DYRUPEG 6 мг Инъекционный раствор в преднаполненном шприце

Содержание инструкции

1. Dyrupeg 6 mg injectable solution in pre-filled syringe
   1. What is Dyrupeg and what it is used for
   2. What you need to know before you use Dyrupeg
   3. How to use Dyrupeg
   4. Possible side effects
   5. How to store Dyrupeg
   6. Contents of the pack and other information

Dyrupeg 6 mg injectable solution in pre-filled syringe

pegfilgrastim

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Dyrupeg is and what it is used for
• 2. What you need to know before you use Dyrupeg
• 3. How to use Dyrupeg
• 4. Possible side effects
• 5. How to store Dyrupeg
• 6. Contents of the pack and other information

1. What is Dyrupeg and what it is used for

Dyrupeg contains the active substance pegfilgrastim. Pegfilgrastim is a protein produced with a
biotechnological technique in a bacterial cell called Escherichia coli. It belongs to a
group of proteins called cytokines and is very similar to a natural protein (granulocyte colony-stimulating
factor) produced by our body.
Dyrupeg is used to reduce the duration of neutropenia (low number of white blood cells) and the
occurrence of febrile neutropenia (low number of white blood cells with fever), which may be
caused by the use of cytotoxic chemotherapy (drugs that destroy rapidly growing cells),
in adults aged 18 years or older. White blood cells are important because they help
the body fight infections. These cells are very sensitive to the effects of
chemotherapy; this can cause a decrease in the number of these cells in the body.
If the number of white blood cells drops to a low level, there may not be enough left to
fight bacteria and you may be at greater risk of contracting an infection.
Your doctor has prescribed Dyrupeg to stimulate the bone marrow (the part of the bone that produces
blood cells) to produce more white blood cells to help the body fight infections.

2. What you need to know before you use Dyrupeg

Do not use Dyrupeg
 if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you use Dyrupeg:

• if you have an allergic reaction including weakness, low blood pressure, difficulty breathing, swelling of the face (anaphylaxis), redness and flushing, skin rash and itchy skin areas.  if you have cough, fever and difficulty breathing. This may be a sign of Acute Respiratory Distress Syndrome (ARDS).  if you have one or more of the following side effects:
• swelling or bloating, which may be associated with decreased fluid drainage, difficulty breathing, abdominal swelling and a feeling of fullness and a general feeling of tiredness. These could be symptoms of a condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels in the body. See section 4.  if you have pain in the upper left side of your abdomen or pain at the tip of your shoulder. These could be signs of a problem with the spleen (splenomegaly).  if you have recently had a severe lung infection (pneumonia), fluid in the lungs (pulmonary edema), inflammation of the lungs (interstitial lung disease) or an abnormality found on an X-ray (pulmonary infiltration).  if you know you have abnormal blood cell counts (e.g. increased white blood cells or anemia) or a decrease in platelet levels, which reduces the body's ability to clot (thrombocytopenia). Your doctor may want to monitor you closely.  if you have sickle cell anemia. Your doctor may want to monitor you closely  if you have breast or lung cancer, Dyrupeg in combination with chemotherapy and/or radiotherapy may increase the risk of a pre-cancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms may include fatigue, fever and easy bruising or bleeding.  if you suddenly have signs of allergy such as skin rash, hives or itching, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing: these could be signs of a severe allergic reaction.  Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body) has been rarely reported in cancer patients and healthy donors. Symptoms may include fever, abdominal pain, malaise, back pain and increased markers of inflammation. Tell your doctor if you experience such symptoms.

The doctor will regularly check your blood and urine because Dyrupeg can damage the
tiny filters inside your kidneys (glomerulonephritis).
Severe skin reactions (Stevens-Johnson syndrome) have been observed with the use of Dyrupeg. If
you notice any of the symptoms described in section 4, stop using Dyrupeg and seek
immediate medical attention.
You should talk to your doctor about the risks of developing a blood cancer. If you have or may have
a blood cancer, you should not use Dyrupeg unless directed to do so by your
doctor.

Loss of response to pegfilgrastim
If you have a decrease in response or failure to maintain response to treatment
with pegfilgrastim, your doctor will investigate the reasons, including the possibility that you have developed
antibodies that neutralize the activity of pegfilgrastim.

Children and adolescents
Dyrupeg is not recommended for use in children and adolescents due to insufficient data
on safety and efficacy.

Other medicines and Dyrupeg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Dyrupeg has not been studied in pregnant women. Therefore, your doctor may decide not to
use this medicine. It is important to tell your doctor if:
 you are pregnant;
 you suspect you are pregnant; or
 you are planning to become pregnant.
If you become pregnant during treatment with Dyrupeg, tell your doctor.
Unless your doctor tells you otherwise, you should stop breastfeeding if you use Dyrupeg.

Driving and using machines
Dyrupeg does not alter or has a negligible effect on the ability to drive and operate
machines.

Dyrupeg contains sorbitol (E420)
This medicine contains 30 mg of sorbitol per pre-filled syringe, equivalent to 50 mg/mL.

Dyrupeg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 6 mg dose, i.e. essentially
“sodium-free”.

Dyrupeg contains polysorbate 20 (E432)
This medicine contains 0.02 mg of polysorbate 20 in each pre-filled syringe. Polysorbates
can cause allergic reactions. Tell your doctor if you have known allergies.

3. How to use Dyrupeg

Use Dyrupeg following the doctor's instructions exactly at all times. If you have any doubts, consult your doctor or pharmacist. The recommended dose is a subcutaneous injection (injection under the skin) of 6 mg using a prefilled syringe, which must be administered at least 24 hours after the last dose of chemotherapy at the end of each chemotherapy cycle.

How to self-inject Dyrupeg
Your doctor may believe that it is best for you to self-inject Dyrupeg. Your doctor or nurse will show you how to self-inject Dyrupeg. Do not attempt to self-inject if you have not been shown how to do so.
Dyrupeg alone.
Do not shake Dyrupeg vigorously as this may compromise its activity.

If you use more Dyrupeg than you should
If you use more Dyrupeg than you should, you should contact your doctor, pharmacist or nurse.

If you forget to inject Dyrupeg
If you are self-injecting and have forgotten a dose of Dyrupeg, you should contact your doctor to determine when to inject the next dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor immediately if you experience any or a combination of the following side effects:
 swelling or edema, which may be associated with urinating less frequently,
difficulty breathing, abdominal swelling and a feeling of fullness, and a general feeling
of fatigue. These symptoms usually develop rapidly.
These could be symptoms of an uncommon condition (may affect up to 1 in 100 people) called “Capillary Leak Syndrome”, which causes blood to leak from small blood vessels inside the body and requires urgent medical attention.

• 100) called “Capillary Leak Syndrome”, which causes blood to leak from small blood vessels inside the body and requires urgent medical attention.

Very common side effects(may affect more than 1 in 10 people):
 bone pain. Your doctor will tell you what to take to relieve bone pain.
 nausea and headache.

Common side effects(may affect up to 1 in 10 people):
 pain at the injection site.
 general pain and joint and muscle pain.
 some changes may occur in the blood, but these will be detected during routine blood tests. White blood cell levels may rise for a short period of
time. Platelet levels may decrease causing bruising.

Uncommon side effects(may affect up to 1 in 100 people):
 allergic-type reactions, including redness and flushing, skin rash (skin redness) and itchy skin swelling.
 severe allergic reactions including anaphylaxis (weakness, low blood pressure,
difficulty breathing, facial swelling).
 increased spleen volume.
 spleen rupture. Some cases of spleen rupture have been fatal. It is important that you contact
your doctor immediately if you feel pain in the upper left side of your abdomen or left shoulder as this may indicate problems with the spleen.
 breathing problems. If you have cough, fever and difficulty breathing, contact your doctor.
 cases of Sweet syndrome (purple, raised and painful lesions on the
limbs and sometimes on the face and neck, associated with fever) have occurred, but other
factors may have contributed.
 cutaneous vasculitis (inflammation of the skin blood vessels).
 damage to the tiny filters inside the kidneys (glomerulonephritis).
 redness at the injection site.
 coughing up blood (hemoptysis).
 blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukemia [AML]).

Rare side effects(may affect up to 1 in 1,000 people):
 inflammation of the aorta (the large blood vessel that carries blood from the heart to the rest
of the body), see section 2.
 bleeding from the lung (pulmonary hemorrhage).
 Stevens-Johnson syndrome, which can manifest with reddish patches or round spots,
often with central blisters, located on the trunk, skin peeling, ulcers in the mouth,
throat, nose, genitals and eyes and which may be preceded by fever and flu-like symptoms. If
you develop these symptoms, stop using Dyrupeg and contact your doctor or seek immediate
medical assistance. See also section 2.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

Come tutti i medicinali, questo medicinale può causare effetti indesiderati sebbene non tutte le persone
li manifestino.
Informi immediatamente il medico se lei manifesta qualcuno o una combinazione dei seguenti effetti
indesiderati:
 tumefazione o gonfiore, che può essere associata al fatto che lei urina meno frequentemente,
difficoltà respiratorie, gonfiore addominale e sensazione di pienezza, e una sensazione generale
di stanchezza. Questi sintomi di solito si sviluppano in modo rapido.
Questi potrebbero essere i sintomi di una condizione non comune (può riguardare fino a 1 persona su

• 100) chiamata “Sindrome da Perdita Capillare”, che causa la fuoriuscita di sangue dai piccoli vasi sanguigni all’interno del corpo e che necessita di cure mediche urgenti.

Effetti indesiderati molto comuni(possono riguardare più di 1 persona su 10):
 dolore osseo. Il medico le dirà cosa prendere per alleviare il dolore osseo.
 nausea e mal di testa.

Effetti indesiderati comuni(possono riguardare fino a 1 persona su 10):
 dolore nel sito di iniezione.
 dolore generale e dolori alle articolazioni e ai muscoli.
 alcuni cambiamenti possono avvenire nel sangue, ma questi verranno rilevati durante gli esami
del sangue di routine. I livelli di globuli bianchi potrebbero alzarsi per un breve periodo di
tempo. I livelli delle piastrine potrebbero abbassarsi causando ematomi.

Effetti indesiderati non comuni(possono riguardare fino a 1 persona su 100):
 reazioni di tipo allergico, inclusi arrossamento e vampate di calore, rash cutaneo (arrossamenti
della pelle) e rigonfiamenti della pelle con prurito.
 reazioni allergiche gravi inclusa l’anafilassi (debolezza, caduta della pressione sanguigna,
difficoltà a respirare, gonfiore del viso).
 aumento del volume della milza.
 rottura della milza. Alcuni casi di rottura della milza sono stati fatali. È importante che contatti
immediatamente il medico se sente dolore alla parte in alto a sinistra dell’addome o alla spalla
sinistra poiché questo può indicare problemi a livello della milza.
 problemi respiratori. Se ha tosse, febbre e difficoltà a respirare contatti il medico.
 si sono verificati casi di sindrome di Sweet (lesioni di colore violaceo, rilevate e dolorose sugli
arti e talvolta sul viso e sul collo, associate a febbre), ai quali però possono aver contribuito altri
fattori.
 vasculite cutanea (infiammazione dei vasi sanguigni cutanei).
 danni ai minuscoli filtri all’interno dei reni (glomerulonefrite).
 rossore nel sito di iniezione.
 emissione di sangue con la tosse (emottisi).
 malattie del sangue (sindrome mielodisplastica [SMD] o leucemia mieloide acuta [LMA]).

Effetti indesiderati rari(possono riguardare fino a 1 persona su 1.000):
 infiammazione dell’aorta (il grande vaso sanguigno che trasporta il sangue dal cuore al resto
dell’organismo), vedere paragrafo 2.
 sanguinamento dal polmone (emorragia polmonare).
 sindrome di Stevens-Johnson, che può manifestarsi con chiazze rossastre o macchie rotonde,
spesso con vescicole centrali, localizzate sul tronco, esfoliazione della pelle, ulcere in bocca,
gola, naso, genitali e occhi e che può essere preceduta da febbre e sintomi simil-influenzali. Se
sviluppa questi sintomi interrompa l’uso di Dyrupeg e contatti il medico o richieda assistenza
medica immediatamente. Vedere anche il paragrafo 2.

Segnalazione degli effetti indesiderati
Se manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si rivolga
al medico, al farmacista o all’infermiere. Può inoltre segnalare gli effetti indesiderati direttamente
tramite il sistema nazionale di segnalazione riportato nell’ Allegato V . Segnalando gli effetti
indesiderati può contribuire a fornire maggiori informazioni sulla sicurezza di questo medicinale.

5. How to store Dyrupeg

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 package and on the label of the
syringe after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C).
You can take Dyrupeg out of the refrigerator and store it at room temperature (not exceeding 25 °C) for
no more than three days. Once a syringe has been removed from the refrigerator and has reached
room temperature (not exceeding 25 °C), it must be used within three days.
Do not freeze. Dyrupeg can be used if it has been accidentally frozen only once for
less than 72 hours.
Store the pre-filled syringe in the outer packaging to protect it from light.
Do not use this medicine if you notice that it is cloudy or if you see particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dyrupeg contains
 The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in
0.6 mL of solution.
 Other ingredients: sodium acetate, sorbitol (E420), polysorbate 20 (E432), and water for
injections. See section 2, "Dyrupeg contains sorbitol (E420), polysorbate 20 (E432) and sodium".

Description of Dyrupeg and contents of the pack
Dyrupeg is a clear, colourless injectable solution in a pre-filled syringe (6 mg/0.6 mL).
Each pack contains one pre-filled glass syringe with a rubber plunger stopper, a plunger rod, a stainless
steel needle attached and a needle cap. The syringe is supplied in a blister tray.
The syringe is packaged with an automatic needle protection device.

Marketing Authorisation Holder and Manufacturer
CuraTeQ Biologics s.r.o,
Trtinova 260/1,
Prague, 19600,
Czech Republic
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website,
https://www.ema.europa.eu.
Instructions for use:

o Guide to the parts
Before use	After use
Plunger Finger flange Syringe label Syringe barrel Syringe safety guard n Needle safety spring a Grey needle cap i	c Used plunger m Syringe r label a Used syringe F barrel l e Used needle d Used needle safety spring Grey needle cap removed
l a Caution: Avoid contact with the plunger and the needle during syringe preparation. The safety device is normally activated by the pressure of the syringe plunger.

Important
Before using a pre-filled Dyrupeg syringe with automatic needle protection
device, read these important instructions:

• It is important that you do not attempt to give yourself an injection unless you have received
  adequate instructions from your doctor or healthcare professional.
• Dyrupeg is given as an injection into the tissue just under the skin (subcutaneous injection). Do
  notremove the needle cap from the pre-filled syringe until you are ready to inject. Donot use
  the pre-filled syringe if it has been dropped onto a hard surface. Use a new pre-filled syringe and
  contact your doctor or healthcare professional. Donot try to activate the pre-filled syringe
  before injecting. Donot try to remove the transparent safety shield from the pre-filled syringe.
  Donot try to remove the peel-off label from the syringe barrel before giving yourself the injection.

Contact your doctor or healthcare professional if you have any questions.

C	e Warning/Caution: DO NOT pull the product by the plunger or the needle cover. Grasp the syringe safety guard to remove the pre-filled syringe from the blister tray.
t a l i a n a

D	Remove the pre-filled syringe from the blister tray as illustrated.
a Do not use the pre-filled syringe if: The medicine is cloudy or there are particles inside. It should be a clear and colourless liquid. z Any parts appear cracked or broken. The grey needle cap is missing or not firmly attached. n The expiry date printed on the label has passed the last day of the month indicated. In all cases, contact your doctor or healthcare professional.
e g Medicinal A

Step 2: Preparation
A	Wash your hands thoroughly. Prepare and clean the injection site.
c a m Upper arm Belly r a F Upper thigh l
e You can use: d The upper thigh. The belly, except for an area of 5 centimetres around the navel. The outer upper arm (only if someone else is giving you the injection). Clean the injection site with an alcohol swab. Allow the skin to dry. Do not touch the injection site before the injection. Do not inject into areas where the skin is sore, bruised, red, or hardened. Avoid injecting into areas with scars or stretch marks.

B	i Carefully pull off the grey needle cap and pull it away from your body.
z i a I t a l
n Warning/Caution: DO NOT twist the needle cap and do not touch the needle or the plunger. Pull the cap straight off as shown and handle the guard to avoid injury or bending.

C	Pinch up the skin at the injection site to create a firm surface.
o c a m r Warning/Caution: It is important to keep the skin pinched during the injection.

F Step 3: Injection
A	Keep the skin pinched. INSERT the needle into the skin. Push the plunger down while holding the finger flanges.
l e d a n a i l Warning/Caution: Do not touch the cleaned skin area.

B	PUSH the plunger with a slow and steady pressure until you feel or hear a “click”. Push all the way down until it stops. To activate the guard, it is necessary to deliver the entire dose.
I a i CLICK z n e g Caution: It is important to push all the way down to the “click” to inject the entire dose.

C	RELEASE your thumb. Then WITHDRAW the syringe from the skin.
o c a m r After releasing the plunger, the safety guard of the pre-filled syringe will cover the injection needle safely. Warning/Caution: Do not put the needle cap back on used pre-filled syringes. F If the guard does not activate or only activates partially, discard the product – without replacing the cap.

For healthcare professionals only
The trade name of the product administered must be clearly recorded in the
patient’s medical record.
Remove and retain the syringe label.

Turn the plunger to move the label to a position where it can be removed.

t Step 4: End
A	I Dispose of the used pre-filled syringe and other materials in a sharps container.
A g e n z i a

Medicines should be disposed of in accordance with local regulations. Ask your pharmacist
how to dispose of medicines you no longer use. These measures will help protect the environment.
Keep the syringe and the sharps container out of the sight and reach of children.

Warnings:
Donot reuse the pre-filled syringe.