Active ingredient
- trastuzumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/00/145/002.
Herceptin 600 mg Solution for Injection in Vial
PACKAGE LEAFLET: INFORMATION FOR THE USER
Herceptin 600 mg solution for injection in vial
Trastuzumab
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What Herceptin is and what it is used for
2. What you need to know before you are given Herceptin
3. How Herceptin is given
4. Possible side effects
5. How to store Herceptin
6. Contents of the pack and other information
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:
2. What you need to know before you are given Herceptin
Do not use Herceptin if:
Warnings and precautions
Your doctor will closely supervise your therapy.
Heart checks
Treatment with Herceptin alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer). The effects may be moderate to severe and could cause death. Therefore, your heart function will be checked before, during (every three months) and after (up to two to five years) treatment with Herceptin. If you develop any signs of heart failure (i.e. inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Herceptin treatment.
Talk to your doctor, pharmacist or nurse before you are given Herceptin if:
If you receive Herceptin with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, carboplatin or cisplatin you should also read the patient information leaflets for these products.
Children and adolescents
Herceptin is not recommended for anyone under the age of 18 years.
Other medicines and Herceptin
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
It may take up to 7 months for Herceptin to be removed from the body. Therefore you should tell your doctor, pharmacist or nurse that you have had Herceptin if you start any new medicine in the 7 months after stopping treatment.
Pregnancy
Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy. In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving Herceptin. This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death.
Breast-feeding
Do not breast-feed your baby during Herceptin therapy and for 7 months after the last dose of Herceptin as Herceptin may pass to your baby through your breast milk.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Driving and using machines
Herceptin may affect your ability to drive a car or operate machines. If during treatment, you experience symptoms, such as dizziness, sleepiness, chills or fever, you should not drive or use machines until these symptoms disappear.
Sodium
Herceptin contains less than 1 mmol of sodium per dose, i.e. it is essentially sodium-free.
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:
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 stop using Herceptin
Do not stop using this medicine without talking to your doctor first. All doses should be taken at the right time every three weeks. This helps your medicine work as well as it can.
It may take up to 7 months for Herceptin to be removed from your body. Therefore your doctor may decide to continue to check your heart functions, even after you finish treatment.
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, 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.
Serious side effects
Other side effects can occur at any time during treatment with Herceptin. Tell a doctor or nurse straight away, if you notice any of the following side effects:
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:
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
Common side effects of Herceptin: may affect up to 1 in 10 people
Uncommon side effects of Herceptin: may affect up to 1 in 100 people
Rare side effects of Herceptin: may affect up to 1 in 1,000 people
Other side effects that have been reported with Herceptin use: frequency cannot be estimated from the available data
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
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
What Herceptin contains
What Herceptin looks like and contents of the pack
Herceptin is a solution for injection that is supplied in a glass vial with a butyl rubber stopper containing 5 mL (600 mg) of trastuzumab. The solution is clear to opalescent and colourless to yellowish.
Each carton contains one vial.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in July 2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
uk-pl-herceptin-clean-200716-600mg-vial
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