Orencia

(or-en-see-ah)
Abatacept (ab-ah-ta-sept) (rch) Powder for intravenous infusion; Abatacept (rch) solution for Injection (pre-filled syringe, one with needle guard and one with flange extender)
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Orencia. It does not contain all the information that is known about Orencia. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Orencia is used for

Rheumatoid arthritis is a disease that causes pain and joint inflammation (tenderness and swelling). It can also cause joint damage. Orencia is available in two formulations:
Orencia powder for infusion MUST ONLY BE GIVEN BY YOUR DOCTOR OR NURSE. The intravenous infusion will take about 30 minutes.
Orencia solution for injection is injected under the skin and can be injected by your doctor, nurse, carer or yourself.
The first dose should be done under medical supervision. Patients can self inject after the treating physician/healthcare practitioner is assured that the patient's and/or carer's injection technique is satisfactory, and while providing medical follow-up as necessary.
Orencia contains abatacept; a medicine which is used to treat moderate to severe rheumatoid arthritis in adults.
Orencia infused intravenously is also used to treat moderate to severe polyarticular juvenile idiopathic arthritis in children and adolescents 6 years of age and older who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.
There is no clinical trial data for the use of Orencia subcutaneous formulation in children, therefore its use in children cannot be recommended.
ORENCIA is a medicine that keeps the immune system from attacking healthy tissues in the body. The immune system is the body's defence against attack by infections caused by bacteria and viruses. A normal immune system leaves healthy body tissues alone. In adults with rheumatoid arthritis and in children and adolescents (> 6 years of age) with polyarticular juvenile idiopathic arthritis, the immune system attacks normal body tissues. This can cause damage and inflammation especially in the tissues of your joints. ORENCIA interferes with an important step in this attack; it decreases the immune system's attack on normal tissues. ORENCIA can reduce pain, joint inflammation, and damage to your bones and cartilage.
ORENCIA can also reduce your body's ability to fight infection, so treatment with ORENCIA may make you more prone to getting infections, or make any infection that you might have worse. It is important to tell your doctor if you think you have any infections.
Ask your doctor if you have any questions about why Orencia has been prescribed for you.
This medicine is available only with a doctor's prescription.
Orencia is not recommended for use in children under 6 years of age, as there have been no formal studies of its effects in children under 6 years of age.

Before you are given Orencia

When you must not be given Orencia

You must not be given Orencia if your doctor determines or you have an allergy to Orencia or to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Orencia may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin

When you should not be given Orencia

You should not be given Orencia if you are currently being treated with certain other medicines such as adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™); you may have a higher chance of getting a serious infection. Orencia is not recommended to be given with other biologic rheumatoid arthritis medicines such as anakinra (Kineret™), since there is limited experience in the use of these medicines with Orencia.
You should not be given Orencia if you currently have any infections, as Orencia can affect your body's ability to fight serious infection.
You should not be given Orencia if you have recently had a vaccination.
If your child is to receive Orencia, discuss your child's vaccination history and plans with your doctor. All vaccines should be brought up-to-date before starting Orencia. Talk with your doctor about your vaccination plans prior to receiving Orencia.
You should not be given Orencia if the packaging is torn or shown signs of tampering.
You should not be given Orencia if the expiry date printed (EXP) printed on the pack has passed as it may not work as well.
If you are not sure whether you should be given Orencia, talk to your doctor.

Before you are given Orencia

Tell your doctor if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
Tell your doctor if you are pregnant or intend to become pregnant.
The effects of Orencia in pregnant women are not known. Your doctor will discuss the possible risks and benefits of using Orencia during pregnancy.
Tell your doctor if you are breastfeeding.
The effects of Orencia are not known in nursing babies. Your doctor will discuss the possible risks and benefits of using Orencia during breast-feeding.
Tell your doctor if you have diabetes and 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,( intravenous formulation only.
Tell your doctor if you are on a diet that restricts your sodium (salt) intake.
Orencia contains sodium chloride and your doctor will advise you how the use of Orencia should be considered in your overall dietary intake of sodium.
Tell your doctor if you have or have had any medical conditions, especially the following:
have any kind of infection including an infection that is in only one place in your body (such as an open cut or sore), or an infection that is in your whole body (such as the flu). Having an infection could put you at risk for serious side effects from Orencia. If you are unsure, please ask your doctor;
have an infection that won't go away or a history of infections that keep coming back;
have had tuberculosis, or if you recently have been in close contact with someone who has had tuberculosis. If you develop any of the symptoms of tuberculosis (a dry cough that doesn't go away, weight loss, fever, night sweats) call your doctor right away. Before you start Orencia, your doctor may examine you for tuberculosis or perform a skin test;
have a history of chronic obstructive pulmonary (lung) disease (COPD);
are scheduled to have surgery;
recently received a vaccination or are scheduled for any vaccination; or
are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV.
If you have not told your doctor about any of the above, please do so before you are given Orencia.

Taking other medicines

It is especially important to tell your doctor if you are taking any other medication, including over the counter, pharmacy medication, supermarket or health food shop. These medications may be affected by Orencia, or may affect how well it works.
You should not be given Orencia if you are currently being treated with certain other medicines such as adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™); you may have a higher chance of getting a serious infection. Orencia is not recommended to be given with other biologic rheumatoid arthritis medicines such as anakinra (Kineret™), as there is limited experience in the use of these medicines with Orencia.

How Orencia is given

How much is given

Powder for intravenous infusion only:
Your doctor will decide what dose you will be given. Your dose will depend on factors such as your weight. After you have been given your first dose of Orencia, you will receive an additional dose at 2 weeks and then again at 4 weeks. Thereafter, you will be given your dose every 4 weeks.

How it is given

Orencia is given as a slow infusion into a vein. It will take about 30 minutes to give you your full dose of medicine. Orencia must only be given by a doctor or nurse.
Solution for injection subcutaneous administration:
There is no clinical trial data for the use of Orencia subcutaneous formulation in children, therefore its use in children cannot be recommended.
After allowing the Orencia solution to reach room temperature, immediate use is recommended.
Each syringe of Orencia is for single use only, in one patient only. Discard any residue.
Follow all directions given to you by your healthcare practitioner carefully.
They may differ from the information contained in this leaflet.
If you are injecting Orencia yourself, there are detailed instructions provided in the leaflet inside the pack to assist you.
Orencia is injected under the skin. When using Orencia, it is important that you do not pull back on the plunger at any time. Orencia can be injected by your doctor, nurse, carer or by yourself. The first dose should be done under medical supervision. Patients can self inject after the treating physician/healthcare practitioner is assured that the patient's and/or carer's injection technique is satisfactory, and while providing medical follow-up as necessary.
When you have finished injecting Orencia, discard the needle and syringe into a sharps container.
If you do not understand the instructions for injecting Orencia found in the pack, ask your doctor or pharmacist for help.
To help you remember, use a diary to write in the day of the week you should have your Orencia injection.

When to use it

Your healthcare practitioner will tell you how to inject Orencia. A different site should be used for each new injection. Each new injection site should be approximately 1 inch (2.5cm) from where you last injected Orencia.
The recommended dose is 125mg per week regardless of your weight and Orencia should be injected under the skin. Your doctor will determine whether you will receive an intravenous loading dose prior to using your solution for injection.

How long to take it

You should continue to inject Orencia for as long as your doctor recommends.
Never inject more than the dose recommended.
If you forget to take it, contact your doctor or pharmacist.
If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

Overdose

Your doctor has information on how to recognise and treat an overdose. Ask your doctor or nurse if you have any concerns.

While you are being treated with Orencia

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given Orencia.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being given Orencia.
Seek medical help urgently if you develop symptoms of an allergic reaction.
These symptoms may be:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
chills, fever, fast heart beat, dizziness
flushing, sweating
Tell your doctor immediately if you have or develop any serious infection while using Orencia. Symptoms of an infection may include:
fever
feeling very tired
have a cough
have flu-like symptoms
warm, red, or painful skin
Patients with Chronic Obstructive Pulmonary Disease (COPD) may develop certain respiratory problems more often if you receive Orencia, including:
worsened COPD
pneumonia
cough
trouble breathing
Be careful driving or operating machinery until you know how Orencia affects you.
As with other medicines Orencia may cause dizziness in some people. Make sure you know how you react to Orencia before you drive a car, operate machinery, or do anything that could be dangerous if you feel dizzy.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Orencia.
Like other medicines, Orencia can help people with rheumatoid arthritis, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
The more common side effects of Orencia in adults are:
lower respiratory tract infection such as bronchitis, urinary tract infection, herpes (cold sores), upper respiratory tract infection such as sore throat, runny or blocked nose
headache, dizziness, limb pain
increase in blood pressure
reduction in white blood cells
cough
abdominal pain, diarrhoea, mouth ulcers, nausea
rash, dermatitis
hair loss
fatigue
The most frequent side effects in children and adolescents (> 6 years of age) with polyarticular juvenile idiopathic arthritis are:
headache
nausea
diarrhoea
cough
infections of nose and throat
fever
upper abdominal pain
Seek medical help immediately if any of the following happen:
severe rash
swollen face
breathing difficulty
Infections
Serious infections have been reported in patients given Orencia. These infections are rare and include tuberculosis, pneumonia and other infections caused by viruses, bacteria and fungi.
Infusion-related reactions
Some patients may experience reactions related to the infusion of Orencia. Most of these reactions are mild to moderate and may include:
dizziness
headache
increase in blood pressure
In rare cases, infusion-related reactions may be severe and require that you discontinue treatment.
Hypersensitivity reactions
Although it is uncommon, some patients may experience hypersensitivity reactions within 24 hours of treatment with Orencia. Most of these reactions are mild to moderate and may include:
low blood pressure
rash
shortness of breath
Serious hypersensitivity reactions are rarely reported. You should go immediately to a doctor or hospital if you suddenly feel faint or have difficulty breathing within 24 hours after being given Orencia.
Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.
There have been rare reports of some types of cancer developing in patients using Orencia. The role of Orencia in the development of cancer is not known.
Do not be alarmed by possible side effects.
You may not experience any of them.
Ask your doctor to answer any questions you may have.

Product description

What it looks like

Powder for intravenous infusion only:
Orencia is provided as a sterile white powder, it is supplied with a silicone-free disposable syringe.

Ingredients

Active Ingredient: abatacept 250mg in a 15mL vial.
Other Ingredients: 500mg maltose, 17.2mg sodium phosphate monobasic and 14.6mg sodium chloride.
Orencia does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Storage

Orencia must be refrigerated at 2°C to 8°C. It must be protected from light.
Solution for injection subcutaneous administration - adults only
Orencia solution for injection is provided as a 1mL single-dose, disposable pre-filled syringe with flange extender. There are four single dose pre-filled glass syringes in a pack containing Orencia solution. Each syringe contains 125mg of abatacept.
Active ingredient: Abatacept (rch) 125mg per pre-filled syringe.
Other Ingredients: 170mg sucrose, 8mg poloxamer 188, 0.286mg sodium phosphate monohydrate, 0.838mg sodium phosphate dibasic anhydrous and up to 1 mL water for injection.
Orencia solution does not contain maltose.

Storage

Orencia must be refrigerated at 2°C to 8°C. Do not Freeze. It must be protected from light.

Sponsored by

Bristol-Myers Squibb Australia Pty Ltd,
4 Nexus Court, Mulgrave,
Victoria 3170, Australia

Registration Number:

Powder for intravenous infusion
AUST R 130100
 
Solution for injection subcutaneous administration - adults only
AUST R 177176
  
Date of preparation: November 2012
AU_CMI_Orencia_V13.0_Nov12.docx