What is it and how is it used?
ORENCIA is an infusion treatment for adults with moderate to severe rheumatoid arthritis and for children and adolescents aged 6 to 17 years with polyarticular juvenile idiopathic arthritis. It is used in combination with a medicine called methotrexate. The active ingredient of ORENCIA, abatacept, is a protein produced in cell cultures.
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. 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 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 TNF blockers.
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 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:
What do you have to consider before using it?
Do not use ORENCIA
If you are allergic (hypersensitive) to abatacept or any of the other ingredients.
If you have a severe or uncontrolled infection, therapy with ORENCIA must not be started. Having an infection could put you at risk of serious side effects from ORENCIA.
Take special care with ORENCIA
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, or often get infections. It is important you tell your doctor if you have symptoms of infection (e.g. fever, malaise, dental problems). ORENCIA also can lower your body's ability to fight infection and the treatment can make you more prone to getting 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 have to decide if you can still be given ORENCIA. If you recently had a vaccination or are planning to have one. Some vaccines should not be given while receiving ORENCIA. Check with your doctor before you receive 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.
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.
ORENCIA and older people
ORENCIA can be used by people over 65 with no change in dose. Since the elderly are more susceptible to infections and cancer, ORENCIA should be used with caution in this patient population.
ORENCIA and children
ORENCIA has not been studied in patients under 6 years of age, therefore ORENCIA is not recommended in this patient population.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
ORENCIA is not to be used with biological medicines for rheumatoid arthritis including adalimumab, etanercept, and infliximab; there is insufficient evidence to recommend co-administration with anakinra and rituximab.
ORENCIA can be taken with other medicines commonly used in the treatment of 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. Pregnancy must be avoided while using ORENCIA. Your doctor will advise you on adequate contraceptive methods while using ORENCIA and up to 14 weeks after the last dose. If you become pregnant while using ORENCIA, tell your doctor.
It is not known whether abatacept, the active ingredient, passes into human milk. Y ou 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
If you are feeling tired or unwell after receiving ORENCIA, you should not drive or operate any machinery. It is not known if ORENCIA will affect the ability to drive or use machines.
Important information about some of the ingredients of ORENCIA
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.
How is it used?
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.
The recommended dose of abatacept for adults with rheumatoid arthritis is based on body weight:
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.
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 medications you may continue to take while on ORENCIA.
If you use more ORENCIA than you should
In case 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 use 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 product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, ORENCIA can cause side effects, although not everybody gets them. The most common side effects with ORENCIA are headache and nausea. Like all medicines that affect your immune system, ORENCIA can cause serious side effects, which may need treatment.
Possible serious side effects include serious infections, malignancies and allergic reactions.
Tell your doctor immediately if you notice any of the following:
Severe rash, hives or other signs of allergic reaction
Swollen face, hands, feet
Trouble breathing or swallowing
Tell your doctor as soon as possible if you notice any of the following:
Signs of infection such as fever, malaise, 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:
The frequency of possible side effects listed below is defined using the following convention:
Very common side effects: headache.
Common side effects: infections of nose, throat and lungs, urinary infections, painful skin blisters (herpes), rhinitis, dizziness, high blood pressure, flushing, cough, nausea, diarrhoea, upset stomach, abdominal pain, rash, fatigue, weakness and abnormal liver function tests.
Uncommon side effects: tooth infection, infected skin ulcer, nail fungal infection, skin cancer, low blood platelet count, low blood cell counts, allergic reactions, anxiety, numbness, hives, eye inflammation, dry eye, reduced vision, palpitation, rapid heart rate, low heart rate, low blood pressure, hot flush, mouth sores, increased tendency to bruise, hair loss, dry skin, painful joints, pain in the extremities, flu-like illness, increased weight, infusion-related reactions, depression, absence of menstruation, migraine, kidney infection, psoriasis, difficulty in breathing and throat tightness.
Rare side effects: blood stream infection.
Your doctor may also do tests to examine your blood values.
Children and adolescents with polyarticular juvenile idiopathic arthritis
The most frequent side effects are listed below:
Very common side effects: headache, nausea.
Common side effects: diarrhoea, cough, infections of nose and throat, fever, upper abdominal pain.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use 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.
