograms solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Plegridy 63 micrograms solution for injection in pre-filled syringe
Plegridy 94 micrograms solution for injection in pre-filled syringe
Plegridy 125 micrograms solution for injection in pre-filled syringe
peginterferon beta-1a
Read the entire 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 questions, ask your doctor, pharmacist or nurse.
-
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as yours, 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.
Leaflet contents
-
What Plegridy is and what it is used for
-
What you need to know before using Plegridy
-
How to use Plegridy
-
Possible side effects
-
How to store Plegridy
-
Contents of the pack and other information
-
Instructions for injection with 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 (RRMS) in adults aged 18 years and 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 signals between the brain and other parts of the body, causing the symptoms of MS.
Patients with relapsing-remitting MS experience periods when the disease is not active (remission) between episodes of 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 progression of MS-related disability. 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 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 you inform them if you have previously had depression or any other mood-related condition.
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 your dose, carefully follow the instructions provided in section 7 “Instructions for injecting from the Plegridy pre-filled syringe” 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, 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 you start using Plegridy, at regular intervals after starting treatment, and periodically throughout treatment—even if you do not have specific symptoms. These blood tests are in addition to the routine tests used to monitor your MS.
-
Your thyroid gland function will be monitored regularly or at any time your doctor considers necessary.
-
Blood clots may form in small blood vessels during treatment. These clots may affect your kidneys. This may occur several weeks or even years after starting Plegridy treatment. 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, wash the affected area immediately with soap and water and seek medical advice from a doctor or nurse as soon as possible.
Children and adolescents
Plegridy must not be used in children and adolescents, as its safety and effectiveness 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).
Tell 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.
You may occasionally need to remind other healthcare professionals that you are being treated with Plegridy, for example, if you are prescribed other medicines or 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, talk to 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
Plegridy has no or negligible influence on the ability to drive or operate machinery.
Plegridy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg); that is, essentially “sodium-free”.
3. How to use Plegridy
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, please 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 and 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 to help you 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 syringe with Plegridy 63 micrograms (for day 0) and a blue syringe with Plegridy 94 micrograms (for day 14).
Afterwards, you will be supplied with a maintenance pack containing grey syringes with Plegridy 125 micrograms (for day 28 and then every two weeks).
Read the instructions in section 7 “Instructions for injection of the pre-filled syringe of Plegridy” at the end of this leaflet before starting to use Plegridy.
Use the printed registration box inside 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 assistance from your doctor if you have been trained to do so.
-
Refer to and follow the instructions provided in section 7 “Instructions for injection of the pre-filled syringe of Plegridy” before starting.
-
If you have difficulty handling the syringe, speak with 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 unless 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 forget to inject on your usual day, inject the dose as soon as possible and 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 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 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 whites of the eyes;
-
widespread itching;
-
feeling unwell (nausea and vomiting);
-
easy bruising 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.
-
Serious 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 fit.
-
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 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 first starting Plegridy. As you continue using the injections, these symptoms gradually decrease over time. See below for some simple ways to help manage these flu-like symptoms if they occur.
Three simple ways to help reduce the impact of flu-like symptoms:
-
Consider the timing of your Plegridy injection. The onset and duration of flu-like symptoms vary between patients. On average, flu-like symptoms begin approximately 10 hours after injection and last between 12 and 24 hours.
-
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.
-
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 blood pressure in the 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 type of 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 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 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 required.
-
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 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 in total.
- Discard any syringe that has been kept outside the refrigerator for more than 30 days.
- If it is not certain how many days a syringe has been kept outside the refrigerator, discard the syringe.
-
Do not use this medicine if you observe that:
- the syringe is broken.
- the solution has changed colour, is cloudy, or contains visible particles.
-
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of 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 63 microgram pre-filled syringe contains 63 micrograms of peginterferon beta-1a in 0.5 ml of injectable solution.
Each 94 microgram pre-filled syringe contains 94 micrograms of peginterferon beta-1a in 0.5 ml of injectable solution.
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 glass pre-filled syringe with an attached needle.
Pack sizes:
- The Plegridy starter pack contains one orange 63 microgram pre-filled syringe and one blue 94 microgram pre-filled syringe.
- The grey 125 microgram syringes are supplied in packs containing either 2 or 6 pre-filled syringes.
Only certain pack sizes may be commercially available.
Marketing Authorisation 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
For more information about this medicine, you can contact the local representative of the Marketing Authorisation Holder:
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
| ||
|
Date of the most recent review 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.
7. Instructions for injecting from the Plegridy pre-filled syringe
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 available. This information does not replace discussion with your doctor or nurse about your condition or treatment.
Note:
- Before using the Plegridy pre-filled syringe for the first time, your doctor or nurse must instruct you or your caregiver on how to prepare and inject the Plegridy pre-filled syringe.
- The Plegridy pre-filled syringe is intended only for injecting the medicine under the skin (subcutaneous route).
- Each Plegridy pre-filled syringe can only be used once.
Do not share the Plegridy pre-filled syringe with anyone else to avoid spreading infections.
Do not use more than one pre-filled syringe every 14 days (every 2 weeks).
Do not use the syringe if it has been dropped or shows visible damage.
Dosing schedule
The starter pack contains your first two injections to gradually adjust your dose. Select the correct syringe from the pack.
When | Dose | Container |
Day 0 (63 micrograms) | First injection: 63 micrograms select the orange syringe |
|
Day 14 (94 micrograms) | Second injection: 94 micrograms select the blue syringe | |
Day 28 and every two weeks thereafter (125 micrograms) | Full dose injection: 125 micrograms select the grey syringe |
|
Do not use more than one pre-filled syringe within a 14-day period (every 2 weeks).
Materials needed for Plegridy injection
Plegridy pre-filled syringe (see Figure A)
Before use – Parts of the Plegridy pre-filled syringe (Figure A)
|
Additional materials not included in the package (see Figure B):
-
alcohol-impregnated wipe
-
gauze
-
adhesive bandage
Ask your doctor, pharmacist, or nurse for instructions on how to dispose of used syringes.
|
Preparation for injection
Step 1: Remove the pre-filled syringe from the refrigerator
- Take one package of Plegridy out of the refrigerator and select the appropriate pre-filled syringe from the package.
- Close the package and return it to the refrigerator after removing the pre-filled syringe.
- Allow the Plegridy pre-filled syringe to reach room temperature for at least 30 minutes.
Do not use external heat sources, such as warm water, to heat the Plegridy pre-filled syringe.
Step 2: Gather supplies and wash your hands
- For preparation, use a clean, flat, well-lit surface, such as a table. Gather all materials needed to administer or have the injection administered.
- Wash your hands with soap and water.
Step 3: Check the Plegridy pre-filled syringe | |
Do not use the Plegridy pre-filled syringe after the expiry date.
Do not use the Plegridy pre-filled syringe if the liquid is colored, cloudy, or contains particles in suspension. o You may see air bubbles in the Plegridy medicine. This is normal and it is not necessary to remove the bubbles before injection. |
|
Administration of the injection
Step 4: Choose and clean the injection site | |
Do not inject directly into the navel. Do not inject into any area of skin that is irritated, sore, red, bruised, tattooed, infected, or scarred.
|
|
Step 5: Firmly remove the needle cap | |
Be careful when removing the needle cap to avoid accidentally pricking yourself with the needle. Do not touch the needle. Warning: do not re-cap the needle on the Plegridy pre-filled syringe. You could prick yourself with the needle. |
|
Step 6: Gently pinch the injection site | |
|
|
Step 7: Inject the medication | |
Do not pull back on the plunger. |
|
Do not remove the Plegridy pre-filled syringe from the injection site until the plunger has been fully depressed. |
|
|
|
Step 8: Remove the pre-filled syringe from the injection site | |
Warning: Do not re-cap the needle of the Plegridy pre-filled syringe. You could prick yourself with the needle. Do not reuse the Plegridy pre-filled syringe. |
|
After the injection
Step 9: Disposal of the used Plegridy pre-filled syringe
- Consult your doctor, pharmacist, or nurse about the proper way to dispose of the used syringe.
Step 10: Care of the injection site
- If necessary, apply gauze or a bandage to the injection site.
Step 11: Check the injection site
- Two hours after the injection, 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 of each injection.
- For the first injections, you may use the recording box printed on the inside of the starter pack lid.
General warnings
Do not reuse the Plegridy pre-filled syringe.
Do not share the Plegridy pre-filled syringe.
- Keep the Plegridy pre-filled syringe and all medicines out of the reach of children.
Storage
- Store in the refrigerator at a controlled temperature between 2°C and 8°C, in the original closed packaging to protect from light.
- If necessary, Plegridy may be stored outside the refrigerator, in the original closed packaging, at a temperature 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 a temperature up to 25°C must not exceed 30 days.
Do not freeze or expose to high temperatures.