Orencia (or-en-see-a) is a medicine which is used in rheumatoid arthritis. Orencia contains abatacept. It is supplied by Bristol-Myers Squibb Pharmaceuticals Ltd.

The information in this Medicine Guide for Orencia varies according to the condition being treated and the particular preparation used.

We have information for a single preparation used in the treatment of rheumatoid arthritis. The preparation name is shown in red below.

Orencia 250mg powder for concentrate for solution for infusion vials

Form: Injection

Regulated Information Patient Information Leaflet Summary of Product Characteristics

 

To get the most benefit from your medicine, take it exactly as prescribed. You should also take care to look after your medicine.

Orencia is an immunosuppressive medicine. It helps to suppress overactivity of the immune system in rheumatoid arthritis. It can help to reduce pain and swelling by limiting inflammation. Orencia is used in combination with the medicine methotrexate to treat rheumatoid arthritis. Because of its effects on the immune system, people who have Orencia are prone to getting infections. Some infections may be serious. For this reason, people who have Orencia are monitored for infections.

Orencia is usually given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber or someone involved in your medical care.

The person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Orencia, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

The person in charge of your care will make the decision about whether you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

As Orencia will be given to you as an injection, it will usually be stored by the medical team.

Your prescriber will not give you this medicine if they know of any reasons why you must not take it. Sometimes it is necessary to prescribe this medicine with extra caution. For more information see the ‘Whether this medicine is suitable for you’ section.

If you have been prescribed this medicine you need to be aware of the side-effects that you could develop while taking this medicine. For more information see the 'Side-effects' section.

Orencia is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child or an adolescent.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Orencia can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Orencia has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience. Very occasionally, certain side-effects can be beneficial.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

As part of treatment, this medicine may be used in combination with other medicines. There is no information available about the side-effects of Orencia when it is taken on its own. The information included here relates to the side-effects caused by the combination of this medicine with other medicines that it is usually given with. There may be more information on the side-effects of Orencia in the Patient Information Leaflet for Orencia.

Very common: More than 1 in 10 people who take Orencia

• headaches

Common: More than 1 in 100 people who take Orencia

• abnormal laboratory test results
• bronchitis
• cough
• dermatitis
• diarrhoea
• feeling dizzy
• flushing
• indigestion
• infections such as pneumonia or sepsis - these may be fatal. Seek medical advice if you develop an infection
• nausea
• raised blood pressure
• rhinitis
• skin rash or rashes
• stomach pain
• tiredness
• weakness
• worsening of chronic obstructive pulmonary disease

Uncommon: More than 1 in 1000 people who take Orencia

• amenorrhoea
• blood problems
• breathing difficulties
• bronchospasm
• cancer
• cystitis
• depression
• dry eye
• dry skin
• easy bruising of the skin
• eye or eyesight problems
• faster heart rate
• feeling anxious
• flu or flu-like symptoms
• gastritis
• hair loss
• hot flushes
• hypersensitivity reactions
• inflammation of the mouth
• itching
• joint pain
• lowered blood pressure
• migraine
• mouth ulcers
• pain in the extremities
• palpitations
• paraesthesiae
• psoriasis or psoriasis-like rash
• slower heart rate
• throat tightness
• urticaria
• vertigo
• weight gain
• wheezing

The frequency of these side-effects is unknown

• allergic reactions including anaphylaxis - seek medical advice if you develop allergic or anaphylactic reactions
• may affect the results of blood glucose readings with certain types of blood glucose monitors. For more information about which blood glucose monitors are affected by Orencia speak to your prescriber or someone involved in your medical care
• reactivation of hepatitis B

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you have been prescribed this medicine you and your prescriber may need to think about whether you need to change any of your everyday activities. You must also discuss with your prescriber any other medicines and any complementary preparations you are taking.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Orencia:

The following types of medicine may interact with Orencia:

If you are taking Orencia and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Orencia.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Orencia can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Orencia:

Alcohol can interact with certain medicines.

In the case of Orencia:

Taking this medicine could have an impact on your decisions relating to family planning, pregnancy and breast-feeding.

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Orencia:

You should discuss your personal circumstances with your doctor if you are pregnant or want to become pregnant. This is so that together you can make a decision about what treatment you may need during your pregnancy.

You should discuss whether there are any other medicines which you could take during pregnancy which would treat your condition.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Orencia:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Orencia contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Orencia before, do not take Orencia. Talk to your prescriber, pharmacist or nurse as soon as possible.