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 and stomach cancer.

Trastuzumab is used to treat breast and stomach 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 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.

Stomach cancer that has large amounts of HER2 on its cells is known as HER2-positive stomach cancer. It accounts for between 6 and 40 per cent of cases.

Trastuzumab works in a similar way to the natural antibodies produced by our immune system. Our natural antibodies recognise foreign invaders 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 and stomach cancer cells. This stops the cancer cells from growing and multiplying and also triggers the immune system to attack and kill the cancerous cells.

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 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). This medicine may also be given at the same time as the chemotherapy medicines docetaxel and carboplatin. For people who have already had chemotherapy with doxorubicin and cyclophosphamide,it may be given in combination with paclitaxel or docetaxel.
• 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.For postmenopausal women with hormone sensitive cancer, this medicine may be given with an aromatase inhibitor such as anastrazole.
• HER2-positive stomach cancer that has spread to other parts of the body (metastatic gastric cancer). This medicine can be used to treat people who have not had any anti-cancer treatments for their metastatic disease. It is given in combination with the chemotherapy medicines capecitabine, or fluorouracil plus cisplatin.

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 (hypertension).

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 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 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)

• Tremor.
• Dizziness.
• Headache.
• Disturbances of the gut such as diarrhoea, nausea, vomiting or abdominal pain.
• Swelling of the lips and face.
• Rash.
• Increased or irregular heart rate, or awareness of your heartbeat (palpitations).
• Wheezing or difficulties with breathing.
• Chest pain.
• Pain in the muscles and joints.
• Flu-like symptoms.
• Weakness or loss of strength.
• Pain.
• Fever.
• Changes in blood pressure.

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

• Infections.
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).
• Drops in the numbers of red blood cells, white blood cells and platelets in the blood.
• Change in taste.
• Loss of appetite and weight loss.
• Anxiety and depression.
• Difficulty sleeping (insomnia).
• Sleepiness.
• Pins and needles sensations (paraesthesia).
• Shaky movements and unsteady walk (ataxia).
• Eye problems, such as dry eye, increased tear production.
• Nosebleeds (epistaxis).
• Asthma.
• Cough.
• Constipation.
• Dry mouth.
• Indigestion.
• Skin reactions, such as acne, dry skin, itching and excessive sweating.
• Hair loss.
• Breast inflammation.
• Heart failure.
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the liver (hepatitis).

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

• Deafness.
• Heart valve disorders, such as leaking of fluid into the sac surrounding the heart (pericardial effusion). Early symptoms of this may include difficulty breathing, shortness of breath, pounding heart, feeling faint, chest pain, back pain, pelvic pain or swollen legs.
• Fluid in the chest cavity around the lungs (pleural effusion).

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Jaundice.
• Inflammation of the lungs (pneumonitis).

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?

Studies have not been performed to determine the effect of this medicine on other medicines, or vice versa. You should tell your doctor or pharmacist if you are taking any other medicines, including those bought without a prescription and herbal medicines, before starting treatment with Herceptin. Similarly, you should also check with your doctor or pharmacist before taking any new medicines while you are still receiving treatment with Herceptin, so they can check that the combination is safe.

There is a higher risk of side effects on the heart if trastuzumab is used in combination with chemotherapy medicines called anthracyclines. These include doxorubicin, epirubicin and idarubicin. These medicines should not be used in combination with trastuzumab unless there are facilities for heart monitoring.

People who have received an anthracycline medicine before starting treatment with trastuzumab also have a higher risk of side effects on the heart, but the risk is lower than if these medicines are used at the same time.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain trastuzumab as the active ingredient.