Orencia

Package leaflet: Information for the patient

ORENCIA 250 mg powder for concentrate for solution for infusion

abatacept
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What ORENCIA is and what it is used for

ORENCIA contains the active substance abatacept, a protein produced in cell cultures. ORENCIA reduces the immune system's attack 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-cells involved in the inflammatory response of the immune system.

ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults, as well as polyarticular juvenile idiopathic arthritis in children aged 6 years and older.

Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, long-term systemic disease which, if left untreated, can lead to serious consequences such as joint destruction, increased disability, and difficulty performing daily activities. In people with rheumatoid arthritis, the immune system attacks the body's normal tissues, causing joint pain and swelling. This can result in joint damage. Rheumatoid arthritis (RA) affects each person differently. In most individuals, joint symptoms develop gradually over several years. However, in some people, RA may progress rapidly, while others may experience RA for a limited period before entering remission. RA is usually a chronic (long-term) and progressive disease. This means that, even with treatment and regardless of whether symptoms are still present, RA may continue to damage the joints. By identifying the appropriate treatment strategy for you, it may be possible to slow down this pathological process, which could help reduce long-term joint damage, as well as pain and fatigue, and improve overall quality of life.

ORENCIA is used to treat moderate to severe active rheumatoid arthritis when there is an inadequate response to treatment with other disease-modifying drugs 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 in combination with methotrexate to treat very active and progressive rheumatoid arthritis without prior treatment with methotrexate.

Psoriatic Arthritis

Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, a skin inflammatory condition. If you have active psoriatic arthritis, you will initially be treated with other medicines. If you do not respond adequately to these medicines, you may be treated with ORENCIA in order to:

• Reduce the signs and symptoms of your disease.
• Slow down damage to bones and joints.
• Improve physical function and the ability to carry out normal daily activities.

ORENCIA is used to treat psoriatic arthritis either alone or in combination with methotrexate.

Polyarticular Juvenile Idiopathic Arthritis

Polyarticular juvenile idiopathic arthritis is a chronic inflammatory disease affecting one or more joints in children and adolescents.

ORENCIA powder for concentrate for solution for infusion is used in children and adolescents aged 6 to 17 years when a previous disease-modifying medicine has not worked well enough or is not suitable for them. ORENCIA is usually used in combination with methotrexate, although ORENCIA may also be used alone if there is intolerance or if treatment with methotrexate is not appropriate.

ORENCIA is used to:

• Inhibit the progression of joint damage.
• Improve physical function.
• Improve other signs and symptoms of polyarticular juvenile idiopathic arthritis.

2. What you need to know before using ORENCIA

Do not use ORENCIA

• if you are allergic to abatacept or to any of the other ingredients of this medicine (listed in section 6).
• if you have a severe or uncontrolled infection, do not start treatment with ORENCIA. An infection may increase your risk of serious side effects with ORENCIA.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse:

• if you have allergic reactions such as chest tightness, wheezing, severe dizziness or mental confusion, swelling or rash, contact your doctor immediately.

• if you, your partner, or your caregiver notice the onset or worsening of neurological symptoms, including general muscle weakness, vision problems, difficulty speaking, a change in the way you walk, or problems with balance, changes in thinking, memory, and orientation causing confusion and personality changes, contact your doctor immediately, as these may be symptoms of a very rare, serious, and potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML).

• if you have any kind of infection, including long-term or localized infections, or if you frequently get infections, or if you have symptoms of infection (e.g. fever, feeling unwell, dental problems), it is important to inform your doctor. ORENCIA may reduce your body’s ability to fight infections and treatment may make you more susceptible to infections or worsen an existing infection.

• if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever), inform your doctor. Before you are given ORENCIA, your doctor will perform tests for tuberculosis or a skin test.

• if you have viral hepatitis, inform your doctor. Before you are given ORENCIA, your doctor will perform tests for hepatitis.

• if you have cancer, your doctor will decide whether you can still be given ORENCIA.

• if you have recently been vaccinated or are planning to be vaccinated, inform your doctor. Some vaccines should not be given while you are receiving ORENCIA. Check with your doctor before receiving any vaccine. It is recommended that patients with polyarticular juvenile idiopathic arthritis, if possible, complete the vaccination schedule recommended by current vaccination guidelines before starting treatment with ORENCIA. Some vaccinations can cause vaccine-related infections. If you receive ORENCIA during pregnancy, the baby may be at increased risk of acquiring such an infection for approximately 14 weeks after the last dose received during pregnancy. It is important to inform the baby’s doctors and other healthcare providers about your use of ORENCIA during pregnancy so they can determine when the baby should receive a vaccine.

• if you are using a blood glucose monitoring system to check your blood glucose levels. ORENCIA contains maltose, a type of sugar that may cause falsely elevated glucose readings when measured with certain types of glucose monitoring systems. Your doctor may recommend a different method for measuring blood glucose levels.

Your doctor may also perform blood tests to monitor your blood values.
Children and adolescents
ORENCIA powder for concentrate for solution for infusion has not been studied in children under 6 years of age; therefore, ORENCIA powder for concentrate for solution for infusion is not recommended for use in this patient population.
ORENCIA solution for injection in pre-filled syringe is available for subcutaneous administration in pediatric patients aged 2 years and older.
Other medicines and ORENCIA
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
ORENCIA must not be used with biological medicines for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is insufficient evidence to support its use with anakinra or rituximab.
ORENCIA may be used with 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 during pregnancy are unknown; therefore, you must not use ORENCIA during pregnancy unless specifically recommended by your doctor.

• If you are a woman of childbearing age, you must use a reliable method of contraception (birth control) while using ORENCIA and for up to 14 weeks after the last dose. Your doctor will advise you on suitable methods.
• If you become pregnant while using ORENCIA, inform your doctor.

If you receive ORENCIA during pregnancy, the baby may be at increased risk of infection. It is important to inform the baby’s doctors and other healthcare providers about your use of ORENCIA during pregnancy before the baby receives any vaccine (for more information, see the section on vaccinations).
It is not known whether ORENCIA passes into human breast milk. You must stop breastfeeding while being treated with ORENCIA and for up to 14 weeks after the last dose.
Driving and using machines
ORENCIA is not expected to affect your ability to drive, ride a bicycle, or operate machinery. However, if you feel tired or unwell after treatment with ORENCIA, you should not drive, ride a bicycle, or use machinery.
ORENCIA contains sodium
This medicine contains 34.5 mg of sodium (a main component of table salt) per maximum dose of 4 vials (8.625 mg of sodium per vial). This corresponds to 1.7% of the maximum recommended daily dietary intake for an adult.

3. How to use ORENCIA

ORENCIA will be administered to you under the supervision of an experienced physician.
Recommended dose in adults
The recommended dose of abatacept for adults with rheumatoid arthritis or psoriatic arthritis is based on
body weight:

Your doctor will inform you about the duration of treatment and which other medicines, including disease-modifying antirheumatic drugs, you may continue to take during treatment with ORENCIA, if any.

ORENCIA can be used in people over 65 years of age without any dose adjustment.

Use in children and adolescents
For children and adolescents aged 6 to 17 years with polyarticular juvenile idiopathic arthritis weighing less than 75 kg, the recommended intravenous dose of abatacept is 10 mg/kg. Children weighing 75 kg or more should receive ORENCIA powder for concentrate for solution for infusion according to the adult dosing schedule.

How ORENCIA is administered to you
ORENCIA is given to you intravenously, usually into the arm, over a period of 30 minutes. This procedure is called an infusion. Healthcare personnel will monitor you during the ORENCIA infusion.

ORENCIA is supplied as a powder for solution for intravenous infusion. This means that before administration, ORENCIA is dissolved in water for injection, then further diluted with a 9 mg/mL (0.9%) sodium chloride injectable solution.

How often ORENCIA is administered to you
ORENCIA will be administered again 2 and 4 weeks after the first infusion. After that, you will receive a dose every 4 weeks. Your doctor will inform you about the duration of treatment and which other medicines you may continue to take during treatment with ORENCIA.

If you are given more ORENCIA than you should
If this happens, your doctor will monitor you for any signs or symptoms of adverse reactions and, if necessary, treat these symptoms.

If you miss a dose of ORENCIA
If you do not receive ORENCIA when you should, ask your doctor when to schedule the 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 questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common side effects with ORENCIA are upper respiratory tract infections (including infections of the nose and throat), headache and nausea, as listed below. ORENCIA may cause serious side effects, which may require treatment.
Possible serious side effects include serious infections, tumours (cancer), and allergic reactions, as listed below.
Contact your doctor immediately if you notice any of the following side effects:

• severe skin redness, hives, or other symptoms of an allergic reaction
• swelling of the face, hands or feet
• breathing or swallowing difficulties
• fever, persistent cough, weight loss, lack of energy

Contact your doctor as soon as possible if you notice any of the following side effects:

• general feeling of being unwell, dental problems, burning sensation when urinating, painful skin redness, painful skin blisters, cough

The symptoms described above may be signs of the side effects listed below, all of which have been observed with ORENCIA in clinical studies in adults:
Very common (may affect more than 1 in 10 people):

• upper respiratory tract infections (including infections of the nose, throat and sinuses)

Common (may affect up to 1 in 10 people):

• lung infections, urinary tract infections, painful skin blisters (herpes), influenza
• headache, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhoea, nausea, stomach discomfort, mouth ulcers, vomiting
• skin rash
• fatigue, weakness
• abnormal liver function test results

Uncommon (may affect up to 1 in 100 people):

• dental infections, fungal nail infection, muscle infection, blood infection, pus accumulation under the skin, kidney infection, ear infection
• low levels of white blood cells in the blood
• skin tumour, skin warts
• low levels of platelets in the blood
• allergic reactions
• depression, anxiety, sleep disorders
• migraine
• numbness
• dry eye, reduced vision
• eye inflammation
• palpitations, increased heart rate, slowed heart rate
• low blood pressure, hot flushes, inflammation of blood vessels, redness
• breathing difficulties, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• throat tightness
• rhinitis
• increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne
• hair loss, itching, hives
• joint pain
• pain in the extremities
• absence of menstruation, excessive menstruation
• influenza-like illness, weight gain, infusion-related reactions

Rare (may affect up to 1 in 1,000 people):

• tuberculosis
• inflammation of the uterus, fallopian tubes and/or ovaries
• gastrointestinal infection
• white blood cell tumour, lung tumour

Children and adolescents with polyarticular juvenile idiopathic arthritis
Side effects observed in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those observed in adults as described above, with the following differences:
Common (may affect up to 1 in 10 people):

• upper respiratory tract infection (including infection of the nose, sinuses and throat)
• fever

Uncommon (may affect up to 1 in 100 people):

• blood in the urine
• ear infection

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORENCIA

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 “Scad.”. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C).
Keep in the original packaging to protect the medicine from light.
After reconstitution and dilution, the infusion solution is stable for 24 hours when stored in the refrigerator; however, for bacteriological reasons, immediate use is recommended.
Do not use this medicine if you notice cloudy particles, change in colour, or any other foreign particles present in the infusion solution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ORENCIA contains

• The active substance is abatacept. Each vial contains 250 mg of abatacept.
• After reconstitution, each mL contains 25 mg of abatacept.
• The other components are maltose, monosodium dihydrogen phosphate monohydrate and sodium chloride (see section 2 “ORENCIA contains sodium”).

Description of the appearance of ORENCIA and contents of the pack
ORENCIA powder for concentrate for solution for infusion is a white to almost white powder
which may appear solid or fragmented.
ORENCIA is available in packs containing 1 vial and 1 silicone-free syringe, and in multiple packs
containing 2 or 3 vials and 2 or 3 silicone-free syringes (2 or 3 packs of 1).
It is possible that not all pack sizes are marketed.

Marketing Authorisation 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

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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The following information is intended exclusively for healthcare professionals:

Reconstitution and dilution must be performed in accordance with good preparation practices,
particularly maintaining aseptic conditions.
Dosage calculation: see section 3 “How to use ORENCIA” of the Package Leaflet.
Reconstitution of the vials: under aseptic conditions, reconstitute each vial with 10 mL of water for
injections, using the single-use, silicone-free syringe supplied with each vial and an 18–21 gauge
needle. Remove the cap from the vial and disinfect the stopper with an alcohol-impregnated cotton
swab. Insert the needle of the syringe into the vial through the center of the rubber stopper, directing the
stream of water for injections toward the glass wall of the vial. Do not use the vial if it is not under vacuum.
Remove the syringe and needle after injecting 10 mL of water for injections into the vial. To minimize
foam formation in the ORENCIA solution, gently rotate the vial by turning it until the contents are
completely dissolved. Do not shake. Do not vigorously or repeatedly agitate. At the time of complete
dissolution of the powder, the vial should be vented with a needle to dissolve any foam that may be
present. After reconstitution, the solution should be clear and colorless to pale yellow. Do not use if
opaque particles, discoloration, or other foreign matter are present.
Preparation of the infusion: immediately after reconstitution, dilute the concentrate to a final volume
of 100 mL with an injectable solution of sodium chloride 9 mg/mL (0.9%). From a 100 mL infusion bag
or bottle, withdraw a volume of 0.9% sodium chloride injectable solution equal to the volume of the
reconstituted vials. Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or
bottle using the same single-use, silicone-free syringe supplied with each vial. Gently mix. The final
concentration of abatacept in the bag or bottle will depend on the amount of active substance added,
but will not exceed 10 mg/mL.
Administration: when reconstitution and dilution of ORENCIA have been performed under aseptic
conditions, the infusion solution may be used immediately or within 24 hours if stored refrigerated at
2°C to 8°C. However, for microbiological reasons, the solution should be used immediately. Prior to
administration, the ORENCIA solution must be visually inspected for the presence of particles or
discoloration. Do not use the solution if particles or discoloration are observed. The entire diluted
ORENCIA solution must be administered over a period of 30 minutes and must be administered using an
infusion set with a sterile, non-pyrogenic filter with low protein binding capacity (pore size 0.2 to 1.2 µm).
Do not store unused solution for later use.
Other medicines: ORENCIA must not be mixed with other medicinal products or co-infused with
other drugs in the same intravenous line. No studies have been conducted on the physical or biochemical
compatibility of ORENCIA when co-administered with other medicines.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer in use. This will help protect the environment.

Patient information leaflet

ORENCIA 50 mg solution for injection in pre-filled syringe, 87.5 mg solution for injection in pre-filled syringe, 125 mg solution for injection in pre-filled syringe

abatacept
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What ORENCIA is and what it is used for
2. What you need to know before using ORENCIA
3. How to use ORENCIA
4. Possible side effects
5. How to store ORENCIA
6. Contents of the pack and other information

1. What ORENCIA is and what it is used for

ORENCIA contains the active substance abatacept, a protein produced in cell cultures. ORENCIA
reduces the immune system's attack 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 cells involved in the immune system's inflammatory response.
ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults, as well as polyarticular juvenile idiopathic arthritis in children aged 2 years and older.

Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, long-term systemic disease which, if left untreated, can lead to serious consequences such as joint destruction, increasing disability, and difficulty performing daily activities. In people with rheumatoid arthritis, the immune system attacks the body's normal tissues, causing pain and swelling in the joints. This can lead to joint damage. Rheumatoid arthritis (RA) affects each person differently. In most people, joint symptoms develop gradually over several years. However, in some individuals, RA may progress rapidly, while others may have RA for a limited time and then enter a period of remission. RA is usually a chronic (long-term) and progressive disease. This means that, even if you are receiving treatment and regardless of whether you still have symptoms, RA may continue to damage your joints. By identifying the right treatment strategy for you, it may be possible to slow down this disease process, which can 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 the response to treatment with other disease-modifying drugs or with another group of medicines called 'tumour necrosis factor (TNF) inhibitors' is inadequate. It is used in combination with a medicine called methotrexate.

ORENCIA may also be used in combination with methotrexate to treat very active and progressive rheumatoid arthritis without prior treatment with methotrexate.

ORENCIA is used to:

• inhibit the progression of joint damage
• improve physical function

Psoriatic Arthritis
Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, an inflammatory skin condition. If you have active psoriatic arthritis, you will initially be treated with other medicines. If you do not respond adequately to these medicines, you may be treated with ORENCIA in order to:

• reduce the signs and symptoms of your disease
• slow down damage to bones and joints
• improve physical function and the ability to carry out normal daily activities

ORENCIA is used to treat psoriatic arthritis either alone or in combination with methotrexate.

Polyarticular Juvenile Idiopathic Arthritis
Polyarticular juvenile idiopathic arthritis is a chronic inflammatory disease affecting one or more joints in children and adolescents.

ORENCIA pre-filled syringe injection solution 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 not appropriate.

ORENCIA is used to:

• inhibit the progression of joint damage
• improve physical function
• improve other signs and symptoms of polyarticular juvenile idiopathic arthritis

2. What you need to know before using ORENCIA

Do not use ORENCIA

• if you are allergic to abatacept or to any of the other ingredients of this medicine (listed in section 6).
• if you have a severe or uncontrolled infection , do not start treatment with ORENCIA. An infection may increase your risk of serious side effects with ORENCIA.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse:

• if you have allergic reactions such as chest tightness, wheezing, severe dizziness or mental confusion, swelling or rash, inform your doctor immediately.
• if you, your partner, or caregiver notice the onset or worsening of neurological symptoms, including general muscle weakness, vision problems, difficulty speaking, a change in the way you walk, or a problem with balance, changes in thinking, memory, and orientation causing confusion and personality changes, contact your doctor immediately, as these may be symptoms of a very rare, serious, and potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML).
• if you have any type of infection, including long-term or localized infections, or if you frequently get infections, or if you have symptoms of infection (for example, fever, feeling unwell, dental problems), it is important that you inform your doctor. ORENCIA may reduce the ability

of your body to fight infections, and treatment may make you more susceptible to infections
or worsen an existing infection.

• if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, fatigue, mild fever), inform your doctor. Before using ORENCIA, your doctor will perform tests to check for tuberculosis or a skin test.
• if you have viral hepatitis, inform your doctor. Before using ORENCIA, your doctor will perform tests for hepatitis.
• if you have cancer, your doctor will decide whether you can still be given ORENCIA.
• if you have recently been vaccinated or are planning to get vaccinated, inform your doctor. Some vaccines should not be given while you are receiving ORENCIA. Check with your doctor before receiving any vaccine. Some vaccinations may cause vaccine-related infections. If you receive ORENCIA during pregnancy, the baby may be at increased risk of such infection for up to approximately 14 weeks after your last dose during pregnancy. It is important that you inform the child's doctors and other healthcare providers about your use of ORENCIA during pregnancy so they can determine when the child should receive a vaccine.

Your doctor may also perform tests to monitor your blood values.
Children and adolescents
ORENCIA pre-filled syringe injectable solution has not been studied in children and adolescents
under 2 years of age. Therefore, the use of ORENCIA in pre-filled syringes is not recommended
in this patient population.
Other medicines and ORENCIA
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
ORENCIA must not be used with biological medicines for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is insufficient evidence to support its use with anakinra or rituximab.
ORENCIA may be used with other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatory drugs such as
ibuprofen or diclofenac.
Ask your doctor or pharmacist for advice before taking any other medicine if you are using
ORENCIA.
Pregnancy and breastfeeding
The effects of ORENCIA in pregnancy are unknown; therefore, do not use ORENCIA if you are pregnant
unless specifically recommended by your doctor.

• if you are a woman of childbearing age, you must use a reliable method of contraception (birth control) while using ORENCIA and for up to 14 weeks after the last dose. Your doctor will advise you on suitable methods.
• if you become pregnant while using ORENCIA, inform your doctor.

If you receive ORENCIA during pregnancy, the baby may be at increased risk
of developing an infection. It is important that you inform the child's doctors and other healthcare providers
about your use of ORENCIA during pregnancy before the child receives any vaccine (for
more information, see the section on vaccinations).
It is not known whether ORENCIA passes into human breast milk. You must stop
breastfeeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.
Driving and using machines
ORENCIA is not expected to affect your ability to drive, ride a bicycle, or operate machinery. However, if you feel tired or unwell after treatment with ORENCIA, you must not drive, ride a bicycle, or use machinery.
ORENCIA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially 'sodium-free'.

3. How to use ORENCIA

Use this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

ORENCIA injectable solution is injected under the skin (subcutaneous use).

Recommended dose in adults
The recommended dose of ORENCIA in adults with rheumatoid arthritis or psoriatic arthritis is 125 mg weekly, regardless of body weight.

Your doctor may start treatment with ORENCIA with or without a single dose of powder for concentrate for infusion solution (administered intravenously, usually into the arm, over 30 minutes). If the single intravenous dose is administered to initiate treatment, the first subcutaneous injection of ORENCIA must be given within one day after the intravenous infusion, followed by weekly subcutaneous injections of 125 mg.

ORENCIA can be used in people over 65 years of age without any dose adjustment.

Use in children and adolescents
For patients aged 2 to 17 years with polyarticular juvenile idiopathic arthritis, the recommended weekly dose of ORENCIA injectable solution in a pre-filled syringe is based on body weight:

Weekly dose of ORENCIA
Patient body weight Dose
from 10 kg to less than 25 kg 50 mg
from 25 kg to less than 50 kg 87.5 mg
50 kg or more 125 mg

If you are already being treated with ORENCIA intravenously and wish to switch to subcutaneous ORENCIA, you should receive the 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 which other medicines, including disease-modifying antirheumatic drugs, you may continue taking during treatment with ORENCIA, if any.

Initially, your doctor or a nurse may administer the ORENCIA injection. However, you and your doctor may decide that you can self-administer ORENCIA. In this case, you will be instructed on how to inject yourself with ORENCIA.

Speak with your doctor if you have any questions about self-injecting. Detailed instructions for the preparation and administration of ORENCIA can be found 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. You will be monitored for any signs or symptoms of adverse effects and, if necessary, these symptoms will be treated.

If you forget to use ORENCIA
Keep track of your next dose. It is very important to use ORENCIA exactly as prescribed by your doctor. If you missed your dose by no more than three days from when it should have been taken, take your dose as soon as you remember, then continue with your original dosing schedule on your chosen day. If you missed your dose by more than three days, ask your doctor when to take your next dose.

If you stop using ORENCIA
The decision to stop treatment with ORENCIA should be discussed with your doctor.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects with ORENCIA are upper respiratory tract infections (including infections of the nose and throat), headache and nausea, as listed below. ORENCIA may cause serious side effects, which may require treatment.
Possible serious side effects include serious infections, tumours (cancer), and allergic reactions, as listed below.
Contact your doctor immediately if you notice any of the following side effects:

• severe skin redness, hives or other symptoms of an allergic reaction
• swelling of the face, hands or feet
• breathing or swallowing difficulties
• fever, persistent cough, weight loss, tiredness

Contact your doctor as soon as possible if you notice any of the following side effects:

• general feeling of being unwell, dental problems, burning sensation when urinating, painful skin redness, painful skin blisters, cough

The symptoms described above may be signs of the side effects listed below, all of which have been observed with ORENCIA in clinical studies in adults:

List of side effects:
Very common (may affect more than 1 in 10 people):

• upper respiratory tract infection (including infections of the nose, throat and sinuses)

Common (may affect up to 1 in 10 people):

• lung infections, urinary tract infections, painful skin blisters (herpes), influenza
• headache, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhoea, nausea, stomach discomfort, mouth ulcers, vomiting
• skin rash
• fatigue, weakness, injection site reactions
• abnormal liver function test results

Uncommon (may affect up to 1 in 100 people):

• dental infections, fungal nail infection, muscle infection, blood infection, pus accumulation under the skin, kidney infection, ear infection
• low white blood cell count
• skin tumour, skin warts
• low platelet count
• allergic reactions
• depression, anxiety, sleep disorders
• migraine
• numbness
• dry eye, reduced vision
• eye inflammation
• palpitations, increased heart rate, slowed heart rate
• low blood pressure, hot flushes, blood vessel inflammation, redness
• breathing difficulties, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• throat tightness
• rhinitis
• increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne
• hair loss, itching, hives
• joint pain
• limb pain
• absence of menstruation, excessive menstruation
• influenza-like illness, weight gain

Rare (may affect up to 1 in 1,000 people):

• tuberculosis
• inflammation of the uterus, fallopian tubes and/or ovaries
• gastrointestinal infection
• white blood cell tumour, lung tumour

Children and adolescents with polyarticular juvenile idiopathic arthritis
Side effects observed in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those observed in adults as described above, with the following differences:
Common (may affect up to 1 in 10 people):

• upper respiratory tract infection (including infection of the nose, sinuses and throat)
• fever

Uncommon (may affect up to 1 in 100 people):

• blood in the urine
• ear infection

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORENCIA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after “EXP” and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Store in the refrigerator (between 2°C and 8°C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine if the solution is cloudy or discoloured, or contains large particles. The
solution should be colourless to pale yellow.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ORENCIA contains
ORENCIA 50 mg solution for injection in pre-filled syringe

• The active substance is abatacept.
• Each pre-filled syringe contains 50 mg of abatacept in 0.4 mL.

ORENCIA 87.5 mg solution for injection in pre-filled syringe

• The active substance is abatacept.
• Each pre-filled syringe contains 87.5 mg of abatacept in 0.7 mL.

ORENCIA 125 mg solution for injection in pre-filled syringe

• The active substance is abatacept.
• Each pre-filled syringe contains 125 mg of abatacept in 1 mL.
• The other components are sucrose, poloxamer 188, monosodium dihydrogen phosphate monohydrate, anhydrous disodium hydrogen phosphate and water for injections (see section 2 “ORENCIA contains sodium”).

Description of the appearance of ORENCIA and contents of the pack
ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution.
ORENCIA is available in the following pack presentations:
ORENCIA 50 mg solution for injection in pre-filled syringe with white plunger

• pack containing 4 pre-filled syringes with needle safety device.

ORENCIA 87.5 mg solution for injection in pre-filled syringe with blue plunger

• pack containing 4 pre-filled syringes with needle safety device.

ORENCIA 125 mg solution for injection in pre-filled syringe with orange plunger

• packs containing 1 or 4 pre-filled syringes and multiple pack containing 12 pre-filled syringes (3 packs of 4).
• packs containing 1, 3 or 4 pre-filled syringes with needle safety device and multiple pack containing 12 pre-filled syringes with needle safety device (3 packs of 4).

Not all pack sizes may be marketed.
Marketing Authorisation 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
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
Important instructions for use. Read carefully.
HOW TO USE
ORENCIA 50 mg
ORENCIA 87.5 mg
ORENCIA 125 mg
solution for injection in pre-filled syringe with needle safety device
Abatacept
Subcutaneous use

Read these instructions before using the ORENCIA pre-filled syringe.
Before using the pre-filled syringe for the first time, ensure that your doctor, nurse or pharmacist shows you the correct way to use it.
Keep refrigerated until ready to use. DO NOT FREEZE.
If you have questions about this medicine, read the Package Leaflet.
BEFORE YOU START:
What you need to know about the Pre-filled Syringe
There are 3 types of pre-filled syringe:

50 mg/0.4 mL
white plunger
87.5 mg/0.7 mL
blue plunger

125 mg/mL
orange plunger
The type of pre-filled syringe you have received depends on the dose prescribed by your doctor. The 125 mg/mL pre-filled syringe is shown below.
Before use

Inspection window Plunger
Needle cap
Expiry date
Wing
After use

Needle safety
device (extended over needle) Wing
The pre-filled syringe has a wing to assist grip and injection, and a passive needle safety device that automatically covers the needle after completion of an injection.

DO NOT remove the needle cap until you are ready to give the injection.
NEVER retract the plunger.
NEVER recap the needle of the pre-filled syringe as this may damage, bend or break the needle.
Always hold the syringe by the barrel.
Proceed to Step 1
Step 1: Prepare for an ORENCIA injection
Gather the injection support materials on a clean, flat surface.
The pack contains only the pre-filled syringe:

• Alcohol swab

• Adhesive plaster

• Cotton ball or gauze

• Pre-filled syringe with passive needle safety device UltraSafe

• Sharps disposal container

Allow your pre-filled syringe to warm up.
Remove one pre-filled syringe from the refrigerator and wait 30 minutes to allow the syringe to reach room temperature.

• Do not speed up the warming process in any way, such as using a microwave or placing the syringe in warm water.
• DO NOT remove the needle cap while the pre-filled syringe is warming to room temperature. Wait

30 Minutes
Wash your hands thoroughly with soap and water to prepare for the injection.

Proceed to Step 2
Step 2: Examine the pre-filled syringe
Hold the syringe by the barrel, with the covered needle pointing downwards as shown.

• Check the expiry date printed on the label. Do not use if the expiry date has passed.
• Check that the pre-filled syringe has no damage. Do not use if cracked or broken.

Expiry date
Barrel
Needle cap
Check the liquid
Inspect the liquid in the pre-filled syringe through the inspection window. It should be clear and colourless to pale yellow.
You may see a small air bubble. Do not try to remove it.
Do not give the injection if the liquid is cloudy, discoloured or contains particles.

Inspection window
Air bubble
Liquid
Note: the image shows the 50 mg pre-filled syringe
Proceed to Step 3
Step 3: Check the dose in the pre-filled syringe
Hold the syringe at eye level. Carefully examine to ensure that the amount of liquid in the pre-filled syringe is at or just above the corresponding dose control line for the prescribed dose:
125 mg/mL
Pre-filled syringe
87.5 mg/0.7 mL
Pre-filled syringe

50 mg/0.4 mL
Pre-filled syringe
Blue plunger Orange plunger
White plunger
1 mL

Control line
0.7 mL
for liquid
Control line
level
for liquid
0.4 mL
level
Control line
for liquid
Do not use the pre-filled syringe if it does not contain the correct amount of liquid. Contact your doctor, nurse or pharmacist for further instructions.
Proceed to Step 4
Step 4: Choose and prepare the injection site
Choose your injection site in the abdomen, the front of the thighs, or the outer side of the upper arm (only if the injection is administered by someone caring for you).
Change the injection site

• Each week you may use the same area of your body, but use a different injection site within that area.
• Do not inject in areas where the skin is tender, bruised, red, scaly or hardened. Do not give the injection in areas with scars or stretch marks.
• Record the date, time and site where you administered the injection.

Injection sites
Self-injection and injection
administered by someone
caring for you
Abdomen, avoid 5 cm around
the navel
Front of thighs

ONLY by someone
caring for you
Outer side of upper arms
Clean the injection site gently

• Wipe the injection site with an alcohol swab and allow the skin to dry.
• Do not touch the injection site again before giving the injection.
• Do not blow or fan the cleaned area.

Remove the needle cap by holding the pre-filled syringe by the barrel with one hand and pulling the needle cap straight off with the other hand.
Do not reinsert the needle cap after removal. The cap may be disposed of in household waste after the injection.

• Do not use the pre-filled syringe if it has been dropped after removing the needle cap.
• Do not use the pre-filled syringe if the needle is damaged or bent.

Note: It is normal to see a drop of liquid at the needle tip.
Needle cap

NEVER RECAP THE NEEDLE of the pre-filled syringe as this may damage the needle.
Proceed to Step 5
Step 5: Inject the dose of ORENCIA
Hold the barrel of the pre-filled syringe in one hand between thumb and index finger. With the other hand, gently pinch the skin you cleaned.

Pinch the skin
Inserting the needle
Gently insert the needle into the pinched skin at a 45º angle.

Complete ALL steps to deliver the full dose of medicine

Plunger
Injection: push the plunger all the way down using your thumb.

Needle safety
device
Activating the needle safety device: slowly lift your thumb from the plunger to activate the needle safety device

click
Needle safety
device
Confirmation: after completing the injection, the safety device will cover the needle and you may hear a click.
Remove the pre-filled syringe from the injection site and release the pinched skin.
Proceed to Step 6
Step 6: After the injection
Care of the injection site:

• Mild bleeding at the injection site may occur. You may press a cotton ball or gauze on the site.
• Do not rub the injection site.
• If needed, you may cover the injection site with an adhesive plaster.

Cotton ball or gauze

Adhesive plaster
Dispose of the pre-filled syringe in a sharps disposal container immediately after use. If you have any questions, ask your pharmacist.
For further information on disposal, see the Package Leaflet.
If the injection is administered by someone caring for you, that person must also handle the syringe carefully to avoid accidental needle sticks and potential spread of infections.
Keep the medicine 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 be instructed by your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe.
Do not attempt to administer the injection until you are certain you understand how to prepare and give the injection. After adequate training, the injection may be given by you or by another person, such as a family member or friend.

Figure 1
Before starting – What to do and what not to do
What to do

• Always handle the ORENCIA syringe carefully, especially around other people and children.
• Always hold the syringe by the barrel.
• Store unused syringes in the refrigerator in the original carton.
• Have the support materials ready before giving the injection.  Support materials list: alcohol swabs, cotton ball or gauze, adhesive plaster, sharps disposal container. Sharps disposal containers are special puncture-resistant waste containers that can be purchased at many retail outlets.

What not to do
 Do not remove the needle cap (cover) until you are ready to give the injection.
 Never retract the plunger.
 Do not shake the syringe, as this may damage the ORENCIA medicine.
 Do not recap the needle.
STEP 1: Prepare the syringe
A. Check the expiry date and batch number on the carton

• The expiry date is located on the ORENCIA carton and on each syringe.
• If the expiry date has passed, do not use the syringes. Contact your doctor or pharmacist for assistance.

B. Allow the syringe to warm up

• Find a comfortable space with a clean, flat working surface.
• Remove the syringe from the refrigerator. Keep all remaining unused syringes in the original carton, refrigerated.
• Check that the expiry date and batch number match those on the carton.
• Inspect the syringe for visible defects, but do not remove the needle cap.
• Allow the syringe to sit at room temperature for 30 to 60 minutes before injection.  Do not speed up the warming process in any way, such as using a microwave or placing the syringe in warm water.

C. Check the liquid in the syringe

• Hold the syringe by the barrel, with the covered needle pointing downwards.

Figure 2

• Look at the liquid in the syringe (Figure 2). The liquid should be colourless to pale yellow.  Do not inject if the liquid is cloudy, discoloured or contains visible particles.
• It is normal to see an air bubble, and there is no need to remove it. The entire contents of the syringe must be injected.

D. Gather the support materials and keep them within reach.
E. Wash your hands thoroughly with soap and warm water.
STEP 2: Choose and prepare the injection site
Have the syringe ready for immediate use after preparing the injection site.
A. Choose an area of your body for the injection (injection site)

• You may use: the front of the thigh or the abdomen, except for the area within 5 cm around the navel (Figure 3).

Figure 3

• Choose a different injection site for each new injection. You may use the same thigh for weekly injections, provided each injection site is approximately 2.5 cm away from the previous one.  Do not inject in areas where the skin is tender, bruised, red, scaly or hardened. Avoid areas with scars or stretch marks.

B. Prepare the injection site

• Wipe the injection site with an alcohol swab using a circular motion.
• Allow the skin to dry before injecting.  Do not touch the injection site again before giving the injection.  Do not blow or fan the cleaned area.

STEP 3: Inject ORENCIA
A. Remove the needle cap (cover) only when ready to administer the injection.

• Hold the syringe by the barrel with one hand and pull the needle cap straight off with the other hand (Figure 4).

Figure 4
There may be a small air bubble in the liquid inside the syringe. There is no need to remove the air bubble.
You may notice a drop of liquid at the needle tip. This is normal and does not affect the dose.
 Do not touch the plunger while removing the needle cap.
 Do not remove the needle cap until you are ready to inject ORENCIA.
 Do not touch the needle or let it touch any surface.
 Do not use the syringe if it is dropped without the needle cap in place.
 Do not recap the needle once the cap has been removed.
 Do not use the syringe if there are visible signs of damage or bending of the needle.
B. Position the syringe and inject ORENCIA

• Hold the syringe by the barrel in one hand between thumb and index finger (Figure 5).  Do not press on the plunger head until you start the injection.  Never retract the plunger.
• Using the other hand, gently pinch the skin area you cleaned. Hold it firmly.
• Insert the needle quickly into the pinched skin at a 45° angle (Figure 5).

Figure 5 Figure 6

• Use your thumb to push the plunger down firmly until it stops and all the medicine has been injected (Figure 6).
• Remove the needle from the skin and release the surrounding skin.  Do not recap the needle.
• Press a cotton ball on the injection site for 10 seconds.  Do not massage the injection site. Mild bleeding is normal.
• If needed, you may apply a small adhesive plaster to the injection site.

STEP 4: Dispose of the syringe and record the injection
A. Dispose of the used syringe in a sharps disposal container.

• Ask your doctor, nurse or pharmacist about national and local laws regarding proper disposal of medicines containing needles.
• Always keep the sharps container out of reach of children and pets.  Do not throw used syringes into household waste or recycling bins.

B. Record the injection

• Record the date, time and specific body site where the self-administration was performed. It may also be helpful to note any questions or concerns about the injection to discuss with your doctor, nurse or pharmacist.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Patient Information Leaflet

ORENCIA 125 mg solution for injection in pre-filled pen

abatacept
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What ORENCIA is and what it is used for
2. What you need to know before using ORENCIA
3. How to use ORENCIA
4. Possible side effects
5. How to store ORENCIA
6. Contents of the pack and other information

1. What ORENCIA is and what it is used for

ORENCIA contains the active substance abatacept, a protein produced in cell cultures. ORENCIA
reduces the immune system's attack on normal tissues by interfering with immune cells
(known as 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
Rheumatoid arthritis is a progressive, long-term systemic disease which, if left untreated, can
lead to serious consequences such as joint destruction, increasing disability, and difficulty performing
daily activities. In people affected by rheumatoid arthritis, the immune system attacks the body's normal
tissues, causing pain and swelling in the joints. This can lead to joint damage. Rheumatoid arthritis (RA)
affects each person differently. In most people, joint symptoms develop gradually over several years.
However, in some individuals, RA can progress rapidly, while others may have RA for a limited period of
time and then enter a period of remission. RA is usually a chronic (long-term) and progressive disease.
This means that, even if you are receiving treatment and whether or not you still have symptoms, RA
may continue to damage your joints. By identifying the right treatment strategy for you, it may be
possible to slow down this disease process, which can 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 there is an inadequate
response to treatment with other disease-modifying medicinal products or with another group of
medicines called 'tumour necrosis factor (TNF) inhibitors'. It is used in combination with a medicine
called methotrexate.
ORENCIA may also be used in combination with methotrexate to treat very active and progressive
rheumatoid arthritis without prior treatment with methotrexate.
ORENCIA is used to:

• inhibit the progression of joint damage
• improve physical function

Psoriatic Arthritis
Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, an inflammatory
skin disease. If you have active psoriatic arthritis, you will initially be treated with other medicines. If
you do not respond adequately to these medicines, you may be treated with ORENCIA in order to:

• reduce the signs and symptoms of your disease
• slow down damage to bones and joints
• improve physical function and the ability to carry out normal daily activities

ORENCIA is used to treat psoriatic arthritis either alone or in combination with methotrexate.

2. What you need to know before using ORENCIA

Do not use ORENCIA

• if you are allergic to abatacept or to any of the other ingredients of this medicine (listed in section 6).
• if you have a serious or uncontrolled infection, do not start treatment with ORENCIA. An infection may increase your risk of serious side effects with ORENCIA.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse:

• if you have allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling or rash, contact your doctor immediately.
• if you, your partner, or your caregiver notice the onset or worsening of neurological symptoms, including general muscle weakness, vision problems, difficulty speaking, a change in the way you walk, or problems with balance, changes in thinking, memory, and orientation causing confusion and personality changes, contact your doctor immediately, as these may be symptoms of a very rare, serious, and potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML).
• if you have any type of infection, including long-term or localized infections, or if you frequently get infections, or if you have symptoms of infection (e.g., fever, feeling unwell, dental problems), it is important to inform your doctor. ORENCIA may reduce your body's ability to fight infections and treatment may make you more susceptible to infections or worsen an existing infection.
• if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, fatigue, low-grade fever), inform your doctor. Before using ORENCIA, your doctor will perform tests to check for tuberculosis or conduct a skin test.
• if you have viral hepatitis, inform your doctor. Before using ORENCIA, your doctor will test you for hepatitis.
• if you have cancer, your doctor will decide whether you can still receive ORENCIA.
• if you have recently been vaccinated or are planning to get vaccinated, inform your doctor. Some vaccines should not be given while you are receiving ORENCIA. Check with your doctor before receiving any vaccine. Some vaccinations may cause vaccine-related infections. If you receive ORENCIA during pregnancy, your baby may be at increased risk of such infection for approximately 14 weeks after your last dose during pregnancy. It is important to inform your baby's doctors and other healthcare providers about your use of ORENCIA during pregnancy so they can determine when your baby should receive a vaccine.

Your doctor may also perform tests to monitor your blood values.
Children and adolescents
ORENCIA pre-filled pen injectable solution has not been studied in children and adolescents under 18 years of age. Therefore, the use of ORENCIA pre-filled pen injectable solution is not recommended in this patient population.
ORENCIA powder for concentrate for solution for infusion is available for pediatric patients aged 6 years and older.
ORENCIA pre-filled syringe injectable solution is available for pediatric patients aged 2 years and older.
Other medicines and ORENCIA
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
ORENCIA must not be used with biologic medicines for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is insufficient evidence to recommend its use with anakinra or rituximab.
ORENCIA may be used with 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 unknown; therefore, do not use ORENCIA if you are pregnant unless specifically recommended by your doctor.

• if you are a woman of childbearing age, you must use a reliable method of contraception (birth control) while using ORENCIA and for up to 14 weeks after the last dose. Your doctor will advise you on suitable methods.
• if you become pregnant while using ORENCIA, inform your doctor.

If you receive ORENCIA during pregnancy, your baby may be at increased risk of infection. It is important to inform your baby's doctors and other healthcare providers about your use of ORENCIA during pregnancy before your baby receives any vaccine (for more information, see the section on vaccinations).
It is not known whether ORENCIA passes into human breast milk. You must stop breastfeeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.
Driving and using machines
ORENCIA is not expected to affect the ability to drive or use machines. However, if you feel tired or unwell after treatment with ORENCIA, you should not drive or use machines.
ORENCIA contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially 'sodium-free'.

3. How to use ORENCIA

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
ORENCIA injectable solution is administered by injection under the skin (subcutaneous use).
Recommended dose
The recommended dose of ORENCIA in adults with rheumatoid arthritis or psoriatic arthritis is 125 mg of
abatacept per week, regardless of body weight.
Your doctor may start ORENCIA treatment with or without a single dose of powder for concentrate for solution for infusion (administered intravenously, usually into the arm, over a period of 30 minutes). If the single intravenous dose is given to start treatment, the first subcutaneous injection of ORENCIA must be administered within one day after the intravenous infusion, followed by weekly subcutaneous injections of 125 mg.
ORENCIA may be used in people over 65 years of age without any dose adjustment.
If you are already being treated with ORENCIA intravenously and wish to switch to subcutaneous ORENCIA, you should receive the subcutaneous injection instead of your next scheduled intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.
Your doctor will inform you about the duration of treatment and which other medicines, including disease-modifying antirheumatic drugs, you may continue taking during treatment with ORENCIA, if any.
Initially, your doctor or a nurse may administer the ORENCIA injection. However, you and your doctor may decide that you can self-administer ORENCIA. In this case, you will be instructed on how to inject yourself with ORENCIA.
Talk to your doctor if you have any questions about self-injecting the medicine. Detailed instructions for the preparation and administration of ORENCIA are provided 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. You will be monitored for any signs or symptoms of adverse effects and, if necessary, treated accordingly.
If you forget to use ORENCIA
Keep track of when your next dose is due. It is very important to use ORENCIA exactly as prescribed by your doctor. If you have missed your dose by no more than three days since it was due, take your dose as soon as you remember, then continue with your original dosing schedule on your chosen day. If you have missed your dose by more than three days, ask your doctor when to take your next dose.
If you stop using ORENCIA
The decision to stop treatment with ORENCIA should be discussed with your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The most common side effects with ORENCIA are upper respiratory tract infections (including nose and throat infections), headache and nausea, as listed below. ORENCIA may cause serious side effects, which may require treatment.
Possible serious side effects include serious infections, tumours (cancer), and allergic reactions, as listed below.
Contact your doctor immediately if you notice any of the following side effects:

• severe skin redness, hives or other symptoms of an allergic reaction
• swelling of the face, hands or feet
• difficulty breathing or swallowing
• fever, persistent cough, weight loss, lack of energy

Contact your doctor as soon as possible if you notice any of the following side effects:

• general feeling of being unwell, dental problems, burning sensation when urinating, painful skin redness, painful skin blisters, cough

The symptoms listed above may be signs of the side effects described below, all of which have been observed with ORENCIA in clinical studies in adults:

List of side effects:
Very common (may affect more than 1 in 10 people):

• upper respiratory tract infection (including infections of the nose, throat and sinuses).

Common (may affect up to 1 in 10 people):

• lung infections, urinary tract infections, painful skin blisters (herpes), influenza
• headache, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhoea, nausea, stomach discomfort, mouth ulcers, vomiting
• rash
• fatigue, weakness, injection site reactions
• abnormal liver function test results.

Uncommon (may affect up to 1 in 100 people):

• dental infections, fungal nail infection, muscle infection, blood infection, pus accumulation under the skin, kidney infection, ear infection
• low levels of white blood cells in the blood
• skin tumour, skin warts
• low levels of platelets in the blood
• allergic reactions
• depression, anxiety, sleep disorders
• migraine
• numbness
• dry eyes, reduced vision
• eye inflammation
• palpitations, increased heart rate, slowed heart rate
• low blood pressure, hot flushes, inflammation of blood vessels, redness
• breathing difficulties, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• throat tightness
• rhinitis
• increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne
• hair loss, itching, hives
• joint pain
• pain in the extremities
• absence of menstruation, excessive menstruation
• influenza-like syndrome, weight gain.

Rare (may affect up to 1 in 1,000 people):

• tuberculosis
• inflammation of the uterus, fallopian tubes and/or ovaries
• gastrointestinal infection
• white blood cell cancer, lung cancer

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORENCIA

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 “Scad.”. The expiry date refers to the last day of that month.
Store in a refrigerator (from 2°C to 8°C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine if the solution is cloudy or discoloured, or contains large particles. The
solution should be colourless to pale yellow.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ORENCIA contains

• The active substance is abatacept.
• Each pre-filled pen contains 125 mg of abatacept in 1 mL.
• The other ingredients are sucrose, poloxamer 188, monosodium dihydrogen phosphate monohydrate, anhydrous disodium hydrogen phosphate, and water for injections (see section 2, “ORENCIA contains sodium”).

Description of the appearance of ORENCIA and contents of the pack
ORENCIA injectable solution (injection) is a clear, colourless to pale yellow solution,
supplied in a pre-filled pen called ClickJect.
ORENCIA is available in the following pack sizes:

• pack of 4 pre-filled pens and a multiple pack containing 12 pre-filled pens (3 packs of 4).

Not all pack sizes may be marketed.
Marketing Authorisation 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
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Important instructions for use. Read carefully.
HOW TO USE
ORENCIA (abatacept)
Pre-filled ClickJect Pen
125 mg, injectable solution
for subcutaneous use

Read these instructions before using the Pre-filled ClickJect Pen
Before using the ClickJect pen for the first time, make sure your doctor or nurse shows you the correct way to use it.
Keep the pen in the refrigerator until you are ready to use it. DO NOT FREEZE.
If you have any questions about how to use this medicine, read the Package Leaflet.
BEFORE YOU START
What you need to know about the Pre-filled ClickJect Pen

• The pen automatically delivers the medicine. The transparent tip covers the needle automatically once the injection is complete and the pen is removed from the skin.
• DO NOT remove the orange needle cap until you are ready to give the injection.

Before use

After use

Gather the injection supplies on a clean, flat surface
(the package contains only the pre-filled ClickJect pen):

• Alcohol swab
• Adhesive plaster
• Cotton ball or gauze pad
• Pre-filled ClickJect pen
• Sharps disposal container

Proceed to Step 1

1. PREPARE YOUR CLICKJECT PEN

Allow your ClickJect pen to warm up
Remove one pen from the refrigerator and let it sit at room temperature (approximately 25°C) for
30 minutes.
DO NOT remove the needle cap from the pen while allowing it to reach room temperature.
Wait

30 Minutes
Wash your hands thoroughly with soap and water before preparing for injection.
Inspect the pre-filled ClickJect pen:

• Check the expiration date printed on the label. DO NOT use if the expiration date has passed.
• Check that the pen is not damaged. DO NOT use if cracked or broken.
• Check the liquid through the inspection window. It should be clear, ranging from light yellow to pale yellow. A small air bubble may be visible. There is no need to remove it. DO NOT inject if the liquid is cloudy, discolored, or contains visible particles.

Proceed to Step 2

2. PREPARING FOR INJECTION

Choose your injection site on the abdomen or the front of the thigh.
Each week, you may use the same area of your body, but use a different injection site within that area.
DO NOT inject into an area where the skin is tender, injured, red, scaly, or hard. Avoid areas with scars or stretch marks.

Clean the injection site gently with an alcohol swab and allow the skin to dry.
REMOVE THE ORANGE NEEDLE CAP STRAIGHT OFF

• DO NOT twist the needle cap.
• DO NOT replace the cap on the pen. You may dispose of the cap in household waste after the injection.
• DO NOT use the pen if it falls after the cap has been removed. It is normal to see a drop of fluid coming out of the needle.

Proceed to Step 3

3. INJECT THE DOSE

Hold the ClickJect pen so that you can see the inspection window, ensuring it forms a
90º angle with the injection site. With your other hand, gently pinch the skin area you have cleaned.

Complete ALL steps for full dose delivery:

PUSH AND HOLD

15 Seconds
Push down on the skin to unlock the pen.
Press the button, HOLD for 15 seconds, and watch the window.

• You will hear a click when the injection starts.
• For complete dose delivery, keep the pre-filled pen in place for 15 seconds and wait until the blue indicator stops moving in the window.

Remove the pre-filled ClickJect pen from the injection site by lifting it vertically.
Once removed from the skin, the transparent tip will automatically cover the needle. Release the skin fold.
Proceed to Step 4.

4. AFTER INJECTION

Care of the injection site:

• Mild bleeding at the injection site may occur. You can press a cotton ball or gauze pad against the injection site.
• DO NOT rub the injection site.
• If needed, you may cover the injection site with a small adhesive bandage.

Dispose of the pre-filled ClickJect pen into a sharps disposal container
immediately after use. If you have any questions, ask your pharmacist.

• DO NOT re-cap the used pen.

Refer to the Package Leaflet for additional information on disposal.
If someone else is administering the injection for you, that person should also
handle the pen carefully to avoid accidental needle sticks and possible infections.
Keep the pen and the disposal container out of reach of children.
Record the date, time, and injection site where you administered the injection.