NEPEXTO 25 mg Инъекционный Раствор

Содержание инструкции

1. Nepexto 25 mg injectable solution in pre-filled syringe, 50 mg injectable solution in pre-filled syringe
   1. What is Nepexto and what it is used for
   2. What you need to know before using Nepexto
   3. How to use Nepexto
   4. Possible side effects
   5. How to store Nepexto
   6. Contents of the pack and other information
   7. Instructions for Use
2. Nepexto 50 mg injectable solution in pre-filled pen
   1. What is Nepexto and what is it used for
   2. What you need to know before using Nepexto
   3. How to use Nepexto
   4. Possible side effects
   5. How to store Nepexto
   6. Contents of the pack and other information
   7. Instructions for Use

Nepexto 25 mg injectable solution in pre-filled syringe, 50 mg injectable solution in pre-filled syringe

etanercept

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.
• Your doctor will provide you with the Patient Card which contains important safety information that you should be aware of before and during treatment with Nepexto.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or for your child. Do not give it to other people, even if they have the same symptoms as you or your child, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Nepexto and what it is used for

Nepexto contains the active substance etanercept.
Nepexto is a medicine made from two human proteins that blocks the activity of another protein
present in the body and which causes inflammation. This medicine works by reducing
inflammation associated with certain diseases.
In adults (aged 18 years and over), Nepexto can be used for the treatment of:

• rheumatoid arthritis(a long-lasting autoimmune disease that mainly affects the joints) from moderate to severe;
• psoriatic arthritis(a type of inflammatory arthritis that can affect any joint in the body);
• severe axial spondyloarthritis(a type of chronic inflammatory arthritis that affects the spine and/or sacroiliac joints), including ankylosing spondylitis(a type of arthritis that affects the spine);
• psoriasis(raised, red and scaly patches on the skin) from moderate to severe. In any case, Nepexto is usually used when other widely used treatments have not worked well enough or are not suitable for you.

For rheumatoid arthritis, this medicine is usually used in combination with methotrexate,
although it can also be used alone if treatment with methotrexate is not suitable for
you. Whether used alone or in combination with methotrexate, Nepexto may slow down the damage to the
joints caused by rheumatoid arthritis and improve the ability to perform normal daily
activities.
For patients with psoriatic arthritiswith involvement of multiple joints, this medicine
can improve the ability to perform normal daily activities.
For patients with multiple symmetrical painful or swollen joints(e.g., hands, wrists and
feet), this medicine can slow down the structural damage to these joints caused by the
disease.
Nepexto is also prescribed for the treatment of the following conditions in children and adolescents:

• for the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
• polyarthritis (positive or negative for rheumatoid factor) and extended oligoarthritis in patients starting from 2 years of age and weighing 62.5 kg or more
• psoriatic arthritis in patients starting from 12 years of age and weighing 62.5 kg or more
• for arthritis related to enthesitis in patients starting from 12 years of age and weighing 62.5 kg or more or when other widely used treatments have not given a sufficiently good response or are not appropriate,
• severe psoriasis in patients starting from 6 years of age and weighing 62.5 kg or more who have had an inadequate response with (or cannot follow) phototherapies or other systemic therapies.

2. What you need to know before using Nepexto

Do not use Nepexto

• if you, or the child, are allergic to etanerceptor to any of the other ingredientsof Nepexto (listed in section 6). If you or the child experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Nepexto and contact your doctor immediately;
• if you, or the child, have or are at risk of developing a severe blood infectioncalled sepsis. If you are unsure, contact your doctor;
• if you, or the child, have an infection of any kind. If you are unsure, contact your doctor.

Warnings and precautions
Talk to your doctor before using Nepexto.

• Allergic reactions: if you, or the child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject this medicine and contact your doctor immediately.
• Infections/surgery: if you, or the child, develop a new infection or are about to have any major surgery, your doctor may want to monitor treatment with this medicine.
• Infections/diabetes: tell your doctor if you, or the child, have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections/monitoring:tell your doctor about any recent travel outside of Europe. If you, or the child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. The doctor may decide to continue monitoring you or the child for infections after you or the child have stopped taking Nepexto.
• Tuberculosis: because cases of tuberculosis have been reported in patients treated with Nepexto, your doctor will check you for signs and symptoms of tuberculosis

before starting treatment with this medicine. This may include a thorough
medical history, a chest X-ray and a tuberculin test. The results of these tests should be
recorded on the Patient Card. It is very important that you tell your doctor if you or the
child have ever had tuberculosis or if you have been in close contact with someone with
tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness,
low-grade fever) or any other infection appear during or after therapy, tell your
doctor immediately.

• Hepatitis B: tell your doctor if you or the child have or have had hepatitis B. Your doctor should test for hepatitis B before you or the child start treatment with this medicine. Treatment with Nepexto may cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. If this happens, you must stop using this medicine.
• Hepatitis C: tell your doctor if you or the child have hepatitis C. Your doctor may consider monitoring treatment with this medicine if the infection worsens.
• Blood disorders: seek immediate medical attention if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. These symptoms may indicate the presence of blood disorders that could be life-threatening and may require discontinuation of treatment with Nepexto.
• Nervous system and eye disorders: tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). The doctor will assess whether using this medicine is an appropriate treatment.
• Congestive heart failure: tell your doctor if you or the child have a history of congestive heart failure (a condition in which the heart muscle does not pump blood as it should), as this medicine should be used with caution in these circumstances.
• Cancer: tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking this medicine. Patients with severe, long-standing rheumatoid arthritis may be at higher risk of developing lymphoma than average. Children and adults using this medicine may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with etanercept or other medicines that act like etanercept have developed tumors, sometimes rare and even fatal. Some patients receiving Nepexto have developed skin tumors. Tell your doctor if you or the child develop any changes in the appearance of the skin or growths on the skin.
• Chickenpox: tell your doctor if you or the child are exposed to chickenpox while using this medicine. The doctor will assess whether preventive treatment for chickenpox is appropriate.
• Alcohol abuse: this medicine should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or the child have a history of alcohol abuse.
• Wegener's granulomatosis: this medicine is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or the child have Wegener's granulomatosis, consult your doctor.
• Anti-diabetic medicines: tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. The doctor may decide whether it is necessary to reduce the dose of anti-diabetic medicine for you or the child while you are taking this medicine. Children and adolescents
• Vaccinations: if possible, before using Nepexto, children should be up to date with all vaccinations. Some vaccines, such as oral polio vaccine, should not be given while taking this medicine. Consult your doctor before you or the child receive any vaccine.

Nepexto should not be used in children and adolescents weighing less than 62.5 kg.
Generally Nepexto should not be used in children with polyarthritis or extended oligoarthritis under the age of
2 years, or in children with arthritis related to enthesitis or psoriatic arthritis under the age of
12 years, or in children with psoriasis under the age of 6 years.

Other medicines and Nepexto
Tell your doctor or pharmacist if you, or the child, are taking, have recently taken or might
take other medicines (including sulfasalazine), even those available without a prescription.
You or the child must notuse Nepexto with medicines containing the active ingredient anakinra or
abatacept.

Pregnancy and breastfeeding
Nepexto should be used in pregnancy only if clearly necessary. If you are pregnant,
suspect you are pregnant or are planning a pregnancy, ask your doctor for advice.
If you have received Nepexto during pregnancy, the newborn may be at increased risk of
infection. In addition, one study indicated that a higher number of birth defects were detected in mothers who received etanercept during pregnancy compared to mothers who had not received
this medicine or other similar medicines (TNF antagonists), although no particular type of birth defect emerged among those reported. Another study did not show an increased
risk of birth defects when mothers received etanercept during pregnancy. The
doctor will help you decide if the benefits of treatment outweigh the potential risk to the
child.
Talk to your doctor if you wish to breastfeed while using Nepexto. It is important
to inform pediatricians and other healthcare professionals about the use of Nepexto during
pregnancy and breastfeeding before the child receives any vaccine.

Driving and using machines
It is not expected that using Nepexto will affect your ability to drive or use
machines.

Nepexto contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is essentially “sodium-free”.

3. How to use Nepexto

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
If you feel that the effect of Nepexto is too strong or too weak, consult your doctor or
pharmacist.

Use in adults
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week, or 50 mg once a week
by subcutaneous injection.
In any case, the doctor may establish a different frequency at which to inject Nepexto.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week, or 50 mg administered once a
week.
Alternatively, a dose of 50 mg may be administered twice a week for up to
12 weeks, followed by a dose of 25 mg administered twice a week or a dose of
50 mg administered once a week.
The doctor will decide how long you should take Nepexto and whether, based on your response, a
new treatment is necessary. If, after 12 weeks, Nepexto has no effect on your
condition, your doctor may advise you to discontinue treatment.

Use in children and adolescents
The dose and frequency of dosage in children or adolescents will depend on body weight and
the disease.
The doctor will establish the correct dose for the child and prescribe an appropriate dosage of etanercept.
Nepexto should not be used in children and adolescents weighing less than 62.5 kg.
Other medicines containing etanercept with pharmaceutical formulations appropriate for
children are available.
For polyarthritis or extended oligoarthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of
etanercept per kg of body weight (up to a maximum of 25 mg), administered 2 times a week,
or 0.8 mg of etanercept per kg of body weight (up to a maximum of 50 mg), administered once a
week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of etanercept per kg of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Nepexto has no effect on the child's condition after 12 weeks, the doctor may advise you
to stop treatment with this medicine.

How to administer and route of administration
Nepexto is administered by injection under the skin (subcutaneous use).

Detailed instructions on how to prepare and inject Nepexto are provided in section 7,
“Instructions for Use”.
Do not mix the solution with other medicines.
To help you remember, it may be useful to write in an agenda on which day(s) of the week
Nepexto should be used.

If you use more Nepexto than you should
If you have used more Nepexto than you should (either by injecting an excessive amount on a
single occasion or by using it too frequently), seek immediate medical or
pharmacist advice. Always keep the medicine box with you, even if empty.

If you forget to take Nepexto
If you forget a dose, administer it as soon as you remember the omission, unless the next dose is scheduled for the next day, in which case you should skip the forgotten dose. Then continue to administer the medicine on the scheduled day(s). If you realize
the omission on the day the next dose is due, do not take a double dose (two doses
on the same day) to make up for the missed dose.

If you stop treatment with Nepexto
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Nepexto any further. Inform your doctor immediately or go to the nearest hospital emergency room.

• Difficulty swallowing or breathing
• Swelling of the face, throat, hands or feet
• Feeling of nervousness or anxiety, palpitations, sudden redness of the skin and/or feeling of warmth
• Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Severe allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to this medicine; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical care:

• symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or presence of a warm, red, tender, painful area on the skin or in the joints;
• symptoms of blood disorders, such as bleeding, bruising or paleness;
• symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg;
• symptoms of heart failureor worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the nails or lips;
• symptoms of tumors: tumors can affect any part of the body, including skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin;
• symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensation or vision;
• symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue;
• symptoms of inflammation of blood vessels, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon but are serious conditions (some of which can in rare cases cause death). If any of these symptoms occur, inform your doctor immediately or go to the nearest hospital emergency room.
The known side effects of etanercept include those listed below, grouped by decreasing frequency.

• Very common(may affect more than 1 in 10 people): infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these do not occur as often after the first month of treatment; some patients have developed a reaction at a recently used injection site) and headache.
• Common(may affect up to 1 in 10 people): allergic reactions; fever; itching; antibodies directed against normal tissue (formation of autoantibodies).
• Uncommon(may affect up to 1 in 100 people): serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin tumor (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); eye inflammation; psoriasis (first occurrence or worsening), inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common), abdominal cramps and pain, diarrhea, weight loss or blood in the stool (signs of bowel problems).
• Rare(may affect up to 1 in 1,000): severe allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); joint reduction in the number of platelets, red blood cells and white blood cells; changes in the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); skin rash that can lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish/purple rash and/or whitish-gray filamentous lines on mucous membranes); inflammation of the liver caused by the immune system (autoimmune hepatitis; in patients also treated with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also treated with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys which determines reduced kidney function (glomerulonephritis).
• Very rare(may affect up to 1 in 10,000): inability of the bone marrow to produce essential blood cells.
• Not known(frequency cannot be estimated based on available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
Side effects and their frequency in children and adolescents are similar to those described above.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nepexto

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 pack and on the pre-filled syringe
after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled syringes in the outer packaging to protect the medicine from light.
Nepexto can be stored for one time only outside the refrigerator at a maximum temperature of
25°C for a maximum of 4 weeks; after this period it cannot be put back in the fridge. If
not used within 4 weeks outside the fridge, Nepexto must be discarded. It is recommended to
note the date on which Nepexto is placed outside the fridge and the date by which Nepexto must be
discarded (no more than 4 weeks outside the fridge).
Inspect the solution inside the syringe. The solution should be from clear to opalescent, from
colourless to yellow and may contain small, white or almost transparent protein particles. This
appearance is normal. Do not use this solution if it shows changes in colour or appears cloudy or
if particles are visible other than those described. If you have any doubts about the appearance of the solution
contact your pharmacist.
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 Nepexto contains
The active substance is etanercept. Each pre-filled syringe contains 25 mg or 50 mg of etanercept.
The other excipients are: sodium citrate, disodium hydrogen phosphate dihydrate, glycine, sucrose, sodium
chloride and water for injection.

Description of Nepexto and contents of the pack
Nepexto is supplied as a pre-filled syringe containing an injectable solution that is
clear to opalescent, from colourless to yellow.
Nepexto 25 mg is available in packs of 4, 12 pre-filled syringes, in a multipack
containing 2 packs of 4 pre-filled syringes and in a multipack containing 2
packs of 12 pre-filled syringes.
Nepexto 50 mg is available in packs containing 4 or 12 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36
Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
DUBLIN
Ireland
D13 R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biocon Biologics Belgium BV
Tél/Tel: 0080008250910

Lietuva
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

България
Biosimilar Collaborations Ireland Limited
Тел: 0080008250910

Luxembourg/Luxemburg
Biocon Biologics France S.A.S
Tél/Tel: 0080008250910

Česká republika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Magyarország
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Danmark
Biocon Biologics Finland OY
Tlf: 0080008250910

Malta
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Deutschland
Biocon Biologics Germany GmbH
Tel: 0080008250910

Nederland
Biocon Biologics France S.A.S
Tel: 0080008250910

Eesti
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Norge
Biocon Biologics Finland OY
Tlf: +47 800 62 671

Ελλάδα
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε
Τηλ.: 0080008250910

Österreich
Biocon Biologics Germany GmbH
Tel: 0080008250910

España
Biocon Biologics Spain S.L.
Tel: 0080008250910

Polska
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

France
Biocon Biologics France S.A.S
Tel: 0080008250910

Portugal
Biocon Biologics Spain S.L.
Tel: 0080008250910

Hrvatska
Biocon Biologics Germany GmbH
Tel: 0080008250910

România
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ireland
Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794

Slovenija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ísland
Biocon Biologics Finland OY
Sími: +345 800 4316

Slovenskárepublika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Italia
Biocon Biologics Spain S.L .
Tel: 0080008250910

Suomi/Finland
Biocon Biologics Finland OY
Puh/Tel: 99980008250910

Κύπρος
Biosimilar Collaborations Ireland Limited
Τηλ: 0080008250910

Sverige
Biocon Biologics Finland OY
Tel: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Further details on this medicinal product are available on the website of the European Medicines
Agency: http://www.ema.europa.eu .

7. Instructions for Use

This section is divided into the following subsections:

Introduction
Phase 1: preparing for the injection
Phase 2: choosing the injection site
Phase 3: injecting the Nepexto solution
Phase 4: disposing of materials
The following instructions explain how to prepare and inject Nepexto. Read the instructions for use
before starting to use Nepexto and each time you renew the prescription. There may be new
information.

• Do not attempt to administer an injection unless your doctor or nurse has shown you how to do it.

The solution should not be mixed with any other medication before use.
Not included in the package:

• alcohol swab
• gauze pad and adhesive bandage
• sharps disposal container

Device Parts

Phase 1: preparing for the injection
Choose a clean, well-lit, and flat surface and have everything you need readily available.

• 1. Remove the box containing the pre-filled syringes from the refrigerator and place it on the flat work surface. Remove a pre-filled syringe and place it on the work surface. Do not shake the pre-filled Nepexto syringe. Return the box containing any remaining pre-filled syringes to the refrigerator. See section 5 for instructions on how to store Nepexto. If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
• 2. Inspect the solution:
• observe the medication through the body of the syringe;
• the medication should be from clear to opalescent, from colorless to yellow, and may contain small, white or nearly transparent protein particles;
• do not use the solution if it presents color changes or appears cloudy, or if particles other than those described are visible.
• 3. Allow the medication to reach room temperature. Remove a pre-filled syringe from the box stored in the refrigerator and leave it at room temperature for 15 - 30 minutes before performing the injection. This step is important because it makes the medication easier and more comfortable to inject.
• Do not remove the needle cover until you are ready for the injection.
• Do not use other heat sources, such as a microwave or hot water, to heat the injectable solution.
• 4. Prepare the other materials needed for the injection. These include the alcohol swab, a cotton ball or gauze.
• 5. Wash your hands with soap and warm water.

Phase 2: choosing the injection site

• 1. The three recommended sites for injection are: (1) the mid-anterior thigh; (2) the abdomen; and (3) the outer area of the arms (see Figure 1). If you are performing the injection in the abdomen, you must maintain a distance of at least 5 cm from the navel. In case of self-injection, do not use the outer area of the arms.

• 2. A different site should be used for each new injection. Each new injection should be made at least 3 cm away from a previous site. Do not inject into areas where the skin is sensitive, bruised, red, or hardened. Avoid areas where there are scars or stretch marks (it may be helpful to note the location of previous injection sites).

• 3. If you suffer from psoriasis, do not inject directly onto raised, thick, red, or scaly skin patches (“psoriatic skin lesions”).

Phase 3: injecting the solution

• 1. Rub the skin at the injection site with an alcohol swab, making a circular motion. DO NOTtouch this area again before the injection.

• 2. Take the pre-filled syringe from the flat work surface. Remove the needle cover by firmly pulling it off the syringe (see Figure 2). Do not rotate or bend the needle cover while removing it to avoid damaging it.

When removing the needle cover, a drop of liquid may remain at the end
of the needle; this is normal. Do not touch the needle or let the needle touch any surface. Do not
touch or push the plunger. This could cause the liquid to leak.

• 3. When the cleaned skin area is dry, pinch it and hold it firmly with one hand. With the other hand, hold the syringe like a pencil.
• 4. With a quick, short motion, insert the needle completely into the skin at an angle of 45° to 90° (see Figure 3). With experience, you will find the angle that is most comfortable for you. Be careful not to push the needle into the skin too slowly or with too much force.

• 5. Once the needle is fully inserted into the skin, leave the skin pinched. With your free hand, hold the syringe near the base to stabilize it. Then push the plunger to inject all the solution, maintaining a slow and steady speed (see Figure 4).

• 6. When the syringe is empty, remove the needle from the skin, being careful to maintain the same angle with which it was inserted. A slight bleeding may occur at the injection site. You can hold a cotton ball or gauze on the injection site for 10 seconds. Do not rub the injection site. If necessary, cover the injection site with a bandage.

Phase 4: disposing of materials
The pre-filled syringe must be used only once. The syringe and needle must NEVER
be reused. Never recap the needle with the needle cover. Dispose of the needles and syringe as
indicated by your doctor, nurse, or pharmacist (see Figure 5).

If you have any doubts or need further information, please contact your doctor, nurse, or
pharmacist.

Nepexto 50 mg injectable solution in pre-filled pen

etanercept

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.
• Your doctor will provide you with the Patient Card which contains important safety information that you should be aware of before and during treatment with Nepexto.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or for your child. Do not give it to other people, even if they have the same symptoms as you or your child, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Nepexto and what is it used for

Nepexto contains the active substance etanercept.
Nepexto is a medicine made from two human proteins that blocks the activity of another protein
present in the human body and which causes inflammation. This medicine works by reducing
inflammation associated with certain diseases.
In adults (aged 18 years or older), Nepexto can be used for the treatment

• of rheumatoid arthritis(a long-lasting autoimmune disease that mainly affects the joints) from moderate to severe;
• of psoriatic arthritis(a type of inflammatory arthritis that can affect any joint in the body);
• of severe axial spondyloarthritis(a type of chronic inflammatory arthritis that affects the spine and/or sacroiliac joints), including ankylosing spondylitis(a type of arthritis that affects the spine);
• of psoriasis(raised, red, and scaly patches on the skin) from moderate to severe. In any case, Nepexto is usually used when other widely used treatments have not worked well enough or are not suitable for you. For rheumatoid arthritis, this medicine is usually used in association with methotrexate, although it can also be used alone if treatment with methotrexate is not suitable for you. Whether used alone or in combination with methotrexate, Nepexto can slow down the damage to

the joints caused by rheumatoid arthritis and improve the ability to perform normal daily activities.
For patients with psoriatic arthritiswith involvement of multiple joints, this medicine
can improve the ability to perform normal daily activities.
For patients with multiple symmetrical painful or swollen joints(e.g., hands, wrists and
feet), this medicine can slow down the structural damage to these joints caused by
the disease.
Nepexto is also prescribed for the treatment of the following conditions in children and adolescents:

• for the following types of juvenile idiopathic arthritis, when treatment with methotrexate has not given a sufficiently good response or is not appropriate:
• polyarthritis (positive or negative for rheumatoid factor) and extended oligoarthritis in patients starting from 2 years of age and weighing 62.5 kg or more
• Psoriatic arthritis in patients starting from 12 years of age and weighing 62.5 kg or more.
• for arthritis related to enthesitis in patients starting from 12 years of age weighing 62.5 kg or more or when other widely used treatments have not given a sufficiently good response or are not appropriate,
• severe psoriasis in patients starting from 6 years of age and weighing 62.5 kg or more who have had an inadequate response with (or cannot follow) phototherapies or other systemic therapies.

2. What you need to know before using Nepexto

Do not use Nepexto

• if you, or the child, are allergic to etanerceptor to any of the other ingredients ofNepexto(listed in section 6). If you or the child experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject any more Nepexto and contact your doctor immediately.
• if you, or the child, have or are at risk of developing a severe blood infectioncalled sepsis. If you are unsure, contact your doctor;
• if you, or the child, have an infection of any kind. If you are unsure, talk to your doctor.

Warnings and precautions
Talk to your doctor before using Nepexto.

• Allergic reactions: if you, or the child, experience allergic reactions such as tightness in the chest, wheezing, dizziness or skin rash, do not inject this medicine and contact your doctor immediately.
• Infections/surgery: if you, or the child, develop a new infection or are about to have any major surgery, your doctor may want to monitor treatment with this medicine.
• Infections/diabetes: tell your doctor if you, or the child, have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection.
• Infections/monitoring: tell your doctor about any recent travel outside of Europe. If you, or the child, develop symptoms of an infection such as fever, chills or cough, inform your doctor immediately. The doctor may decide to continue monitoring you or the child for infections after you or the child have stopped taking Nepexto.
• Tuberculosis: because cases of tuberculosis have been reported in patients treated with Nepexto, your doctor will check you for signs and symptoms of tuberculosis before starting treatment with this medicine. This may include a thorough medical history, a chest X-ray and a tuberculin test. The results of these tests must be reported on the Patient Card. It is very important that you tell your doctor if you or the child have ever had tuberculosis or if you have been in close contact with someone with tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, weakness, low-grade fever) or any other infection appear during or after therapy, tell your doctor immediately.
• Hepatitis B: tell your doctor if you or the child have or have had hepatitis B. Your doctor should test for hepatitis B before you or the child start treatment with this medicine. Treatment with Nepexto may cause reactivation of hepatitis B in patients with a previous hepatitis B virus infection. In this case, you must stop using this medicine.
• Hepatitis C: tell your doctor if you or the child have hepatitis C. Your doctor may consider monitoring treatment with this medicine if the infection worsens.
• Blood disorders: seek immediate medical attention if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. These symptoms may indicate the presence of blood disorders that could be life-threatening and may require discontinuation of treatment with Nepexto.
• Nervous system and eye disorders: tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the optic nerves) or transverse myelitis (inflammation of the spinal cord). The doctor will assess whether this medicine is an appropriate treatment.
• Congestive heart failure: tell your doctor if you or the child have a history of congestive heart failure (a condition in which the heart muscle does not pump blood as it should), as this medicine should be used with caution in these circumstances.
• Cancer: tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer, before taking this medicine. Patients with severe, long-standing rheumatoid arthritis may be at a higher risk of developing lymphoma than average. Children and adults using this medicine may have an increased risk of developing lymphoma or another cancer. Some children and adolescent patients who have been treated with etanercept or other medicines that act like etanercept have developed tumors, sometimes rare, sometimes fatal. Some patients receiving Nepexto have developed skin tumors. Tell your doctor if you or the child develop any changes in the appearance of the skin or growths on the skin.
• Chickenpox: tell your doctor if you or the child are exposed to chickenpox while using this medicine. The doctor will assess whether preventive treatment for chickenpox is appropriate.
• Alcohol abuse: this medicine should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or the child have a history of alcohol abuse.
• Wegener's granulomatosis: this medicine is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease. If you or the child have Wegener's granulomatosis, contact your doctor.
• Anti-diabetic medicines: tell your doctor if you or the child suffer from diabetes or are taking medicines to treat diabetes. The doctor may decide to reduce the dose of anti-diabetic medicine for you or the child while you are taking this medicine. Children and adolescents
• Vaccinations: if possible, before using Nepexto, children should be up to date with all vaccinations. Some vaccines, such as the oral polio vaccine, should not be given while taking this medicine. Consult your doctor before you or the child receive any vaccine.

Nepexto should not be used in children and adolescents weighing less than 62.5 kg.
As a rule, Nepexto should not be used in children with polyarthritis or extended oligoarthritis aged
under 2 years, or in children with arthritis related to enthesitis or psoriatic arthritis aged under
12 years, or in children with psoriasis aged under 6 years.

Other medicines and Nepexto
Tell your doctor or pharmacist if you, or the child, are taking, have recently taken or might
take other medicines (including sulfasalazine), even those available without a prescription.
You or the child must notuse Nepexto with medicines containing the active ingredient anakinra or
abatacept.

Pregnancy and breastfeeding
Nepexto should only be used during pregnancy if clearly necessary. If you are pregnant,
suspect you are pregnant or are planning a pregnancy, ask your doctor for advice.
If you have received Nepexto during pregnancy, the newborn may be at increased risk of
infection. In addition, one study indicated that a higher number of birth defects were detected in mothers who received etanercept during pregnancy compared to mothers who had not received
this medicine or other similar medicines (TNF antagonists), although no particular type of birth defect emerged among those reported. Another study did not show an increased
risk of birth defects when mothers received etanercept during pregnancy. The
doctor will help you decide whether the benefits of treatment outweigh the potential risk to the
child.
Contact your doctor if you wish to breastfeed while using Nepexto. It is important
to inform the child's pediatricians and other healthcare professionals about the use of Nepexto during
pregnancy and breastfeeding before the child receives any vaccine.

Driving and using machines
It is not expected that using Nepexto will affect your ability to drive or use
machines.

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

3. How to use Nepexto

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
If you feel that the effect of Nepexto is too strong or too weak, consult your doctor or pharmacist.

Use in adults
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis
The usual dose is 25 mg, administered twice a week, or 50 mg once a week
by subcutaneous injection.
In any case, the doctor may establish a different frequency at which to inject Nepexto.
Plaque psoriasis
The usual dose is 25 mg, administered twice a week, or 50 mg administered once a week.
Alternatively, a dose of 50 mg may be administered twice a week for up to
12 weeks, followed by a dose of 25 mg administered twice a week or a dose of
50 mg administered once a week.
The doctor will decide how long you should take Nepexto and whether, based on your response, further treatment is
necessary. If, after 12 weeks, Nepexto has no effect on your
condition, your doctor may advise you to discontinue treatment.

Use in children and adolescents
The dose and frequency of dosing in children or adolescents will depend on body weight and
the disease.
The doctor will establish the correct dose for the child and prescribe an appropriate dosage of etanercept.
Nepexto should not be used in children and adolescents weighing less than 62.5 kg.
Other medicines containing etanercept are available with pharmaceutical formulations appropriate for
children.
For polyarticular or extended oligoarticular arthritis in patients starting from 2 years of age, or arthritis related to
enthesitis or psoriatic arthritis in patients starting from 12 years of age, the usual dose is 0.4 mg of
etanercept per kg of body weight (up to a maximum of 25 mg) administered 2 times a week or
0.8 mg of etanercept per kg of body weight (up to a maximum of 50 mg) administered once a
week.
For psoriasis in patients starting from 6 years of age, the usual dose is 0.8 mg of etanercept per kg of
body weight (up to a maximum of 50 mg) and must be administered once a week. If
Nepexto has no effect on the child's condition after 12 weeks, the doctor may advise you to
discontinue treatment with this medicine.

How and route of administration
Nepexto is administered by injection under the skin (subcutaneous use).

Detailed instructions on how to prepare and inject Nepexto are provided in section 7,
Instructions for Use.
Do not mix the solution with other medicines.
To help you remember, it may be useful to write in an agenda on which day(s) of the week
Nepexto should be used.

If you use more Nepexto than you should
If you have used more Nepexto than you should have (either by injecting an excessive amount on a single
occasion or by using it too frequently), seek immediate medical advice or contact a
pharmacist. Always keep the medicine box with you, even if it is empty.

If you forget to take Nepexto
If you forget a dose, administer it as soon as you remember, unless the next dose is scheduled for the next day, in which case you should skip the forgotten dose. Then continue to administer the medicine on the scheduled day(s). If you realize
you have forgotten on the day the next dose is due, do not take a double dose (two doses
on the same day) to make up for the forgotten dose.

If you stop taking Nepexto
Following discontinuation of treatment, the symptoms of the disease may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Allergic reactions
If any of the following side effects occur, do not inject Nepexto any further. Immediately inform your doctor, or go to the nearest hospital emergency room.

• Difficulty swallowing or breathing
• Swelling of the face, throat, hands or feet
• Feeling of nervousness or anxiety, palpitations, sudden flushing of the skin and/or feeling of warmth
• Severe skin rash, itching, hives (raised, red or pale patches of skin that often itch)

Severe allergic reactions are rare. However, any of the symptoms listed above may indicate an allergic reaction to this medicine; therefore, you should seek immediate medical attention.

Serious side effects
If you notice any of the following effects, you or the child may need urgent medical care.

• symptoms of serious infections, such as high fever which may be accompanied by cough, shortness of breath, chills, weakness, or presence of a warm, red, tender, painful area on the skin or in the joints;
• symptoms of blood disorders, such as bleeding, bruising or paleness;
• symptoms of nerve disorders, such as numbness or tingling, changes in vision, eye pain or onset of weakness in an arm or leg;
• symptoms of heart failureor worsening of heart failure, such as fatigue or shortness of breath during activity, swelling of the ankles, a feeling of swelling in the neck or abdomen, shortness of breath at night or cough, bluish color of the nails or lips;
• symptoms of tumors: tumors can affect any part of the body, including skin and blood, and the possible symptoms depend on the type and location of the tumor. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, presence of cysts or growths on the skin;
• symptoms of autoimmune reactions(where antibodies are created that can damage normal body tissues), such as pain, itching, weakness, abnormalities in breathing, thinking, sensations or vision;
• symptoms of lupus or lupus-like syndrome, such as changes in body weight, persistent rash, fever, joint or muscle pain, or fatigue;
• symptoms of inflammation of blood vessels, such as pain, fever, redness or overheating of the skin or itching.

These side effects are rare or uncommon but are serious conditions (some of which may in rare cases cause death). If any of these symptoms occur, immediately inform your doctor, or go to the nearest hospital emergency room.
The known side effects of etanercept include those listed below, grouped by decreasing frequency:

• Very common(may affect more than 1 in 10 people): infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); reactions at the injection site (including bleeding, bruising, redness, itching, pain and swelling) (these are less common after the first month of treatment; some patients have developed a reaction at a recently used injection site) and headache.
• Common(may affect up to 1 in 10 people): allergic reactions; fever; itching; antibodies directed against normal tissue (formation of autoantibodies).
• Uncommon(may affect up to 1 in 100 people): serious infections (including pneumonia, deep skin infections, joint infections, blood infections and infections in various sites); worsening of congestive heart failure; low number of red blood cells, low number of white blood cells, low number of neutrophils (a type of white blood cells); reduced number of platelets in the blood; skin tumor (excluding melanoma); localized swelling of the skin (angioedema); hives (raised, red or pale patches of skin that often itch); eye inflammation; psoriasis (first appearance or worsening), inflammation of blood vessels affecting more than one organ; elevated liver enzymes in the blood (in patients also treated with methotrexate, the frequency of increased liver enzymes in the blood is common), abdominal cramps and pain, diarrhea, weight loss or blood in the stool (signs of bowel problems).
• Rare(may affect up to 1 in 1,000 people): severe allergic reactions (including severe localized swelling of the skin and difficulty breathing); lymphoma (a type of blood cancer); leukemia (a cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); joint reduction in the number of platelets, red blood cells and white blood cells; changes in the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eye or spinal cord); tuberculosis; new onset of congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include a persistent rash, fever, joint pain and fatigue); skin rash that can lead to blisters and severe skin peeling; lichenoid reactions (itchy reddish/purple rash and/or whitish-greyish linear strands on mucous membranes); inflammation of the liver caused by the immune system (autoimmune hepatitis; in patients also treated with methotrexate, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also treated with methotrexate, the frequency of inflammation or scarring of the lungs is uncommon); damage to the tiny filters inside the kidneys which determines reduced kidney function (glomerulonephritis).
• Very rare(may affect up to 1 in 10,000 people): inability of the bone marrow to produce essential blood cells.
• Not known(frequency cannot be estimated from available data): Merkel cell carcinoma (a type of skin cancer); Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin; excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness, accompanied by a rash).

Additional side effects in children and adolescents
The side effects and their frequency observed in children and adolescents are similar to those
described above.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nepexto

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 pack and on the pre-filled pen after “Exp.”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store the pre-filled pen in the outer carton to protect the medicine from light.
After taking a pen from the refrigerator, wait approximately 30 minutes to allow the
solution of Nepexto in the pen to reach room temperature. Do not heat it in any other
way. Use it immediately.
Nepexto can be stored for one time only outside the refrigerator at a maximum temperature of
25°C for a maximum of 4 weeks; after this period it cannot be returned to the refrigerator. If
not used within 4 weeks outside the refrigerator, Nepexto must be discarded. It is recommended to
record the date on which Nepexto is removed from the refrigerator and the date by which Nepexto must be
discarded (no more than 4 weeks outside the refrigerator).
Inspect the solution inside the pen. The solution should be from clear to opalescent, from
colourless to yellow and may contain small, white or almost transparent protein particles. This is
the normal appearance of Nepexto. Do not use this solution if it shows a change in colour or appears
cloudy or if particles are visible that are different from those described. If you have any doubts about the
appearance of the solution, contact your pharmacist.
Do not dispose of any medicine in the 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 Nepexto contains

• The active substance is etanercept. Each pre-filled pen contains 50 mg of etanercept.
• The other excipients are: sodium citrate, disodium hydrogen phosphate dihydrate, glycine, sucrose, sodium chloride and water for injection.

Description of the appearance of Nepexto and contents of the pack
Nepexto is supplied as a pre-filled pen containing an injectable solution from clear
to opalescent, from colourless to yellow.
Nepexto is available in packs of 4 or 12 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36
Grange Parade,
Baldoyle Industrial Estate,
Dublin 13
DUBLIN
Ireland
D13 R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Biocon Biologics Belgium BV
Tél/Tel: 0080008250910

Lietuva
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

България
Biosimilar Collaborations Ireland Limited
Тел: 0080008250910

Luxembourg/Luxemburg
Biocon Biologics France S.A.S
Tél/Tel: 0080008250910

Česká republika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Magyarország
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Danmark
Biocon Biologics Finland OY
Tlf: 0080008250910

Malta
Biosimilar Collaborations Ireland Limited
Tel.: 0080008250910

Deutschland
Biocon Biologics Germany GmbH
Tel: 0080008250910

Nederland
Biocon Biologics France S.A.S
Tel: 0080008250910

Eesti
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Norge
Biocon Biologics Finland OY
Tlf: +47 800 62 671

Ελλάδα
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε
Τηλ.: 0080008250910

Österreich
Biocon Biologics Germany GmbH
Tel: 0080008250910

España
Biocon Biologics Spain S.L.
Tel: 0080008250910

Polska
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

France
Biocon Biologics France S.A.S
Tel: 0080008250910

Portugal
Biocon Biologics Spain S.L.
Tel: 0080008250910

Hrvatska
Biocon Biologics Germany GmbH
Tel: 0080008250910

România
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ireland
Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794

Slovenija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Ísland
Biocon Biologics Finland OY
Sími: +345 800 4316

Slovenskárepublika
Biocon Biologics Germany GmbH
Tel: 0080008250910

Italia
Biocon Biologics Spain S.L .
Tel: 0080008250910

Suomi/Finland
Biocon Biologics Finland OY
Puh/Tel: 99980008250910

Κύπρος
Biosimilar Collaborations Ireland Limited
Τηλ: 0080008250910

Sverige
Biocon Biologics Finland OY
Tel: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .

7. Instructions for Use

Read the instructions for use before starting to use Nepexto and each time you renew the prescription.
There may be new information.

• Do not attempt to administer an injection unless your doctor or nurse has shown you how to perform it.

Not included in the package:

• alcohol swab
• gauze pad and adhesive bandage
• sharps disposal container

Device Parts

• A.Preparing for the Injection

Choose a comfortable, flat surface that is well-lit and clean and keep everything you need
within reach.

• 1. Remove the Nepexto box containing the pre-filled pens from the refrigerator and place it on the flat work surface. Remove a pre-filled pen and place it on the work surface. Do not shake the pre-filled pen. Return the box containing any remaining pre-filled pens to the refrigerator. Never replace the needle cover. See section 5 for instructions on how to store Nepexto. If you have any questions about storage, contact your doctor, nurse or pharmacist for further instructions.
• Do not use the pre-filled pen after the expiration date.
• Do not use the pre-filled pen if it has fallen onto a hard surface (the components inside the pre-filled pen may have broken).
• Do not use the pre-filled pen if the needle cap is missing or is not securely attached.
• 2. Inspect the solution: observe the medicine through the inspection window.
• the medicine should be from clear to opalescent, from colorless to yellow, and may contain small, white or almost transparent protein particles,
• do not use the solution if it has changes in color or appears cloudy, or if particles other than those described are visible.
• 3. Allow the medicine to reach room temperature. Remove a pre-filled pen from the box stored in the refrigerator and leave it at room temperature for at least 30 minutes before administering the injection. This step is important because it makes the medicine easier and more comfortable to inject.
• Do not remove the needle cap until you are ready for the injection.
• Do not use heat sources, such as a microwave or hot water, to warm Nepexto.

• 4. Choose an injection site: the pre-filled pen is for subcutaneous injection. The injection must be administered in the thigh, abdomen, or back of the arm (see figure on the right). Rotate the site with each injection.

If you are injecting into the abdomen, stay at least 5 cm from the
navel.

• Do not inject into areas that are red, hardened, bruised, or painful.
• Do not inject into scars or stretch marks.
• If you have psoriasis, you should try to avoid injecting into areas of the skin that are swollen, thickened, red, or scaly.
• B.Injection Steps

Step 1:
Wash your hands thoroughly with soap and water.

Step 2:

Rub the skin at the injection site with an alcohol swab.
See point 4. “Choose an injection site” for instructions on choosing the
injection site.

• Do not touch this area again before the injection.

Step 3:

Remove the needle cap by pulling it straight off and dispose of it in the
trash or sharps container.

• Do not rotate or bend the needle cap while removing it to avoid damaging the needle.
• Never replace the needle cover.

Step 4:

Gently pinch the skin at the cleaned injection site.
Place the pre-filled pen at approximately 90 degrees to the skin.

• Do not pinch the skin.
• Pinching the skin creates a firm surface.

Step 5:

Firmly press the pre-filled pen down on the site to start the injection.
The device will emit a click at the start of the injection.
Continue to hold the pre-filled pen firmly pressed on the site.
The device will emit a second click.

Step 6:

After the second click, slowly count to 15 to ensure that
the injection is complete.

• Do not release pressure on the injection site before completing the injection.
• Do not move the pre-filled pen during the injection.

Step 7:
Detach the empty pen from the skin.
The needle guard will completely cover the needle.
Check for the presence of the pink plunger in the window to confirm
that the entire dose has been delivered.

Disposal:

Dispose of the used pen in an approved sharps container.
Check with your healthcare provider on how to properly dispose of the sharps
container once it is full.
Sharps containers can be purchased at your local pharmacy.

• Do not dispose of the sharps container in household waste.
• Do not recycle it.
• Always keep the sharps container out of sight and reach of children.
• C.Injection Site Care

If you notice a spot of blood at the injection site, press a cotton ball or gauze on
the injection site.

• Do not rub the injection site.

If necessary, cover the injection site with an adhesive bandage.

If you have any doubts or need further information, please contact your doctor,
nurse or pharmacist.