Patient Medication Information: uses, side effects, how to take - Perjeta-Herceptin
What is PERJETA used for?
PERJETA, pronounced “per-JE-tah” is used to treat people with breast cancer when:
- there are a large number of “HER2-positive” cancer cells involved – your doctor will test for this.
- the cancer has spread to other parts of the body (metastasized)
- the cancer may have advanced in one region and has not spread to other parts of the body and treatment is going to be given before surgery (treatment before surgery is called neoadjuvant therapy)
- the cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy)
Serious Warnings and Precautions
Heart Problems: PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Your health care provider may run tests to monitor your heart function before and during treatment with PERJETA. Based on test results your doctor may hold or discontinue treatment with PERJETA. See “Serious side effects” for more details about signs of heart problems to look out for. Embryo-Fetal Toxicity: Exposure to PERJETA can result in embryo-fetal death and birth defects. Studies in animals have shown a reduction in the amount of amniotic fluid, delayed renal development, and death. Your health care provider will advise you of these risks and the need for effective contraception while you are taking PERJETA in combination with trastuzumab and 7 months after the last dose of treatment because of the length of time PERJETA and trastuzumab can remain in the body. Hypersensitivity reactions / anaphylaxis and Infusion-related reactions: PERJETA has been associated with severe reactions. Deaths have been reported. You will be observed and carefully monitored during and after infusions. If you have a severe reaction, your doctor may need to completely stop your PERJETA treatment. |
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As well as PERJETA you will also receive trastuzumab and medicines called chemotherapy.
- Information about these medicines is described in separate patient information leaflets. Ask your doctor or nurse to give you information about these other medicines.
How does PERJETA work?
PERJETA is a type of medicine called a “monoclonal antibody” which attaches itself to specific targets in your body.
PERJETA recognizes and attaches to a protein in your body called “human epidermal growth factor 2” or HER2 for short. 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.
What are the ingredients in PERJETA?
Medicinal ingredients: pertuzumab (pronounced per-TOOZ-ue-mab)
Non-medicinal ingredients: glacial acetic acid, L-histidine, polysorbate 20, sucrose, water for injection
PERJETA comes in the following dosage forms:
PERJETA is a clear to slightly pearly (opalescent), colourless to pale brown solution for intravenous (IV) infusion. PERJETA is supplied as a single-use vial containing 14 mL preservative-free liquid concentrate, at a concentration of 30 mg/mL for dilution for intravenous infusion.
Do not use PERJETA if:
- you are allergic to this drug or to any ingredient in the formulation. See What are the ingredients in PERJETA. If you are not sure, talk to your doctor or nurse before you are given PERJETA.
PERJETA is not recommended for anyone under the age of 18 years because there is no information on how well it works in this age group.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PERJETA. Talk about any health conditions or problems you may have, including if you:
- You have ever had heart problems (such as heart failure, heart attack, treatment for serious irregular heartbeats, uncontrolled high blood pressure) - your doctor will run tests to check if your heart is working properly
- You have ever had heart problems during previous treatment with trastuzumab
- You have ever had a chemotherapy medicine from the class called anthracycline, e.g. doxorubicin - these medicines can damage heart muscle and increase the risk of heart problems with PERJETA
Other warnings you should know about:
Pregnancy, breast-feeding and contraception
- Before starting treatment, you must tell your healthcare provider if you are pregnant, think you may be pregnant or are planning to have a baby. You should also tell your healthcare provider if you are breast-feeding.
- Tell your healthcare provider straight away if you get pregnant during treatment with PERJETA and trastuzumab or during the 7 months after stopping treatment.
- Ask your healthcare provider about whether you can breast-feed during or after treatment with PERJETA.
PERJETA may harm the unborn baby. You should use effective contraception during treatment with PERJETA and trastuzumab and for 7 months after stopping treatment. If you are a male patient taking PERJETA with a female partner who can become pregnant you should use effective contraception during treatment with PERJETA and trastuzumab and for 7 months after stopping treatment. Talk to your healthcare provider about the best contraception for you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
It may take up to 7 months for PERJETA and trastuzumab to be removed from the body. Therefore, you should tell your doctor that you have had PERJETA if you start any new medication in the 7 months after stopping treatment.
How to take PERJETA:
Usual dose:
PERJETA will be given to you by your healthcare provider in a hospital or clinic.
- It is given by a drip into a vein (intravenous infusion) once every three weeks.
- The amount of medicine you are given and how long the infusion will last are different for the first, second and following doses.
- The number of infusions you will be given depends on how you respond to treatment and whether you are receiving treatment before surgery (neoadjuvant therapy), after surgery (adjuvant therapy) or for disease which has spread.
- PERJETA is given with other cancer treatments (trastuzumab and chemotherapy).
The first infusion:
- you will be given 840 mg of PERJETA over 60 minutes
- you will also be given trastuzumab and chemotherapy
For all following infusions, if the first infusion was well tolerated:
- you will be given 420 mg of PERJETA over 30 to 60 minutes
- you will also be given trastuzumab and chemotherapy
For further information on dosing of trastuzumab and chemotherapy (which can cause side effects as well), please refer to the package insert for these products. If you have questions about these medications, please ask your healthcare provider.
Overdose:
| If you think you, or a person you are caring for, have taken too much PERJETA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
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
You will then return to receiving a dose of 420 mg PERJETA for following infusions.
If you stop having PERJETA
Do not stop having this medicine without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your healthcare provider.
What are possible side effects from using PERJETA?
These are not all the possible side effects you may have when taking PERJETA. If you experience any side effects not listed here, tell your healthcare professional.
Unwanted effects are possible with all medicines. Talk to your doctor, nurse or pharmacist if you are worried about side effects or find them very bothersome, and report any new or continuing symptoms to your doctor immediately. Your doctor will be able to tell you what to do and may be able to help you with these side effects.
Very common (may affect more than 1 in 10 people):
- hair loss
- dizziness
- loss of, or altered, taste
- producing more tears
- headache
- sore throat, red, sore or runny nose, flu-like symptoms and a fever
- feeling sick (nausea, vomiting)
- having less of an appetite
- nail problems
- rash, dry, itchy or acne like skin
- joint or muscle pain, muscle weakness
- weak, numb, tingling or prickling sensations mainly affecting the feet and legs
- pain in the body, arms, legs, and abdomen
- inflammation of your digestive tract (e.g. sore mouth)
- swollen ankles or other body parts due to your body holding onto too much water
- not being able to sleep
- decrease in the number of red and white blood cells – shown in a blood test
- fever associated with dangerously low levels of a type of white blood cell (neutrophils)
- cough
- nose bleeds
- heartburn
- hot flushes
- fatigue
Common (may affect up to 1 in 10 people):
- inflammation of the nail bed where the nail and skin meet
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
If you experience any of the above symptoms after treatment with PERJETA has been stopped, you should consult your doctor immediately and inform them that you have previously been treated with PERJETA.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Diarrhea | ✓ | ||
| Swelling of your face and throat with difficulty breathing, feeling sick (nausea), fever, chills, feeling tired, headache, loss of appetite, constipation and mouth ulcers. | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Swollen ankles or other body parts | ✓ | ||
| Shortness of breath and cough | ✓ | ||
| Hot flushes | ✓ | ||
| Loss of appetite | ✓ | ||
| Constipation | ✓ | ||
| COMMON | |||
| Chest pain, nausea, discomfort radiating to the back, jaw, throat, or arm. | ✓ | ||
| RARE | |||
| Vomiting, muscle cramps, numbness or tingling | ✓ | ||
| Decreased urination | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking PERJETA, contact your doctor or pharmacist.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
PERJETA will be stored by the health professionals at the hospital or clinic. The storage details are as follows:
- 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 vial and carton.
- Store vials in a refrigerator at 2-8°C.
- Keep vial in the outer carton in order to protect from light.
- Do not freeze or shake PERJETA.
- Do not use this medicine if you notice any particles in the liquid or it is the wrong colour (see PERJETA comes in the following dosage forms).
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Keep out of reach and sight of children.
If you want more information about PERJETA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.rochecanada.com, or by calling 1-888-762-4388 .
Last Revised: February 25, 2021
©Copyright 2013-2021, Hoffmann-La Roche Limited
PERJETA® is a registered trade-mark of F. Hoffmann-La Roche AG, used under license
HERCEPTIN® is a registered trade-mark of Genentech Inc., used under license
Hoffmann-La Roche Limited
Mississauga, ON L5N 5M8