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 is: PLGB 15105/0174.
ORENCIA 125 mg solution for injection in pre-filled pen
ORENCIA 125 mg solution for injection in pre-filled pen
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.
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 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
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 pen has not been studied in children and adolescents under the age of 18 years. Therefore, ORENCIA solution for injection in pre-filled pen is not recommended for use in this patient population.
ORENCIA powder for concentrate for solution for infusion is available for paediatric patients 6 years of age and older.
ORENCIA solution for injection pre-filled syringe is available for paediatric patients 2 years of age and older.
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.
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 or use machines. However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive 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 abatacept 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.
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):
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 solution for injection (injection) is a clear, colourless to pale yellow solution provided in a pre-filled pen called ClickJect.
ORENCIA is available in the following presentations:
Not all pack sizes may be marketed.
This leaflet was last revised in July 2023
HOW TO USE
ClickJect Pre-filled Pen
125 mg, solution for injection
Before you use the ClickJect Pen for the first time, make sure your healthcare provider shows you the right way to use it.
Keep the pen refrigerated until ready to use. DO NOT FREEZE.
If you have questions about this product, please read the Package Leaflet.
Get to know the ClickJect Pre-filled Pen
(only the ClickJect Pre-filled Pen is included in the package):
Proceed to Step 1
Let your ClickJect Pen warm up.
Remove one Pen from the refrigerator and let it rest at room temperature (about 25°C) for 30 minutes.
DO NOT remove the needle cover from the Pen while allowing it to reach room temperature.
Wash your hands well with soap and water to prepare for injection.
Examine the ClickJect Pre-filled Pen:
Proceed to Step 2
Choose your injection site in either the abdomen or front of the thigh.
Each week you can use the same area of your body, but use a different injection site in that area.
DO NOT inject into an area where the skin is tender, bruised, red, scaly, or hard. Avoid any areas with scars or stretch marks.
Gently clean injection site with an alcohol swab and let your skin dry.
Pull orange needle cover STRAIGHT off.
Proceed to Step 3
Position the ClickJect Pen so you can see the viewing window and it’s at a 90º angle to the injection site. With your other hand, gently pinch the cleaned skin.
Complete ALL steps for full-dose delivery:
Push DOWN on skin to unlock the Pen.
Press button, HOLD for 15 seconds AND watch window.
Remove the ClickJect Pre-filled Pen from the injection site by lifting it straight up. Once you remove it from your skin, the transparent tip will lock over the needle. Release skin pinch.
Proceed to Step 4
Care of injection site:
Dispose of used ClickJect Pre-filled Pen into sharps disposal container right away after use. Should you have any questions, ask your pharmacist.
See Package Leaflet for additional disposal information.
If your injection is administered by a caregiver, this person must also handle the Pen carefully to prevent accidental needle stick injury and possibly spreading infection.
Keep Pen and the disposal container out of the reach of children.
Record the date, time and site where you injected.