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The product code(s) for this leaflet is: PLGB 15105/0136.
ORENCIA 50 mg, 87.5 mg and 125 mg solution for injection (pre-filled syringe)
ORENCIA 50 mg solution for injection in pre-filled syringe
ORENCIA 87.5 mg solution for injection in pre-filled syringe
ORENCIA 125 mg solution for injection in pre-filled syringe
abatacept
1. What ORENCIA is and what it is used for
2. What you need to know before you use ORENCIA
3. How to use ORENCIA
4. Possible side effects
5. How to store ORENCIA
6. Contents of the pack and other information
ORENCIA contains the active substance abatacept, a protein produced in cell cultures. ORENCIA lessens the immune system's attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T cells involved in the immune system's inflammatory response.
ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults and also polyarticular juvenile idiopathic arthritis in children 2 years of age and older.
Rheumatoid Arthritis
Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities. In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints. This can cause joint damage. Rheumatoid arthritis (RA) affects everyone differently. In most people, joint symptoms develop gradually over several years. However, in some, RA may progress rapidly and yet other people may have RA for a limited period of time and then enter a period of remission. RA is usually a chronic (long-term), progressive disease. This means, even if you’re on treatment, whether or not you’re still having symptoms, RA could be continuing to damage your joints. By finding the right treatment plan for you, you may be able to slow down this disease process, which may help reduce long-term joint damage, as well as pain and fatigue and improve your overall quality of life.
ORENCIA is used to treat moderate to severe active rheumatoid arthritis when you do not respond well enough to treatment with other disease-modifying medicines or with another group of medicines called 'tumour necrosis factor (TNF) blockers'. It is used in combination with a medicine called methotrexate.
ORENCIA can also be used with methotrexate to treat highly active and progressive rheumatoid arthritis without previous methotrexate treatment.
ORENCIA is used to:
Psoriatic Arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. If you have active psoriatic arthritis you will first be given other medicines. If you do not respond well enough to these medicines, you may be given ORENCIA to:
ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate.
Polyarticular Juvenile Idiopathic Arthritis
Polyarticular juvenile idiopathic arthritis is a long-term inflammatory disease affecting one or more joints in children and adolescents.
ORENCIA solution for injection in pre-filled syringe is used in children and adolescents aged 2 to 17 years when a previous disease-modifying medicine has not worked well or is not suitable for them. ORENCIA is usually used in combination with methotrexate, although ORENCIA may also be used alone if treatment with methotrexate is inappropriate.
ORENCIA is used to:
Talk to your doctor, pharmacist or nurse:
Your doctor may also do tests to examine your blood values.
ORENCIA solution for injection in pre-filled syringe has not been studied in children and adolescents under 2 years of age. Therefore, ORENCIA solution for injection in pre-filled syringe is not recommended for use in this patient population.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
ORENCIA should not be used with biological medicines for rheumatoid arthritis, including TNF-blockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its being given with anakinra and rituximab.
ORENCIA can be used with other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatories such as ibuprofen or diclofenac.
Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.
The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if you are pregnant unless your doctor specifically recommends it.
If you received ORENCIA during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your ORENCIA use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
It is not known whether ORENCIA passes into human milk. You must stop breast-feeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.
The use of ORENCIA is not expected to affect the ability to drive, cycle or use machines. However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive, cycle or operate any machinery.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
ORENCIA solution for injection is injected under the skin (subcutaneous use).
The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg given every week regardless of weight.
Your doctor may start your ORENCIA treatment with or without a one-time dose of powder for concentrate for solution for infusion (given to you into a vein, usually in your arm, over a period of 30 minutes). If a single intravenous dose is given to start the treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by the weekly 125 mg subcutaneous injections.
ORENCIA can be used by adults over 65 with no change in dose.
For patients 2 to 17 years of age with polyarticular juvenile idiopathic arthritis, the recommended weekly dose of ORENCIA solution for injection in pre-filled syringe is based on body weight:
Weekly Dose of ORENCIA
Body Weight of Patient Dose
10 kg to less than 25 kg 50 mg
25 kg to less than 50 kg 87.5 mg
50 kg or more 125 mg
If you are already on intravenous ORENCIA treatment and wish to transition to ORENCIA subcutaneous, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.
Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.
At the start, your doctor or nurse may inject ORENCIA. However, you and your doctor may decide that you can inject ORENCIA yourself. In this case, you will get training on how to inject ORENCIA yourself.
Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed instructions for the preparation and administration of ORENCIA at the end of this leaflet (see "Important instructions for use").
If this happens, contact immediately your doctor who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Keep track of your next dose. It is very important to use ORENCIA exactly as prescribed by your doctor. If you miss your dose within three days of when you are supposed to take it, take your dose as soon as you remember and then follow your original dosing schedule on your chosen day. If you miss your dose by more than three days, ask your doctor when to take your next dose.
The decision to stop using ORENCIA should be discussed with your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects with ORENCIA are infections of the upper airway (including infections of the nose and throat), headache and nausea, as listed below. ORENCIA can cause serious side effects, which may need treatment.
Possible serious side effects include serious infections, malignancies (cancer) and allergic reactions, as listed below.
Tell your doctor immediately if you notice any of the following:
Tell your doctor as soon as possible if you notice any of the following:
The symptoms described above can be signs of the side effects listed below, all of which have been observed with ORENCIA in adult clinical trials:
List of side effects:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Children and adolescents with polyarticular juvenile idiopathic arthritis
The side effects experienced in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults as described above with the following differences:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 label and the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Store in the original package in order to protect from light.
Do not use this medicine if the liquid is cloudy or discoloured, or has large particles. The liquid should be clear to pale yellow.
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 to protect the environment.
ORENCIA 50 mg solution for injection in pre-filled syringe
ORENCIA 87.5 mg solution for injection in pre-filled syringe
ORENCIA 125 mg solution for injection in pre-filled syringe
ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution.
ORENCIA is available in the following presentations:
ORENCIA 50 mg solution for injection in pre-filled syringe with white plunger
ORENCIA 87.5 mg solution for injection in pre-filled syringe with light blue plunger
ORENCIA 125 mg solution for injection in pre-filled syringe with orange plunger
Not all pack sizes may be marketed.
This leaflet was last revised in March 2022
HOW TO USE
ORENCIA 50 mg
ORENCIA 87.5 mg
ORENCIA 125 mg
solution for injection in pre-filled syringe with needle guard
Abatacept
Subcutaneous use
Before you use the pre-filled syringe for the first time, make sure your doctor, nurse or pharmacist shows you the right way to use it.
Keep refrigerated until ready to use. DO NOT FREEZE.
If you have questions about this product, please read the Package Leaflet.
Get to know your Pre-filled Syringe
There are 3 types of pre-filled syringes:
50 mg/0.4 mL white plunger
87.5 mg/0.7 mL light blue plunger
125 mg/mL orange plunger
The type of pre-filled syringe you receive depends on the dose prescribed by your doctor. The 125 mg/mL pre-filled syringe is shown below.
Before Use
After Use
The pre-filled syringe has a flange extender that makes it easier to hold and inject, and a needle guard that automatically covers the needle after a complete injection.
DO NOT remove the needle cover until you are ready to inject.
DO NOT PULL back the plunger at any time.
DO NOT RECAP the pre-filled syringe at any time, as this may damage, bend, or break the needle.
Always hold the syringe by its body.
Proceed to Step 1
Gather supplies for your injection on a clean, flat surface.
Only the pre-filled syringe is included in the package:
Let your Pre-filled syringe warm up.
Remove one pre-filled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature.
Wash your hands well with soap and water to prepare for injection.
Proceed to Step 2
Hold the pre-filled syringe by the body with the needle cover pointing down as shown.
Check the liquid
Check the liquid in the pre-filled syringe through the viewing window. It should be clear and colourless to pale yellow.
You may see a small air bubble. Do not attempt to remove it.
Do not inject if the liquid is cloudy, discoloured, or has particles.
Note: the figure shows the 50 mg pre-filled syringe
Proceed to Step 3
Hold the syringe at eye level. Look closely to make sure that the amount of liquid in the pre-filled syringe is at or just above the fill line for your prescribed dose:
Do not use if your pre-filled syringe does not have the correct amount of liquid. Contact your doctor, nurse, or pharmacist for further instructions.
Proceed to Step 4
Choose your injection site in either the abdomen, front of the thighs, or outer area of upper arm (only if caregiver administered).
Change injection site
Injection Areas
Self-Injection and Caregiver
Caregiver ONLY
Gently clean injection site
Remove the needle cover by holding the body of the pre-filled syringe with one hand and pulling the cover straight off with your other hand.
Do not put the needle cover back on the needle after you remove it. You can discard the cap in your household waste after the injection.
Note: It is normal to see a drop of fluid leaving the needle.
DO NOT RECAP the Pre-filled Syringe, as this may damage the needle.
Proceed to Step 5
Hold the body of the pre-filled syringe in your hand using your thumb and index finger. With your other hand, pinch the cleaned skin.
Insert the needle
Gently insert the needle into the pinched skin at a 45º angle.
Complete ALL steps to deliver your full dose of the medicine
Inject: push the plunger with your thumb as far as it will go.
Release Needle Guard: slowly lift your thumb from the plunger to activate the needle guard.
Confirm: after a complete injection, the needle guard will cover the needle and you may hear a click.
Remove the pre-filled syringe from the injection site and let go of the pinched skin.
Proceed to Step 6
Care of injection site:
Dispose of the used pre-filled syringe into sharps disposal container right away after use. Should you have any questions, ask your pharmacist.
See the Package Leaflet for additional disposal information.
If your injection is administered by a caregiver, this person must also handle the syringe carefully to prevent accidental needle stick injury and possibly spreading infection.
Keep this medicine and the disposal container out of the sight and reach of children.
Please read these instructions carefully and follow them step by step.
You will be trained by your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe.
Don’t try to self-inject until you are sure that you understand how to prepare and give the injection. After proper training, you can give the injection to yourself, or it can be given by another person, for example a family member or friend.
Figure 1
Before you start - some Do's and Don'ts
Do
Don’t
A. Check the expiry date and batch number on the carton
B. Let the syringe warm up
C. Check the liquid in the syringe
Figure 2
D. Gather your additional supplies and keep them within easy reach.
E. Wash your hands thoroughly with soap and warm water.
Have the syringe ready for use immediately after you have prepared your injection site.
A. Choose an area of your body for the injection (injection site)
Figure 3
B. Prepare your injection site
A. Remove the needle cover (cap) only when you are ready to administer the injection.
Figure 4
There may be a small air bubble in the liquid in the syringe. There is no need to remove the air bubble.
You may notice a drop of fluid leaving the needle. This is normal and will not affect your dose.
B. Position the syringe and inject ORENCIA
Figure 5 Figure 6
A. Dispose of the used syringe in a Sharps container.
B. Keep a record of your injection
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.