Prospecto: information for the user

ORENCIA250mg powder for concentrate for solution for infusion

abatacept

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1.What is ORENCIA and how it is 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, 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 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 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 can also be used with methotrexate to treat progressive rheumatoid arthritis and high activity without prior methotrexate treatment.

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 first be given other medications. If you do not respond well enough 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.

Polyarticular Juvenile Idiopathic Arthritis

Polyarticular juvenile idiopathic arthritis is a long-term inflammatory disease that affects one or more joints in children and adolescents.

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

ORENCIA is used to:

• delay joint damage
• improve physical function
• improve other signs and symptoms of polyarticular juvenile idiopathic arthritis

Do not use ORENCIA

• if you are allergicto abatacept or to 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 could put you at risk due to the side effects of 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 infection, or if you frequently get infections orif you have symptoms of an infection (for example, 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 acquiring infections or worsening any infection you have.
• 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 on ORENCIA treatment.Consult with your doctor before receiving any vaccine.It is recommended that patients with juvenile idiopathic polyarticular arthritis update their vaccination schedule, if possible, according to current vaccination guidelines before starting ORENCIA treatment. Certain vaccines may cause infections. If ORENCIA is administered 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 and other healthcare professionals about your baby and the use of ORENCIA during pregnancy so that they can decide when to administer any vaccine to your baby.
• if you use a blood glucose meterto check your blood glucose levels. ORENCIA contains maltose, a type of sugar that may give falsely elevated blood glucose readings with certain types of blood glucose meters. Your doctor may recommend an alternative method for monitoring your blood glucose levels.

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

Children and adolescents

ORENCIA powder for concentrate for solution for infusion has not been studied in children and adolescents under 6years of age, therefore, ORENCIA powder for concentrate for solution for infusion is not recommended for use in this patient population.

ORENCIA injectable solution in pre-filled syringe is available for subcutaneous administration in pediatric patients from 2years.

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 co-administration with anakinra and rituximab.

ORENCIA can be usedwith other medications commonly used to treat rheumatoid arthritis, such as steroids or analgesics, including non-steroidal 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 specifically.

• if you are a woman who may become pregnant, use a reliable contraceptive method (birth control) during ORENCIA treatment 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 and other healthcare professionals about your baby and 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, ride a bike, or operate machinery. However, if you feel tired or unwell after ORENCIA administration, do not drive, ride a bike, or operate any machinery.

ORENCIA contains sodium

This medication contains34.5mg of sodium (main component of table salt/for cooking) in each maximum dose of 4vials (86.25mg of sodium per vial). This represents 1.7% of the recommended daily maximum sodium intake for an adult.

Orencia will be administered under the supervision of a specialist doctor.

Recommended dose in adults

The recommended dose of abatacept for adults with rheumatoid arthritis or psoriatic arthritis is based on their body weight:

Your doctor will inform you about the duration of treatment and which other medications, including other disease-modifying drugs, if any, you may continue to take while on Orencia treatment.

Orencia can be used in adults over 65years without changing the dose.

Use in children and adolescents

For children and adolescents aged 6 to 17years with juvenile idiopathic polyarticular arthritis weighing less than 75kg, the recommended dose of intravenous abatacept is 10mg/kg. For children weighing 75kg or more, Orencia powder for concentrate for solution for infusion should be administered following the adult dosing regimen.

How Orencia is administered

Orencia is administered intravenously, usually in the arm, over a period of 30minutes. This procedure is called infusion. Healthcare professionals will supervise you while you receive the Orencia infusion.

Orencia is presented as powder for solution for infusion. This means that before you receive Orencia, it must first be dissolved in water for injection preparations, and then diluted with sodium chloride 9mg/ml (0.9%) injectable solution.

How often Orencia is administered

After the first Orencia infusion, you should receive it again at 2and 4weeks. After that, you will receive a dose every 4 weeks. Your doctor will inform you about the duration of treatment and which other medications you may continue to take while on Orencia treatment.

If you receive more Orencia than you should

If this happens, your doctor will monitor you for any signs or symptoms of adverse effects, and treat them if necessary.

If you forget to use Orencia

If you forget to receive Orencia when you should, ask your doctor to schedule 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 can 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 can cause serious side effects that may 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 signs 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, burning sensation 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:

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), rhinitis, flu
• headaches, dizziness
• high blood pressure
• cough
• abdominal pain, diarrhea, nausea, stomach discomfort, mouth sores, vomiting
• skin rash
• fatigue, weakness
• 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
• skin cancer, warts
• low platelet count
• 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 flashes, 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 illness, weight gain, reactions related to perfusion

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

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

Children and adolescents with juvenile idiopathic polyarticular arthritis

The side effects in children and adolescents with juvenile idiopathic polyarticular arthritis are similar to those experienced in adults, as described above, with the following differences:

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

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

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

• blood in urine
• ear infection

Communication 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).

Store in the original packaging to protect it from light.

After reconstitution and dilution, the infusion solution is stable in the refrigerator for 24 hours, but for microbiological reasons, it should be used immediately.

Do not use this medication if you observe opaque particles, color changes, or other foreign particles in the infusion solution.

Medications should not be disposed of through drains or 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 vial contains 250 mg of abatacept.
• After reconstitution, each ml contains 25 mg of abatacept.

• The other components are maltose, sodium dihydrogen phosphate monohydrate, and sodium chloride (see section 2 "ORENCIA contains sodium").

Appearance of the product and contents of the pack

ORENCIA powder for concentrate for solution for infusion is a white to off-white powder that may be presented in a compact or fragmented form.

ORENCIA is available in packs of 1 vial and 1 syringe without silicone, and in multiple packs with 2, or 3 vials and 2, or 3 syringes without silicone (2 or 3 packs of 1).

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

Responsible Person

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 this 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.

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This information is intended solely for healthcare professionals:

The reconstitution and dilution must be performed in accordance with good practices, particularly in terms of asepsis.

Dose selection:see section 3 of the leaflet "How to use ORENCIA".

Reconstitution of the vials:in aseptic conditions, reconstitute each vial with 10 ml of injectable water, using the disposable syringe without silicone that comes with each vial and a 18-21 gauge needle. Remove the stopper from the vial and clean the top with a moistened cotton swab. Insert the syringe needle into the vial through the center of the rubber stopper and direct the jet of injectable water to the glass wall of the vial. Do not use the vial if there is no vacuum. Remove the syringe and needle after injecting 10 ml of injectable water into the vial. To minimize foam formation in ORENCIA solutions, the vial should be rotated with spiral movements until the contents are completely dissolved.Do not agitate..Avoid vigorous or prolonged agitation.. Once the powder is dissolved, the air from the vial should be extracted with a needle to disperse any foam that may be present. After reconstitution, the solution should be transparent and colorless to pale yellow. Do not use if opaque particles, color changes, or other foreign particles are observed.

Preparation of the infusion:immediately after reconstitution, dilute the concentrate to 100 ml with sodium chloride 9 mg/ml (0.9%) injectable solution. Extract 100 ml from the infusion bag or bottle, a volume of sodium chloride 0.9% injectable solution equal to the volume of the reconstituted ORENCIA vials. Add the reconstituted ORENCIA solution from each vial slowly to the infusion bag or bottle using the same disposable syringe without silicone that comes with each vial.syringe.Mix carefully. The final concentration of abatacept in the infusion bag or bottle will depend on the amount of active ingredient added, but will not exceed 10 mg/ml.

Administration:when reconstitution and dilution are performed in aseptic conditions, the ORENCIA infusion solution can be used immediately or within 24 hours if stored in the refrigerator at 2°C to 8°C. However, for microbiological reasons, it should be used immediately. Before administration, the ORENCIA solution should be visually inspected for the presence of particles and color changes. Discard the solution if particles or color changes are observed. The entire ORENCIA solution that has been fully diluted must be administered within 30 minutes and using an infusion set and a sterile low-protein binding filter (pore size of 0.2 to 1.2 μm). Do not store the unused portion of the infusion solution for reuse.

Other medicinal products:ORENCIA should not be mixed or administered simultaneously with other medicinal products via the same intravenous route. No studies of physical or biochemical compatibility have been conducted to evaluate the concomitant administration of ORENCIA with other medicinal products.

Medicines should not be disposed of by flushing down the toilet or by throwing them away. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.