patient information leaflet herceptin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Herceptin 150 mg powder for concentrate for solution for infusion

trastuzumab

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1. What Herceptin is and what it is used for
2. Before you use Herceptin
3. How to use Herceptin
4. Possible side effects
5. How to store Herceptin
6. Further information

1. WHAT HERCEPTIN IS AND WHAT IT IS USED FOR

Each pack of Herceptin contains one vial. This vial contains a white to pale yellow lyophilised (“freeze-dried”) powder for concentrate for solution for infusion. The lyophilised powder must be reconstituted and diluted before use.

Herceptin contains the active substance trastuzumab, which is a humanised monoclonal antibody. This is similar to the antibodies produced naturally by the body which protect it against infections with viruses and bacteria. Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body called antigens. Trastuzumab binds selectively to an antigen called human epidermal growth factor 2 (HER2). HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth. When Herceptin binds to HER2 it stops the growth of such cells.

Herceptin is prescribed by doctors for the treatment of patients with early breast cancer, where it is used after you have finished your chemotherapy, and for the treatment of patients with metastatic breast cancer (i.e., breast cancer that has spread beyond the original tumour) who have tumours that produce large amounts of HER2. It is used alone in conditions where other treatments proved unsuccessful. It is also used in combination with the chemotherapy agents paclitaxel or docetaxel as first treatment for metastatic breast cancer. It is also used in combination with an aromatase inhibitor for the treatment of patients with HER2-positive and hormone receptor-positive metastatic breast cancer.

If you receive Herceptin with paclitaxel, docetaxel or an aromatase inhibitor you should also read the package inserts for these products.

2. BEFORE YOU USE HERCEPTIN

Do not use Herceptin

If you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients.
If you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.

Take special care with Herceptin

If you have had heart failure, coronary artery disease or high blood pressure. This is because Herceptin can cause heart failure.
If you have ever had chemotherapy with a drug called doxorubicin or a drug related to doxorubicin (your doctor can advise you here). These drugs can damage heart muscle and increase the risk of heart problems with Herceptin.
If you are breathless. Herceptin can cause breathing difficulties, especially when it is first given. This could be more serious if you are already breathless.

Apart from breathing difficulties, Herceptin can cause fever, chills, flu-like symptoms, swelling of the face and lips, rash, wheezing, heart rhythm disturbances and blood pressure changes. These effects mainly occur with the first infusion and during the first few hours after the start of the infusion. Occasionally, symptoms start later than six hours after the infusion begins. Sometimes, symptoms may improve and then get worse later. If either of these happens to you, contact your doctor immediately. You will therefore be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions. If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects. Very rarely, patients with severe breathing difficulties before treatment have died when they are given Herceptin.

Your doctor will closely supervise your therapy with Herceptin. Treatment with Herceptin may affect the heart. Therefore, your heart function will be checked before and during the treatment with Herceptin. If you develop any signs of heart failure (i.e., inadequate pumping of blood by the heart), you may have to stop Herceptin.

It may take up to 6 months for Herceptin to be removed from the body. Therefore, you should tell your doctor or pharmacist that you have had Herceptin if you start any new medication in the 6 months after stopping treatment.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Please tell your doctor or pharmacist that you have had Herceptin if you start any medication in the 6 months after stopping treatment with Herceptin.

Use in children and adolescents

At present, Herceptin is not recommended for anyone under the age of 18 years because there is not enough information in this age group.

Pregnancy and breast-feeding

Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing foetus within the amniotic sac has been observed in pregnant women receiving Herceptin. Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.

Do not breast-feed your baby during Herceptin therapy and for 6 months after the last dose of Herceptin.

Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

We do not know whether Herceptin could affect your ability to drive a car or operate machinery. However, if you experience symptoms, such as chills or fever, during an infusion of Herceptin (see 4.), you should not drive or use machines until these symptoms disappear.

3. HOW TO USE HERCEPTIN

Dosage and frequency of administration

Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Herceptin depends on your body weight. The number of infusions you receive will depend on how you respond to the treatment. Your doctor will discuss this with you.

For early breast cancer, Herceptin is given every 3 weeks. The intravenous infusion (“drip”) will be given over approximately 90 minutes.

For metastic breast cancer, Herceptin is given once a week. It is given as an intravenous infusion (“drip”) by a health care professional. The first dose is given over 90 minutes. The subsequent doses may be given over 30 minutes. You will also be observed for some time at the end of each infusion (see 2. under “Take special care with Herceptin”).

4. POSSIBLE SIDE EFFECTS

Like all medicines, Herceptin can cause side effects, although not everybody gets them. Some of these side effects may be serious and may lead to hospitalisation.

During a Herceptin infusion, chills, fever and other flu like symptoms may occur. These are very common (more than 10 out of 100 patients). They mainly occur with the first infusion and are temporary. Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired. These symptoms can be serious and some patients have died (see 2. under “Take special care with Herceptin”). You will be observed by a health professional during and after each infusion. If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects. The infusion may be continued after the symptoms improve.

Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion. Heart problems can sometimes occur and can be serious. They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart (pericarditis), and heart rhythm disturbances. Your doctor will monitor your heart regularly during treatment but you should tell your doctor immediately if you notice breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, or palpitations (heart fluttering or irregular heart beat).

Other very common side effects of Herceptin, occurring in more than 10 out of 100 patients, are: diarrhoea, weakness, skin rashes, chest pain, abdominal pain, joint pain, and muscle pain.

Other common side effects of Herceptin, occurring in less than 10 out of 100 patients, are: allergic reactions, abnormal blood counts (anaemia, low platelet count and low white blood count), constipation, heartburn (dyspepsia), infections, including bladder and skin infections, shingles, inflammation of the breast, inflammation of the pancreas or liver, kidney disorders, increased muscle tone /tension (hypertonia), tremor, numbness or tingling of the fingers and toes, nail disorders, hair loss, inability to sleep (insomnia), sleepiness (somnolence), nose bleeds, acne, itchiness, dry mouth and skin, dry or watery eyes, sweating, feeling weak and unwell, anxiety, depression, abnormal thinking, dizziness, loss of appetite, weight loss, altered taste, asthma, lung disorders, back pain, neck pain, bone pain, leg cramps, haemorrhoids (piles), bruises and arthritis.

Some of the side effects you experience may be due to your underlying breast cancer. If you receive Herceptin in combination with chemotherapy, some of them may also be due to the chemotherapy.

If you experience any of the side effects mentioned in this leaflet or notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. HOW TO STORE HERCEPTIN

Keep out of the reach and sight of children.

Store in a refrigerator (2°C – 8°C).

Do not use this medicine after the expiry date stated on the outer carton and on the vial label (EXP).

Medicine: herceptin