Herceptin 600 mg Solution for Injection in Vial

PACKAGE LEAFLET: INFORMATION FOR THE USER

Herceptin 600 mg solution for injection in vial

Trastuzumab

1. What Herceptin is and what it is used for

Herceptin contains the active substance trastuzumab, which is a monoclonal antibody. Monoclonal antibodies attach to specific proteins or antigens. Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 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 and causes them to die.

Your doctor may prescribe Herceptin for the treatment of breast cancer when:

• You have early breast cancer, with high levels of a protein called HER2.
• You have metastatic breast cancer (breast cancer that has spread beyond the original tumour) with high levels of HER2. Herceptin may be prescribed in combination with the chemotherapy medicines paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful. It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).

2. What you need to know before you are given Herceptin

3. How Herceptin is given

Before starting the treatment your doctor will determine the amount of HER2 in your tumour. Only patients with a large amount of HER2 will be treated with Herceptin. Herceptin should only be given by a doctor or nurse.

Two different types (formulations) of Herceptin exist:

• one is given as an infusion into a vein (intravenous infusion)
• the other is given as an injection under the skin (subcutaneous injection).

It is important to check the product labels to ensure that the correct formulation is being given as prescribed. Herceptin subcutaneous fixed dose formulation is not for intravenous use and should be given as a subcutaneous injection only.

Your doctor may consider switching your Herceptin intravenous treatment to Herceptin subcutaneous treatment (and vice versa) if considered appropriate for you.

In order to prevent medication errors it is also important to check the vial labels to ensure that the medicine being prepared and given is Herceptin (trastuzumab) and not trastuzumab emtansine.

The recommended dose is 600 mg. Herceptin is given as a subcutaneous injection (under the skin) over 2 to 5 minutes every three weeks.

The injection site should be alternated between the left and right thigh. New injections should be given at least 2.5 cm away from an old site. No injection should be given into areas where the skin is red, bruised, tender or hard.

If other medicines for subcutaneous use are used during the treatment course with Herceptin, a different injection site should be used.

Herceptin should not be mixed or diluted with other products.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

During treatment with Herceptin, chills, fever and other flu like symptoms may occur. These are very common (may affect more than 1 in 10 people). Other 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. Some of these symptoms can be serious and some patients have died (see the section “Warnings and precautions”).

You will be observed by a healthcare professional during the administration and for six hours after the start of the first administration and for two hours after the start of other administrations.

Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious. They include weakening of the heart muscle possibly leading to heart failure, inflammation (swollen, red, hot, and in pain) of the lining around the heart and heart rhythm disturbances. This can lead to symptoms such as:

• breathlessness (including breathlessness at night)
• cough
• fluid retention (swelling) in the legs or arms
• palpitations (heart fluttering or irregular heart beat).

Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms.

If you experience any of the above symptoms when your treatment with Herceptin has finished, you should see your doctor and tell them that you have previously been treated with Herceptin.

Two different types (formulations) of Herceptin exist:

• one is given as an infusion into a vein over 30 to 90 minutes
• the other is given as a subcutaneous injection over 2 to 5 minutes.

In the clinical study comparing these two formulations, infections and cardiac events leading to hospitalisation were more frequent with the subcutaneous formulation. There were also more local reactions at the site of injection and more increases in blood pressure. Other side effects were similar.

Very common side effects of Herceptin: may affect more than 1 in 10 people

• infections
• diarrhoea
• constipation
• heartburn (dyspepsia)
• weakness
• skin rashes
• chest pain
• abdominal pain
• joint pain
• low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
• muscle pain
• conjunctivitis
• watery eyes
• nose bleeds
• runny nose
• hair loss
• tremor
• hot flush
• dizziness
• nail disorders
• weight loss
• loss of appetite
• inability to sleep (insomnia)
• altered taste
• low platelet count
• bruising
• numbness or tingling of the fingers and toes
• redness, swelling or sores in your mouth and/or throat
• pain, swelling, redness or tingling of hands and/or feet
• breathlessness
• headache
• cough
• vomiting
• nausea.

Common side effects of Herceptin: may affect up to 1 in 10 people

• allergic reactions
• throat infections
• bladder and skin infections
• shingles
• inflammation of the breast
• inflammation of the liver
• kidney disorders
• increased muscle tone or tension (hypertonia)
• pain in the arms and/or legs
• itchy rash
• sleepiness (somnolence)
• haemorrhoids
• itchiness
• dry mouth and skin
• dry eyes
• sweating
• feeling weak and unwell
• anxiety
• depression
• abnormal thinking
• asthma
• infection of lungs
• lung disorders
• back pain
• neck pain
• bone pain
• acne
• leg cramps

Uncommon side effects of Herceptin: may affect up to 1 in 100 people

• deafness
• bumpy rash
• blood infection.

Rare side effects of Herceptin: may affect up to 1 in 1,000 people

• weakness
• jaundice
• inflammation or scarring of the lungs.

Other side effects that have been reported with Herceptin use: frequency cannot be estimated from the available data

• abnormal or impaired blood clotting
• anaphylactic reactions
• high potassium levels
• swelling of the brain
• swelling or bleeding at the back of the eyes
• shock
• swelling of the lining of the heart
• slow heart rate
• abnormal heart rhythm
• respiratory distress
• respiratory failure
• acute accumulation of fluid in the lungs
• acute narrowing of the airways
• abnormally low oxygen levels in the blood
• difficulty in breathing when lying flat
• liver damage/failure
• swelling of the face, lips and throat
• kidney failure
• abnormally low levels of fluid around baby in womb
• failure of the lungs of the baby to develop in the womb
• abnormal development of the kidneys of the baby in the womb

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 get any side effects, talk to your doctor, pharmacist or nurse.

5. How to store Herceptin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Keep the vial in the outer carton to protect from light.

Do not freeze.

Upon opening of the vial, the solution should be used immediately.

Do not use this medicine if you notice any particulate matter or discoloration prior to administration.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.