Agalsidase alfa (ag-al-sid-aze al-fa) is a medicine which is used in Fabry disease.

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

This medicine may be available from different manufacturers and in several different forms and so you should check the Patient Information Leaflet or the medicine label for exact details on when and how to take it and how to look after it.

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 alfa is given to treat the enzyme deficiency in people who have Fabry disease to prevent these problems from occurring.

Agalsidase alfa is an injection that is usually given 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 Agalsidase alfa, 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 Agalsidase alfa 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.

Agalsidase alfa 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 someone under the age of 18 years.

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

• headaches
• flushing
• nausea
• rigors
• fever
• pain and discomfort
• tiredness

Common: More than 1 in 100 people who take Agalsidase alfa

• oedema of the extremities
• dizziness
• taste changes
• nerve pain
• tremors
• sleepiness
• hypoaesthesia
• paraesthesiae
• increased tear production
• tinnitus or worsening of tinnitus
• faster heart rate
• palpitations
• raised blood pressure
• cough
• hoarse voice
• throat tightness
• breathing difficulties
• infection or inflammation of the nose and throat
• increased secretions in the throat
• runny nose
• diarrhoea
• vomiting
• stomach pain and discomfort
• acne
• redness of the skin
• itching
• skin rash or rashes
• livedo reticularis
• pain or tenderness of the muscles or joints
• back pain
• limb pain
• swelling of the extremities
• joint swelling
• worsening of tiredness
• feeling hot or cold
• weakness
• chest pain
• chest tightness
• flu or flu-like symptoms
• injection site rash
• general feeling of being unwell
• eye or eyesight problems

Uncommon: More than 1 in 1000 people who take Agalsidase alfa

• changes to sense of smell
• angioedema
• urticaria
• sensation of heaviness
• decreased level of oxygen in the blood

The frequency of these side-effects is unknown

• production of antibodies to Agalsidase alfa
• hypersensitivity reactions

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 Agalsidase alfa:

If you are taking Agalsidase alfa 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 alfa.

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 Agalsidase alfa 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 Agalsidase alfa:

Alcohol can interact with certain medicines.

In the case of Agalsidase alfa:

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.

Careful consideration needs to be given to the risks and the benefits of using this medicine during pregnancy.

You need to discuss your specific circumstances with your doctor to make a decision about whether you are going to take this medicine during pregnancy. You should only take this medicine during pregnancy if your doctor thinks you need to take it. If the decision is that you should not have Agalsidase alfa, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

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

In the case of Agalsidase alfa:

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 alfa.

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