125 mg solution for injection in pre-filled pen
abatacept
What ORENCIA is and what it is used for
ORENCIA contains the active substance abatacept, a protein produced in cell cultures. ORENCIA reduces the immune system’s attacks on normal tissue by disrupting the immune cells ( T cells ) that contribute to the development of rheumatoid arthritis. ORENCIA selectively affects the activation of the T cells involved in the inflammatory response of the immune system.
ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults.
Rheumatoid arthritis
Rheumatoid arthritis is a progressive chronic systemic disease that, left untreated, can have serious consequences, such as joint destruction, increased disability, and impaired ability to perform everyday tasks. In individuals with rheumatoid arthritis, normal body tissue is attacked by the body’s immune system, leading to pain and swollen joints. This can damage the joints. All individuals are affected differently by rheumatoid arthritis (RA). In most people, the symptoms from the joints gradually increase over several years. In some, however, RA can quickly worsen and in others, RA manifests itself only for a limited time and then improves. RA is usually a chronic (long-term) disease, which gradually worsens. This means that even if you undergo treatment, your RA can continue to damage your joints, whether you still have symptoms or not. By finding the best treatment strategy for you, you can successfully slow down this course of the disease, which can reduce long-term joint damage, pain, and fatigue as well as improve your overall quality of life.
ORENCIA is used to treat moderate to severe active rheumatoid arthritis when you have not responded well enough to treatment with other disease-modifying medicines or with another group of medicines called ‘tumor necrosis factor ( TNF ) inhibitors. 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 not previously treated with methotrexate.
ORENCIA is used to:
– brake joint damage
– improve your physical ability
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 can get ORENCIA to:
- Reduce the signs and symptoms of your illness
- Brake the leg and joint damage.
- Improve your physical ability and your ability to do normal daily activities.
ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate.
What you need to know before using 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 serious or uncontrolled infection do not start treatment with ORENCIA. An infection puts you at risk of getting serious side effects from ORENCIA.
Warnings and cautions
Talk to a doctor, pharmacist, or nurse:
- If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or unsteadiness, swelling or rash, tell your doctor immediately .
- If you have an infection of any kind , including a long-term or local infection , if you often get an infection , or if you have symptoms of infection (eg fever, malaise, dental problems), it is important that you tell your doctor . ORENCIA can impair your body’s ability to fight infections and treatment can make you more prone to infections or aggravate existing infections .
- If you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, lethargy, mild fever), tell your doctor . Before using ORENCIA you will be tested for tuberculosis or have a skin test.
- If you have viral hepatitis , tell your doctor. Before using ORENCIA, your doctor will examine you to see if you have hepatitis .
- If you have cancer , your doctor will decide if you can still get ORENCIA.
- If you have recently been vaccinated or are planning to get vaccinated, tell your doctor . Some vaccines should not be given while you are being treated with ORENCIA. Check with your doctor before getting vaccinated . Some vaccinations can cause infection caused by the vaccine. If you received ORENCIA while you were pregnant, your baby may be at higher risk of getting such an infection for up to about 14 weeks after the last dose you received during pregnancy. It is important that you tell your child’s doctor and other healthcare professionals about your use of ORENCIA during pregnancy so that they can decide when your child should receive a vaccine.
Your doctor may also take blood samples to check your blood counts.
Children and young people
ORENCIA solution for injection in a pre-filled pen has not been studied in children and adolescents under 18 years of age. ORENCIA solution for injection in a pre-filled pen is therefore not recommended for this patient group.
ORENCIA powder for concentrate for solution for infusion is available for pediatric patients aged 6 years and older.
ORENCIA solution for injection in a pre-filled syringe is available for pediatric patients aged 2 years and older.
Other medicines and ORENCIA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ORENCIA should not be used with biological drugs for rheumatoid arthritis, including TNF inhibitors such as adalimumab, etanercept, and infliximab. There are insufficient data to recommend that it be co-administered 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-inflammatory drugs such as ibuprofen or diclofenac.
Ask your doctor or pharmacist for advice before taking any other medicine while you are taking ORENCIA.
Pregnancy and breastfeeding
The effects of ORENCIA during pregnancy are not known, so do not use ORENCIA if you are pregnant unless your doctor specifically recommends it.
- If you are a woman and could become pregnant, you must use safe contraception while using ORENCIA and up to 14 weeks after the last dose . Your doctor will advise you on appropriate contraceptive methods.
- If you become pregnant while taking ORENCIA, tell your doctor.
If you have been given ORENCIA during pregnancy, your baby may be at a higher risk of getting an infection. Before your child receives a vaccine, you must talk to your child’s doctor and other healthcare professionals about your use of ORENCIA during pregnancy (for more information, see the section on vaccination).
It is not known whether ORENCIA is excreted in human milk. You must stop breastfeeding if you are being treated with ORENCIA and do not breastfeed until 14 weeks after the last dose.
Driving and using machines
The use of ORENCIA is not expected to affect your ability to drive or use machines. If you get tired or feel unwell after receiving ORENCIA, do not drive or use machines.
ORENCIA contains excipients
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free’.
How to use ORENCIA
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
ORENCIA solution for injection under the skin ( subcutaneous use).
Recommended dose
The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg abatacept per week, regardless of weight.
Your doctor may start your ORENCIA treatment with or without a single dose of ORENCIA powder for concentrate for solution for infusion (given to you in a vein, usually in the arm, for 30 minutes). If a single intravenous dose is given to start treatment, the first subcutaneous injection of ORENCIA should be given within one day after the end of the intravenous infusion, followed by weekly subcutaneous injections of ORENCIA 125 mg.
ORENCIA can be used by people over 65 years of age without dose adjustment.
If you are already being treated with intravenous ORENCIA and wish to switch to subcutaneous ORENCIA, you will 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, you may continue to take while you are being treated with ORENCIA.
Initially, your doctor or nurse will inject ORENCIA. However, you and your doctor can agree together that you can inject ORENCIA yourself. If so, you will be trained on how to inject ORENCIA.
Talk to your doctor if you have any questions about injecting yourself. You will find detailed instructions for the preparation and administration of ORENCIA at the end of this leaflet (see ” Important user instructions “).
If you use more ORENCIA than you should
If this happens, contact a doctor immediately, who will monitor you for any signs or symptoms of side effects and, if necessary, treat them.
If you forget to use ORENCIA
Keep track of when to take your next dose. It is very important to use ORENCIA exactly as your doctor prescribes it. If you miss your dose and it is within 3 days after you were supposed to take it, take your dose as soon as possible and then follow your original dosing schedule on your appointed day. If you miss a dose for more than 3 days, consult your doctor about when to take the next dose.
If you stop using ORENCIA
You should discuss a possible decision to stop using ORENCIA with your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse .
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 upper respiratory tract infections (including nose and throat infections), headaches, and nausea, which are listed below. ORENCIA can cause serious side effects that may require treatment.
Possible serious side effects include serious infections, malignancies (cancer), and allergic reactions, which are listed below.
Tell your doctor immediately if you notice any of the following:
- severe rash, hives or other signs of allergic reaction
- swelling of the face or swollen hands and feet
- difficulty breathing or swallowing
- fever, prolonged cough, weight loss and lethargy
Tell your doctor as soon as possible if you notice any of the following:
- general malaise, dental problems, burning when urinating, painful skin rash, painful blisters, cough
The symptoms described above may be signs of the side effects listed below, all of which have been observed in adults treated with ORENCIA in clinical trials:
List of side effects:
Very common (may affect more than 1 in 10 patients):
- upper respiratory tract infections (including infection of the nose, throat and sinuses)
Common (may affect up to 1 in 10 people):
- lung infection, urinary tract infection, painful blisters ( herpes ), flu
- headache, dizziness
- high blood pressure
- cough
- abdominal pain, diarrhea, nausea, stomach upset, cold sores, vomiting
- rash
- fatigue, feeling of weakness, reactions at the injection site
- abnormal liver function tests
Uncommon (may affect up to 1 in 100 people):
- dental infection, nail fungus infection, muscle infection, blood infection, skin undergrowth, kidney infection, ear infection
- low white blood cell count
- skin cancer, skin warts
- low platelet count
- allergic reactions
- depression, anxiety, sleep disorders
- migraine
- numbness
- dry eyes, visual impairment
- eye inflammation
- palpitations, high heart rate, low heart rate
- low blood pressure , hot flashes, blood vessel inflammation, flushing
- difficulty breathing, wheezing, shortness of breath, acute exacerbation of a lung disease called chronic obstructive pulmonary disease (COPD)
- feeling of tightness in the throat
- rhinitis
- increased susceptibility to bruising, dry skin, psoriasis , reddening of the skin, excessive sweating, acne
- hair loss, itching , hives
- joint pain
- pain in arms and legs
- missed menstruation, abundant menstruation
- flu-like illness, weight gain
Rare (may affect up to 1 in 1000 people):
- tuberculosis
- inflammation of the uterus, fallopian tubes and / or ovaries
- infection of the stomach or intestines
- blood cancer (in the white blood cells ), lung cancer
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 (EXP), the vial (EXP), and the carton (EXP). The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C to 8 ° C). Do not freeze.
Store in original packaging. Sensitive to light.
Do not use this medicine if the liquid is cloudy, discolored, or contains large particles. The liquid should be clear to pale yellow.
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.
Contents of the pack and other information
Content declaration
- The active substance is abatacept.
- Each pre-filled pen contains 125 mg of abatacept.
- 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 the medicine looks like and contents of the pack
ORENCIA solution for injection ( injection ) is a clear, colorless to a pale yellow solution provided in a pre-filled pen called ClickJect.
ORENCIA is available in the following packages:
– pack of 4 pre-filled pens and multi-pack of 12 pre-filled pens (3 4-packs).
It is possible that certain pack sizes may not be marketed.
Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland
Manufacturer
CATALENT ANAGNI SRL
Loc. Fontana del Ceraso snc
Provincial Street 12 Casilina, 41
03012 Anagni (FR)
Italy
Swords Laboratories Unlimited Company t / a Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15
Ireland