Orencia
abatacept
abatacept
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 ORENCIA is and what it is used for
What you need to know before you are given ORENCIA
How to use ORENCIA
Possible side effects
How to store ORENCIA
Contents of the pack and other information
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 and also polyarticular juvenile idiopathic arthritis in children 6 years of age and older.
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 powder for concentrate for solution for infusion is used in children and adolescents aged 6 to 17 years when a previous disease-modifying medicine has not worked well enough or is not suitable for them. ORENCIA is usually used in combination with methotrexate, although ORENCIA may also be used alone in case of intolerance to methotrexate or if treatment with methotrexate is inappropriate.
ORENCIA is used to:
slow down the damage to joints
improve physical function
improve other signs and symptoms of polyarticular juvenile idiopathic arthritis
Talk to your doctor, pharmacist or nurse:
examine you for hepatitis.
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.
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 powder for concentrate for solution for infusion has not been studied in children and adolescents under 6 years of age, therefore ORENCIA powder for concentrate for infusion is not recommended for use in this patient population.
ORENCIA solution for injection pre-filled syringe is available for subcutaneous administration for paediatric patients 2 years of age and older.
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.
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.
The use of ORENCIA is not expected to affect the ability to drive, cycle or use machines. However, if you are feeling tired or unwell after receiving ORENCIA, you should not drive, cycle or operate any machinery.
This medicine contains 34.5 mg sodium (main component of cooking/table salt) per maximum dose of 4 vials (8.625 mg sodium per vial). This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
ORENCIA will be given to you under the supervision of an experienced doctor.
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 | 2 |
60 kg - 100 kg | 750 mg | 3 |
More than 100 kg | 1,000 mg | 4 |
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.
ORENCIA can be used by adults over 65 with no change in dose.
For children and adolescents aged 6 to 17 years with polyarticular juvenile idiopathic arthritis who weigh less than 75 kg, the recommended dose of intravenous abatacept is 10 mg/kg. Children weighing 75 kg or more should be administered ORENCIA powder for concentrate for solution for infusion following the adult dosing regimen.
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.
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 this happens, your doctor will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
If you miss receiving ORENCIA when you are supposed to, ask your doctor when to schedule your next dose.
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.
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.
severe rash, hives or other signs of allergic reaction
swollen face, hands or feet
trouble breathing or swallowing
fever, persistent cough, weight loss, listlessness
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:
infections of the upper airway (including infections of the nose, throat and sinuses).
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
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
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 as described above, with the following differences:
upper airway infection (including infections of nose, sinus and throat)
fever
blood in urine
ear infection
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 thenationalreporting systemlistedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
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 this medicine if you notice opaque particles, discolouration or other foreign particles present in the infusion solution.
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.
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").
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.
Blanchardstown Corporate Park 2
Dublin 15, D15 T867 Ireland
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
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Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
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.