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Orencia (abatacept) – Package leaflet - L04AA24

Updated on site: 09-Oct-2017

Medication nameOrencia
ATC CodeL04AA24
Substanceabatacept
ManufacturerBristol-Myers Squibb Pharma EEIG

Article Contents

Package leaflet: Information for the patient ORENCIA 250 mg powder for concentrate for solution for infusion

abatacept

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What ORENCIA is and what it is used for

2.What you need to know before you are given 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 lessens the immune system's attack on normal tissues by interfering with the 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 systems’ inflammatory response.

ORENCIA is used to treat Rheumatoid arthritis and Psoriatic Arthritis in adults.

Rheumatoid Arthritis

Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities. In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints. This can cause joint damage. Rheumatoid arthritis (RA) affects everyone differently. In most people, joint symptoms develop gradually over several years. However, in some, RA may progress rapidly and yet other people 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, even if you’re on treatment, whether or not you’re still having symptoms, RA could be continuing to damage your joints. By finding the right treatment plan for you, you may be able to slow down this disease process, which may 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 well enough to treatment with other disease-modifying medicines or with another group of medicines called 'tumour necrosis factor (TNF) blockers'. It is used in combination with a medicine called methotrexate.

ORENCIA can also be used with methotrexate to treat highly active and progressive rheumatoid arthritis without previous methotrexate treatment.

Psoriatic Arthritis

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

Reduce the signs and symptoms of your disease.

Slow down the damage to your bones and joints.

Improve your physical function and your ability to do normal daily activities. ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate.

Polyarticular Juvenile Idiopathic Arthritis

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

ORENCIA is used in children and adolescents aged 6 to 17 years after another group of medicines called TNF blockers. If you do not respond well enough to these medicines, you will be given ORENCIA with methotrexate to treat your polyarticular juvenile idiopathic arthritis.

ORENCIA is used to:

-slow down the damage to your joints

-improve your physical function

-improve signs and symptoms of polyarticular juvenile idiopathic arthritis

2. What you need to know before you are given ORENCIA

You should not be given ORENCIA

if you are allergic to abatacept or 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. Having an infection could put you at risk of serious side effects from ORENCIA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse:

if you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling or skin rash tell your doctor immediately.

if you have any kind of infection, including long-term or localised infection, if you often get infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is important to tell your doctor. ORENCIA can lower your body's ability to fight infection and the treatment can make you more likely to get infections or make any infection you have worse.

if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) tell your doctor. Before you are given ORENCIA, your doctor will examine you for tuberculosis or do a skin test.

if you have viral hepatitis tell your doctor. Before you are given ORENCIA, your doctor may examine you for hepatitis.

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

if you recently had a vaccination or are planning to have one, tell your doctor. Some vaccines should not be given while you are receiving ORENCIA. Check with your doctor before you are given any vaccines. It is recommended that patients with polyarticular juvenile idiopathic arthritis, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to starting ORENCIA therapy. Certain vaccinations may cause infections from the vaccine. If you received ORENCIA while you were pregnant, your baby may be at a higher risk for getting such an infection for up to approximately 14 weeks after the last dose you received during pregnancy. It is important that you tell your baby’s doctors and other health care professionals about your ORENCIA use during your pregnancy so they can decide when your baby should receive any vaccine.

if you are using a blood glucose monitor to check your blood glucose levels. ORENCIA contains maltose, which is a type of sugar that can give falsely high blood glucose readings with certain types of blood glucose monitors. Your doctor may recommend a different method for monitoring your blood glucose levels.

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

ORENCIA and older people

ORENCIA can be used by people over 65 with no change in dose.

Children and adolescents

ORENCIA has not been studied in patients under 6 years of age, therefore ORENCIA is not recommended in this patient population.

Other medicines and ORENCIA

Tell your doctor if you are taking, have recently taken or might take any other medicines. ORENCIA should not be used with biological medicines for rheumatoid arthritis, including TNF- blockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its being given with anakinra and rituximab.

ORENCIA can be received with other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatories such as ibuprofen or diclofenac. Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.

Pregnancy and breast-feeding

The effects of ORENCIA in pregnancy are not known, so you should not be given ORENCIA if you are pregnant unless your doctor specifically recommends it.

if you are a woman who could become pregnant, you must use reliable contraception (birth control) while using ORENCIA and up to 14 weeks after the last dose. Your doctor will advise you on suitable methods.

if you become pregnant while using ORENCIA, tell your doctor.

If you received ORENCIA during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your ORENCIA use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).

It is not known whether ORENCIA passes into human milk. You must stop breast-feeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.

Driving and using machines

The use of ORENCIA is not expected to affect the ability to drive or use machines. However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive or operate any machinery.

ORENCIA contains sodium

This medicine contains 1.5 mmol (or 34.5 mg) sodium per maximum dose of 4 vials (0.375 mmol or 8.625 mg sodium per vial). To be taken into consideration by patients on a controlled sodium diet.

3.How to use ORENCIA

ORENCIA will be given to you under the supervision of an experienced doctor.

Recommended dose in adults

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

Your weight

Dose

Vials

Less than 60 kg

500 mg

60 kg - 100 kg

750 mg

More than 100 kg

1000 mg

Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.

Use in children and adolescents

For children and adolescents aged 6 to 17 years with polyarticular juvenile idiopathic arthritis who weigh less than 75 kg, the recommended dose of abatacept is 10 mg/kg. Children weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen.

How ORENCIA is given to you

ORENCIA is given to you into a vein, usually in your arm, over a period of 30 minutes. This procedure is referred to as an infusion. Healthcare professionals will monitor you while you receive your ORENCIA infusion.

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

How often ORENCIA is given to you

ORENCIA should be given to you again, 2 and then 4 weeks after the first infusion. After that you will receive a dose every 4 weeks. Your doctor will advise you on the duration of treatment and what other medicines you may continue to take while on ORENCIA.

If you are given more ORENCIA than you should

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

If you forget to receive ORENCIA

If you miss receiving ORENCIA when you are supposed to, ask your doctor when to schedule your next dose.

If you stop using ORENCIA

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

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

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 infections of the upper airway (including infections of the nose and throat), headache and nausea, as listed below. ORENCIA can cause serious side effects, which may need treatment.

Possible serious side effects include serious infections, malignancies (cancer) and allergic reactions, as listed below.

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

severe rash, hives or other signs of allergic reaction

swollen face, hands or feet

trouble breathing or swallowing

fever, persistent cough, weight loss, listlessness

Tell your doctor as soon as possible if you notice any of the following:

feeling generally unwell, dental problems, burning sensation during urination, painful skin rash, painful skin blisters, coughing

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

List of side effects:

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

infections of the upper airway (including infections of the nose, throat and sinuses).

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

infections of lungs, urinary infections, painful skin blisters (herpes), flu

headache, dizziness

high blood pressure

cough

abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting

rash

fatigue, weakness

abnormal liver function tests

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

tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection

low white blood cells count

skin cancer, skin warts

low blood platelet count

allergic reactions

depression, anxiety, sleep disturbance

migraine

numbness

dry eye, reduced vision

eye inflammation

palpitation, rapid heart rate, low heart rate

low blood pressure, hot flush, blood vessels inflammation, flushing

difficulty in 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

hair loss, itching, hives

painful joints

pain in the extremities

absence of menstruation, excessive menses

flu-like illness, increased weight, infusion-related reactions

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

tuberculosis

inflammation of uterus, fallopian tubes and/or ovaries

gastrointestinal infection

cancer of white blood cells, lung cancer

Children and adolescents with polyarticular juvenile idiopathic arthritis

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

Common (may affect up to 1 in 10 people): upper airway infection (including infections of nose, sinus and throat), ear infection, blood in urine, fever.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Store in the original package in order to protect from light.

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

Do not use ORENCIA if you notice opaque particles, discolouration or other foreign particles present in the infusion solution.

6. Contents of the pack 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 ingredients are maltose, sodium dihydrogen phosphate monohydrate and sodium chloride (see section 2 "ORENCIA contains sodium").

What ORENCIA looks like and contents of the pack

ORENCIA powder for concentrate for solution for infusion is a white to off-white powder that can appear solid or broken into pieces.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer

Bristol-Myers Squibb S.R.L.

Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone

Italy

Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics

Cruiserath Road, Mulhuddart

Dublin 15

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: +33 (0)1 58 83 84 96

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 2078 508

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

 

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Other sources of information

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

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only

Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.

Dose selection: see section 3 ‘How to use ORENCIA’ of the Package Leaflet

Reconstitution of vials: under aseptic conditions, reconstitute each vial with 10 mL of water for injections, using the silicone-free disposable syringe provided with each vial and an 18-21 gauge needle. Remove the flip-top from the vial and wipe the top with an alcohol swab. Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream of water for injections to the glass wall of the vial. Do not use the vial if a vacuum is not present. Remove the syringe and needle after 10 mL of water for injections have been injected into the vial. To minimise foam formation in solutions of ORENCIA the vial should be rotated with gentle swirling until the contents are completely dissolved. Do not shake. Do not use prolonged or vigorous agitation. Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any foam that may be present. After reconstitution the solution should be clear and colourless to pale yellow. Do not use if opaque particles, discolouration, or other foreign particles are present.

Preparation of infusion: immediately after reconstitution, dilute the concentrate to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection. From a 100 mL infusion bag or bottle, withdraw a volume of 0.9% sodium chloride injection equal to the volume of the reconstituted ORENCIA vials. Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using the same silicone-free disposable syringe provided with each vial. Gently mix. The final concentration of abatacept in the bag or bottle will depend upon the amount of active substance added, but will be no more than 10 mg/mL.

Administration: when reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C. However, for microbiological reasons, it is to be used immediately. Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration. Discard the solution if any particulate matter or discolouration is observed. The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μm). Do not store any unused portion of the infusion solution for reuse.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Package leaflet: Information for the patient ORENCIA 125 mg solution for injection in pre-filled syringe

abatacept

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

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 lessens the immune system's attack on normal tissues by interfering with the 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.

Rheumatoid Arthritis

Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities. In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints. This can cause joint damage. Rheumatoid arthritis (RA) affects everyone differently. In most people, joint symptoms develop gradually over several years. However, in some, RA may progress rapidly and yet other people 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, even if you’re on treatment, whether or not you’re still having symptoms, RA could be continuing to damage your joints. By finding the right treatment plan for you, you may be able to slow down this disease process, which may 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 well enough to treatment with other disease-modifying medicines or with another group of medicines called 'tumour necrosis factor (TNF) blockers'. It is used in combination with a medicine called methotrexate.

ORENCIA can also be used with methotrexate to treat highly active and progressive rheumatoid arthritis without previous methotrexate treatment.

ORENCIA is used to:

-slow down the damage to your joints

-improve your physical function

Psoriatic Arthritis

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

Reduce the signs and symptoms of your disease.

Slow down the damage to your bones and joints.

Improve your physical function and your ability to do normal daily activities. ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate.

2. What you need to know before you use ORENCIA

Do not use ORENCIA

if you are allergic to abatacept or 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. Having an infection could put you at risk of serious side effects from ORENCIA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse:

if you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling or skin rash tell your doctor immediately.

if you have any kind of infection, including long-term or localised infection, if you often get infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is important to tell your doctor. ORENCIA can lower your body's ability to fight infection and the treatment can make you more likely to get infections or make any infection you have worse.

if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) tell your doctor. Before you use ORENCIA, your doctor will examine you for tuberculosis or do a skin test.

if you have viral hepatitis tell your doctor. Before you use ORENCIA, your doctor may examine you for hepatitis.

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

if you recently had a vaccination or are planning to have one, tell your doctor. Some vaccines should not be given while you are receiving ORENCIA. Check with your doctor before you are given any vaccines. Certain vaccinations may cause infections from the vaccine. If you received ORENCIA while you were pregnant, your baby may be at a higher risk for getting such an infection for up to approximately 14 weeks after the last dose you received during pregnancy. It is important that you tell your baby’s doctors and other health care professionals about your ORENCIA use during your pregnancy so they can decide when your baby should receive any vaccine.

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

ORENCIA and older people

ORENCIA can be used by people over 65 with no change in dose.

Children and adolescents

ORENCIA solution for injection has not been studied in children and adolescents under the age of 18 years. Therefore, ORENCIA solution for injection is not recommended for use in this patient population.

Other medicines and ORENCIA

Tell your doctor if you are taking, have recently taken or might take any other medicines. ORENCIA should not be used with biological medicines for rheumatoid arthritis, including TNF- blockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its being given with anakinra and rituximab.

ORENCIA can be used with other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatories such as ibuprofen or diclofenac. Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.

Pregnancy and breast-feeding

The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if you are pregnant unless your doctor specifically recommends it.

if you are a woman who could become pregnant, you must use reliable contraception (birth control) while using ORENCIA and up to 14 weeks after the last dose. Your doctor will advise you on suitable methods.

if you become pregnant while using ORENCIA, tell your doctor.

If you received ORENCIA during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your ORENCIA use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).

It is not known whether ORENCIA passes into human milk. You must stop breast-feeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.

Driving and using machines

The use of ORENCIA is not expected to affect the ability to drive or use machines. However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive or operate any machinery.

ORENCIA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

3. How to use ORENCIA

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Recommended dose

The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg given every week regardless of weight.

Your doctor may start your ORENCIA treatment with or without a one-time dose of powder for concentrate for solution for infusion (given to you into a vein, usually in your arm, over a period of 30 minutes). If a single intravenous dose is given to start the treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by the weekly

125 mg subcutaneous injections.

If you are already on intravenous ORENCIA treatment and wish to transition to ORENCIA subcutaneous, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.

Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.

At the start, your doctor or nurse may inject ORENCIA. However, you and your doctor may decide that you can inject ORENCIA yourself. In this case, you will get training on how to inject ORENCIA yourself.

Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed "Instructions for preparing and giving a subcutaneous injection of ORENCIA" at the end of this leaflet.

If you use more ORENCIA than you should

If this happens, contact immediately your doctor who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.

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 miss your dose within three days of when you are supposed to take it, take your dose as soon as you remember and then follow your original dosing schedule on your chosen day. If you miss 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 using ORENCIA should be discussed with your doctor.

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

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 infections of the upper airway (including infections of the nose and throat), headache and nausea, as listed below. ORENCIA can cause serious side effects, which may need treatment.

Possible serious side effects include serious infections, malignancies (cancer) and allergic reactions, as listed below.

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

severe rash, hives or other signs of allergic reaction

swollen face, hands or feet

trouble breathing or swallowing

fever, persistent cough, weight loss, listlessness

Tell your doctor as soon as possible if you notice any of the following:

feeling generally unwell, dental problems, burning sensation during urination, painful skin rash, painful skin blisters, coughing

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

List of side effects:

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

infections of the upper airway (including infections of the nose, throat and sinuses).

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

infections of lungs, urinary infections, painful skin blisters (herpes), flu

headache, dizziness

high blood pressure

cough

abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting

rash

fatigue, weakness, injection site reactions

abnormal liver function tests.

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

tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection

low white blood cells count

skin cancer, skin warts

low blood platelet count

allergic reactions

depression, anxiety, sleep disturbance

migraine

numbness

dry eye, reduced vision

eye inflammation

palpitation, rapid heart rate, low heart rate

low blood pressure, hot flush, blood vessels inflammation, flushing

difficulty in 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

hair loss, itching, hives

painful joints

pain in the extremities

absence of menstruation, excessive menses

flu-like illness, increased weight

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

tuberculosis

inflammation of uterus, fallopian tubes and/or ovaries

gastrointestinal infection

cancer of white blood cells, lung cancer

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C). Do not freeze.

Store in the original package in order to protect from light.

Do not use this medicine if the liquid is cloudy or discoloured, or has large particles. The liquid should be clear to pale yellow.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What ORENCIA contains

The active substance is abatacept.

Each pre-filled syringe contains 125 mg of abatacept in one mL.

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

What ORENCIA looks like and contents of the pack

ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution. ORENCIA is available in the following presentations:

-packs of 1, or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of 4).

-packs of 1, 3, or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer

Bristol-Myers Squibb S.R.L.

Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone

Italy

Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics

Cruiserath Road, Mulhuddart

Dublin 15

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

 

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: +33 (0)1 58 83 84 96

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 2078 508

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Other sources of information

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

Instructions for preparing and giving a subcutaneous injection of ORENCIA:

Please read these instructions carefully and follow them step by step.

You will be trained by your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe.

Don’t try to self-inject until you are sure that you understand how to prepare and give the injection. After proper training, you can give the injection to yourself, or it can be given by another person, for example a family member or friend.

Plunger head

 

 

 

 

 

Needle

 

 

 

Syringe body

 

 

 

 

Needle Cover (cap)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Drug Level

 

 

 

 

 

Plunger

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 1

Before you start - some Do's and Don'ts

Do

Always handle the ORENCIA syringe carefully, especially when you are around other people, and children.

Always hold the syringe by its body.

Store unused syringes in the refrigerator in the original carton.

Have your additional injection supplies ready before you inject.

Supplies checklist: alcohol swabs, cotton ball or gauze, adhesive plaster, Sharps container. Sharps containers are special puncture-resistant disposal bins that can be bought at many retail outlets.

Don’t

Don’t remove the needle cover (cap) until you are ready to inject.

Don’t pull back on the plunger at any time.

Don’t shake the syringe, as this may damage the ORENCIA medicine.

DON’T recap the needle.

STEP 1: Get the syringe ready

A.Check the expiry date and batch number on the carton

The expiry date can be found 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.Let the syringe warm up

Find a comfortable space with a clean, flat, working surface.

Remove the syringe from the refrigerator. Keep any remaining unused syringes in their original carton, in the refrigerator.

Check that the expiry date and batch number match the ones on the carton.

Inspect the syringe for obvious flaws, but don't remove the needle cover.

Allow the syringe to rest at room temperature for 30 to 60 minutes before you inject.

Don't speed the warming process in any way, such as using the microwave or placing the syringe in warm water.

C.Check the liquid in the syringe

Hold the syringe by its body, with the covered needle pointing down.

Figure 2

Look at the liquid in the syringe (Figure 2). The liquid should be clear to pale yellow. Don't inject if the liquid is cloudy or discoloured, or has visible particles.

It is normal to see an air bubble, and there is no reason to remove it. All contents of the syringe should be injected.

D.Gather your additional supplies and keep them within easy reach.

E.Wash your hands thoroughly with soap and warm water.

STEP 2: Choose and prepare your injection site

Have the syringe ready for use immediately after you have prepared your injection site.

A.Choose an area of your body for the injection (injection site)

You can use:

o the front of your thigh

o your abdomen, except for the 5 cm area 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, as long as each injection site is approximately 2.5 cm away from where you last injected.

Don't inject into areas where your skin is tender, bruised, red, scaly, or hard. Avoid any areas with scars or stretch marks.

B.Prepare your injection site

Wipe your injection site with an alcohol swab in a circular motion.

Let your skin dry before injecting.

Don't touch your injection site again before giving the injection.

Don’t fan or blow on the clean area.

STEP 3: Inject ORENCIA

A.Remove the needle cover (cap) only when you are ready to administer the injection.

Hold the syringe by its body in one hand, and pull the needle cover straight off with your other hand (Figure 4).

Figure 4

There may be a small air bubble in the liquid in the syringe. There is no need to remove the air bubble.

You may notice a drop of fluid leaving the needle. This is normal and will not affect your dose.

Don’t touch the plunger while you remove the needle cover.

Don’t remove the needle cover until you are ready to inject ORENCIA.

Don’t touch the needle or let it touch any surfaces.

Don’t use the syringe if it is dropped without the needle cover in place.

Don’t put the needle cover back on the needle once removed.

Don’t use the syringe if there are visible signs of needle damage or bending.

B. Position the syringe and inject ORENCIA

Hold the syringe by its body in one hand between your thumb and index finger (Figure 5).

Don't press on the plunger head until you begin your injection.

Don't pull back on the plunger at any time.

Using your other hand, gently pinch the area of skin you cleaned. Hold it firmly.

Insert the needle with a quick motion into the pinched skin at a 45° angle (Figure 5).

Figure 5

Figure 6

 

Use your thumb to push the plunger down, pressing firmly until the plunger will go no further, and all of the medicine has been injected (Figure 6).

Remove the needle from the skin and let go of the surrounding skin.

DON’T recap the needle.

Press a cotton ball over the injection site and hold for 10 seconds.

Don’t rub the injection site. Slight bleeding is normal.

If needed, you may apply a small adhesive plaster to the injection site.

STEP 4: Dispose of the syringe and keep a record

A.Dispose of the used syringe in a Sharps container.

Ask your doctor, nurse, or pharmacist about national and local laws regarding the proper

disposal of medical products that contain needles.

Always keep your Sharps container out of reach of children and animals.

Don’t throw away used syringes in your household rubbish or recycling bins.

B.Keep a record of your injection

Write down the date, time, and specific part of your body where you injected yourself. It may also be helpful to write down any questions or concerns about the injection so you can ask your doctor, nurse or pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Instructions for preparing and giving a subcutaneous injection of ORENCIA:

Please read these instructions carefully and follow them step by step.

You will be trained by your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe with needle guard.

Don't try to self-inject until you are sure that you understand how to prepare and give the injection. After proper training, you can give the injection to yourself, or it can be given by another person, for example a family member or friend.

Plunger Head

Plunger

Drug Level

Indicator Line

Window

Syringe Body

Needle Guard

Activation Spring

Needle

Needle Cover

Figure 1

Before you start - some Do's and Don'ts

Do

Always handle the ORENCIA syringe carefully, especially when you are around other people, and children.

Always hold the syringe by its body.

Store unused syringes in the refrigerator in the original carton.

Have your additional injection supplies ready before you inject.

Supplies checklist: alcohol swabs, cotton ball or gauze, adhesive plaster, Sharps container. Sharps containers are special puncture-resistant disposal bins that can be bought at many retail outlets.

Don’t

Don’t pull by the plunger or the needle cover when removing the syringe from the tray.

Don’t remove the needle cover until you are ready to inject.

Don’t pull back on the plunger at any time.

Don’t shake the syringe, as this may damage the ORENCIA medicine.

DON’T recap the needle.

STEP 1: Get the syringe ready

A. Check the expiry date and batch number on the carton

The expiry date can be found 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. Let the syringe warm up

Find a comfortable space with a clean, flat working surface.

Remove the syringe from the refrigerator. Keep any remaining unused syringes in their original carton, in the refrigerator.

To remove the syringe from the package, hold it by its body as indicated by the arrows in the tray.

Don't hold it by the plunger.

Check that the expiry date and batch number match the ones on the carton.

Inspect the syringe for obvious flaws, but don't remove the needle cover.

Allow the syringe to rest at room temperature for 30 to 60 minutes before you inject.

Don't speed the warming process in any way, such as using the microwave or placing the syringe in warm water.

C.Check the liquid in the pre-filled syringe

Hold the syringe by its body with the covered needle pointing down.

CHECK

Figure 2

Look at the liquid in the syringe window (Figure 2). The liquid should be clear to pale yellow.

Don't inject if the liquid is cloudy or discoloured, or has visible particles.

It is normal to see an air bubble, and there is no reason to remove it. All contents of the syringe should be injected.

D. Gather your additional supplies and keep them within easy reach.

E. Wash your hands thoroughly with soap and warm water.

STEP 2: Choose and prepare your injection site

Have the syringe ready for use immediately after you have prepared your injection site.

A. Choose an area of your body for the injection (injection site)

You can use:

o the front of your thigh

o your abdomen, except for the 5 cm area 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, as long as each injection site is approximately 2.5 cm away from where you last injected.

Don't inject into areas where your skin is tender, bruised, red, scaly, or hard. Avoid any areas with scars or stretch marks.

B. Prepare your injection site

Wipe your injection site with an alcohol swab in a circular motion.

Let your skin dry before injecting.

Don't touch your injection site again before giving the injection.

Don't fan or blow on the clean area.

STEP 3: Inject ORENCIA

A. Remove the needle cover (cap) only when you are ready to administer the injection.

Hold the syringe by its body in one hand and pull the needle cover straight off with your other hand (Figure 4).

Figure 4

There may be a small air bubble in the liquid in the syringe. There is no need to remove the air bubble.

You may notice a drop of fluid leaving the needle. This is normal and will not affect your dose.

Don’t touch the plunger while you remove the needle cover.

Don’t remove the needle cover until you are ready to inject ORENCIA.

Don’t touch the needle or let it touch any surfaces.

Don’t use the syringe if it is dropped without the needle cover in place.

Don’t put the needle cover back on the needle once removed.

Don’t use the syringe if there are visible signs of needle damage or bending.

B. Position the syringe and inject ORENCIA

Hold the syringe by its body in one hand between your thumb and index finger (Figure 5).

Don't press on the plunger head until you begin your injection.

Don't pull back on the plunger at any time.

Using your other hand, gently pinch the area of skin you cleaned. Hold it firmly.

Insert the needle with a quick motion into the pinched skin at a 45° angle (Figure 5).

 

 

 

Figure 5

 

Figure 6

Use your thumb to push the plunger down, pressing firmly until the plunger will go no further, and all of the medicine has been injected (Figure 6).

When the plunger is pushed in as far as it will go, keep your thumb on the plunger head.

Slowly relax the pressure of your thumb on the plunger head and allow it to move your thumb back upwards. This lets the empty syringe move up until the whole needle is covered by the needle guard (Figure 7).

Figure 7

Once the needle is completely covered by the needle guard, let go of the surrounding skin. Remove the syringe.

Press a cotton ball over the injection site and hold for 10 seconds. Don’t rub the injection site. Slight bleeding is normal.

If needed, you may apply a small adhesive plaster to the injection site.

STEP 4: Dispose of the syringe and keep a record

A. Dispose of the used syringe in a Sharps container.

Ask your doctor, nurse, or pharmacist about national and local laws regarding the proper disposal of medical products that contain needles.

Always keep your Sharps container out of reach of children and animals.

Don’t throw away used syringes in your household rubbish or recycling bins.

B. Keep a record of your injection

Write down the date, time, and specific part of your body where you injected yourself. It may also be helpful to write down any questions or concerns about the injection so you can ask your doctor, nurse, or pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Package leaflet: Information for the patient ORENCIA 125 mg solution for injection in pre-filled pen abatacept

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 further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 lessens the immune system's attack on normal tissues by interfering with the 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.

Rheumatoid Arthritis

Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities. In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints. This can cause joint damage. Rheumatoid arthritis (RA) affects everyone differently. In most people, joint symptoms develop gradually over several years. However, in some, RA may progress rapidly and yet other people 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, even if you’re on treatment, whether or not you’re still having symptoms, RA could be continuing to damage your joints. By finding the right treatment plan for you, you may be able to slow down this disease process, which may 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 well enough to treatment with other disease-modifying medicines or with another group of medicines called 'tumour necrosis factor (TNF) blockers'. It is used in combination with a medicine called methotrexate.

ORENCIA can also be used with methotrexate to treat highly active and progressive rheumatoid arthritis without previous methotrexate treatment.

ORENCIA is used to:

-slow down the damage to your joints

-improve your physical function

Psoriatic Arthritis

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

Reduce the signs and symptoms of your disease.

Slow down the damage to your bones and joints.

Improve your physical function and your ability to do normal daily activities. ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate

2. What you need to know before you use ORENCIA

Do not use ORENCIA

if you are allergic to abatacept or 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. Having an infection could put you at risk of serious side effects from ORENCIA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse:

if you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling or skin rash tell your doctor immediately.

if you have any kind of infection, including long-term or localised infection, if you often get infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is important to tell your doctor. ORENCIA can lower your body's ability to fight infection and the treatment can make you more likely to get infections or make any infection you have worse.

if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) tell your doctor. Before you use ORENCIA, your doctor will examine you for tuberculosis or do a skin test.

if you have viral hepatitis tell your doctor. Before you use ORENCIA, your doctor may examine you for hepatitis.

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

if you recently had a vaccination or are planning to have one, tell your doctor. Some vaccines should not be given while you are receiving ORENCIA. Check with your doctor before you are given any vaccines. Certain vaccinations may cause infections from the vaccine. If you received ORENCIA while you were pregnant, your baby may be at a higher risk for getting such an infection for up to approximately 14 weeks after the last dose you received during pregnancy. It is important that you tell your baby’s doctors and other health care professionals about your ORENCIA use during your pregnancy so they can decide when your baby should receive any vaccine.

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

ORENCIA and older people

ORENCIA can be used by people over 65 with no change in dose.

Children and adolescents

ORENCIA solution for injection has not been studied in children and adolescents under the age of 18 years. Therefore, ORENCIA solution for injection is not recommended for use in this patient population.

Other medicines and ORENCIA

Tell your doctor if you are taking, have recently taken or might take any other medicines. ORENCIA should not be used with biological medicines for rheumatoid arthritis, including TNF- blockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its being given with anakinra and rituximab.

ORENCIA can be used with other medicines commonly used to treat rheumatoid arthritis, such as steroids or painkillers, including non-steroidal anti-inflammatories such as ibuprofen or diclofenac. Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.

Pregnancy and breast-feeding

The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if you are pregnant unless your doctor specifically recommends it.

if you are a woman who could become pregnant, you must use reliable contraception (birth control) while using ORENCIA and up to 14 weeks after the last dose. Your doctor will advise you on suitable methods.

if you become pregnant while using ORENCIA, tell your doctor.

If you received ORENCIA during your pregnancy, your baby may have a higher risk for getting an infection. It is important that you tell your baby’s doctors and other health care professionals about your ORENCIA use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).

It is not known whether ORENCIA passes into human milk. You must stop breast-feeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.

Driving and using machines

The use of ORENCIA is not expected to affect the ability to drive or use machines. However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive or operate any machinery.

ORENCIA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

3. How to use ORENCIA

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Recommended dose

The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg given every week regardless of weight.

Your doctor may start your ORENCIA treatment with or without a one-time dose of powder for concentrate for solution for infusion (given to you into a vein, usually in your arm, over a period of 30 minutes). If a single intravenous dose is given to start the treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by the weekly

125 mg subcutaneous injections.

If you are already on intravenous ORENCIA treatment and wish to transition to ORENCIA subcutaneous, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.

Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.

At the start, your doctor or nurse may inject ORENCIA. However, you and your doctor may decide that you can inject ORENCIA yourself. In this case, you will get training on how to inject ORENCIA yourself.

Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed "Important instructions for use" in the booklet provided in the carton.

If you use more ORENCIA than you should

If this happens, contact immediately your doctor who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.

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 miss your dose within three days of when you are supposed to take it, take your dose as soon as you remember and then follow your original dosing schedule on your chosen day. If you miss 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 using ORENCIA should be discussed with your doctor.

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

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 infections of the upper airway (including infections of the nose and throat), headache and nausea, as listed below. ORENCIA can cause serious side effects, which may need treatment.

Possible serious side effects include serious infections, malignancies (cancer) and allergic reactions, as listed below.

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

severe rash, hives or other signs of allergic reaction

swollen face, hands or feet

trouble breathing or swallowing

fever, persistent cough, weight loss, listlessness

Tell your doctor as soon as possible if you notice any of the following:

feeling generally unwell, dental problems, burning sensation during urination, painful skin rash, painful skin blisters, coughing

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

List of side effects:

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

infections of the upper airway (including infections of the nose, throat and sinuses).

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

infections of lungs, urinary infections, painful skin blisters (herpes), flu

headache, dizziness

high blood pressure

cough

abdominal pain, diarrhoea, nausea, upset stomach, mouth sores, vomiting

rash

fatigue, weakness, injection site reactions

abnormal liver function tests.

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

tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection

low white blood cells count

skin cancer, skin warts

low blood platelet count

allergic reactions

depression, anxiety, sleep disturbance

migraine

numbness

dry eye, reduced vision

eye inflammation

palpitation, rapid heart rate, low heart rate

low blood pressure, hot flush, blood vessels inflammation, flushing

difficulty in 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

hair loss, itching, hives

painful joints

pain in the extremities

absence of menstruation, excessive menses

flu-like illness, increased weight

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

tuberculosis

inflammation of uterus, fallopian tubes and/or ovaries

gastrointestinal infection

cancer of white blood cells, lung cancer

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C). Do not freeze.

Store in the original package in order to protect from light.

Do not use this medicine if the liquid is cloudy or discoloured, or has large particles. The liquid should be clear to pale yellow.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What ORENCIA contains

The active substance is abatacept.

Each pre-filled pen contains 125 mg of abatacept in one mL.

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

What ORENCIA looks like and contents of the pack

ORENCIA solution for injection (injection) is a clear, colourless to pale yellow solution provided in a pre-filled pen called ClickJect.

ORENCIA is available in the following presentations:

- pack of 4 pre-filled pens and multipack containing 12 pre-filled pens (3 packs of 4).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer

Bristol-Myers Squibb S.R.L.

Contrada Fontana del Ceraso

I-03012 Anagni-Frosinone

Italy

Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics

Cruiserath Road, Mulhuddart

Dublin 15

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: +33 (0)1 58 83 84 96

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 2078 508

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Other sources of information

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

Important instructions for use. Read carefully.

HOW TO USE ORENCIA (abatacept) ClickJect Pre-filled Pen

125 mg, solution for injection subcutaneous use

Read these instructions before you use the ClickJect Pre-filled Pen.

Before you use the ClickJect Pen for the first time, make sure your healthcare provider shows you the right way to use it.

Keep the pen refrigerated until ready to use. DO NOT FREEZE.

If you have questions about this product, please read the section Frequently Asked Questions and the Package Leaflet.

BEFORE YOU BEGIN

Get to know the ClickJect Pre-filled Pen

The Pen automatically delivers the medicine. The transparent tip locks over the needle once the injection is complete and the Pen is removed from the skin.

DO NOT remove the orange needle cover until you are ready to inject.

Before Use

Viewing Window

Grip

Expiry Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Needle Cover (ORANGE Cap)

 

 

Activation Button (BLUE)

After Use

Blue Indicator

Transparent Tip

Gather supplies for your injection on a clean, flat surface

(only the ClickJect Pre-filled Pen is included in the package):

Alcohol swab

Adhesive plaster

Cotton ball or gauze

ClickJect Pre-filled Pen

Sharps disposal container

Proceed to Step 1

1. PREPARE YOUR CLICKJECT PEN Let your ClickJect Pen warm up.

Remove one Pen from the refrigerator and let it rest at room temperature (about 25°C) for 30 minutes. DO NOT remove the needle cover from the Pen while allowing it to reach room temperature.

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

Examine the ClickJect Pre-filled Pen:

Check the expiry date printed on the label.

DO NOT use if past the expiry date.

Check the Pen for damage.

DO NOT use if it is cracked or broken.

Check the liquid through the viewing window. It should be clear to pale yellow. You may see a small air bubble. You do not need to remove it.

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

Expiry Date

Liquid

Proceed to Step 2

2.PREPARE FOR INJECTION

Choose your injection site in either the abdomen or front of the thigh.

Each week you can use the same area of your body, but use a different injection site in that area.

DO NOT inject into an area where the skin is tender, bruised, red, scaly, or hard. Avoid any areas with scars or stretch marks.

Injection Areas Self-Injection and Caregiver

Abdomen, avoid 5 cm around navel

Front of thighs

Gently clean injection site with an alcohol swab and let your skin dry.

Pull orange needle cover STRAIGHT off.

DO NOT replace the cap on the Pen.

You can discard the cap in your household waste after the injection.

DO NOT use the Pen if it is dropped after the cap is removed. It’s normal to see a drop of fluid leaving the needle.

Remove

Needle Cover

Proceed to Step 3

3.INJECT YOUR DOSE

Position the ClickJect Pen so you can see the viewing window and it’s at a 90º angle to the injection site. With your other hand, gently pinch the cleaned skin.

90°

 

Skin Pinch

Window

 

Complete ALL steps for full-dose delivery:

PUSH

DOWN

on skinWAIT until blue

indicator stops moving

Push DOWN on skin to unlock the Pen.

Press button, HOLD for 15 seconds AND watch window.

You will hear a click as the injection begins.

For full-dose delivery, hold the Pre-filled Pen in place for 15 seconds AND wait until blue indicator stops moving in window.

Remove the ClickJect Pre-filled Pen from the injection site by lifting it straight up. Once you remove it from your skin, the transparent tip will lock over the needle. Release skin pinch.

Proceed to Step 4

4. AFTER THE INJECTION Care of injection site:

There may be a little bleeding at the injection site. You can press a cotton ball or gauze over the injection site.

DO NOT rub the injection site.

If needed, you may cover the injection site with a small adhesive plaster.

Cotton ball or gauze

Adhesive plaster

Dispose of used ClickJect Pre-filled Pen into sharps disposal container right away after use. Should you have any questions, ask your pharmacist.

DO NOT replace the cap on the used Pen.

See Frequently Asked Questions or Package Leaflet for additional disposal information.

If your injection is administered by a caregiver, this person must also handle the Pen carefully to prevent accidental needle stick injury and possibly spreading infection.

Keep Pen and the disposal container out of the reach of children.

Record the date, time and site where you injected.

Continued on next page

FREQUENTLY ASKED QUESTIONS

Q. Why do I need to allow the

Pre-filled Pen to warm up at room temperature for 30 minutes prior to injecting?

A.This step is primarily for your comfort. If the medicine is cold, the injection may take longer than 15 seconds. Never try to speed the warming process in any way, like using the microwave or placing the Pen in warm water.

Q. What if I accidentally remove the needle cover (orange cap) before I’m ready to use the Pre- filled Pen?

A.If you remove the cover before you are ready to use the Pen, be careful. Do not try to replace it. Use the Pen as soon as possible according to these instructions for use. While you prepare for the injection, carefully place the Pen on its side on a clean, flat surface. Be sure to keep the Pen away from children.

Q.What if the Pre-filled Pen appears to be broken or damaged?

A.Do not use the Pen. Contact your doctor, nurse, or pharmacist for further instructions.

Q.What if the injection was not triggered?

A.Before the injection can be triggered, the device must be unlocked. To unlock, firmly push the Pen down on the skin without touching the button. Once the stop-point is felt, the device is unlocked and can be triggered by pushing the button.

Q.I feel a little bit of burning and/or pain during injection. Is this normal?

A.When giving an injection, you may feel a prick from the needle. Sometimes, the medicine can cause slight irritation near the injection site. If this occurs, the discomfort should be mild to moderate. If you experience any side effects, including pain, swelling, or discoloration near the injection site, contact your doctor, nurse, or pharmacist immediately. You are encouraged to report side effects, please refer to section 4 of the Package Leaflet: Reporting of Side Effects.

Continued on next page

FREQUENTLY ASKED QUESTIONS

Q.How do I know I received my full dose?

A.Before lifting the Pen from the injection site, check to ensure that the blue indicator has stopped moving. Then, before disposing of the Pen, check the bottom of the transparent viewing window to make sure there is no liquid left inside. If the medicine has been incompletely injected, consult your doctor, nurse, or pharmacist.

Q.How should I dispose of a used Pre-filled Pen?

A.Ask your doctor, nurse, or pharmacist about national and local laws regarding the proper disposal of medical products that contain needles. These measures will help protect the environment.

Q.How should I keep my Pre-filled Pen cool while travelling?

A.Your doctor, nurse, or pharmacist may be familiar with special carrying cases for injectable medicines. Store at 2°C to 8°C. Do not freeze. Protect from light.

Q.Can I take my Pre-filled Pen on board an aircraft?

A.Generally, this is allowed. Be sure to pack your Pen in your carry-on, and do not put it in your checked luggage. You should carry it with you in your travel cooler at a temperature of 2°C to 8°C until you are ready to use it. Do not freeze. Airport security procedures and airline policies change from time to time, so it’s best to check with airport authorities and the airline for any special rules. Prior to flying, get a letter from your doctor to explain that you are travelling with prescription medicine that uses a device with a needle; and if you are carrying a sharps container in your carry-on baggage, notify the screener at the airport.

Q. What if my

Pre-filled Pen does not stay cool for an extended period of time? Is it dangerous to use?

A.Contact your healthcare provider.

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