Velcade 3.5mg powder for solution for injection vials

Velcade is used to treat multiple myeloma.

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

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

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

Velcade 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 18 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 Velcade can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Velcade 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 Velcade:

• blood and bone marrow problems
• bowel problems including constipation - seek medical advice if this occurs
• fever
• gastrointestinal pain
• gastrointestinal problems including nausea, diarrhoea or vomiting
• headaches
• infections - seek medical advice if you develop seizure, headache, lethargy, confusion or eye or eyesight problems
• loss of appetite
• muscle, bone or joint pain
• neuralgia
• neuropathies - seek medical advice if you develop symptoms such as: hypersensitivity to external stimuli such as light, noise or physical contact; numbness; burning sensation; paraesthesiae; discomfort; pain; or weakness
• neuropathy of the extremities including sensory problems or motor problems
• skin rash or rashes
• stomach pain
• tiredness
• weakness

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

• a drop in blood pressure on standing or sitting up - seek medical advice if you develop symptoms such as dizziness, light-headedness or fainting
• abnormal laboratory test results
• bleeding from the stomach
• chills
• dehydration
• dermatitis
• distension of the stomach
• dry eye
• dry skin
• eye or eyesight problems
• fainting or brief loss of consciousness
• faster heart rate
• feeling anxious
• feeling dizzy
• flatulence
• general feeling of being unwell
• heart problems or worsening of heart problems - seek medical advice if fluid retention occurs
• indigestion
• inflammation of the mouth
• injection site problems such as pain, bleeding or phlebitis
• itching
• kidney problems
• lethargy
• lowered blood pressure
• lung problems including pneumonia or respiratory distress - these may be fatal. Seek medical advice if you develop a cough or breathing difficulties
• metabolic problems
• mood changes
• mouth or throat pain
• mouth problems
• muscle spasm
• muscle weakness
• nose bleed
• oedema
• oedema of the extremities
• pain
• painful extremities
• raised blood pressure
• redness of the skin
• respiratory tract infection
• sleeping problems
• stomach discomfort
• swelling around the eyes
• taste changes
• urticaria
• vertigo
• weight loss

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

• abnormal gait
• abnormal muscle movements or problems controlling muscle movement
• acne
• angina
• balance or coordination problems
• bleeding from the eye
• bleeding from the gums
• bleeding in the brain
• bleeding problems
• blood in the urine
• brain or central nervous system problems
• bronchospasm
• bruising
• burns
• cellulitis
• changes to sense of smell
• chest discomfort
• chest pain
• collapse
• collection of blood under the skin
• concentration problems
• confusion
• deafness
• death
• deep vein thrombosis
• difficult or painful urination
• difficulty speaking
• discharge from the eye
• double vision
• ear or hearing problems
• endocrine problems
• erectile dysfunction
• eye pain
• eyelid infections
• failure to thrive
• falls
• feeling cold
• feeling of body temperature change
• feeling restless
• feelings of heaviness
• fluid around the lungs
• fluid retention
• flushing
• gastritis
• gastrointestinal problems
• gastro-oesophageal reflux
• genital pain
• hair problems
• hallucinations
• hand-foot syndrome
• hiccups
• high blood sugar - people with diabetes may be advised to adjust their anti-diabetic therapy
• hot flushes
• hypersensitivity reactions
• hypovolaemia
• hypoxia
• increased sweating
• increased tear production
• inflammation of the lungs
• influenza
• irregular heart rate
• irritable bowel syndrome
• irritation or inflammation of the eye
• joint stiffness
• joint swelling
• leakage of Velcade into the surrounding tissues
• liver problems
• lowered blood sugar - people with diabetes may be advised to adjust their anti-diabetic therapy
• lymphadenopathy
• malignant tumours
• memory problems
• mental health problems
• migraine
• mouth ulcers
• mucous membrane problems
• muscle problems
• muscle twitching
• nail problems
• neurotoxicity
• night sweats
• oedema of the face
• oesophagitis
• paleness
• palpitations
• pancreatitis
• petechiae
• phlebitis
• proteinuria
• psoriasis or psoriasis-like rash
• pulmonary embolism
• pulmonary hypertension
• pulmonary oedema
• red eye
• reflex problems
• restless legs syndrome
• retching
• runny nose
• salivary problems
• sciatica
• sepsis
• skin colour changes
• skin infections
• skin lesions
• skin problems
• slower heart rate
• speech problems
• swallowing difficulties
• swelling of the lips
• testicular problems
• thirst
• thrombophlebitis
• thyroid problems
• tinnitus
• tremors
• tumour lysis syndrome
• unexplained or easy bruising of the skin or mucous membranes
• urinary retention
• urinary tract infection
• urinating less or less often
• urinating more often
• vaginal bleeding
• vasculitis
• vitamin B12 levels reduced
• vomiting blood
• weight gain
• wheezing

Rare: More than 1 in 10,000 people who have Velcade:

• alcohol intolerance
• anal fissure
• anaphylactic shock
• apnoea
• appetite gain
• ascites
• autoimmune problems
• benign tumour
• bladder irritation
• blindness
• blisters
• bone problems
• bowel routine changes
• breast problems in women
• Budd-Chiari syndrome
• bulging of the eyeballs
• cancer of the kidney
• cerebrovascular problems
• cold sweats
• convulsions
• coughing blood
• Cushing's syndrome or cushing-like symptoms
• decreased carbon dioxide levels in the blood
• decreased libido
• delirium
• diabetes
• drooling
• ECG changes
• embolus
• erythema multiforme
• faecal incontinence
• feeling irritable
• fistula
• gallstones
• healing problems
• heart attack
• heart or circulation problems
• hernia
• hyperactivity
• hyperventilation
• hypervolaemia
• jaw pain
• joint problems
• leukaemia
• lip pain
• meningitis or meningitis-like symptoms
• muscle tone decreased
• over-sensitivity or fear of light
• paralysis
• paresis
• pelvic pain
• photopsia
• photosensitivity skin reaction
• prostate problems
• psychiatric problems
• psychosis or psychotic-like behaviour
• rhabdomyolysis
• rigors
• seborrhoea
• shortness of breath
• skin hardening
• skin wounds
• skull fracture
• strange dreams
• thinking problems
• thoughts of committing suicide
• throat dryness or irritation
• throat tightness
• throbbing and burning pain of the skin affecting the hands, legs or feet
• tongue oedema
• ulcers
• urine odour changes
• vasodilatation
• vein colour changes
• viral infections

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 Velcade:

The following types of medicine may interact with Velcade:

If you are taking Velcade 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.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Velcade:

If you have been prescribed Velcade you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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 Velcade:

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 Velcade:

Alcohol can interact with certain medicines.

In the case of Velcade:

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 Velcade:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Velcade, 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 Velcade:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. 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.

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