Orencia 250 mg powder for concentrate for infusion solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

ORENCIA 250 mg powder for concentrate for solution for infusion

abatacept

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet Contents:

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 obtained from cell cultures. ORENCIA reduces the immune system's attack on normal tissues by interfering with immune cells (so-called T-lymphocytes) that contribute to the development of rheumatoid arthritis. ORENCIA selectively modulates the activation of T-lymphocytes 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 from 6 years of age.

Rheumatoid arthritis

Rheumatoid arthritis is a progressive, long-term systemic disease which, if left untreated, can have serious consequences such as joint destruction, increasing disability, and inability to perform daily activities. In people with rheumatoid arthritis, the body's own immune system attacks normal tissues, causing pain and swelling in the joints. This can damage the joints. Rheumatoid arthritis (RA) affects each person differently. In most people, joint symptoms develop gradually over several years. However, in some patients, RA can progress rapidly, while others may have RA for a limited period of time and then enter a period of remission. RA is typically a chronic (long-term), progressive disease. This means that, even if you receive treatment and whether or not you have symptoms, RA could continue to damage your joints. With the best treatment plan for you, you may be able to slow this disease process, which could help reduce long-term joint damage, as well as pain and fatigue, and improve your overall quality of life.

ORENCIA is used to treat moderate to severe active rheumatoid arthritis when you have not responded adequately to treatment with other disease-modifying drugs or with another group of drugs called "tumour necrosis factor (TNF) inhibitors". It is used in combination with a medicine called methotrexate.

ORENCIA may also be used with methotrexate to treat progressive, highly active rheumatoid arthritis without prior methotrexate treatment.

Psoriatic arthritis

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

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

ORENCIA, either 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 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 previous treatment with a disease-modifying drug 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 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

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. Having an infection could put you at risk due to the side effects of ORENCIA.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse:

• if you experience allergic reactions such as chest tightness, asthma, severe dizziness or lightheadedness, swelling or skin rash—inform your doctor immediately.
• if you, your partner, or caregiver notice new or worsening neurological symptoms, including general muscle weakness, changes in vision, difficulty speaking, a change in the way you walk, or problems with balance, changes in thinking, memory, and orientation leading to 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 a prolonged or localized infection, or if you frequently suffer from infections, or if you have symptoms of an 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 any existing infection.
• if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, lack of energy, low-grade fever), inform your doctor. Before using ORENCIA, your doctor will perform a tuberculosis test or a skin test.
• if you have viral hepatitis, inform your doctor. Before using ORENCIA, your doctor may test you for hepatitis.
• if you have cancer, your doctor will decide whether ORENCIA can be given to you.
• if you have recently been vaccinated or are planning to get vaccinated, inform your doctor. Some vaccines should not be given while you are being treated with ORENCIA. Consult your doctor before receiving any vaccine. It is recommended that patients with polyarticular juvenile idiopathic arthritis update, if possible, their vaccination schedule according to current vaccination guidelines before starting treatment with ORENCIA. Certain vaccines may cause infections. If you receive ORENCIA during pregnancy, your baby may have an increased risk of contracting such an infection for approximately 14 weeks after your last dose during pregnancy. It is important that you inform your baby’s doctors and other healthcare professionals about your use of ORENCIA during pregnancy so they can determine when your baby should receive any vaccines.
• if you use a blood glucose monitor to check your blood glucose levels. ORENCIA contains maltose, a type of sugar that may cause falsely high blood glucose readings with certain types of blood glucose monitoring systems. Your doctor may recommend a different method to monitor your blood glucose levels.

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

Children and adolescents

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

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

Using ORENCIA with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

ORENCIA should not be used with biologic medicines for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab; there is insufficient evidence to recommend co-administration with anakinra or rituximab.

ORENCIA may be used with other medicines commonly used to treat rheumatoid arthritis, such as steroids or analgesics, 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, you should not use ORENCIA during pregnancy unless specifically recommended by your doctor.

• If you are a woman who could become pregnant, you should use a reliable method of contraception (birth control) during treatment with ORENCIA and for 14 weeks after the last dose. Your doctor will advise you on suitable methods.
• If you become pregnant while being treated with ORENCIA, inform your doctor.

If you receive ORENCIA during pregnancy, your baby may have an increased risk of infection. It is important that you inform your baby’s doctors and other healthcare professionals about your use of ORENCIA during pregnancy before any vaccine is administered (for more information, see the section on vaccination).

It is unknown whether ORENCIA passes into breast milk. You must stop breastfeeding if you are being treated with ORENCIA until 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 receiving ORENCIA, you should not drive, ride a bicycle, or operate any machinery.

ORENCIA contains sodium

This medicine contains 34.5 mg of sodium (the main component of table/cooking salt) in each maximum dose of 4 vials (8.625 mg of sodium per vial). This is equivalent to 1.7% of the maximum daily recommended sodium intake for an adult.

3. How to use ORENCIA

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 your body weight:

Your doctor will inform you about the duration of treatment and which other medicines, including other disease-modifying medicines, if any, you may continue taking while being treated with ORENCIA.

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

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. For children weighing 75 kg or more, ORENCIA powder for concentrate for solution for infusion should be administered according to the adult dosing regimen.

How ORENCIA is administered

ORENCIA is administered into the vein, usually in the arm, over a period of 30 minutes. This procedure is called an infusion. Healthcare professionals will monitor you while you are receiving the ORENCIA infusion.

ORENCIA is supplied as a powder for solution for infusion. This means that before you are given ORENCIA, it must first be dissolved in water for injections and then diluted with sodium chloride 9 mg/ml (0.9%) injection solution.

How often ORENCIA is administered

After the first ORENCIA infusion, you should receive another dose at weeks 2 and 4. After this, 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 taking while being treated with ORENCIA.

If you are given more ORENCIA than you should

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

If you forget to use ORENCIA

If you forget to receive ORENCIA when scheduled, ask your doctor when to schedule your next dose.

If you stop treatment with ORENCIA

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The most common adverse effects with ORENCIA are upper respiratory tract infections (including infections of the nose and throat), headache, and nausea. ORENCIA may cause serious adverse effects that may require treatment.

Possible serious adverse effects include serious infections, malignant neoplasms (cancer), and allergic reactions, as listed below.

Contact your doctor immediately if you notice any of the following symptoms:

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

Contact your doctor immediately if you notice any of the following:

• general malaise, dental problems, burning sensation when urinating, painful skin rash, painful blisters on the skin, cough

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

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

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

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

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

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

• dental infection, fungal nail infection, muscle infection, bloodstream infection, pus accumulation under the skin, kidney infection, ear infection
• low white blood cell count
• skin cancer, warts
• low platelet count
• allergic reactions
• depression, anxiety, sleep disturbances
• migraines
• numbness
• dry eye, decreased vision
• eye inflammation
• palpitations, rapid heartbeat, slow heartbeat
• low blood pressure, hot flushes, blood vessel inflammation, flushing
• difficulty breathing, 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
• alopecia, pruritus, urticaria
• painful joints
• limb pain
• absence of menstruation, heavy menstrual periods
• flu-like syndrome, weight gain, infusion-related reactions

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

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

Children and adolescents with polyarticular juvenile idiopathic arthritis

Adverse effects in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those observed in adults described above, with the following differences:

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

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

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

• blood in urine
• ear infection

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 packaging after CAD. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Keep in the original packaging to protect from light.

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

Do not use this medicine if you notice cloudy particles, colour changes, or other foreign particles in the infusion solution.

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

6. Package contents and other information

Composition of ORENCIA

• 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").

Appearance of the product and contents of the pack

ORENCIA powder for concentrate for solution for infusion is a white to off-white powder which may appear compact or fragmented.

ORENCIA is available in packs of 1 vial and 1 silicon-free syringe, and in multiple packs containing 2 or 3 vials and 2 or 3 silicon-free syringes (2 or 3 packs of 1).

Only certain 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

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Reconstitution and dilution must be performed in accordance with good practice standards, particularly with regard to aseptic technique.

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

Reconstitution of the vials: under aseptic conditions, reconstitute each vial with 10 ml of water for injections, using the disposable silicon-free syringe supplied with each vial and an 18–21 gauge needle. Remove the vial cap and disinfect the top with an alcohol-moistened cotton swab. Insert the syringe needle through the center of the rubber stopper into the vial, directing the stream of water for injection onto 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 water for injection into the vial. To minimize foam formation in ORENCIA solutions, gently rotate the vial in a spiral motion until the powder is completely dissolved. Do not shake. Avoid prolonged or vigorous agitation. Once the powder is dissolved, remove air from the vial using a needle to dissipate any foam present. After reconstitution, the solution should be clear and colourless to pale yellow. Do not use if opaque particles, discoloration, 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%) solution for injection. From the 100 ml infusion bag or bottle, withdraw a volume of 0.9% sodium chloride solution for injection equal to the volume of reconstituted ORENCIA from the vials. Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same disposable silicon-free syringe supplied with each vial. Mix gently. 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 are performed under aseptic conditions, the ORENCIA infusion solution may be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C. However, for microbiological reasons, it is recommended to use it immediately. Prior to administration, the ORENCIA solution should be visually inspected for the presence of particles and discoloration. Discard the solution if particles or discoloration are observed. The entire diluted ORENCIA solution must be administered within 30 minutes using an infusion set and a sterile, pyrogen-free, low protein-binding filter (pore size 0.2 to 1.2 µm). Do not store any unused portion of the infusion solution for later reuse.

Other medicines: ORENCIA must not be mixed or administered simultaneously with other medicines in the same intravenous line. No physical or biochemical compatibility studies have been conducted to evaluate co-administration of ORENCIA with other medicines.

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