Agalsidase beta 5mg powder for solution for infusion vials

People who have Fabry disease have a problem with a particular enzyme in their body. They either do not have enough of the enzyme or the enzyme that they have does not work properly. This leads to a build up of a chemical which can cause heart, kidney or cerebrovascular problems. Agalsidase beta is given to treat the enzyme deficiency in people who have Fabry disease to prevent these problems from occurring.

Other information about Agalsidase beta:

Agalsidase beta needs to be injected. Your prescriber or another healthcare professional may give you your injections. If you are going to have this medicine for a long time or if you need to have injections very often your prescriber will show you how to inject this medicine yourself. If you are injecting this medicine yourself then follow the instructions from your prescriber.

There should also be instructions on how to inject this medicine in the Patient Information Leaflet that comes with this medicine or on the pharmacy label.

The pharmacy label on your medicine tells you how much medicine you should have. It also tells you how often you should have your medicine. This is the dose that you and your prescriber have agreed you should have. You should not change the dose of your medicine unless you are told to do so by your prescriber.

Do not share your medicine with other people. It may not be suitable for them and may harm them.

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

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 Agalsidase beta, 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 when 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 Agalsidase beta will be given to you as an injection, it will usually be stored by the medical team.

Agalsidase beta 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 under eight years of age.

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

Over time it is possible that Agalsidase beta can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Agalsidase beta 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.

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.

Very common: More than 1 in 10 people who have Agalsidase beta:

• chills, fever, nausea, vomiting or headache - seek medical advice if you have any of these symptoms on the day that you have Agalsidase beta
• feeling cold
• paraesthesiae

Common: More than 1 in 100 people who have Agalsidase beta:

• angioedema, breathing difficulties, wheezing, throat tightness, chest discomfort, itching, urticaria, facial oedema, faster heart rate, palpitations, pain such as muscle pain or tenderness, stomach pain or pain in the extremities - seek medical advice if you have any of these symptoms on the day that you have Agalsidase beta
• back pain
• blocked nose
• blood pressure changes
• burning sensation
• chest pain
• cough
• diarrhoea
• fainting or brief loss of consciousness
• feeling dizzy
• feeling hot
• flushing
• hot flushes
• hypoaesthesia
• hypoaesthesia of the mouth
• increased body temperature
• increased tear production
• inflammation of the nose and throat
• lethargy
• muscle spasm
• muscle tightness
• oedema of the extremities
• pain or stiffness of muscles, bones or joints
• paleness
• redness of the skin
• skin rash or rashes
• sleepiness
• slower heart rate
• stomach discomfort
• swelling of the face
• tinnitus
• tiredness
• vertigo
• weakness
• worsening of breathing difficulties

Uncommon: More than 1 in 1000 people who have Agalsidase beta:

• changes in the colour of blood vessels
• coldness of the extremities
• ear pain
• flu or flu-like symptoms
• general feeling of being unwell
• hypersensitivity to external stimuli such as light, noise and physical contact
• indigestion
• injection site problems such as pain or thrombosis
• itchy eyes
• oedema
• red eye
• rhinitis, bronchospasm or faster breathing rate - seek medical advice if you have any of these symptoms on the day that you have Agalsidase beta
• runny nose
• skin colour changes
• skin discomfort
• swallowing difficulties
• swelling of the ear
• throat pain
• tremors
• upper respiratory tract congestion

The frequency of these side-effects is unknown:

• allergic or anaphylactic reactions - seek immediate medical advice if you have an allergic or anaphylactic reaction while you are having Agalsidase beta
• hypoxia
• production of antibodies to Agalsidase beta
• vasculitis

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 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 Agalsidase beta:

If you are taking Agalsidase beta and any of the above 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 Agalsidase beta.

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.

In the case of Agalsidase beta:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, 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 Agalsidase beta:

Alcohol can interact with certain medicines.

In the case of Agalsidase beta:

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 Agalsidase beta:

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 Agalsidase beta:

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. They may also be used to prolong the life of the medicine.

This medicine contains agalsidase beta.

We are unable to list all of the ingredients for your medicine here. For a full list, you should refer to the patient information leaflet that comes with this medicine or ask your prescriber. You should check that you are able to take the ingredients of your medicine, especially if you have any allergies.

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 Agalsidase beta before, do not take Agalsidase beta. Talk to your prescriber, pharmacist or nurse as soon as possible.