50 mg solution for injection in pre-filled pen
etanercept
What Nepexto is and what it is used for
Nepexto contains the active substance etanercept.
Nepexto is a medicine made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. This drug reduces inflammation that is associated with certain diseases.
In adults (18 years and older), Nepexto can be used for:
- moderate or severe rheumatoid arthritis (long-term autoimmune disease that primarily affects the joints, also called rheumatoid arthritis )
- psoriatic arthritis (a type of inflammatory joint disease that can affect all joints in the body)
- severe axial spondylitis (a type of chronic inflammatory joint disease involving the spine and / or pelvic joints) including ankylosing spondylitis (a type of inflammatory joint disease affecting the spine)
- moderate or severe psoriasis (raised, red, scaly patches on the skin).
Nepexto is usually used when other commonly used treatments have not worked well enough or are unsuitable for you.
This medicine is usually used in combination with methotrexate to treat rheumatoid arthritis, but it can also be used as a single medicine if treatment with methotrexate is unsuitable for you. Whether Nepexto is used alone or in combination with methotrexate, Nepexto can slow down the damage to your joints caused by rheumatoid arthritis and improve your ability to perform daily activities.
For patients who have multiple joints affected by psoriatic arthritis, this drug may increase the ability to perform daily activities.
For patients with multiple symmetrical aching or swollen joints (eg hands, ankles, and feet), this medicine may delay the breakdown of joint surfaces caused by the disease.
Nepexto is also used to treat the following diseases in children and adolescents:
- For the following types of pediatric rheumatoid arthritis ( juvenile idiopathic arthritis ), when treatment with methotrexate has not given sufficient results or is not suitable for them:
- Inflammation of many joints (polyarthritis) (rheumatoid factor positive or negative) and inflammation affecting 5 or more joints (enlarged oligoarthritis) in patients from 2 years of age and weighing 62.5 kg or more.
- Psoriatic arthritis in patients from 12 years of age weighing 62.5 kg or more.
- For patients from 12 years of age and weighing 62.5 kg or more with musculoskeletal and joint inflammation ( arthritis-related arthritis ) when other commonly used treatments have not given sufficient results or are not suitable for them.
- Severe psoriasis in patients from 6 years of age and weighing 62.5 kg or more who have had insufficient effect of (or who can not be treated with) light therapy or other systemic treatments (drugs that affect the whole body).
What you need to know before using Nepexto
Do not use Nepexto
- if you or your child are allergic to etanercept or any of the other ingredients of Nepexto (listed in section 6). If you or your child have allergic reactions, such as tightness in the chest, wheezing, dizziness or rash, stop injecting Nepexto and contact your doctor immediately.
- if you or your child have or are at risk of developing a serious blood infection called sepsis. If you are not sure, talk to your doctor
- if you or your child have an infection of any kind . If you are not sure, talk to your doctor.
Warnings and cautions
Talk to your doctor before using Nepexto.
- Allergic reactions : If you or your child get allergic reactions, such as tightness in the chest, wheezing, dizziness or rash, stop using this medicine and contact your doctor immediately.
- Infections / operations : If you or your child develops a new infection or is facing a major operation, your doctor may want to monitor the treatment with this medicine.
- Infections / Diabetes : Tell your doctor if you or your child have had a recurring infection or have diabetes or any other condition that increases the risk of infection .
- Infections / follow-up : Tell your doctor if you have recently been traveling outside of Europe. If you or your child develops symptoms of an infection such as fever, chills or cough, contact your doctor immediately. Your doctor may want to continue to monitor you or your child for the presence of infection after you stop taking Nepexto.
- Tuberculosis : As cases of tuberculosis have been reported in patients treated with Nepexto, your doctor will perform an examination to see if there are any signs or symptoms of tuberculosis before starting treatment with this medicine. This may include a thorough review of your medical history, a chest x-ray and a tuberculin test. The results of these examinations must be entered on the Patient Card. It is very important that you tell your doctor if you or your child have ever had tuberculosis or had close contact with a person who has had tuberculosis . About symptoms of tuberculosis(eg persistent cough, weight loss, worsening of general condition or mild fever) or any other infection that occurs during treatment, contact your doctor immediately.
- Hepatitis B : Tell your doctor if you or your child have or have ever had hepatitis B. Your doctor should test for hepatitis B before you or your child start 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 happens, treatment with this medicine should be stopped.
- Hepatitis C : Tell your doctor if you or your child have hepatitis C. Your doctor may want to check the treatment with this medicine if the infection worsens.
- Blood disorders : Tell your doctor immediately if you or your child have signs or symptoms such as persistent fever, sore throat, bruising, bleeding or pallor. Such symptoms may indicate a potentially life-threatening blood disorder, which requires discontinuation of Nepexto.
- Nervous system and eye diseases : Tell your doctor if you or your child have multiple sclerosis , optic neuritis ( inflammation of the nerves in the eye) or transverse myelitis ( inflammation of the spinal cord). Your doctor will decide if the use of this medicine is the right treatment.
- Heart failure : Tell your doctor if you or your child have a history of heart failure (when the heart muscle is not pumping blood as well as it should), as this medicine must be used with caution in such circumstances.
- Cancer : Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other type of cancer before using this medicine. Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher-than-average risk of developing lymphoma . Children and adults who use this medicine may be at greater risk of developing lymphomaor other type of cancer. Some children and teens who have been given etanercept or other medicines that work in a similar way to etanercept have developed cancer, including unusual types that sometimes lead to death. Some patients who have received Nepexto have developed skin cancer. Tell your doctor if you or your child develops any type of skin change or growth on the skin.
- Chickenpox : Tell your doctor if you or your child have been exposed to chickenpox during treatment with this medicine. Your doctor will decide if prophylactic treatment for chickenpox needs to be prescribed.
- Alcohol abuse : Do not use this medicine for the treatment of alcohol-related hepatitis . Tell your doctor if you or your 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). Tell your doctor if you or your child have Wegener’s granulomatosis .
- Medicines for diabetes : Tell your doctor if you or your child have diabetes or are taking medicines to treat diabetes . Your doctor will decide if you or your child need a smaller dose of antidiabetic medicine during treatment with this medicine.
Children and young people
- Vaccinations : If possible, children should have received all vaccinations according to the vaccination program before starting treatment with Nepexto. Some vaccines, e.g. oral polio vaccine, should not be taken while treatment with this medicine. Tell your doctor before you or your child receive any vaccination.
Nepexto should not be used in children and adolescents weighing less than 62.5 kg.
Nepexto should not be used in children under 2 years of age with polyarthritis or enlarged oligoarthritis, or children under 12 years of age with encephalitis-related arthritis or psoriatic arthritis, or children under 6 years of age with psoriasis.
Other medicines and Nepexto
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines (including sulfasalazine), even those not prescribed by your doctor.
You or your child should not use Nepexto at the same time as medicines containing the active substances anakinra or abatacept.
Pregnancy and breastfeeding
Nepexto should be used during pregnancy only if needed. Contact your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.
If you have been given Nepexto during pregnancy, your baby may be at greater risk of getting an infection. One study also found more malformations when the mother had received etanercept during pregnancy,
compared to mothers who had not received this medicine or other similar medicines ( TNF antagonists ), but no specific type of malformation was reported. Another study did not show an increased risk of malformations when the mother received etanercept during pregnancy. Your doctor will help you determine if the benefits of the treatment outweigh the potential risk to your child. You must tell the infant’s doctor or other healthcare professional that Nepexto has been used during pregnancy before the infant receives any vaccination (see section 2, “Vaccinations” for more information).
You should not breastfeed while using Nepexto as Nepexto passes into breast milk.
Driving and using machines
The use of Nepexto is not expected to affect your ability to drive or use machines.
Nepexto contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How to use Nepexto
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
If you have the impression that the effect of Nepexto is too strong or too weak, talk to your doctor or pharmacist.
Use for adults
Rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis including ankylosing spondylitis
The recommended dose is 25 mg twice a week or 50 mg once a week in the form of an injection under the skin. Your doctor may prescribe a different frequency for your Nepexto injections.
Plaque psoriasis
The recommended 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 if resuming treatment is needed based on the treatment results. If Nepexto has not had any effect on your condition after 12 weeks, your doctor may ask you to stop treatment.
Use for children and adolescents
Dose one and how often it should be given to the child or adolescent depends on body weight and illness.
The doctor will determine the correct dose for the child and prescribe the appropriate strength of etanercept.
Nepexto should not be used in children or adolescents weighing less than 62.5 kg.
There are other medicines with etanercept available with suitable medicines for children.
For patients from 2 years of age with polyarthritis or extended oligoarthritis, or patients from 12 years of age with enthesitis-related arthritis or psoriatic arthritis, the usual dose is 0.4 mg etanercept per kilogram body weight (up to a maximum of 25 mg) given twice per day. per week, or 0.8 mg etanercept per kilogram body weight (up to a maximum of 50 mg) given once weekly.
For patients from 6 years of age with psoriasis, the usual dose is 0.8 mg etanercept per kilogram body weight (up to a maximum of 50 mg) given once a week. If Nepexto does not show any effect on your baby’s condition after 12 weeks, your doctor may ask you to stop treatment with this medicine.
Method and route of administration
Nepexto is injected under the skin ( subcutaneous use).
Detailed instructions on how to prepare and inject Nepexto can be found in section 7, “Instructions for use”.
Do not mix the solution with any other medicine.
To make it easier for you to remember, it can be helpful to write in a calendar which days of the week Nepexto should be taken.
If you use more Nepexto than you should
If you take more Nepexto than you should (either by injecting too much at one time or by taking Nepexto too often) you should contact your doctor or pharmacist immediately. Always carry the labeled outer packaging of the medicine, even if it is empty.
If you forget to inject Nepexto
If you miss a dose, inject one as soon as you remember, unless the next scheduled dose is to be taken the next day, then skip the missed dose. Then continue to inject the medicine on the usual scheduled day. If you do not remember a dose until the same day as the next injection, do not take 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 if treatment is stopped.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
If any of the following symptoms occur, do not inject Nepexto anymore. Contact a doctor immediately or go to the emergency room at the nearest hospital.
- Difficulty swallowing or breathing.
- Swelling of the face, neck, hands or feet.
- Feeling of nervousness or anxiety, throbbing sensation, sudden redness of the skin with or without feeling hot.
- Severe rash, itching or hives (raised spots of red or pale skin that often itch).
Severe allergic reactions are rare but one or more of the above symptoms may indicate an allergic reaction caused by this medicine and medical attention should be sought immediately.
Serious side effects are
If you or your child develops any of the following symptoms, seek medical attention immediately.
- Symptoms of a serious infection , such as a high fever that may be associated with coughing, difficulty breathing, chills, feeling weak or a warm, red, tense, sore surface in the skin or joints.
- Symptoms of blood disease , such as bleeding, bruising or pallor.
- Symptoms of neurological disease , such as loss of feeling or a stinging sensation, changes in vision, pain in the eye or weakness in the arms or legs.
- Symptoms of heart failure or worsening of heart failure , such as fatigue or difficulty breathing during exertion, swollen ankles, a feeling of swollen neck or abdomen, difficulty breathing or coughing at night, bluish color of nails or lips.
- Symptoms of cancer : Cancer can affect all parts of the body, including the skin and blood, and the symptoms depend on the type of cancer and its location. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, lumps or growths on the skin.
- Symptoms of autoimmune reactions (when antibodies are formed that can damage the body’s normal tissues ) such as pain, itching , weakness, abnormal breathing, thoughts, sensations or vision.
- Symptoms of lupus or lupus-like syndrome such as weight change, persistent skin rash, fever, joint or muscle aches, or fatigue.
- Symptoms of inflammation of the blood vessels such as pain, fever, redness or feeling of warmth in the skin, or itching .
These are rare or uncommon side effects, but serious (some of them can be fatal). If any of the above symptoms occur, contact a doctor immediately or go to the emergency room at the nearest hospital.
Known side effects of etanercept are the following, divided into groups according to decreasing frequency:
- Very common (may affect more than 1 user in 10):
Infections (including colds, sinusitis, bronchitis, urinary tract infections, and skin infections); injection site reactions (including bleeding, bruising, redness, itching , pain, and swelling that often subside after the first month of treatment,
some patients develop a reaction at a recently used injection site) and headache.
- Common (may affect up to 1 in 10 people):
Allergic reactions, fever, itching, antibody are directed against normal tissue (autoantibody formation).
- Uncommon (may affect up to 1 in 100 people):
Serious infections (including pneumonia, deep skin infections, joint infections, sepsis, and infections in various places); aggravated chronic heart failure, low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell count ); low platelet count, skin cancer (excluding melanoma ); local swelling of the skin ( angioedema ); hives (raised spots with red or pale skin that often itch); eye inflammation; psoriasis (new onset or worsening); inflammation of the blood vessels that can affect several organs; elevated liver values in blood tests (in patients who also receive methotrexate, the frequency of elevated liver values is “normal”), cramps and pain in the abdomen, diarrhea, weight loss or blood in the stool (signs of intestinal disease).
- Rare (may affect up to 1 in 1,000 people):
Severe allergic reactions (including severe local swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukemia (cancer that affects the blood and bone marrow ); melanoma (a type of skin cancer); a combination of low platelet counts , red and white blood cells; effects on the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammationin the nerves or spinal cord of the eye); tuberculosis; newly debuted heart failure; seizures; lupus or lupus-like syndrome (symptoms include persistent rash, fever, joint pain and fatigue); skin rash that can lead to severe blistering and flaking of the skin; lichenoid reactions (itchy red-purple rash and / or filamentous white-gray lines on mucous membranes); inflammation of the liver caused by the body’s own immune system ( autoimmune hepatitis; in patients who also receive methotrexate, the frequency is “less common”), immune disease that can affect the lungs, skin and lymph nodes ( sarcoidosis ); inflammation or fibrosis of the lungs (in people who also receive methotrexate is the frequency of inflammationand fibrosis of the lungs (“uncommon”).
- Very rare (may affect up to 1 in 10,000 people):
The inability of bone marrow to produce blood cells.
- No known frequency (can not be calculated from the available data):
Merkel cell cancer (a type of skin cancer); Kaposi’s sarcoma (a rare type of cancer-related to human herpesvirus infection 8. Kaposi ‘sarcoma usually occurs as purple lesions on the skin); overactivation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness accompanied by skin rash).
Additional side effects in children and adolescents
Side effects and frequency in children and adolescents are similar to those described above.
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 carton and pre-filled pen after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store the pre-filled pens in the outer carton. Sensitive to light.
After removing a pre-filled pen from the refrigerator, wait approximately 30 minutes for the Nepexto solution in the pre-filled pen to reach room temperature. Do not heat Nepexto in any other way. Use it immediately.
Nepexto can be stored outside 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 stored in the refrigerator again. Nepexto should be discarded if not used within four weeks of removal from the refrigerator. It is recommended that you note the date that Nepexto is removed from the refrigerator and the date when Nepexto is to be discarded (no longer than 4 weeks after removal from the refrigerator).
Inspect the solution in the pen. It should be clear or opalescent, colorless to yellow, and may contain small white or almost transparent particles of protein. This appearance is normal for Nepexto. Do not use the solution if it is discolored, cloudy or if particles other than those described above occur. If you have any further questions on the use of this product, ask your pharmacist for help.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is etanercept. Each pre-filled pen contains 50 mg etanercept.
- The other ingredients are sodium citrate, sodium dihydrogen phosphate dihydrate, glycine , sucrose, sodium chloride and water for injections.
What the medicine looks like and contents of the pack
Nepexto is supplied as a pre-filled pen containing a clear to slightly opalescent, colorless, or pale yellow solution for injection.
Nepexto is available in packs containing 4 or 12 pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan IRE Healthcare Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
Manufacturer
McDermott Laboratories Ltd T / A Mylan Dublin Biologics
Newenham Court
Northern Cross
Malahide Road
Dublin 17
Ireland
Mylan Germany GmbH
Branch release Bad Homburg vd Hoehe, Benzstrasse 1
Bad Homburg vd Hoehe
Hessen, 61352
Germany