Patient leaflet - Plegridy 125 micrograms solution for injection in Pre Filled pen
What Plegridy is used for
This medicine is used to treat relapsing‑remitting m sclerosis (MS) in adults aged 18 or over.
ultiple
MS is a long term illness that affects the central nervo system (CNS), including the brain and spinal cord, in
us
which
the body’s immune system (its natural defences) dam the protective layer (myelin) that surrounds the nerve brain and spinal cord. This disrupts the messages bet brain and other parts of the body, causing the sympt MS. Patients with relapsing‑remitting MS have period the disease is not active (remission) in between flare‑symptoms (relapses).
ages
s in the ween the oms of
s when ups of
Everyone has their own set of MS symptoms. These include:
can
Feeling off‑balance or light headed, walking proble stiffness and muscle spasms, tiredness, numbness i face, arms or legs
ms,
n the
Acute or chronic pain, bladder and bowel problems problems and problems with vision
, sexual
Difficulty thinking and concentrating, depression.
How Plegridy works
Plegridy seems to work by stopping the body’s immu system from damaging your brain and spinal cord. Thi help to reduce the number of relapses that you have and down the disabling effects of MS. Treatment with Plegrid to prevent you from getting worse, although it will not cu
ne
s can
slow
y can help re MS.
peginterferon beta-1a
2. What you need to know b use Plegridy
efore you
Do not use Plegridy
If you are allergic to peginterferon be
ta‑1a, interferon is medicine (listed in toms of an allergic
beta‑1a or any of the ingredients of th section 6). See section 4 for the symp reaction.
If you have severe depression or thin
k about committing suicide.
Warnings and precautions
Talk to your doctor if you have ever had
:
Depression or problems affecting you
r mood
Thoughts about committing suicide
Your doctor may still prescribe Pleg it’s important to let your doctor kno depression or any similar problems mood in the past.
ridy for you, but w if you have had affecting your e before injecting ns listed below.
Talk to your doctor, pharmacist or nurs
Plegridy if you have any of the conditio They may get worse while using Plegrid
y:
- Serious liver or kidney problems
Irritation at an injection site, which ca
n lead to skin and tissue damage (injection site necro are ready to inject, carefully follow the section 7 “Instructions for injecting Ple at the end of this leaflet. This is to redu injection site reactions.
sis). When you instructions in gridy pre-filled pen”, ce the risk of
Epilepsy or other seizure disorders, n
ot controlled by medicine
Heart problems, which can cause sym
ptoms such as chest pain (angina), particularly after ankles, shortness of breath (congestiv an irregular heartbeat (arrhythmia).
any activity; swollen e heart failure); or
- Thyroid problems platelets, which n, or bleeding
- A low number of white blood cells or can cause an increased risk of infectio
Other things to consider when using Pl
egridy
You will need blood tests to determine y
our numbers of vels of liver enzymes. t using Plegridy, as been initiated even if you have no will be in addition to nitor your MS.
blood cells, blood chemistry and your le These will be performed before you star regularly after treatment with Plegridy h and then periodically during treatment, particular symptoms. These blood tests the tests which are normally done to mo
The functioning of your thyroid gland
will be checked ary by your doctor
regularly or whenever thought necess for other reasons.
Blood clots in the small blood vessels
may occur during ld affect your
your treatment. These blood clots cou kidneys. This might happen several we years after starting Plegridy. Your doc check your blood pressure, blood (pla function of your kidneys.
eks to several tor may want to telet count) and the
If you accidentally prick yourself or someo needle in Plegridy, the area affected shoul immediately with soap and water and a do should be contacted as soon as possible.
ne else with the d be washed ctor or nurse
Children and adolescents
Plegridy should not be used in children an because it is yet to be established whether them and whether it would be safe.
d adolescents it would work for
Other medicines and Plegridy
Plegridy should be used carefully with me broken down in the body by a group of pr “cytochrome P450” (e.g. some medicines depression).
dicines that are oteins called used for epilepsy or
Tell your doctor or pharmacist if you are recently taken or might take any other m
taking, have edicines, especially those used to treat epilepsy or depressi medicines obtained without a prescripti
on. This includes any on.
Sometimes you will need to remind other h professionals that you are being treated wi example, if you are prescribed other medic a blood test. Plegridy may affect the other test result.
ealthcare th Plegridy. For ines, or if you have medicines or the
Pregnancy and breast‑feeding
If you are pregnant or breast‑feeding, thin pregnant or are planning to have a baby, a pharmacist for advice before taking this m No harmful effects on the breastfed newbo anticipated. Plegridy can be used during b
k you may be sk your doctor or edicine.
rn/infant are reast‑feeding.
Driving and using machines
Plegridy has no or negligible influence on t and use machines.
he ability to drive
Plegridy contains sodium
This medicine contains less than 1 mmol so is to say it is essentially “sodium‑free”.
dium (23 mg), that
3. How to use Plegrid
y
Always use this medicine exact has told you. Check with your d not sure.
ly as your doctor or pharmacist octor or pharmacist if you are
The usual dose
One injection of Plegridy 125 m two weeks). Try to use Plegridy day, every time you inject.
icrograms every 14 days (every at the same time on the same
Starting Plegridy
If you are new to Plegridy, your d gradually increase your dose so t of Plegridy before taking the full an Initiation Pack containing you pen with Plegridy 63 microgram with Plegridy 94 micrograms (fo
octor may advise you to hat you can adjust to the effects dose. You will be provided with r first 2 injections: one orange s (for day 0) and one blue pen r day 14).
After that you will be provided containing grey pens with Pleg 28 and then every two weeks).
with a maintenance pack ridy 125 micrograms (for day
Read the instructions in section
7 “Instructions for injecting
Plegridy pre-filled pen” at the e start using Plegridy.
nd of this leaflet before you
Use the record table printed on Initiation Pack to keep a track o
the inside of the lid of the f your injection dates.
Injecting yourself
Plegridy is to be injected under injection). Alternate the sites yo the same injection site for cons You can inject Plegridy yourself doctor, if you have been trained
the skin (subcutaneous u use for injections. Do not use ecutive injections.
without the help of your how to do this.
Read and follow the advice g section 7 “Instructions for inj before you start.
iven in the instructions in ecting Plegridy pre-filled pen”
If you have trouble handling nurse who may be able to he
the pen, ask your doctor or lp.
How long to use Plegridy
Your doctor will tell you how lo Plegridy. It is important to cont Do not make changes unless yo
ng you need to keep using inue using Plegridy regularly. ur doctor tells you.
If you use more Plegridy t
han you should
You must only inject Plegridy o
nce every 2 weeks.
If you have used more than o
ne injection of Plegridy in a
7‑day period, contact your d
octor or nurse straight away.
If you forget to use Plegri
dy
You need to inject Plegridy onc schedule helps to deliver the tr
e every 2 weeks. This regular eatment as evenly as possible.
If you do miss your usual day, in carry on as usual. However, do a 7‑day period. Do not use two missed injection.
ject as soon as you can and not inject more than once in injections to make up for a
If you have any further quest medicine, ask your doctor, ph
ions on the use of this armacist or nurse.
4. Possible side effec
ts
Like all medicines, this medicin although not everybody gets th
e can cause side effects, em.
Serious side effects Liver problems
(common - may affect up to 1 If you get any of these sympt
in 10 people)
oms:
Yellowing of your skin or th
e whites of your eyes
- Itching all over
Feeling sick, being sick (na
usea and vomiting)
Easy bruising of the skin iately. They may be signs of a
Contact a doctor immed possible liver problem.
Depression
(common - may affect up to 1 If you:
in 10 people)
Feel unusually sad, anxious
or worthless or
Have thoughts about suici
de
Contact a doctor immed
iately.
Serious allergic reaction
(uncommon - may affect up t If you get any of these:
o 1 in 100 people)
- Difficulty breathing
Swelling around the face (l
ips, tongue or throat)
Skin rashes or redness
Contact a doctor immed
iately.
Seizures
(uncommon - may affect up t If you have a seizure or a fit
o 1 in 100 people)
Contact a doctor immed
iately.
Injection site dam
age
(rare - may affect If you get any of t
up to 1 in 1,000 people)
hese symptoms:
Any break in th
e skin together with swelling, inflammation around the injection site
or fluid leaking
Contact a do
ctor for advice.
Kidney problems kidney function
including scarring that may reduce your
(rare - may affect If you get some o
up to 1 in 1,000 people)
r all of these symptoms:
- Foamy urine
- Fatigue
Swelling, partic
ularly in the ankles and eyelids, and weight gain.
Contact a do kidney probl
ctor as they may be signs of a possible em.
Blood problems
(rare - may affect The following may blood vessels that thrombocytopeni syndrome). Symp bleeding, fever, ex
up to 1 in 1,000 people)
occur: Blood clots in the small can affect your kidneys (thrombotic c purpura or haemolytic uremic toms may include increased bruising, treme weakness, headache, dizziness or light‑headedness. blood and the fun
Your doctor may find changes in your ction of your kidneys.
If you get some o
r all of these symptoms:
Increased bruisi
ng or bleeding
Extreme weakn
ess
Headache, dizzi
ness or light‑headedness
Contact a do
ctor immediately.
Other side effec Very common sid
ts e effects
(may affect more
than 1 in 10 people)
Flu‑like sympto
ms. These symptoms are not really flu, can’t pass it on to anyone else.
see below. You
- Headache
Muscle pain (m
yalgia)
Pain in your join
ts, arms, legs or neck (arthralgia)
- Chills
- Fever
Feeling weak a
nd tired (asthenia)
Redness, itchin
g or pain around the place you have injected
If any of thes
e effects trouble you, contact a doctor.
Flu‑like symptoms
Flu‑like symptoms a
re more common when you first start using Plegridy. They injections. See belo symptoms if you ge
gradually get less as you keep using your w for simple ways to manage these flu‑like t them.
Three simple ways to
help reduce the impact of flu‑like symptoms: g of your Plegridy injection. The start and ptoms are different for every patient. On ymptoms begin approximately 10 hours last between 12 and 24 hours.
- 1. Consider the timin end of flu‑like sym average, flu‑like s after injection and
- 2.
Take paracetamol
or ibuprofen half an hour before your and continue to take paracetamol or duration of your flu‑like symptoms. Speak pharmacist about how much to take and t.
Plegridy injection ibuprofen for the to your doctor or how long to take i
- 3.
If you have a fever,
drink plenty of water to keep you hydrated.
Common side eff
ects
(may affect up to
1 in 10 people)
Feeling or bein
g sick (nausea or vomiting)
Hair loss (alope
cia)
Itchy skin (pruri
tus)
Increase in bod
y temperature
Changes aroun
d the place you have injected such as mation, bruising, warmth, rash or colour
swelling, inflam change
Changes in you
r blood which might cause tiredness or to fight infection
reduced ability
Increases in live
r enzymes in the blood (will show up in blood tests)
If any of thes
e effects trouble you, talk to your doctor.
Uncommon side e
ffects
(may affect up to
1 in 100 people)
- Hives
Changes in you
r blood which might cause unexplained ding.
bruising or blee
If any of thes
e effects trouble you, talk to your doctor.
Frequency not kno
wn
(frequency cannot b
e estimated from the available data) rial hypertension: A disease of severe e blood vessels in the lungs resulting ressure in the blood vessels that carry heart to the lungs. Pulmonary arterial s been seen at various time points during ding several years after starting treatment beta‑products.
- Pulmonary arte narrowing of th in high blood p blood from the hypertension ha treatment, inclu with interferon
Children (10 years o
f age and above) and adolescents
In clinical trials, som commonly in both a injection site, flu‑like
e side effects were reported very dults and children, e.g., redness at the symptoms, headache, and fever.
Reporti
ng of side effects
If you ge or nurse. this leafl national
t any side effects, talk to your doctor, pharmacist This includes any possible side effects not listed in et. You can also report side effects directly via the reporting system:
United K
ingdom
Yellow C Website: Yellow C
ard Scheme www.mhra.gov.uk/yellowcard or search for MHRA ard in the Google Play or Apple App Store
By repor informati
ting side effects you can help provide more on on the safety of this medicine.
In order doctor o number file. You you are a
to improve the traceability of this medicine, your r pharmacist should record the name and the lot of the product you have been given in your patient may also wish to make a note of these details in case sked for this information in the future.
5. Ho
w to store Plegridy
Keep this
medicine out of the sight and reach of children.
Do not u on the ca to the las
se this medicine after the expiry date which is stated rton and the label after “EXP”. The expiry date refers t day of that month.
Store i Only o
n the original package in order to protect from light. pen the pack when you need a new pen.
n a refrigerator (fridge), 2°‑8°C.
Store i
Do n
ot freeze. Throw away any Plegridy that is dentally frozen.
acci
Plegrid to 25°C
y can be kept outside a fridge at room temperature (up ) for up to 30 days but it must be kept away from light. s can be taken out of the fridge and then put back in dge more than once if you need to.
- Pack a fri
Mak
e sure the time the pens spend out of a fridge is no e than 30 days in total.
mor
Thro
w away any pen that is kept out of the fridge for e than 30 days.
mor
If yo
u are unsure of the number of days you have kept a out of the fridge, throw the pen away.
pen
Do not
use this medicine if you notice any of the following: e pen is broken.
- If th
If th
e solution is coloured, cloudy or you can see particles ing in it.
float
Do not house medici protec
throw away any medicines via wastewater or hold waste. Ask your pharmacist how to throw away nes you no longer use. These measures will help t the environment.
6. Con
tents of the pack and other information
What P
legridy contains
The activ
e ingredient is peginterferon beta‑1a.
Each 63 peginterf Each 94 peginterf Each 125 peginterf
microgram pre‑filled pen contains 63 micrograms of eron beta‑1a in 0.5 mL solution for injection. microgram pre‑filled pen contains 94 micrograms of eron beta‑1a in 0.5 mL solution for injection. microgram pre‑filled pen contains 125 micrograms of eron beta‑1a in 0.5 mL solution for injection.
The othe acid glac for inject
r ingredients are: Sodium acetate trihydrate, acetic ial, arginine hydrochloride, polysorbate 20 and water ions (see Section 2 “Plegridy contains Sodium”).
What P
legridy looks like and contents of the pack
Plegridy glass pre
is a clear and colourless solution for injection in a ‑filled pen with an attached needle.
Pack size
s:
The Ple
gridy Initiation Pack contains one orange pre‑filled pen icrograms and one blue pre‑filled pen of 94 micrograms. 5 micrograms grey pens are provided in a pack ning either two or six pre‑filled pens.
of 63 m
- The 12 contai
Not all p
ack sizes may be marketed.
Marketin
g Authorisation Holder Manufacturer
Biogen N Prins Ma 1171 LP B
etherlands B.V. Biogen Netherlands B.V. uritslaan 13 Prins Mauritslaan 13 adhoevedorp 1171 LP Badhoevedorp
The Neth
erlands The Netherlands
For any i local rep
nformation about this medicine, please contact the resentative of the Marketing Authorisation Holder:
United K
ingdom
Biogen I ( +44 (0
dec Limited
) 1628 50 1000
This leafl
et was last revised in 01/2026
Instru
ctions overleaf
How to Inject Plegridy Read the instructions for use before you start using P prescription. There may be new information. This info doctor or nurse about your medical condition or your Note:
The Initiation Pack contains your first two injections to from a pack. When Which dose | ||||||||||||
re‑filled pen y to inject. legridy and each time you get a refill of your rmation does not take the place of talking to your treatment. tor or nurse should show you or your carer how to us). ing an infection to them or getting an infection weeks). ibly damaged. gradually adjust your dose. Choose the correct pen Which pack | Step 4: Choose and clean your injection site a. Choose an injection site in your thigh, abdomen, or t (see highlighted areas in Figure D).
b. Wipe your skin with an alcohol wipe. Note: Do not touch or blow on this area again be c. Let your injection site dry on its own before injectin Giving your injection Step 5: Remove the Plegridy pen cap a. Pull the pen cap straight off and set it aside (see Fig Your pen is now ready to inject. Warning! Do not touch, clean, or manipulate the nee needle injury or the pen may lock. Caution! Do not re‑cap your pen. This could lock the | he back of your upper arm k a carer who has been skin is irritated, red, bruised, fore giving your injection. g your dose. ure E). dle cover. You could get a pen | ||||||||||
Day 0 First injection 63 micrograms, choose (63 micrograms) Day 14 Second injectio 94 micrograms, choos (94 micrograms) Day 28 and Full dose injecti 125 micrograms, c then every two weeks after that (125 micrograms) grey pen Do not use more than one pen per 14‑day period ( | : orange pen n: e blue pen | Step 6: Give the injection a. Hold the pen over your injection site. Make sure you the injection status window (see Figure F).
Warning! Do not rest the pen on the injection site un This may cause the pen to accidently lock. | can see the green stripes in t 90o angle. til you are ready to inject. | |||||||||
on: hoose | ||||||||||||
every 2 weeks).
ction:
n site, the needle cover will lock to protect against e right way to throw away the used pen. plaster to the injection site. | ||||||||||||
After the injection After Use – Parts of your Plegridy pen (see Figure K): Note: After the pen has been removed from the injectio needle injury. Do not re‑cap the pen. Step 9: Dispose of used Plegridy pen
Step 10: Care for your injection site
| ||||||||||||
Supplies needed for your Plegridy Pen inje
Before use – Parts of Plegridy Pen (Figure A) | b. Firmly press and hold down the pen on your injectio clicking sounds start. This tells you that the injection c. Continue to hold the pen firmly down on your injecti sounds have stopped (see Figure H). Do not lift your pen off your injection site until the c | n site. You will hear the is happening (see Figure G). on site until the clicking licking sounds stop and you | Step 11: Check injection site
| elling, or tenderness. a few days, contact your doctor or nurse. | ||||||||
| ord table printed on the inside of the lid of the | ||||||||||||
| children. | ||||||||||||
| to 8°C in the closed original carton to protect from al carton without refrigeration up to 25°C for up to efrigerator if necessary. The total combined time out not exceed 30 days. | ||||||||||||
Caution! Do not remove the cap until you are read Re‑capping could cause the pen to lock. Additional supplies which are not included in the pack ( Alcohol Wipe Ga P Figure B Preparing for your injection Step 1: Remove your pen from the fridge. a. Remove your Plegridy pack from the fridge and sel b. Close the pack and put back in the fridge after rem c. Let the pen warm to room temperature for at leas Do not use external heat sources, such as hot w Step 2: Collect your supplies and wash your a. Find a well‑lit, clean, flat surface to work on like a t yourself, or receive, an injection. b. Wash your hands with soap and water. | y to inject. If you remove the cap, do not re‑cap the pen. see Figure B): uze ad Adhesive Bandage ect the appropriate pen (dosage) from the pack. oving one pen. t 30 minutes. ater, to warm your pen. hands. able. Collect all the supplies you will need to give | see green ticks in the injection status window. Warning! If you do not hear clicking sounds or you injection status window after attempting to inject, th you may not have received your injection. You shoul nurse or pharmacist. Step 7: Remove the Plegridy pen from your i a. After the clicking sound has stopped, lift the pen fro needle cover will extend to cover the needle and wil
Step 8: Check to make sure you received you a. Check the injection status window. You should see g b. Check the medicine window. You should see a yellow | do not see green ticks in the e pen may have locked and d then contact your doctor, njection site m your injection site. The l lock (see Figure I). ith the gauze pad and apply r full dose of Plegridy (see Figure J) reen ticks. plunger. | Do not freeze or expose to high temperatures. | ||||||||
Step 3: Check your Plegridy pen (see Figure a. Check the injection status window. You should see b. Check the expiry date. c. Check the medicine window and make sure the Ple clear and colourless. Do not use the pen if:
Note: You might see air bubbles in the medicine window. not affect your dose. Do not use the pen if it has been dropped or is visibly | C) green stripes. gridy medicine is ion status window. ating particles. This is normal and will damaged. | |||||||||||
