Plegridy 125 micrograms solution for injection in pre-filled syringe SC
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 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, and you should not give it to other people, even if they have the same symptoms as you. It could harm them.
-
If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
-
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 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 (RRMS) in adults 18 years of age 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 messages between the brain and the rest of the body, causing the symptoms of MS.
Patients with relapsing-remitting MS experience periods during which the disease is not active (remission) between exacerbations of symptoms (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 a patient experiences 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 the 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 mood-related problems;
-
suicidal thoughts.
-
Your doctor may still prescribe Plegridy, but it is important that they know if you have ever 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 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 uncontrolled seizure disorders;
-
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 monitoring tests performed for 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 blood 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 stuck with the needle of the Plegridy syringe, the affected area should be washed immediately with soap and water and medical advice should be sought as soon as possible.
Children and adolescents
Plegridy must not be used in children and adolescents, as it has not yet been established whether it is effective and safe for them.
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 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.
You may occasionally 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 in 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 minor.
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 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 gradually increase the dose 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 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 using the Plegridy pre-filled syringe” at the end of this leaflet before starting to use Plegridy.
Use the printed record box on the inside of the lid of the starter pack to keep track of injection dates.
Self-injection
Plegridy is injected under the skin (subcutaneous injection). Alternate the injection site. Do not use the same injection site every time.
You may self-inject Plegridy without help from your doctor if you have been trained to do so.
-
Refer to and follow the instructions provided in section 7 “Instructions for using the Plegridy pre-filled 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 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 miss your scheduled dose, 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 everybody gets 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.
-
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
-
have 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 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 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 confusion. Your doctor may detect abnormalities in your blood and kidney function.
If you experience any or all of the following symptoms:
-
increased bruising or bleeding;
-
extreme weakness;
-
headache, dizziness, or confusion.
-
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. You cannot pass them on to anyone else;
-
headache;
-
muscle pain (myalgia);
-
joint, arm, leg, or neck pain (arthralgia);
-
chills;
-
fever;
-
weakness and tiredness (asthenia);
-
redness, itching, or pain at 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 disappear. 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:
-
Consider the time of day when you administer 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.
-
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 at the injection site such as swelling, inflammation, bruising, warmth, rash, or discoloration;
-
blood changes that may cause tiredness 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 (from 10 years of age) 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 effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed 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 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 the carton after EXP/CAD. 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 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 the number of days a syringe has been kept outside the refrigerator is uncertain, discard the syringe.
-
Do not use this medicine if you observe that:
-
the syringe is damaged.
-
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 any unused medicines and their packaging. This helps 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”).
Appearance of the product and contents of the pack
Plegridy is a clear, colourless injectable solution in a pre-filled glass 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 marketed.
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 further information about this medicine, please 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.
- Instructions for injecting from the Plegridy pre-filled syringe
How to inject Plegridy
Read these 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 the conversation 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 train you or your caregiver on how to prepare and administer the injection from the Plegridy pre-filled syringe.
- The Plegridy pre-filled syringe is intended for subcutaneous injection only (under the skin).
- Each Plegridy pre-filled syringe must be used only 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, designed 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 the Plegridy injection
Pre-filled syringe of Plegridy (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.
|
Injection Preparation
Step 1: Remove the pre-filled syringe from the refrigerator
- Take one carton of Plegridy out of the refrigerator and select the appropriate pre-filled syringe from the carton.
- Close the carton 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 hot water, to warm the Plegridy pre-filled syringe.
Step 2: Gather materials and wash your hands
- For preparation, use a clean, flat, and 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 expiration date.
Do not use the Plegridy pre-filled syringe if the liquid is colored, cloudy, or contains particles in suspension. It is normal to see air bubbles in the Plegridy solution. There is no need 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, painful, red, bruised, tattooed, infected, or scarred.
Do not touch or blow on the area before giving the injection. |
|
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 recap the needle of the Plegridy pre-filled syringe. You may get a needle stick. 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
- After 2 hours, check the injection site for redness, swelling, or tenderness upon touch.
- If you experience a skin reaction and it does not go away 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 printed log box located 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
- It is recommended to store in the refrigerator at a controlled temperature between 2°C and 8°C, in the original closed packaging to protect it from light.
- If necessary, Plegridy may be stored in the original closed packaging outside the refrigerator 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 then returned. The total combined time outside the refrigerator at a temperature up to 25°C must not exceed
30 days.
Do not freeze or expose to high temperatures.