Active ingredient
- pertuzumab
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/1/13/813/001.
Perjeta 420 mg Concentrate for Solution for Infusion
Package Leaflet: Information for the user
Perjeta 420 mg concentrate for solution for infusion
pertuzumab
Read all of this leaflet carefully before you start being given this medicine because it contains important information for you.
What is in this leaflet:
1. What Perjeta is and what it is used for
2. What you need to know before you are given Perjeta
3. How you are given Perjeta
4. Possible side effects
5. How to store Perjeta
6. Contents of the pack and other information
1. What Perjeta is and what it is used for
Perjeta contains the active substance pertuzumab and is used to treat adult patients with breast cancer when:
As well as Perjeta you will also receive trastuzumab and medicines called chemotherapy Information about these medicines is described in separate package leaflets. Ask your doctor or nurse to give you information about these other medicines.
How Perjeta works
Perjeta is a type of medicine called a “monoclonal antibody” which attaches itself to specific targets in your body and on the cancer cells.
Perjeta recognises and attaches to a target 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 Perjeta attaches to the HER2 cancer cells, it may slow or stop the cancer cells from growing, or may kill them.
2. What you need to know before you are given Perjeta
You must not be given Perjeta
If you are not sure, talk to your doctor or nurse before you are given Perjeta.
Warnings and precautions
Treatment with Perjeta may affect the heart. Talk to your doctor or nurse before you are given Perjeta:
If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you are given Perjeta. See section 4 “Serious side effects” for more details about signs of heart problems to look out for.
Infusion reactions
Infusion reactions, allergic or anaphylactic (more severe allergic) reactions can happen. Your doctor or nurse will check for side effects during your infusion and for 30 to 60 minutes afterwards. If you get any serious reaction, your doctor may stop treatment with Perjeta. Very rarely, patients have died due to anaphylactic reactions during Perjeta infusion. See section 4 “Serious side effects” for more details about infusion reactions to look out for during the infusion and thereafter.
Febrile neutropenia (Low white blood cells with fever)
When Perjeta is given with other cancer treatments (trastuzumab and chemotherapy), the number of white blood cells may drop and fever (raised temperature) may develop. If you have inflammation of the digestive tract (e.g.sore mouth or diarrhoea) you may be more likely to develop this side effect.
Diarrhoea
Treatment with Perjeta may cause severe diarrhoea. Patients over 65 years of age have a higher risk of diarrhoea compared with patients younger than 65 years of age. Diarrhoea is a condition where your body produces more watery stools than normal. If you experience severe diarrhoea while receiving your anti-cancer treatment, your doctor may start you on anti-diarrhoeal treatment and may stop your treatment with Perjeta until the diarrhoea is under control.
Use in children and adolescents
Perjeta should not be given to patients under the age of 18 years because there is no information on how it works in this age group.
Use in the elderly
Patients over 65 years of age who are treated with Perjeta are more likely to experience side effects such as reduced appetite, decrease in the number of red blood cells, weight loss, feeling tired, loss or altered taste, weak, numb, tingling or prickling sensations mainly affecting the feet and legs and diarrhoea, compared to patients younger than 65 years of age.
Other medicines and Perjeta
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
Before starting treatment, you must tell your doctor or nurse if you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby. They will advise you about the benefits and risks for you and your baby of taking Perjeta while you are pregnant.
Perjeta may harm the unborn baby. You should use effective contraception during treatment with Perjeta and for 6 months after stopping treatment. Talk to your doctor about the best contraception for you.
Driving and using machines
Perjeta may have a minor effect on you being able to drive or use machines. However, if you get any dizziness, infusion reactions, allergic or anaphylactic reactions, wait until these have gone away before driving or using machines.
Sodium
Perjeta contains less than 1 mmol of sodium per dose, i.e. it is essentially sodium-free.
3. How you are given Perjeta
Being given this medicine
Perjeta will be given to you by a doctor or nurse in a hospital or clinic.
For the first infusion:
For all following infusions, if the first infusion was well tolerated:
For further information on dosing of trastuzumab and chemotherapy (which can cause side effects as well), please refer to the package leaflet for these products. If you have questions about these medicines, please ask your doctor or nurse.
If you forget to have Perjeta
If you forget or miss your appointment to receive Perjeta make another appointment as soon as possible. If it has been 6 weeks or more since your last visit a higher Perjeta dose of 840 mg will be given to you.
If you stop having Perjeta
Do not stop having this medicine without talking to your doctor first. It is important that you are given all the infusions that have been recommended.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell a doctor or nurse straight away, if you notice any of the following side effects:
Tell a doctor or nurse straight away, if you notice any of the side effects above.
Other side effects include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
If you experience any of the above symptoms after treatment with Perjeta has been stopped, you should consult your doctor immediately and inform him or her that you have previously been treated with Perjeta.
Some of the side effects which you get may be due to your breast cancer. If you are given Perjeta with trastuzumab and chemotherapy at the same time, some side effects may also be due to these other medicines.
Reporting of side effects
If you get any side effects, talk to your doctor 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 Perjeta
Perjeta will be stored by the health professionals at the hospital or clinic. The storage details are as follows:
6. Contents of the pack and other information
What Perjeta contains
What Perjeta looks like and contents of the pack
Perjeta is a concentrate for solution for infusion. It is a clear to slightly pearly (opalescent), colourless to pale yellow liquid. It is supplied in a glass vial containing 14 ml concentrate.
Each pack 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 April 2020.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
uk-pil-perjeta-clean-200417-450mg-inf
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