Active ingredient
- etanercept
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/15/1074/005 , EU/1/15/1074/006, EU/1/15/1074/007.
Benepali 25mg solution for injection in pre-filled syringe
Package leaflet: Information for the user
Benepali 25 mg solution for injection in pre-filled syringe
etanercept
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Benepali is and what it is used for
2. What you need to know before you use Benepali
3. How to use Benepali
4. Possible side effects
5. How to store Benepali
6. Contents of the pack and other information
7. Instructions for use (see overleaf)
1. What Benepali is and what it is used for
Benepali contains the active substance etanercept.
Benepali is a medicine that is made from two human proteins. It blocks the activity of another protein in the body that causes inflammation. Benepali works by reducing the inflammation associated with certain diseases.
In adults (aged 18 and over), Benepali can be used for:
In each case Benepali is used, usually when other widely used treatments have not worked well enough or are not suitable for you.
For rheumatoid arthritis, Benepali 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, Benepali 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, Benepali can improve your ability to do normal daily activities.
For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Benepali can slow down the structural damage to those joints caused by the disease.
Benepali is also prescribed for the treatment of the following diseases in children and adolescents.
2. What you need to know before you use Benepali
Do not use Benepali
Warnings and precautions
Talk to your doctor before taking Benepali.
Children and adolescents
Benepali is not indicated for use in children and adolescents who weigh less than 62.5 kg.
Benepali should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis below the age of 6 years or weighing less than 62.5 kg.
Other medicines and Benepali
Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including sulfasalazine).
You or the child should not use Benepali with medicines that contain the active substance anakinra or abatacept.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy.
Benepali should only be used during pregnancy if clearly needed.
If you received Benepali 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 etanercept 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. It is important that you tell the baby’s doctors and other healthcare professionals about the use of Benepali during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Women using Benepali should not breast-feed, since Benepali passes into human breast milk.
Driving and using machines
No information is available if the use of Benepali effects the ability to drive or use machines.
Benepali contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How to use Benepali
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 Benepali is too strong or too weak, talk to your doctor or pharmacist.
Use in adult patients (aged 18 years or over)
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 Benepali.
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 Benepali and whether retreatment is needed based on your response. If Benepali 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.
Paediatric patients weighing 62.5 kg or more can be dosed 25 mg given twice a week or 50 mg given once a week using a fixed-dose pre-filled syringe or pre-filled pen.
Other etanercept products with appropriate dosage forms for children are available.
For polyarthritis or extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more, the usual dose is 25 mg given twice a week or 50 mg given once a week.
For psoriasis in patients from the age of 6 years and weighing 62.5 kg or more, the usual dose is 50 mg and should be given once weekly. If Benepali has no effect on the child’s condition after 12 weeks, your doctor may tell you to stop using this medicine.
The doctor will provide you with detailed directions for preparing and measuring the appropriate dose.
Method and route of administration
Benepali is administered by an injection under the skin (subcutaneous use).
Detailed instructions on how to inject Benepali are provided in section 7,“Instructions for use”.
Do not mix the Benepali solution with any other medicine.
To help you remember, it may be helpful to write in a diary which day(s) of the week Benepali should be used.
If you use more Benepali than you should
If you have used more Benepali 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 use Benepali
If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should 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 take a double dose (two doses on the same day) to make up for a forgotten dose.
If you stop using Benepali
Your symptoms may return upon discontinuation.
If you have any further questions on 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 everybody gets them.
Allergic reactions
If any of the following happen, do not inject more Benepali. Tell your doctor immediately, or go to the casualty department at your nearest hospital.
Serious allergic reactions are rare. However, any of the above symptoms may indicate an allergic reaction to Benepali, 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.
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.
Other side effects
The known side effects of Benepali include the following in groups of decreasing frequency:
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 via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Benepali
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 the label of 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 carton in order to protect from light.
After taking a syringe from the refrigerator, wait approximately 30 minutes to allow the Benepali solution in the syringe to reach room temperature. Do not warm in any other way. Immediate use is then recommended.
Benepali 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. Benepali should be discarded if not used within four weeks after removal from the refrigerator. It is recommended that you record the date that Benepali is removed from the refrigerator and the date after which Benepali 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 slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein. This appearance is normal for Benepali. Do not use this medicine if you notice the solution 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.
6. Contents of the pack and other information
What Benepali contains
What Benepali looks like and contents of the pack
Benepali is supplied as a pre-filled syringe containing a clear to slightly opalescent, colourless or pale yellow solution for injection (injection).
Benepali is available in packs containing 4 pre-filled syringes, multipacks comprising 2 cartons, each containing 4 pre-filled syringes and multipacks comprising 6 cartons, each containing 4 pre-filled syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 11/2020
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
7. Instructions for use
Read the instructions for use before you start using Benepali and each time you get a refill of your prescription. There may be new information.
A single-use pre-filled syringe contains one 25 mg dose of Benepali.
Find a well-lit, clean surface and gather all the equipment you need:
Not included in pack:
A. Before you start
1. Inspect the pre-filled syringe:
Check the expiry date on the pre-filled syringe label.
2. Inspect the solution:
Look at the medicine in the pre-filled syringe.
The medicine should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein.
3. Allow the medicine to reach room temperature:
Remove one pre-filled syringe from the refrigerator and leave at room temperature for at least 30 minutes before injecting.
This is important to make the medicine easier and more comfortable to inject.
4. Choose an injection site:
The Benepali pre-filled syringe is for a subcutaneous injection. It should be injected into the thigh, abdomen, or back of the upper arm (see image on the left).
Rotate the site for each injection.
If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.
B. Injection steps
Step 1:
Wash your hands with soap and water.
Step 2:
Wipe the skin at the injection site with an alcohol swab.
See ‘Choose an injection site’ for guidance with choosing an injection site.
Step 3:
Pull the needle cover straight off and dispose of it in the bin or sharps container.
See ‘Choose an injection site’ for guidance with choosing an injection site.
Step 4:
Gently pinch a fold of skin at the cleaned injection site. Hold the pre-filled syringe at 45 degrees to the skin. With a quick, dart-like motion, insert the needle fully into the skin.
You can let go of the skin that you are pinching after the needle is completely inserted.
Step 5:
Slowly push down the plunger to inject all of the Benepali solution.
Step 6:
When the syringe is empty, remove the needle from the skin at the same angle as inserted.
Disposal:
Dispose of the entire syringe in an approved sharps container.
Check with your healthcare provider for instructions on how to properly dispose a filled sharps container. Sharps disposal containers may be purchased at your local pharmacy.
C. Injection site care
If there is bleeding at the injection site, press a gauze pad over the injection site.
If needed, cover the injection site with a plaster.
Innovation House, 70 Norden Road, Maidenhead, Berkshire, SL6 4AY
+44 (0) 203 608 8622