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The product code(s) for this leaflet are: PLGB 45613/0010 , PLGB 45613/0012.
Ontruzant 150 mg powder for concentrate for solution for infusion
Ontruzant® 150 mg powder for concentrate for solution for infusion
Ontruzant® 420 mg powder for concentrate for solution for infusion
trastuzumab
1. What Ontruzant is and what it is used for
2. What you need to know before you are given Ontruzant
3. How Ontruzant is given
4. Possible side effects
5. How to store Ontruzant
6. Contents of the pack and other information
Ontruzant 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 Ontruzant binds to HER2 it stops the growth of such cells and causes them to die.
Your doctor may prescribe Ontruzant for the treatment of breast and gastric cancer when:
Your doctor will closely supervise your therapy.
Treatment with Ontruzant (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 Ontruzant. If you develop any signs of heart failure (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 Ontruzant treatment.
Talk to your doctor, pharmacist or nurse before you are given Ontruzant if:
If you receive Ontruzant with any other medicine to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin you should also read the patient information leaflets for these products.
Ontruzant is not recommended for anyone under the age of 18 years.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or may take any other medicines.
It may take up to 7 months for Ontruzant to be removed from the body. Therefore, you should tell your doctor, pharmacist or nurse that you have had Ontruzant if you start any new medicine in the 7 months after stopping treatment.
Do not breast-feed your baby during Ontruzant therapy and for 7 months after the last dose, as Ontruzant may pass to your baby through your breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Ontruzant 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.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially sodium-free.
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 Ontruzant. Ontruzant should only be given by a doctor or nurse. Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of Ontruzant depends on your body weight.
Ontruzant is given as an infusion into a vein (intravenous infusion, “drip”). This intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
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 (see section 2 under “Warnings and precautions”). If the first dose is well tolerated the next doses may be given over 30 minutes. The number of infusions you receive will depend on how you respond to the treatment. Your doctor will discuss this with you.
In order to prevent medication errors, it is important to check the vial labels to ensure that the medicine being prepared and given is Ontruzant (trastuzumab) and not another trastuzumab-containing product (e.g. trastuzumab emtansine or trastuzumab deruxtecan).
Ontruzant is given every 3 weeks for early breast cancer, metastatic breast cancer and metastatic gastric cancer. Ontruzant may also be given once a week for metastatic breast cancer.
Do not stop using this medicine without talking to your doctor first. All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule). This helps your medicine work as well as it can.
It may take up to 7 months for Ontruzant 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.
Like all medicines, Ontruzant can cause side effects, although not everybody gets them. Some of these side effects may be serious and may lead to hospitalisation.
During an Ontruzant infusion, chills, fever and other flu like symptoms may occur. These are very common (may affect more than 1 in 10 people). Other infusion-related 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 section 2 under “Warnings and precautions”).
These effects mainly occur with the first intravenous 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 Ontruzant, not just related to an infusion. 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 Ontruzant has finished, you should see your doctor and tell them that you have previously been treated with Ontruzant.
The following list of side effects can occur at any time during treatment with Ontruzant, not just related to an infusion.
Very common side effects of Ontruzant (may affect more than 1 in 10 people):
Common side effects of Ontruzant (may affect up to 1 in 10 people):
Uncommon side effects of Ontruzant (may affect up to 1 in 100 people):
Rare side effects of Ontruzant (may affect up to 1 in 1000 people):
Other side effects that have been reported with Ontruzant use (frequency cannot be estimated from the available data):
During pregnancy:
Some of the side effects you experience may be due to your underlying cancer. If you receive Ontruzant 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.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Ontruzant will be stored by the healthcare professionals at the hospital or clinic.
Ontruzant is a powder for concentrate for solution for intravenous infusion, which is supplied in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab. The powder is a white to pale yellow pellet. Each carton contains 1 vial of powder.
For any information about this medicine, please contact:
This leaflet was last revised in 12/2022.
PIL.OTZ.23.GB.0208.R-IA-4.0-5.0.NoRCN