Herceptin

How does it work?

Herceptin infusion contains the active ingredient trastuzumab, which is a type of medicine called a humanised monoclonal antibody. It is used to treat breast cancer.

Trastuzumab is used to treat breast tumours that have large amounts of a unique protein called human epidermal growth factor receptor 2 protein (HER2) on the surface of the cancer cells. HER2 is present in excessive amounts on the surface of some breast cancer cells. Its presence stimulates the growth of these cancer cells.

Breast cancer that has large amounts of HER2 on its cells is known as HER2-positive breast cancer. This type of breast cancer is particularly aggressive. It accounts for approximately 20 to 30 per cent of women with breast cancer and demands special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse.

Trastuzumab works in a similar way to the natural antibodies produced by our immune system. Our natural antibodies recognise foreign invadors and bind to them, helping our immune systems to attack them and protect us from infections. Monoclonal antibodies like trastuzumab are made in laboratories and can be used to attack cancer cells in a similar way.

Trastuzumab specifically recognises and binds to the HER2 protein on breast cancer cells. This stops the cancer cells from growing and multiplying and also triggers the immune system to attack the cancerous cells.

Trastuzumab can be used to treat early HER2-positive breast cancer, following surgery and chemotherapy, and has been shown to reduce the risk of the cancer returning. Trastuzumab is also to treat HER2-positive breast cancer that has spread to other areas of the body (metastasised), where it has been shown to improve survival.

Trastuzumab only works in people who have high levels of the HER2 protein, so your doctor will need to test for this before you can be treated with this medicine. There are various tests to measure levels of HER2. These can be done on samples of cells from initial breast cancer surgery, or on samples of cancer cells from previous biopsies or surgery.

Trastuzumab is given as a drip into a vein (intravenous infusion) either once a week or once every three weeks. The first dose is administered over 90 minutes, but if this is well tolerated, further doses may be given over 30 minutes.

What is it used for?

Early HER2-positive breast cancer, following surgery, chemotherapy and radiotherapy (if applicable).

HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer). For people who have not previously received chemotherapy for their disease, this medicine may be given in combination with the chemotherapy medicines paclitaxel or docetaxel. For people who have already received at least two courses of chemotherapy, this medicine may be given on its own.

Warning!

Serious reactions to this medicine, such as severe allergic reactions (anaphylaxis), swelling of face and lips (angioedema), breathing difficulties, abnormal heart rhythms, itchy rash, fever, chills and reduction in blood pressure, may occur infrequently. These effects mainly occur after the first infusion. For this reason, you will be observed by a health care professional during all infusions, for at least six hours after the first infusion, and for two hours after subsequent infusions. On very rare occasions, these reactions may occur more than six hours after the infusion. It is important to contact your doctor if you think you have experienced an allergic reaction.

This medicine has been associated with heart failure, particularly when used following anthracycline (doxorubicin or epirubicin) containing chemotherapy. For this reason, your heart function should be checked before starting and regularly during treatment with this medicine. Tests to check your heart function might include an ECG and MRI scan.

This medicine is not recommended for treating early breast cancer in people with a history of chronic heart failure, high-risk uncontrolled abnormal heart beats (arrhythmias), angina pectoris requiring medication, clinically significant heart valve disease, or poorly controlled high blood pressure. This is because clinical trials of this medicine in early breast cancer didn't include people with these conditions, so it is not known if the benefits of treatment outweigh the risks in these cases.

Use with caution in

Heart failure

Coronary artery disease

History of high blood pressure

Not to be used in

Allergy to mouse protein

People with severe breathing difficulties at rest due to complications of advanced cancer

People who need oxygen treatment.

The safety and efficacy of this medicine in children and adolescents under 18 years of age has not been established. It is not recommended for this age group.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

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

The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor and the potential benefit to the mother outweighs any risk to the developing foetus. Seek medical advice from your doctor.

It is not known if this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for six months after the last dose. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Fever (pyrexia)

Chills

Disturbances of the gut such as diarrhoea, constipation, indigestion, nausea, vomiting or abdominal pain

Headache

Chest pain

Weakness or loss of strength

Pain in the muscles and joints

Rash

Flu-like symptoms

Infection

Weight loss

Breast inflammation

Increased heart rate (tachycardia)

Inability of the heart to pump blood efficiently (heart failure)

Dizziness

Pins and needles (paraesthesia)

Excessive fluid retention in the body tissues, resulting in swelling (oedema)

Dry mouth

Nosebleeds

Skin reactions such as rash, itch, sweating or dry skin

Depression

Anxiety

Difficulties with breathing

Lung disorders

Blood disorders

Liver disorders

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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