63/94/125 micrograms solution for injection in a pre-filled pen peginterferon
beta 1a
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 form of interferon that is long-acting. Interferons are natural substances that are produced in the body to 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 and older.
MS is a long-term disease that affects the central nervous system ( CNS ), including the brain and spinal cord, where the body’s immune system (its natural defenses) damages the protective substance (myelin) that surrounds the nerves in the brain and spinal cord. This disrupts the signals between the brain and other parts of the body and causes the symptoms of MS. Patients with relapsing-remitting MS may have periods when the disease is not active ( remission ) between flare-up symptoms ( relapses ).
Everyone has their variants of MS symptoms. These may include:
- Feeling of poor balance or dizziness, difficulty walking, stiffness and muscle spasms, fatigue, numbness of the face, arms, or legs
- Acute or chronic pain, bladder and bowel problems, sexual problems, and vision problems
- Hard to think and concentrate, depression.
How Plegridy works
It seems that Plegridy prevents the body’s immune system from damaging the brain and spinal cord. This can help reduce the number of relapses you have and slow down the disabling effects of MS. Treatment with Plegridy can help prevent you from getting worse, but it does not cure MS.
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 section 4 for symptoms of an allergic reaction.
- If you have severe depression or have suicidal thoughts.
Warnings and cautions
Talk to a doctor if you have ever had:
- Depression or problems that affect your mood
- Suicidal thoughts
- Your doctor may still prescribe Plegridy to you, but you must tell your doctor if you have ever had depression or similar problems that affected your mood.
If you have any of the conditions listed below, talk to your doctor, pharmacist, or nurse before injecting Plegridy. They may get worse when you use Plegridy:
- Serious liver or kidney problems
- Irritation at the injection site may lead to skin or tissue damage ( necrosis at the injection site). When you are ready to inject, carefully follow the instructions in section 7, “ Instructions on how to inject Plegridy pre-filled pen ”, at the end of this leaflet. This is to reduce the risk of injection site reactions.
- Epilepsy or other types of seizures where medication has not given sufficient results.
- Heart problems can cause symptoms such as chest pain (angina), especially after an activity; swollen ankles, shortness of breath ( chronic heart failure ); or irregular heartbeat ( arrhythmia ).
- Thyroid problems
- A low number of white blood cells or platelets, may increase the risk of infection, or bleeding
Additional things to consider when using Plegridy
- You will need to take blood samples to determine the number of your blood cells, blood status, and levels of liver enzymes. These will be performed before you start using Plegridy, regularly after you start treatment with Plegridy, and then for periods during treatment, even if you do not have any special symptoms. These blood tests are done in addition to the tests that are normally taken to check your MS.
- The function of your thyroid gland will be checked regularly or when your doctor deems it necessary for other reasons.
- Blood clots in the small blood vessels can occur during treatment. These blood clots can affect your kidneys. This can occur after several weeks of treatment up to several years after you start taking Plegridy. Your doctor may want to check your blood pressure, blood ( platelet count ), and how your kidneys are working.
Should you accidentally sting yourself or anyone else with the needle in Plegridy, wash the affected area immediately with soap and water and contact a doctor or nurse as soon as possible.
Children and young people
Plegridy must not be used in children and adolescents under 18 years of age. The safety and efficacy of Plegridy in this age group are unknown.
Other drugs and Plegridy
Plegridy should be used with caution in combination with medicines that are broken down in the body by a group of proteins called “cytochrome P450” (eg some medicines used to treat epilepsy or depression).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those used to treat epilepsy or depression. This also applies to over-the-counter medicines.
Sometimes you need to remind other healthcare professionals that you are being treated with Plegridy. For example, if you are being prescribed other medicines or if you are going to have a blood test. Plegridy may affect other medicines or the test result.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
No adverse effects are expected on breast-fed infants/infants. Plegridy can be used during breastfeeding.
Driving and using machines
Plegridy has no or negligible effect on the ability to drive and use machines.
Plegridy contains sodium
This medicine contains less than 1 mmol sodium (23 mg), ie essentially ‘sodium-free’.
How to use Plegridy
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
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 of the week each time you inject.
To begin with Plegridy
If Plegridy is new to you, your doctor may advise you to increase the dose gradually so that you can adjust to the effects of Plegridy before you reach the full dose. You will receive a starter pack containing your first 2 injections: an orange pen with Plegridy 63 micrograms (for day 0) and a blue pen with Plegridy 94 micrograms (for day 14).
After that, you will receive a maintenance pack of gray pencils with Plegridy 125 micrograms (for day 28 and then every other week).
Read the instructions in section 7, “ Instructions on how to inject Plegridy pre-filled pen ”, at the end of the package leaflet before you start using Plegridy.
Use the list printed on the inside of the starter pack cover to keep track of your injection dates.
Inject yourself
Plegridy should be injected under the skin ( subcutaneous injection ). Change the injection site. Do not use the same injection site for subsequent injections.
You can inject Plegridy yourself without the help of your doctor if you have been taught how to do it.
- Read and follow the instructions given in the instructions in section 7, ” Instructions on how to inject Plegridy pre-filled pen “, before you start.
- If you have problems handling the pen, ask your doctor or nurse for help.
How long to use Plegridy
Your doctor will tell you how long you must continue to use Plegridy. You must continue to use Plegridy regularly. Do not make any changes unless your doctor tells you to.
If you use more Plegridy than you should
You should only inject Plegridy once every two weeks.
- If you have used more than one injection of Plegridy over 7 days, contact your doctor or nurse immediately.
If you forget to use Plegridy
You must inject Plegridy once every two weeks. This regular schedule helps to ensure that the treatment is delivered as evenly as possible.
If you miss your normal day, inject as soon as you can and then continue as usual. However, you should not inject more than once during 7 days. Do not use two injections to compensate for a missed injection.
If you have any further questions on the use of this product, 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 are
- Liver problem
(common – may affect up to 1 in 10 people)
If you get any of these symptoms:
- The skin or whites of the eyes turn yellow
- Itching all over the body
- Nausea, vomiting
- Easy to get bruises
- Contact a doctor immediately. This may be a sign of a possible liver problem.
- Depression
(common – may affect up to 1 in 10 people)
If you:
- Feeling abnormally sad, anxious or worthless or
- Have suicidal thoughts
- Contact a doctor immediately.
- Severe allergic reaction
(uncommon – may affect up to 1 in 100 people)
If you get any of this:
- Hard to breathe
- Swelling of the face (lips, tongue, or throat)
- Rash or redness of the skin
- Contact a doctor immediately.
- Seizures
(uncommon – may affect up to 1 in 100 people)
If you have a seizure
- Contact a doctor immediately.
- Injury at the injection site
(rare – may affect up to 1 in 1,000 people)
If you get any of these symptoms:
- A wound on the skin along with swelling, inflammation, or fluid leaking around the injection site
- Contact a doctor for advice.
- Kidney problems including scarring that can impair kidney function
(rare – may affect up to 1 in 1,000 people)
If you get any or all of these symptoms:
- Frothy urine
- Fatigue
- Swelling, especially in the ankles and eyelids, and weight gain.
- Contact a doctor as this may be a sign of a possible kidney problem.
- Blood problem
(rare – may affect up to 1 in 1,000 people)
The following may happen Blood clots in the small blood vessels that can affect your kidneys (thrombotic thrombocytopenic purpura or hemolytic uremic syndrome ). Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness, or fainting. Your doctor may notice changes in your blood and kidney function.
If you get any or all of these symptoms:
- Increased number of bruises or bleeding
- Extreme weakness
- Headache, dizziness, or dizziness
- Contact a doctor immediately.
Other side effects are
Very common side effects are
(may affect more than 1 in 10 people)
- Flu-like symptoms. These symptoms are not flu, see below. You can not infect others.
- Headache
- Muscle pain ( myalgia )
- Pain in the joints, arms, legs, or neck ( arthralgia )
- Overindulge
- Fever
- A feeling of weakness and tiredness ( asthenia )
- Redness, itching, or pain around the injection site
- Contact a doctor if any of these effects bother you.
Flu-like symptoms
Flu-like symptoms are more common when you have just started using Plegridy. They gradually diminish as you continue your injections. See below for easy ways to deal with these flu-like symptoms if you get them.
Three simple ways to help reduce the impact of flu-like symptoms:
- Consider the time of your Plegridy injection. When the flu-like symptoms begin and end are different for each patient. The flu-like symptoms begin on average about 10 hours after injection and last between 12 and 24 hours.
- Take paracetamol or ibuprofen half an hour before Plegridy injection and continue to take paracetamol or ibuprofen for as long as you have flu-like symptoms. Talk to your doctor or pharmacist about how much to take and for how long.
- If you have a fever, drink plenty of water to avoid dehydration.
Common side effects are
(may affect up to 1 in 10 people)
- Nausea or vomiting
- Hair loss ( alopecia )
- Itching of the skin
- Elevated body temperature
- Changes around the place where you injected, e.g. swelling, inflammation, bruising, heat, rash, or discoloration
- Changes in the blood may cause fatigue or decrease the ability to fight infection
- An increased amount of liver enzymes in the blood (shows up in blood tests)
- Contact a doctor if any of these effects bother you.
Uncommon side effects are
(may affect up to 1 in 100 people)
- Hives
- Changes in the blood may cause unexplained bruising or bleeding.
- Contact a doctor if any of these effects bother you.
Has been reported
( occurs in an unknown number of users)
- Pulmonary arterial hypertension: A disease with severe narrowing of the blood vessels of the lungs that leads to high blood pressure in the blood vessels that carry blood from the heart to the lungs. Pulmonary arterial hypertension has been observed at different times during treatment, even up to several years after initiating interferon-beta treatment.
To facilitate the traceability of this medicine, your doctor or pharmacist should document the product name and batch number in your patient record. Note these details in case you are asked about this information in the future.
How to store Plegridy
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Sensitive to light. Only open the package when you need a new pen.
- Store in a refrigerator 2 – 8 ºC.
- Do not freeze. Throw away Plegridy who has been frozen.
- Plegridy can be stored outside the refrigerator at room temperature (up to 25 ° C) for up to 30 days but must be protected from light.
- Plegridy can be taken out of the refrigerator and put back more than once if needed.
- Check that the time that the pens are outside the refrigerator does not exceed 30 days in total.
- Dispose of pens stored outside the refrigerator for more than 30 days.
- If you are unsure how many days you have kept a pen outside the refrigerator, throw away the pen.
- Do not use this medicine if you notice any of the following:
- If the pen is broken.
- If the solution is colored, cloudy, or contains liquid particles.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is peginterferon beta 1a.
- One 63 micrograms pre-filled pen contains 63 micrograms of peginterferon beta 1a in a 0.5 ml solution.
- A 94 microgram pre-filled pen contains 94 micrograms of peginterferon beta 1a in a 0.5 ml solution.
- One 125 micrograms pre-filled pen contains 125 micrograms of peginterferon beta 1a in a 0.5 ml solution.
The other ingredients are Sodium acetate trihydrate, glacial acetic acid, L arginine hydrochloride, polysorbate 20, and water for injections (see section 2 “Plegridy contains sodium”).
What the medicine looks like and the contents of the pack
Plegridy is a clear and colorless solution for injection in a pre-filled glass pen with an attached needle.
Pack sizes:
- Plegridy starter pack contains an orange pre-filled pen with 63 micrograms and a blue pre-filled pen with 94 micrograms.
- The 125 microgram gray pens are supplied in packs containing two or six pre-filled pens.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Manufacturer
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
DK-3400 Hillerød
Denmark
or
Biogen Netherlands BV
Prins Mauritslaan 13
1171 LP Badhoevedorp
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienBiogen Belgium NV / SATel: +32 2 2191218 | LithuaniaUAB “JOHNSON & JOHNSON”Tel: +370 5 278 68 88 |
| BulgariaTP WATERMARMATel: +359 2 962 12 00 | Luxembourg / LuxemburgBiogen Belgium NV / SATel: +32 2 2191218 |
| Czech Republic aBiogen (Czech Republic) sroTel: +420 255 706 200 | HungaryBiogen Hungary Kft.Tel: +36 1 899 9883 |
| DenmarkBiogen Denmark A / STel: +45 77 41 57 57 | MaltaPharma. MT Ltd.Tel: +356 21337008 |
| GermanyBiogen GmbHTel: +49 (0) 89 99 6170 | The NetherlandsBiogen Netherlands BVTel: +31 20 542 2000 |
| EestiUAB “JOHNSON & JOHNSON” Eesti subsidiaryTel: +372 617 7410 | NorwayBiogen Norway ASTel: +47 23 40 01 00 |
| GreeceGenesis Pharma SATel: +30 210 8771500 | AustriaBiogen Austria GmbH.Tel: +43 1 484 46 13 |
| SpainBiogen Spain SLTel: +34 91 310 7110 | PolandBiogen Poland Sp. z ooTel: +48 22 351 51 00 |
| FranceBiogen France SASTel: +33 (0) 1 41 37 9595 | PortugalBiogen Portugal,Sociedade Pharmacêutica Unipessoal, Lda.Tel: +351 21 318 8450 |
| CroatiaMedis Adria dooTel: +385 1 230 34 46 | RomaniaJohnson & Johnson Romania SRLTel: +40 21 207 18 00 |
| IrelandBiogen Idec (Ireland) Ltd.Tel: +353 (0) 1 463 7799 | SloveniaBiogen Pharma dooTel: +386 1 511 02 90 |
| IcelandIcepharma hfTel: +354 540 8000 | Slovak RepublicBiogen Slovakia sroTel: +421 2 323 34 008 |
| ItalyBiogen Italia srlTel: +39 02 584 9901 | Finland / FinlandBiogen Finland OyTel: +358 207 401 200 |
| .ΠροςGenesis Pharma Cyprus LtdTel: +3572 2 769946 | SwedenBiogen Sweden ABTel: +46 8 594 113 60 |
| LatviaUAB “JOHNSON & JOHNSON” filiāle LatvijāTel: +371 678 93561 | United Kingdom (Northern Ireland)Biogen Idec (Ireland) LimitedTel: +44 (0) 1628 50 1000 |