Package Leaflet: Information for the User
ORENCIA50mg solution for injection in pre-filled syringe
ORENCIA87.5mg solution for injection in pre-filled syringe
ORENCIA125mg solution for injection in pre-filled syringe
abatacept
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Contents of the pack:
ORENCIA contains the active substance abatacept, a protein that is produced in cell cultures. ORENCIA reduces the attack of the immune system on normal tissues by interfering with immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T lymphocytes that participate in the inflammatory response of the immune system.
ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults and also polyarticular juvenile idiopathic arthritis in children from 2 years of age.
Rheumatoid Arthritis
Rheumatoid arthritis is a progressive disease of long duration that, if left untreated, can have serious consequences, such as destruction of joints, increased disability, and inability to perform daily activities. In people with rheumatoid arthritis, the body's own immune system attacks normal tissues, producing pain and swelling in the joints. This can damage the joints. Rheumatoid arthritis (RA) affects each person differently. In most people, joint symptoms develop gradually over several years. However, in some patients, RA can progress rapidly, and in others, it can occur for a limited period and then go into remission. RA is usually a chronic (long-term) disease, progressive. This means that, even if you receive treatment, you may still have symptoms or not, and RA could continue to damage your joints. With the best treatment plan for you, you may be able to delay this disease process, which could 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 have not responded sufficiently to treatment with other disease-modifying medicines or with another group of medicines called "tumor necrosis factor (TNF) inhibitors". It is used in combination with a medicine called methotrexate.
ORENCIA may also be used with methotrexate to treat rheumatoid arthritis that is progressive and has high activity without prior treatment with methotrexate.
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 sufficiently well to these medicines, you may be given ORENCIA to:
ORENCIA alone or in combination with methotrexate is used to treat psoriatic arthritis.
Polyarticular Juvenile Idiopathic Arthritis
Polyarticular juvenile idiopathic arthritis is a long-term inflammatory disease that affects one or more joints in children and adolescents.
ORENCIA solution for injection in pre-filled syringe is used in children and adolescents from 2 to 17 years of age when previous treatment with a 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 not appropriate.
ORENCIA is used to:
Do not use ORENCIA
Warnings and precautions
Talk to your doctor, pharmacist, or nurse:
Your doctor may also perform blood tests to check your blood values.
Children and adolescents
ORENCIA solution for injection in pre-filled syringe has not been studied in children and adolescents under 2 years of age. Therefore, it is not recommended to use ORENCIA solution for injection in pre-filled syringe in this patient population.
Using ORENCIA with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
ORENCIA must not be usedwith biological medicines for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is not enough evidence to recommend that it be given with anakinra and rituximab.
ORENCIA can be usedwith other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatory drugs like ibuprofen or diclofenac.
Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.
Pregnancy and breastfeeding
The effects of ORENCIA in pregnancy are not known, therefore, you should not use ORENCIA if you are pregnant unless your doctor recommends it.
If you received ORENCIA during your pregnancy, your baby may have a higher risk of getting an infection. It is essential that you inform your baby's doctors and other healthcare professionals about the use of ORENCIA during your pregnancy before any vaccine is given to your baby.
It is not known whether ORENCIA passes into breast milk. You must stop breastfeedingif you are being treated with ORENCIA, until 14 weeks after the last dose.
Driving and using machines
It is unlikely that the use of ORENCIA will affect your ability to drive, ride a bicycle, or use machines. However, if you feel tired or unwell after receiving ORENCIA, do not drive, ride a bicycle, or operate any machinery.
ORENCIA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
ORENCIA solution for injection is injected under the skin (subcutaneously).
Recommended dose in adults
The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg every week, regardless of weight.
Your doctor may start your treatment with ORENCIA with or without a single dose of powder for concentrate for solution for infusion (which is given into a vein, usually in the arm, over a period of 30 minutes). If you are given a single intravenous dose to start treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by weekly subcutaneous injections of 125 mg.
ORENCIA can be used in adults over 65 years of age without the need to change the dose.
Use in children and adolescents
For patients from 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
Patient's body weight | 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 receiving treatment with intravenous ORENCIA and want to switch to subcutaneous ORENCIA, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.
Your doctor will inform you about the duration of treatment and what other medicines, including other disease-modifying medicines, you can continue to take while being treated with ORENCIA.
Initially, your doctor or nurse may inject ORENCIA for you. However, you and your doctor may decide that you can inject ORENCIA yourself. In this case, you will be instructed on how to inject ORENCIA yourself.
Consult your doctor if you have any doubts about the administration of the 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 you use more ORENCIA than you should
If this happens, contact your doctor immediately, who will monitor you for any signs or symptoms of adverse effects and treat them if necessary.
If you forget to use ORENCIA
Keep track of your next dose. It is very important to use ORENCIA exactly as your doctor tells you. If you forget your dose within 3 days of when it was due, give yourself the dose as soon as you remember, and then follow your original schedule on the designated day. If you forget your dose for more than 3 days, ask your doctor when you should give your next dose.
If you stop treatment with ORENCIA
The decision to stop treatment with 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 adverse effects, although not all people suffer from them. The most frequent adverse effects that occur with ORENCIA are upper respiratory tract infections (including nose and throat infections), headache, and nausea. ORENCIA may cause serious adverse effects that may require treatment.
Possible Serious Adverse Effectsinclude serious infections, malignant neoplasms (cancer), and allergic reactions, as listed below.
Inform your doctor immediatelyif you notice any of the following symptoms:
Inform your doctor immediatelyif you notice any of the following:
The symptoms described above may be signs of the adverse effects listed below, which have been observed with ORENCIA in clinical trials in adults:
List of Adverse Effects:
Very Common(may affect more than 1 in 10 patients):
Common(may affect up to 1 in 10 patients):
Uncommon(may affect up to 1 in 100 patients):
Rare(may affect up to 1 in 1000 patients):
Children and Adolescents with Juvenile Idiopathic Polyarticular Arthritis
The adverse effects in children and adolescents with juvenile idiopathic arthritis are similar to those experienced in adults described above, with the following differences:
Common(may affect up to 1 in 10 patients):
Uncommon(may affect up to 1 in 100 patients):
Reporting Adverse Effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing 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 stated on the label after EXP and on the carton after CAD. The expiry date is the last day of the month indicated.
Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Store in the original packaging to protect from light.
Do not use this medicine if the liquid is cloudy or discolored, or has large particles. The liquid should be colorless to pale yellow.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.
ORENCIA Composition
ORENCIA 50 mg injectable solution in a pre-filled syringe
ORENCIA 87.5 mg injectable solution in a pre-filled syringe
ORENCIA 125 mg injectable solution in a pre-filled syringe
Product Appearance and Container Contents
ORENCIA injectable solution (injection) is a clear, colorless to pale yellow solution.
ORENCIA is available in the following presentations:
ORENCIA 50 mg injectable solution in a pre-filled syringe with a white plunger
ORENCIA 87.5 mg injectable solution in a pre-filled syringe with a light blue plunger
ORENCIA 125 mg injectable solution in a pre-filled syringe with an orange plunger
Only some pack sizes may be marketed.
Marketing Authorization Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
CATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)
Italy
Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15
Ireland
Date of Last Revision of this Leaflet:
Other Sources of Information
Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.
Important Instructions for Use. Read Carefully.
HOW TO USE
ORENCIA 50 mg
ORENCIA 87.5 mg
ORENCIA 125 mg
injectable solution in a pre-filled syringe with a needle guard
Abatacept
Subcutaneous route
Read these instructions before using the ORENCIA pre-filled syringe.
Before using the pre-filled syringe for the first time, make sure your doctor, nurse, or pharmacist has shown you the correct way to use it.
Keep the pre-filled syringe refrigerated until you are ready to use it.DO NOT FREEZE.
If you have any questions about this product, please read the Leaflet.
BEFORE STARTING:
Get to know the pre-filled syringe
There are 3typesof pre-filled syringes:
The type of pre-filled syringe you will 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 wing extensionthat facilitates handling and injection, and a needle guardthat automatically covers the needle after completing the injection.
DO NOTremove the needle cap until you are ready to inject.
DO NOTpull the plunger back at any time.
DO NOTrecap the pre-filled syringe at any time, as this may damage, bend, or break the needle.
Always hold the syringe by the body.
Proceed to Step 1
Step1: Preparation for ORENCIA injection
Gather all necessary items for your injection on a clean and flat surface.
The pack contains only the pre-filled syringe:
Let your pre-filled syringe reach room temperature.
Remove a pre-filled syringe from the refrigerator and wait 30minutesfor it to reach room temperature.
Wash your hands thoroughly with water and soap to prepare for the injection.
Proceed to Step 2
Step2: Examine the pre-filled syringe
Hold the pre-filled syringe by the body with the needle cap pointing downwards as shown.
Do notuse it if the expiration date has passed.
Do notuse it if it is cracked or broken.
Check the liquid
Check the liquidin the pre-filled syringe through the inspection window. It should be clear and colorless to pale yellow.
You may see a small air bubble. Do nottry to remove it.
Do not inject if the liquid is cloudy, has changed color, or has visible particles.
Note: The figure shows the 50 mg pre-filled syringe
Proceed to Step 3
Step3: Check the dose on the pre-filled syringe
Hold the syringe at eye level. Look carefully to make sure the amount of liquid in the pre-filled syringe is at or just above the fill linefor your prescribed dose.
Do notuse it if the pre-filled syringe does not have the correct amount of liquid. Contact your doctor, nurse, or pharmacist for further instructions.
Proceed to Step 4
Step4: Choose and prepare the injection site
Choose the injection siteon the abdomen, front of the thighs, or the outer aspect of the upper arm(only if administered by a caregiver).
Change the injection site
Do notadminister the injection in any area with scars or stretch marks.
Gently clean the injection site
Remove the needle capby holding the pre-filled syringe body with one hand and pulling the cap straight off with your other hand.
Do notreplace the needle cap after removal. You can discard the cap in the household trash after the injection.
Note: It is normal to see a drop of liquid coming out of the needle.
DO NOTrecap the pre-filled syringe, as this may damage the needle.
Proceed to Step 5
Step5: Inject your dose of ORENCIA
Hold the bodyof the pre-filled syringe in your hand using your thumb and index finger. With your other hand, pinch the skinthat you have cleaned.
Insert the needle
Gently insertthe needle into the pinched skin at a 45-degree angle.
Complete ALL the steps to administer your full dose of medication
Inject: press the plungerwith your thumb until the end
Remove the needle guard: slowly lift your thumb off the plungerto activate the needle guard.
Confirm:after completing the injection, the needle guard will cover the needleand you will hear a click.
Remove the pre-filled syringefrom the injection site and release the pinched skin.
Proceed to Step 6
Step6: After the injection
Take care of the injection site:
Dispose of the used pre-filled syringein the sharps container immediately after use. If you have any questions, ask your pharmacist.
For more information on disposal, see the Leaflet.
If the injection is administered by a caregiver, this person should also handle the syringe with care to avoid accidental needlestick injuries and possible infection transmission.
Keep this medication and the sharps container out of the sight and reach of children.
Important Instructions for Use
Read these instructions carefully and follow them step by step.
You will receive instructions from your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe.
Do not attempt to self-inject until you are sure you understand how to prepare and administer the injection. After proper training, you can administer the injection yourself or have it administered by another person, such as a family member or friend.
Before starting–things to do and not to do
Do
Sharps containers are puncture-resistant disposal boxes that can be purchased at many stores.
Do not
STEP1: Have the syringe ready
STEP2: Choose and prepare the injection site
Have the syringe ready for use immediately after preparing the injection site.
STEP3: Inject ORENCIA
An air bubble in the liquid of the syringe. It is not necessary to remove the air bubble.
You may notice a drop of liquid coming out of the needle. This is normal and will not affect the dose.
STEP4: Disposal of the syringe and recording
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.