Busilvex 60mg/10ml concentrate for solution for infusion ampoules

Busilvex is used as preparation for a stem cell transplant. It is used with either cyclophosphamide or melphalan before a stem cell transplant.

Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered.

How well you feel and how you are likely to cope with treatment is also important.

Your cancer treatment will usually consist of a treatment session with Busilvex followed by a break of a number of days before the next treatment session with Busilvex. This cycle may be repeated many times as part of your cancer treatment.

Busilvex works by damaging cancer cells in the body. Busilvex also affects healthy cells and treatment with Busilvex may damage your immune system, liver or lungs. Your medical team may arrange for you to have some tests to check how well your immune system, liver and lungs are working.

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

Busilvex 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 an obese child or an adolescent or for someone who weighs less than 9 Kg.

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

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

• abnormal laboratory test results
• allergic reactions
• anal discomfort
• ascites
• back pain
• blood and bone marrow problems
• breathing difficulties
• chest pain
• chills
• constipation
• cough
• depression
• diarrhoea
• difficult or painful urination
• difficulty sleeping
• faster heart rate
• feeling anxious
• feeling dizzy
• fever
• graft versus host disease - this has occurred in people who have had a stem cell transplant using stem cells from a donor. Graft versus host disease may be fatal
• hair loss
• headaches
• hiccups
• high blood sugar
• indigestion
• infections - some of these may be fatal
• inflammation of the mouth
• injection site problems such as pain or inflammation
• itching
• jaundice
• joint pain
• liver problems - some of these problems have been fatal in people who have had a stem cell transplant using stem cells from a donor
• loss of appetite
• lowered blood pressure
• metabolic problems
• mucous membrane problems
• muscle pain or tenderness
• nausea
• nose bleed
• oedema
• pain
• pharyngitis
• raised blood pressure
• rhinitis
• shortness of breath
• skin rash or rashes
• stomach pain
• thrombosis
• urinating less or less often
• vasodilatation
• vomiting
• weakness
• weight gain

Common: More than 1 in 100 people who have Busilvex:

• asthma
• blood in the urine
• bowel problems
• confusion
• faster breathing rate
• heart problems
• kidney problems
• lung problems
• oesophagitis
• redness of the skin
• skin colour changes
• skin problems
• vomiting blood

Uncommon: More than 1 in 1000 people who have Busilvex:

• bleeding in the brain
• brain or central nervous system problems
• capillary leak syndrome
• circulation problems
• delirium
• feeling agitated
• feeling nervous
• gastrointestinal problems
• hallucinations
• hypoxia
• seizures
• slower heart rate

The frequency of these side-effects is unknown:

• amenorrhoea - this may occur with menopausal symptoms in pre-menopausal women
• cancer
• decrease in the size of the testicles
• hypogonadism
• impotence
• leukaemia
• ovarian problems - these problems may stop pre-adolescent girls from reaching puberty
• premature menopause
• reduced fertility - this may be permanent in men
• respiratory distress syndrome - this may be fatal

The following side-effect has been reported in people who have taken a different form of Busilvex. The frequency of this side-effect is unknown :

• cataracts
• eye or eyesight problems

If you feel unwell or if you have concerns about a side-effect, tell the person looking after you immediately.

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 Busilvex:

The following types of medicine may interact with Busilvex:

If you are taking Busilvex 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 Busilvex.

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 Busilvex 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 Busilvex:

Alcohol can interact with certain medicines.

In the case of Busilvex:

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 Busilvex:

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 Busilvex:

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.

Busilvex 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 Busilvex before, do not have Busilvex. Talk to your prescriber, pharmacist or nurse as soon as possible.