How does it work?

Velcade injection contains the active ingredient bortezomib,which is a type of medicine called a proteasome inhibitor. It is used to treatmultiple myeloma, which is a cancer of a type of white blood cell in the bonemarrow. In multiple myeloma, white blood cells called plasma cells multiply inan uncontrolled way.

Proteasomes are enzymes that are involved in the normal functionand growth of cells. Bortezomib inhibits the function of the proteasomes in thecancerous plasma cells. This affects the normal functioning and growth of thesecells and results in the death of the cancer cells.

Cancer cells seem to be more sensitive to the effects ofbortezomib than normal healthy cells.

Bortezomib is given by injection into a vein. The frequency and length of treatment will depend on if the medicine is being used on its own, or in combination with other treatments.

What is it used for?

• Cancer of the plasma cells in the bone marrow (multiple myeloma).

This medicine is licensed to be used on its own to treat disease that is worsening (progressive multiple myeloma) in people who have already had at leastone prior treatment, and for whom a bone marrow transplant has been unsuccessful or is unsuitable.

It is also licensed to treat people who have not yet had any treatment for their multiple myeloma, and who are unsuitable for high-dose chemotherapy and a bone marrow transplant. In this case it is used in combination with a chemotherapy medicine called melphalan and a steroid called prednisone.

Warning!

• This medicine commonly causes fatigue, dizziness and blurred vision. If affected you should take extra care if you are going to be doing any potentially hazardous activites, such as driving or operating machinary.
• This medicine can occasionally cause your blood pressure to drop when you move from a lying down or sitting position to sitting or standing. This may make you feel dizzy or unsteady and could make some people faint. To avoid this try getting up slowly. If you do feel dizzy, sit or lie down until the symptoms pass and seek medical advice.
• Chemotherapy medicines, as well as the multiple myeloma disease itself, can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting and increase the risk of bleeding. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• This medicine very commonly causes nerve problems and it is important to let your doctor know straight away if you experience any abnormal sensations in your feet and/or hands while having the treatment, for example, numbness, tingling, burning sensations or pain. Your doctor may need to change the dose or schedule of this medicine that you are given.
• As this medicine can sometimes affect the lungs, your doctor may want you to have a chest X-ray before treatment with this medicine is started, so they can check if you have any existing problems with your lungs. Tell your doctor if you get a new or worsening cough, shortness of breath or wheeziness after having treatment with this medicine.
• This medicine could be harmful to an unborn baby. Men should use effective contraception to avoid fathering a child and women should use effective contraception to avoid getting pregnant, both during treatment with this medicine and for three months after the treatment is finished.

Use with caution in

• Decreased kidney function.
• Decreased liver function.
• People with decreased numbers of blood cells called platelets in their blood (thrombocytopenia).
• People with any disease of the nerves (neuropathy).
• People with a history of or increased risk of seizures or fits, eg epilepsy.
• People with low blood pressure (hypotension).
• People with a history of fainting.
• Dehydration, eg due to repeated episodes of diarrhoea or vomiting.
• Heart disease, eg heart failure.
• Lung disease.
• Disorders associated with a build up of protein in the body tissues, such as amyloidosis.
• People with diabetes that is treated with antidiabetic tablets (see end of this page for more information).

Not to be used in

• Severely decreased liver function.
• People who are allergic to boron.
• Severe lung or heart problems (acute diffuse infiltrative pulmonary or pericardial disease).
• This medicine has not been studied in children and adolescents under 18 years of age. It is not recommended for these age groups.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine has not been studied in pregnant women, however it could potentially be harmful to an unborn baby. It should not be used in women who are pregnant unless your doctor thinks it is essential. Men should use effective contraception to avoid fathering a child and women should use effective contraception to avoid getting pregnant, both during treatment with this medicine and for three months after the treatment is finished. Tell your doctor immediately if you think you could be pregnant while you are having treatment with this medicine.
• It is not known if this medicine passes into breast milk. However, the medicine could potentially have serious side effects on a nursing baby if it did pass into the breast milk. For this reason, mothers who need treatment with this medicine should not breastfeed their babies during treatment. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

Very common (affect more than 1 in 10 people)

• Decrease in the normal numbers of red blood cells, white blood cells and platelets in the blood (anaemia, neutropenia, thrombocytopenia) - see warning section above for symptoms to look out for.
• Effects on the nerves (peripheral neuropathy) that may cause pins and needles, tingling, burning, painful or numb sensations in the skin or hands and feet.
• Headache.
• Shortness of breath.
• Feeling sick and vomiting.
• Constipation or diarrhoea. (Tell your doctor or nurse if you get constipated or diarrhoea during your treatment so that this can be treated.)
• Decreased appetite.
• Rash.
• Muscle pain.
• Fatigue.
• Fever.
• Shingles (herpes zoster).

Common (affect between 1 in 10 and 1 in 100 people)

• Dehydration.
• Chest infections.
• Cold sores (herpes simplex).
• Raised blood sugar levels (hyperglycaemia).
• Confusion.
• Depression.
• Anxiety.
• Difficulty sleeping (insomnia).
• Change in taste.
• Tremor.
• Dizziness or spinning sensation.
• A drop in blood pressure that occurs when moving from a lying down or sitting position to sitting or standing, which causes dizziness, lightheadedness and occasionally fainting (postural hypotension).
• Blurred vision, eye pain, swelling around the eyes.
• Nosebleeds.
• Cough.
• Runny nose.
• Sore mouth, mouth ulcers, dry mouth.
• Abdominal pain or bloating, wind, indigestion.
• Itching, flushing, hives, increased sweating or dry skin.
• Pain in the chest, back, limbs, joints or bones.
• Muscle cramps, muscle weakness.
• Swollen ankles, wrists, arms or legs.
• Feeling weak, lethargic or generally unwell.
• Weight loss.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Liver or kidney problems.
• Obstruction or bleeding in the intestines.
• Heart problems, such as palpitations, increased or irregular heart beat, heart failure, heart attack.
• Lung or breathing problems.
• Impaired hearing.
• Eye irritation, watery or dry eyes, red, bleeding or swollen eyes.
• Bleeding in the brain.
• Convulsions.
• Paralysis due to nerve problems.
• Hallucinations, delirium, restlessness, mood swings.
• Various infections, including oral thrush and urinary tract infections.

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines duringtreatment with this one, to make sure that thecombination is safe.

Your doctor may want to perform extra monitoringif you are prescribed any of the following medicines during treatment with thisone:

• fluoxetine
• ketoconazole
• rifampicin
• ritonavir.

If you have diabetes and are treated with antidiabetic tablets,your doctor may want to monitor your blood sugar more frequently while you arehaving treatment with this medicine. This is because it could increase ordecrease the amount of sugar in your blood. Your dose of antidiabetic tabletsmay need to be increased or decreased as a result.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain bortezomib as the active ingredient.