Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nepexto

Document Subject

Generated Narrative: MedicinalProductDefinition mp5f1d2d45d01481d24ca0912f037c6116

identifier: http://ema.europa.eu/identifier/EU/1/20/1436/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Nepexto 25 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5f1d2d45d01481d24ca0912f037c6116

identifier: http://ema.europa.eu/identifier/EU/1/20/1436/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - nepexto

Attesters

7. Instructions for use

What is in 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

Nepexto contains the active substance etanercept.

Nepexto is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. This medicine works by reducing the inflammation associated with certain diseases.

In adults (aged 18 and over), Nepexto can be used for:

• moderate or severe rheumatoid arthritis (long-term autoimmune disorder that primarily affects joints);
• psoriatic arthritis (a type of inflammatory arthritis which can affect any joint in the body);
• severe axial spondyloarthritis (a type of chronic inflammatory arthritis involving the spine and/or sacroiliac joints) including ankylosing spondylitis (a type of arthritis that affects the spine);
• moderate or severe psoriasis (raised, red, scaly patches on the skin). In each case Nepexto is used, usually 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 may also be used alone if treatment with methotrexate is unsuitable for you. Whether used alone or in combination with methotrexate, Nepexto can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities. For psoriatic arthritis patients with multiple joint involvement, this medicine can improve your ability to do 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 those joints caused by the disease.

Nepexto is also prescribed for the treatment of the following diseases in children and adolescents.

• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:

Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more

Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more

• For enthesitis-related arthritis in patients from the age of 12 years and weighing 62.5 kg or more when other widely used treatments have not worked well enough or are not suitable for them

• Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.

Do not use Nepexto

• if you or the child you are caring for, are allergic to etanercept or any of the other ingredients of Nepexto (listed in section 6). If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Nepexto, and contact your doctor immediately.
• if you or the child have or are at risk of developing a serious blood infection called sepsis. If you are not sure, please contact your doctor;
• if you or the child have an infection of any kind. If you are not sure, please 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 chest tightness, wheezing, dizziness or rash, stop using 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 wish to monitor the 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 of any recent travel outside the European region. If you or the child develop symptoms of an infection such as fever, chills or cough, tell your doctor immediately. Your doctor may decide to continue to monitor you or the child for the presence of infections after you stop using Nepexto.
• Tuberculosis: As cases of tuberculosis have been reported in patients treated with Nepexto, your doctor will check 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 conduct 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 have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild 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 ever had hepatitis B. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with this medicine. Treatment with Nepexto may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. If this occurs, you should stop using this medicine.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with this medicine in case the infection worsens.
• Blood disorders: Tell your doctor immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Nepexto.
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord). Your doctor will determine if 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 (when your heart muscle doesn t pump blood as well as it should), because this medicine needs to be used with caution under these circumstances.
• Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you use this medicine. Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. Children and adults using this medicine may have an increased risk of developing lymphoma or another cancer. Some children and teenage patients who have received etanercept or other medicines that work the same way as etanercept have developed cancers, including unusual types, which sometimes resulted in death. Some patients receiving Nepexto have developed skin cancer. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using this medicine. Your doctor will determine if preventive treatment for chickenpox is appropriate.
• Alcohol abuse: Do not use this medicine for the treatment of hepatitis related to alcohol abuse. Tell your doctor if you or the child in your care 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). Tell your doctor if you or the child in your care have Wegener s granulomatosis.
• Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes. Your doctor may decide if you or the child need less anti-diabetic medicine while using this medicine.

Children and adolescents

• Vaccinations: If possible, children should be up to date with all vaccinations before using Nepexto. Some vaccines, such as oral polio vaccine, should not be given while using this medicine. Tell your doctor before you or the child receive any vaccines.

Nepexto should not be used in children and adolescents who weigh less than 62.5 kg.

Nepexto should not be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.

Other medicines and Nepexto

Tell your doctor or pharmacist if you or the child are taking or have recently taken or might take any other medicines (including sulfasalazine), including those not prescribed by your doctor.

You or the child should not use Nepexto with medicines that contain the active substance anakinra or abatacept. Pregnancy and breast-feeding

Nepexto should only be used during pregnancy if clearly needed. You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.

If you received Nepexto during pregnancy, your baby may have a higher risk of getting an infection. In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received this medicine or other similar medicines (TNF- antagonists), but there was no particular kind of birth defect reported. Another study found no increased risk of birth defects when the mother had received etanercept in pregnancy. Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby.

Talk to your doctor if you want to breastfeed while on Enbrel treatment. It is important that you tell your baby s doctors and other healthcare professionals about the use of Enbrel during pregnancy and breastfeeding before your baby receives any vaccine.

Driving and using machines

The use of Nepexto is not expected to affect the ability to drive or use machines.

Nepexto contains sodium

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

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you feel that the effect of Nepexto is too strong or too weak, talk to your doctor or pharmacist.

Use in adults

Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin. However, your doctor may determine an alternative frequency at which to inject Nepexto.

Plaque psoriasis The usual dose is 25 mg twice a week or 50 mg once a week.

Alternatively, 50 mg may be given twice a week for up to 12 weeks, followed by 25 mg twice a week or 50 mg once a week.

Your doctor will decide how long you should use Nepexto and whether retreatment is needed based on your response. If Nepexto has no effect on your condition after 12 weeks, your doctor may tell you to stop using this medicine.

Use in children and adolescents

Dose and frequency of dosing for the child or adolescent will depend on body weight and disease. Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept.

Nepexto should not be used in children and adolescents who weigh less than 62.5 kg. Other etanercept medicines with appropriate pharmaceutical forms for children are available.

For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of etanercept per kg bodyweight (up to a maximum of 25 mg) given twice a week or 0.8 mg of etanecept per kg of bodyweight (up to a maximum of 50 mg) given once a week.

For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of etanercept per kg of bodyweight (up to a maximum of 50 mg) and should be given once weekly. If Nepexto has no effect on the child s condition after 12 weeks, your doctor may tell you to stop using this medicine.

Method and route of administration

Nepexto is administered by an injection under the skin (by 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 any other medicine.

To help you remember, it may be helpful to write in a diary 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 too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately. Always have the outer carton of the medicine with you, even if it is empty.

If you forget to inject Nepexto

If you forget a dose, inject it as soon as you remember, unless the next scheduled dose is the next day; in which case skip the missed dose. Then continue to inject the medicine on the usual day(s). If you do not remember until the day that the next injection is due, do not use a double dose (two doses on the same day) to make up for a forgotten dose.

If you stop using Nepexto

Your symptoms may return upon discontinuation.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

If any of the following happen, do not inject more Nepexto. Tell your doctor immediately or go to the casualty department at your nearest hospital.

• Trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)

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

Serious side effects

If you notice any of the following, you or the child may need urgent medical attention.

• Signs of serious infections, such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints;
• Signs of blood disorders, such as bleeding, bruising, or paleness;
• Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;
• Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips;
• Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer. These signs may include weight loss, fever, swelling (with or without pain), persistent cough, presence of lumps or growths on the skin;
• Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
• Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.

These are rare or uncommon side effects but are serious conditions (some of which may rarely be fatal). If any of the above occurs, tell your doctor immediately, or visit the casualty department at your nearest hospital.

The known side effects of etanercept include the following on groups of decreasing frequency:

• Very common (may affect more than 1 in 10 people): Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (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 an injection site that was recently used) and headache.

• Common (may affect up to 1 in 10 people): Allergic reactions; fever; itching; antibodies directed against normal tissue (autoantibody formation).

• Uncommon (may affect up to 1 in 100 people): Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common), abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).

• Rare (may affect up to 1 in 1,000 people): Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, 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 receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).

• Very rare (may affect up to 1 in 10,000 people): Failure of the bone marrow to produce crucial blood cells.

• Not known (frequency cannot be estimated from available data): Merkel cell carcinoma (a type of skin cancer); Kaposi s sarcoma (a rare cancer related to infection with human herpes virus 8. Kaposi s sarcoma most commonly appears as purple lesions on the skin); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); damage to the tiny filters inside your kidneys leading to poor kidney function (glomerulonephritis), worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).

Additional side effects in children and adolescents

The side effects and their frequencies seen in children and adolescents are similar to those described above.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and 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 carton in order to protect from light.

Nepexto may be stored outside of the refrigerator at temperatures up to a maximum of 25 C for a single period of up to four weeks; after which, it should not be refrigerated again. Nepexto should be discarded if not used within four weeks after removal from the refrigerator. It is recommended that you record the date that Nepexto is removed from the refrigerator and the date after which Nepexto should be discarded (no more than 4 weeks following the removal from the refrigerator). Inspect the solution in the syringe. It should be clear to opalescent, colourless to yellow, and may contain small white or almost transparent particles of protein. This appearance is normal. Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present. If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Nepexto contains

• The active substance is etanercept. Each pre-filled syringe contains 25 mg or 50 mg of etanercept.
• The other ingredients are sodium citrate, sodium dihydrogen phosphate dihydrate, glycine, sucrose, sodium chloride and water for injections.

What Nepexto looks like and contents of the pack

Nepexto is supplied as a pre-filled syringe containing a clear to opalescent, colourless to yellow solution for injection.

Nepexto 25 mg is available in pack sizes of 4,12 pre-filled syringes, in a multipack comprising 2 pack of 4 pre-filled syringes and in a multipack comprising 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/Grange Parade, Baldoyle Industrial Estate, Dublin DUBLIN Ireland D13 R20R

Manufacturer Biosimilar Collaborations Ireland Limited Block B, The Crescent Building, Santry Demesne Dublin D09 C6X8 Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Biocon Biologics Belgium BV T l/Tel: 0080008250Lietuva Biosimilar Collaborations Ireland Limited Tel: 0080008250
Biosimilar Collaborations Ireland Limited : 0080008250Luxembourg/Luxemburg Biocon Biologics France S.A.S T l/Tel: 0080008250 esk republika Biocon Biologics Germany GmbH
Tel: 0080008250Magyarorsz g Biosimilar Collaborations Ireland Limited
Tel.: 0080008250Danmark Biocon Biologics Finland OY
Tlf: 0080008250Malta Biosimilar Collaborations Ireland Limited
Tel.: 0080008250Deutschland Biocon Biologics Germany GmbH
Tel: 0080008250Nederland Biocon Biologics France S.A.S Tel: 0080008250Eesti Biosimilar Collaborations Ireland Limited Tel: 0080008250Norge Biocon Biologics Finland OY
Tlf: +47 800 62
Biocon Biologics Greece . .
.: 0080008250 sterreich Biocon Biologics Germany GmbH
Tel: 0080008250Espa a Biocon Biologics Spain S.L. Tel: 0080008250Polska Biosimilar Collaborations Ireland Limited
Tel: 0080008250France Biocon Biologics France S.A.S
Tel: 0080008250Portugal Biocon Biologics Spain S.L. Tel: 0080008250Hrvatska Biocon Biologics Germany GmbH
Tel: 0080008250Rom nia Biosimilar Collaborations Ireland Limited
Tel: 0080008250Ireland Biosimilar Collaborations Ireland Limited
Tel: 1800 777 Slovenija Biosimilar Collaborations Ireland Limited
Tel: 0080008250 sland Biocon Biologics Finland OY
S mi: +345 800 4Slovensk republika Biocon Biologics Germany GmbH
Tel: 0080008250Italia Biocon Biologics Spain S.L. Tel: 0080008250Suomi/Finland Biocon Biologics Finland OY
Puh/Tel: 99980008250
Biosimilar Collaborations Ireland Limited
: 0080008250Sverige Biocon Biologics Finland OY
Tel: 0080008250Latvija Biosimilar Collaborations Ireland Limited
Tel: 0080008250This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: