For doctors
What is it and how is it used?
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 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 and gastric cancer when:
What do you have to consider before using it?
Do not use Herceptin
Tell your doctor before you use Herceptin
Your doctor will closely supervise your therapy. You should tell your doctor before you use Herceptin:
If you receive Herceptin with paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient informationackage leaflets for these products
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.
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.
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
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. You should use effective contraception during treatment with Herceptin and for at least 6 months after treatment has concluded. 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. 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 machines. However, if you experience symptoms, such as chills or fever, during an infusion of Herceptin (see section 4), you should not drive or use machines until these symptoms disappear.
How is it used?
Herceptin is given as an intravenous infusion (“drip”) directly into your veins. The first dose of your treatment is given over 90 minutes and you will be observed by a health professional while it is being given in case you have any side effects. If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Tell your doctor before you use Herceptin”).
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. 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, metastatic breast cancer and metastatic gastric cancer, Herceptin is given every 3 weeks. Herceptin may also be given once a week for metastatic breast cancer.
What are 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 (affects more than 1 user in 10). 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. Some of these symptoms can be serious and some patients have died (see 2. under “Tell your doctor before you use Herceptin”).
These effects mainly occur with the first infusion (“drip” into your vein) and during the first few hours after the start of the infusion. They are usually temporary. You will 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. The infusion may be continued after the symptoms improve.
Occasionally, symptoms start later than six hours after the infusion begins. If this happens to you, contact your doctor immediately. Sometimes, symptoms may improve and then get worse later
Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion. 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 (i.e. swollen, red, hot, and in pain) of the lining around the heart and heart rhythm disturbances. This can lead to symptoms such as:
Your doctor will monitor your heart regularly during treatment but you should tell your doctor immediately if you notice any of the above symptoms.
If you experience any of the above symptoms after treatment with Herceptin has been stopped, you should consult your doctor and inform him/ her that you have previously been treated with Herceptin.
Very common side effects of Herceptin(affects more than 1 user in 10) :
Other common side effects of Herceptin (affects 1 to 10 users in 100):
Other rare side effects of Herceptin, (affects 1 to 10 users in 10,000) are:
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 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.
How should it be stored?
Keep out of the reach and sight 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.
Store in a refrigerator (2°C – 8°C).
Infusion solutions should be used immediately after dilution. Do not use Herceptin if you notice any particulate matter or discoloration prior to administration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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For doctors
What is it?
Herceptin is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance trastuzumab.
What is it used for?
Herceptin is used to treat the following types of cancer:
Herceptin can only be used when the cancer has been shown to ‘overexpress’ HER2: this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells.
The medicine can only be obtained with a prescription.
How is it used?
Herceptin treatment should only be started by a doctor who has experience in the use of anticancer medicines.
Herceptin is given as a 90-minute infusion every week or every three weeks for breast cancer, and every three weeks for gastric cancer. For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
The infusion can be associated with allergic reactions, so the patient should be monitored during and after the infusion. Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
How does it work?
The active substance in Herceptin, trastuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found on certain cells in the body. Trastuzumab has been designed to attach to HER2. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow. About a quarter of breast cancers and a fifth of gastric cancers overexpress HER2.
How has it been studied?
In early breast cancer, Herceptin has been studied in four main studies involving around 10,000 patients. The first study was in patients who had first been treated with surgery, chemotherapy and radiotherapy (if applicable). Half of the patients received Herceptin, while the other half did not receive it. The other three studies looked at the effects of giving Herceptin earlier in treatment, in combination with chemotherapy. All of these studies measured how many patients had their cancer re-appear within in the body.
In metastatic breast cancer, Herceptin has been studied in four main studies: one looked at Herceptin on its own in 222 patients whose previous treatment had failed; two looked at Herceptin in combination with paclitaxel or docetaxel in a total of 657 patients; and one looked at the combination of Herceptin and anastrozole (an aromatase inhibitor) in 208 women who had been through the menopause. These studies measured how many patients responded to treatment, or how long they lived without their cancer getting worse.
In metastatic gastric cancer, Herceptin in combination with cisplatin and either capecitabine or 5-fluorouracil was compared with the same combination but without Herceptin in one main study involving 594 patients. The main measure of effectiveness was how long the patients survived.
All of the studies were in patients whose cancers expressed HER2.
What benefits has it shown during the studies?
In the first study in early breast cancer, 8% of the patients who received Herceptin after having completed surgery, chemotherapy and radiotherapy (if applicable) experienced a re-appearance of their cancer in the first year of treatment (127 out of 1,693), compared with 13% of the patients who did not receive it (219 out of 1,693). The addition of Herceptin to chemotherapy resulted in fewer patients experiencing a re-appearance of their cancer over three years. The difference was between 4.8 and 11.8% depending on the type of chemotherapy.
In metastatic breast cancer, 15% of the patients whose previous treatment had failed responded to Herceptin. When used in combination with paclitaxel or docetaxel, around half of the patients responded to Herceptin, compared with around a quarter of those receiving paclitaxel or docetaxel alone. Patients receiving Herceptin in combination with anastrozole also lived for longer without their cancer getting worse (4.8 months, on average) than those receiving anastrozole alone (2.4 months, on average).
In metastatic gastric cancer, the patients with higher levels of HER2 expression who received Herceptin survived for an average of 16.0 months, compared with 11.8 months in those receiving cisplatin and either capecitabine or 5-fluorouracil alone.
What is the risk associated?
The most common side effects with Herceptin (seen in more than 1 patient in 10) are febrile neutropenia (low levels of neutrophils, a type of white blood cell that fights infections, together with fever), tremor (shaking), dizziness, headache, decreased blood pressure, increased blood pressure, irregular heart beat, palpitations (a rapid or irregular heartbeat), cardiac flutter (rapid contractions of the heart), decreased ejection fraction (blood pumped out of the heart), wheezing, dyspnoea (difficulty breathing), diarrhoea, vomiting, nausea (feeling sick), lip swelling, abdominal pain (stomach ache), erythema (reddening of the skin), rash, face swelling, arthralgia (joint pain), muscle tightness, myalgia (muscle pain), asthenia (weakness), chest pain, chills, fatigue (tiredness), influenza (flu)-like symptoms, pain and pyrexia (fever). Side effects related to the infusion itself, such as chills, fever, rash, nausea and vomiting, tend to happen during the first few infusions before becoming less common. For the full list of all side effects reported with Herceptin, see the package leaflet.
Herceptin should not be used in people who may be hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients. It must not be used in patients who have serious breathing problems when they are at rest because of their cancer, or who need oxygen therapy.
Herceptin can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should). Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during treatment to check their heart.
Why has it been approved?
The CHMP decided that Herceptin’s benefits are greater than its risks and recommended that it be given marketing authorisation.
How has it been studied?
The company that makes Herceptin is carrying out more studies looking at cardiotoxicity, including looking at the guidance supplied to doctors and how to identify patients at risk of heart problems to ensure that they are carefully monitored.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Herceptin to Roche Registration Limited on 28 August 2000. The marketing authorisation is valid for an unlimited period. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Herceptin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in 04-2011.
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Name
Herceptin 150 mg powder for concentrate for solution for
infusion
Composition
One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
The reconstituted Herceptin solution contains 21 mg/ml of trastuzumab.
For a full list of excipients, (see section 6.1).
Pharmaceutical Form
Powder for concentrate for solution for infusion.
Herceptin is a white to pale yellow lyophilised powder.
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