Alemtuzumab 30mg/1ml solution for infusion vials

Alemtuzumab belongs to a class of medicines called monoclonal antibodies. It is used to treat B-cell chronic lymphocytic leukaemia when other treatments are not suitable. B-cell chronic lymphocytic leukaemia affects certain types of white blood cells. The B-cells carry a chemical on their surface, which is called CD52. Alemtuzumab works by recognising CD52 on the surface of the B-cells and sticking to them. This causes the B-cells to be destroyed. This helps reduce the number of B-cells and limits the effects of the cancer.

Alemtuzumab only destroys cells which have CD52 on their surface. CD52 is found on the diseased B-cells and also on some healthy cells. Because of this, Alemtuzumab can affect the way your immune system works. Your medical team will arrange for you to have some blood tests to check how well your immune system is working. These blood tests are one of the things your medical team will use to decide if your treatment should continue or be stopped or delayed.

When Alemtuzumab is given it may cause a very serious allergic reaction. You may be given some other medicines to prevent these reactions. Your medical team will tell you about the symptoms you need to look out for and they will monitor you for any reactions. Immediately tell the person who is looking after you if you develop any of these symptoms. They may need to change your dose or stop the treatment until the reaction has stopped. In some cases the reaction needs to be treated before treatment with Alemtuzumab can be continued.

Other information about Alemtuzumab:

Alemtuzumab 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.

Your prescriber will advise you when you need to have your injections. The first three doses of Alemtuzumab are given on three consecutive days. After that, Alemtuzumab is usually only given three times a week for up to 12 weeks. It is a good idea to make a note of the date that your next injection is due so that you do not miss any of your appointments.

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

Alemtuzumab 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 17 years.

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

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

• blood problems
• increased sweating
• infections - some infections may be fatal
• loss of appetite
• pneumonia
• post-injection reactions an allergic-type reaction may happen after Alemtuzumab is injected. Some of these reactions may be fatal. Reaction symptoms include: angioedema, shock, lowered blood pressure, chills, rigors, fever, shortness of breath, rashes, nausea, urticaria, vomiting, tiredness, difficulty breathing, headache, itching, diarrhoea, bronchospasm, heart attack, cardiac arrest, heart problems, hypoxia, fainting or brief loss of consciousness, lung problems, respiratory distress syndrome, respiratory arrest, and anaphylactic or other hypersensitivity reactions. Seek immediate medical advice if you are aware of any of these symptoms developing
• sepsis

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

• abscess
• back pain
• bone pain
• bronchitis
• chest pain
• confusion
• constipation
• cough
• coughing blood
• cyanosis
• dehydration
• depression
• dermatitis
• difficulty sleeping
• eye or eyesight problems
• faster heart rate
• feeling anxious
• feeling dizzy
• flatulence
• flu or flu-like symptoms
• flushing
• fungal infection of the mouth
• gastrointestinal problems
• general feeling of being unwell
• hypoaesthesia
• indigestion
• inflammation of the mouth
• injection site problems such as bruising
• joint pain
• liver problems
• loss of taste
• metabolic problems
• mouth ulcers
• mucous membrane problems
• muscle pain or tenderness
• oedema
• oedema of the mouth
• pain
• palpitations
• paraesthesiae
• pharyngitis
• raised blood pressure
• redness of the skin
• sensation of heat and cold
• sinusitis
• skin problems
• sleepiness
• slower heart rate
• stomach pain
• thirst
• tremors
• unexplained or easy bruising of the skin or mucous membranes
• unexplained or unexpected increase in muscle movement
• urinary tract infection
• vasospasm
• vertigo
• weakness
• weight loss

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

• a drop in blood pressure on standing or sitting up
• abnormal formation of clots throughout the whole body
• abnormal gait
• abnormal laboratory test results
• abnormal muscle movement
• allergic reactions
• belching
• bleeding from the gums
• blood in the urine
• bone marrow problems
• breathing problems
• changes in personality
• circulation problems
• collection of fluid around the lungs
• cystitis
• deafness
• depersonalisation
• difficulty speaking
• dry mouth
• ECG changes
• feeling nervous
• fungal infection of the genitals
• fungal infection of the nails or skin
• gastroenteritis
• hiccups
• hot flushes
• hypersensitivity to external stimuli such as light, noise and physical contact
• impotence
• increased blood sugar levels
• increased muscle tone
• infection or inflammation of the nose or throat
• irritation or inflammation of the gums
• kidney problems
• laryngitis
• leg pain
• lymphadenopathy
• lymphoma-like disorder
• mouth discomfort
• muscle spasm
• neuropathies
• nose bleed
• painful urination
• pulmonary oedema
• rhinitis
• runny nose
• stomach discomfort
• swelling around the eyes
• taste changes
• thinking problems
• throat tightness
• tinnitus
• tongue ulcers
• tuberculosis
• tumour lysis syndrome - this may be fatal
• urinary incontinence
• urinary problems
• urinating less or less often
• urinating more often
• worsening of diabetes

The frequency of these side-effects is unknown:

• autoimmune problems - some autoimmune problems may be fatal
• bleeding in the brain - this may be fatal
• graft versus host disease - this may occur in people who have a blood transfusion after having treatment with Alemtuzumab. This may be fatal
• Guillain Barr syndrome - this may be fatal

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 types of medicine may interact with Alemtuzumab:

If you are taking Alemtuzumab and one of the above 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 Alemtuzumab.

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 Alemtuzumab:

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 Alemtuzumab:

Alcohol can interact with certain medicines.

In the case of Alemtuzumab:

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 Alemtuzumab:

This medicine is not suitable during pregnancy. It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.

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

In the case of Alemtuzumab:

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 alemtuzumab.

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