Label: Information for the User

ORENCIA125mg Pre-filled Syringe Solution

abatacept

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is ORENCIA and how is it used

2.What you need to know before starting to use ORENCIA

3.How to use ORENCIA

4.Possible adverse effects

5.Storage of ORENCIA

6.Contents of the package and additional information

ORENCIA contains the active ingredient abatacept, a protein obtained through 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 lymphocytes that participate in the inflammatory response of the immune system.

ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults.

Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, long-term systemic disease that, if left untreated, can have severe consequences, such as joint destruction, 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, which 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 others 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 that, although you receive treatment, you may still have symptoms, 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 do not respond sufficiently to treatment with other disease-modifying medications or with another group of medications called "tumor necrosis factor (TNF) inhibitors." It is used in combination with a medication called methotrexate.

ORENCIA may also be used with methotrexate to treat progressive rheumatoid arthritis and high-activity rheumatoid arthritis without prior methotrexate treatment.

ORENCIA is used for:

• delaying joint damage
• improving your physical function

Psoriatic Arthritis

Psiatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, an inflammatory skin disease. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond sufficiently well to these medications, you may be administered ORENCIA to:

• reduce the signs and symptoms of your disease.
• reduce damage to your bones and joints.
• improve your physical function and ability to perform normal daily activities.

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

Do not use ORENCIA

• if you are allergicto abatacept or any of the other components of this medication (listed in section6).
• if you have a severe or uncontrolled infection, do not start treatment with ORENCIA. Having an infection may put you at risk of serious side effects from ORENCIA.

Warnings and precautions

Consult your doctor, pharmacist, or nurse:

• if you experience allergic reactionssuch as chest tightness, asthma, severe dizziness or vertigo, swelling, or skin rashinform your doctor immediately.
• if you experience any type of infection, including prolonged or localized infections, or if you frequently get infections orif you have symptoms of an infection (such as fever, discomfort, dental problems), it is essential to inform your doctor.ORENCIA may reduce your body's ability to fight an infection, and treatment may make you more prone to infections or worsen any existing infection.
• if you have had tuberculosis (TB)or are experiencing TB symptoms (persistent cough, weight loss, apathy, mild fever)inform your doctor. Before using ORENCIA, your doctor will perform a TB test or a skin test.
• if you have viral hepatitisinform your doctor. Before using ORENCIA, your doctor may perform a hepatitis test.
• if you have cancer,your doctor will decide whether to administer ORENCIA.
• if you have recently been vaccinatedor are planning to get vaccinated,inform your doctor.Some vaccines should not be administered while taking ORENCIA. Consult with your doctor before receiving any vaccine. Certain vaccines may cause infections. If you receive ORENCIA during pregnancy, your baby may be at a higher risk of contracting the infection for approximately 14 weeks after the last dose you received during pregnancy. It is essential to inform your doctors about your baby and other healthcare professionals about the use of ORENCIA during pregnancy so that they can decide when to administer any vaccine to your baby.

Your doctor may also perform blood tests to examine your blood values.

Children and adolescents

ORENCIA prefilled syringe has not been studied in children and adolescents under 18 years old. Therefore, ORENCIA prefilled syringe is not recommended for use in this patient population.

ORENCIA powder for concentrate for solution for infusion is available for pediatric patients aged 6years and older.

ORENCIA prefilled syringe is available for pediatric patients aged 2years and older.

Using ORENCIA with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

ORENCIA should not be usedwith biologic medications for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is insufficient evidence to recommend its use with anakinra and rituximab.

ORENCIA can be usedwith other medications commonly used to treat rheumatoid arthritis, such as steroids or analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or diclofenac.

Consult your doctor or pharmacist before taking any other medication while using ORENCIA.

Pregnancy and breastfeeding

The effects of ORENCIA on pregnancy are unknown, therefore do not use ORENCIA if you are pregnant unless your doctor recommends it explicitly.

• if you are a woman who may become pregnant, you should use reliable contraceptive methods (birth control) while using ORENCIA and for 14weeks after the last dose. Your doctor will advise on suitable methods.
• if you become pregnant during ORENCIA treatment, inform your doctor.

If you received ORENCIA during pregnancy, your baby may be at a higher risk of contracting an infection. It is essential to inform your doctors about your baby and other healthcare professionals about the use of ORENCIA during pregnancy before administering any vaccine (for more information, see the vaccination section).

The passage of ORENCIA into breast milk is unknown.You should stop breastfeedingif you are being treated with ORENCIA for 14weeks after the last dose.

Driving and operating machinery

It is not expected that the use of ORENCIA will affect your ability to drive or operate machinery. However, if you feel tired or unwell after receiving ORENCIA, do not drive or operate any machinery.

ORENCIA contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose, i.e., it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

ORENCIA injectable solution is administered under the skin (subcutaneously).

Recommended dose

The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg of abatacept per 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 administered in a vein, usually in the arm, for a period of 30 minutes). If you are administered a single intravenous dose to start treatment, the first subcutaneous injection of ORENCIA should be administered within one day of the IV infusion, followed by weekly subcutaneous injections of 125 mg.

ORENCIA can be used in adults over 65 years old without the need to change the dose.

If you are already receiving treatment with ORENCIA intravenously and want to switch to ORENCIA subcutaneously, 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 medications, including other disease-modifying drugs, if any, you may continue to take while on ORENCIA treatment.

At the beginning, your doctor or nurse may administer ORENCIA to you. However, you and your doctor may decide that you can administer ORENCIA yourself. In this case, you will be instructed on how to administer ORENCIA yourself.

Consult your doctor if you have any doubts about administering the injection. You will find detailed instructions for preparing and administering ORENCIA at the end of this leaflet (see“Important use instructions”).

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 forgot to use ORENCIA

Keep track of your next dose. It is very important to use ORENCIA exactly as your doctor tells you. If you forgot your dose within three days of when it was due, administer the dose as soon as you remember and then follow your original dosing schedule on the chosen day. If you forget your dose for more than three days, ask your doctor when to administer the next dose.

If you interrupt ORENCIA treatment

The decision to interrupt ORENCIA treatment should be discussed with your doctor.

If you have any other questions about the use of this medication,ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The most common side effects that occur with ORENCIA are upper respiratory tract infections (including nose and throat infections), headaches, and nausea. ORENCIA may cause serious side effects that require treatment.

Possible serious side effectsinclude severe infections, malignant neoplasms (cancer), and allergic reactions, as listed below.

Inform your doctor immediatelyif you notice any of the following symptoms:

• severe rash, urticaria, or other symptoms of allergic reaction
• swollen face, hands, or feet
• difficulty breathing or swallowing
• fever, persistent cough, weight loss, fatigue

Inform your doctor immediatelyif you notice any of the following:

• general feeling of illness, dental problems, sensation of burning while urinating, painful skin rash, painful blisters on the skin, cough

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

List of side effects:

Very common(may affect more than 1 in 10patients):

• upper respiratory tract infections (including nose, throat, and nasal sinus infections).

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

• lung infections, urinary tract infections, painful blisters on the skin (herpes), flu
• headaches, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhea, nausea, stomach discomfort, mouth sores, vomiting
• skin rash
• fatigue, weakness, reactions at the injection site
• abnormal liver function tests.

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

• dental infection, fungal nail infection, muscle infection, bloodstream infection, accumulation of pus under the skin, kidney infection, ear infection
• low white blood cell count in blood
• skin cancer, warts
• low platelet count in blood
• allergic reactions
• depression, anxiety, sleep disturbance
• migraines
• numbness
• dry eyes, decreased vision
• eye inflammation
• palpitations, rapid heart rate, slow heart rate
• low blood pressure, hot flushes, inflammation of blood vessels, flushing
• difficulty breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD)
• throat constriction
• rhinitis
• increased tendency to develop petechiae, dry skin, psoriasis, skin redness, excessive sweating, acne
• hair loss, itching, urticaria
• joint pain
• limb pain
• amenorrhea, heavy menstrual bleeding
• influenza-like syndrome, weight gain

Rare(may affect up to 1 in 1000patients):

• tuberculosis
• inflammation of the uterus, Fallopian tubes, and/or ovaries
• gastrointestinal infection
• leukemia, lung cancer

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after EXP and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Do not use this medication if the liquid is cloudy or discolored, or has large particles. The liquid must be colorless to pale yellow.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of ORENCIA

• The active ingredient is abatacept.
• Each pre-filled syringe contains 125 mg of abatacept in 1 ml.

• The other components are sucrose, poloxamer 188, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, and water for injection (see section 2 "ORENCIA contains sodium").

Appearance of the product and contents of the pack

ORENCIA injectable solution (injection) is a transparent, colorless to pale yellow solution presented in a pre-filled syringe called ClickJect.

ORENCIA is available in the following presentations:

- Pack of 4 pre-filled syringes and multiple pack of 12 pre-filled syringes (3 packs of 4).

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

Last update of the leaflet:

Other sources of information

The detailed information on this medicine 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 syringe ClickJect

125 mg, injectable solution

Subcutaneous use

Read these instructions before using the ClickJect pre-filled syringe.

Before using the ClickJect syringe for the first time, make sure the healthcare professional who is going to administer it shows you the correct way to use it.

Keep the 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 YOU START

Know your ClickJect pre-filled syringe

• The syringe automatically releases the medicine. The transparent cap closes over the needle once the injection is complete and the syringe is removed from the skin.
• DO NOT remove the orange cap from the needle until you are ready to inject.

Before use

After use

Assemble the supplies for your injection on a clean and flat surface

(only the ClickJect pre-filled syringe is included in the pack):

• Alcohol swab
• Band-Aid
• Cotton ball or gauze
• ClickJect pre-filled syringe
• Sharps container

Proceed to Step 1

1. PREPARE YOUR CLICKJECT SYRINGE

Leave your ClickJect syringe to come to room temperature.

Take a syringe out of the refrigerator and leave it to reach room temperature (above 25°C) for 30 minutes .

DO NOT remove the needle cap from the syringe while it is coming to room temperature.

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

Examine the ClickJect pre-filled syringe:

• Check the expiry date printed on the label.

DO NOT use if the expiry date has passed.

• Check if the syringe is damaged.

DO NOT use if it is cracked or broken.

• Check the liquid through the view window. It should be transparent to pale yellow. You may see a bubble of air. There is no need to remove it.

DO NOT inject if the liquid is cloudy, has changed color, or has visible particles.

Proceed to Step 2

2. PREPARE FOR INJECTION

Choose an injection site such as the abdomen or the front of the thigh .

You can use the same injection site each week, but choose a different site in that area.

DO NOT inject into areas where the skin is painful, red, swollen, or hardened. Avoid areas with scars or stretch marks.

Clean the injection site gently with a cotton ball and let the skin dry.

Remove the orange cap from the needle DIRECTLY.

• DO NOT replace the syringe cap.

You can dispose of the cap in household waste after the injection.

• DO NOT use the syringe if it falls after removing the cap.

You may notice a small drop of liquid coming out of the needle.

Proceed to Step 3

3. ADMINISTER YOUR DOSE

Place the ClickJect syringe so that you can see the view window and it is at a 90-degree angle to the injection site. With the other hand, gently pinch the cleaned skin.

Complete ALL the steps to administer the full dose:

PUSH DOWN on the skin to unlock the syringe.

Press the button, HOLD for 15 seconds AND look at the view window.

• You will hear a click when the injection starts.
• To deliver the full dose, hold the syringe in place for 15 seconds AND wait until the blue indicator stops moving in the view window.

Remove the ClickJect syringe from the injection site by lifting it upwards. Once it is removed from your skin, the transparent cap will close over the needle. Stop pinching the skin.

Proceed to Step 4

4. AFTER INJECTION

Care for the injection site:

• You may notice a small amount of bleeding at the injection site. You can press on the injection site with a cotton ball or gauze.
• DO NOT rub the injection site.
• If necessary, you can cover the injection site with a small bandage.

Dispose of the used ClickJect syringe in the sharps container immediately after use. If you are unsure, ask your pharmacist.

• DO NOT put the cap back on the used syringe.

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 potential infection transmission.

Keep the syringe and sharps container out of reach of children.

Record the date, time, and location of the injection.