Ontruzant 150 mg powder for concentrate for solution for infusion Ontruzant 420 mg powder for concentrate for solution for infusion
What Ontruzant is and what it is used for
Ontruzant contains the active substance trastuzumab, which is a monoclonal antibody. Monoclonal antibodies are attached 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 certain cancer cells and then stimulates cell growth. When Ontruzant binds to HER2, the growth of the cancer cells is stopped and it leads to their death.
Your doctor may prescribe Ontruzant for the treatment of breast and stomach cancer then:
- You have early breast cancer , with high levels of protein et HER2 .
- You have metastatic breast cancer (breast cancer that spread outside the original tumor ) with high levels of HER2 . Ontruzant can be prescribed in combination with the cytotoxic drugs paclitaxel or docetaxel as first-line treatment for metastatic breast cancer, or it can be prescribed as the only treatment for conditions where other treatments have not shown effect. It is also used in combination with medicines called aromatase inhibitors for the treatment of patients with high levels of HER2 and hormone receptor positive metastatic (spread) breast cancer (cancer that is sensitive to the presence of female sex hormone).
- You have metastatic gastric cancer with high levels of HER2 , as it is used in combination with capecitabine or 5-fluorouracil and cisplatin.
What you need to know before you use Ontruzant
Do not use Ontruzant
- if you are allergic to trastuzumab, murine (mouse) protein or any of the other ingredients of this medicine (listed in section 6).
- if you have severe breathing problems at rest due to your cancer or if you need oxygen therapy.
Warnings and cautions
Your doctor will closely monitor your treatment.
Control of the heart
Treatment with Ontruzant (alone or with a taxane) can affect the heart, especially if you have previously been treated with an anthracycline (taxanes and anthracyclines are two other types of medicines used to treat cancer).
The effects can be moderate to severe and some patients have died. Your heart function will therefore be checked before and during treatment (every three months) and after (up to two to five years) treatment with Ontruzant. If you develop signs of heart failure (insufficient pumping of blood from the heart), your heart function may be checked more often (every six to eight weeks). You may then receive treatment for heart failure or you may need to discontinue treatment with Ontruzant.
Talk to your doctor, pharmacist, or nurse before receiving Ontruzant about:
- you have had heart failure , coronary heart disease, heart valve disease ( wheezing ) or high blood pressure , if you have taken or are currently taking medicines for high blood pressure .
- you have previously received or are currently receiving a medicine called doxorubicin or epirubicin (a medicine used to treat cancer). These medicines (or other anthracyclines ) can damage the heart muscle and increase the risk of heart problems with Ontruzant.
- you suffer from shortness of breath, especially if you are treated with a taxane at the same time. Ontruzant can cause breathing difficulties, especially when given for the first time. This can be more serious if you are already short of breath. Patients with severe respiratory distress have in very rare cases died in connection with Ontruzant treatment.
- you have previously received any other treatment for cancer.
If you are taking Ontruzant with other medicines used to treat cancer, such as paclitaxel, docetaxel, an aromatase inhibitor, capecitabine, 5-fluorouracil, or cisplatin, you should also carefully read the package leaflets for these products.
Children and young people
Ontruzant is not recommended for anyone under 18 years of age.
Other drugs and Ontruzant
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
It can take up to 7 months for Ontruzant to be removed from the body. You should therefore tell your doctor, pharmacist, or nurse that you have been treated with Ontruzant if you start any new medication within 7 months of stopping treatment.
Pregnancy and breastfeeding
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
- You should use effective contraception during treatment with Ontruzant and for at least 7 months after stopping treatment.
- Your doctor will advise you on the risks and benefits of taking Ontruzant during pregnancy. In rare cases, pregnant women treated with Ontruzant have seen a decrease in the amount of (fetal) fluid that surrounds the growing fetus in the womb. This condition can be harmful to the baby in the womb and has been associated with the lungs not developing fully, resulting in fetal death.
Do not breast-feed your baby during treatment with Ontruzant and within 7 months after the last dose of Ontruzant as Ontruzant may pass to your baby through breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ontruzant may affect your ability to drive or use machines. If you develop symptoms such as dizziness, drowsiness, chills, or fever during treatment, you should not drive or use machines until these symptoms have disappeared.
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How to use Ontruzant
Before starting treatment, your doctor will decide if your tumor is HER2 -positive. Only patients with HER2 -positive cancer (large amounts of HER2 ) will be treated with Ontruzant. Ontruzant should only be given by a doctor or nurse. Your doctor will prescribe the right dose and treatment regimen 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 preparation is not intended for subcutaneous use and should only be given by intravenous infusion.
The first dose is given over 90 minutes and you will be observed by healthcare professionals while receiving it in case of any side effects (see section 2 under “Warnings and precautions”). If the first dose is well tolerated, the following dose can be given for 30 minutes. The number of infusions that you receive depends on the effect of the treatment you have. Your doctor will discuss this with you.
To prevent medication errors, it is important to check the label of the vial to ensure that the medicine is prepared and administered is Ontruzant (trastuzumab) and not any other product containing trastuzumab (eg trastuzumab emtansine or trastuzumab deruxtecan).
In early breast cancer, metastatic breast cancer, and metastatic gastric cancer, Ontruzant is given every three weeks. Ontruzant can also be given once a week for metastatic breast cancer.
If you stop using Ontruzant
Do not stop using this medicine without talking to your doctor first. All doses should be taken at the right time each week or every three weeks (depending on your dosing interval). This helps the drug to work as well as possible.
It can take up to 7 months before Ontruzant disappears from the body. Therefore, your doctor may decide to continue to monitor your heart function even after treatment is stopped.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, Ontruzant can cause side effects, although not everybody gets them. Some of these side effects can be serious and may involve hospitalization.
During an infusion of Ontruzant
chills, fever, and other flu-like symptoms may occur. These side effects are very common (may affect more than 1 in 10 people). Other symptoms caused by infusion one are: nausea, vomiting, pain, increased muscle tension and tremors, headache, dizziness, difficulty breathing, high or low blood pressure, altered heart rhythm (palpitations, heart flutter, or irregular heartbeat), swelling of the face and lips and lips. Some of these symptoms may be severe and some patients have died (see section 2 under “Warnings and precautions”).
These effects occur mainly in connection with the first intravenous infusion (drip) and during the first hours after the start of infusion. They are usually temporary. You will be monitored by healthcare professionals during infusion one and for at least six hours after the start of the first infusion one and two hours after the start of the second infusion. If you develop symptoms, healthcare professionals will slow down or discontinue the infusion and they may give you treatment to counteract the side effects. After improvement of the symptoms, the infusion can be continued.
Occasionally, symptoms may occur later than six hours after the start of the infusion. If this happens to you, contact your doctor immediately. Sometimes the symptoms can improve and later worsen.
Serious side effects
Other side effects may occur at any time during treatment with Ontruzant and are not associated with the infusion itself. Tell a doctor or nurse immediately if you notice any of the following side effects:
- Heart problems can sometimes occur during treatment and sometimes after treatment has stopped and can be serious. They include weakening of the heart muscle that can possibly lead to heart failure , inflammation around the heart and altered heart rhythm. This can lead to symptoms such as shortness of breath (including shortness of breath during the night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart flutter or irregular heartbeat) (see section 2. Checking the heart).
Your doctor will check your heart regularly during and after treatment, but you should tell your doctor immediately if you experience any of the above symptoms.
- Tumor light syndrome (group of metabolic complications that occur after cancer treatment and are characterized by high levels of potassium and phosphate in the blood and low levels of calcium in the blood). Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (heart flutter with a faster or slower heartbeat), cramps, vomiting or diarrhea and tingling in the mouth, hands or feet.
If you experience any of the above symptoms after stopping treatment with Ontruzant, talk to your doctor and tell your doctor that you have previously been treated with Ontruzant.
The side effects listed below may 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):
- infection is
- heartburn ( dyspepsia )
- chest pain
- abdominal pain
- joint pain
- low levels of red blood cells and white blood cells (which help fight you infection ), sometimes with fever
- muscle pain
- conjunctivitis (conjunctivitis of the eye)
- watery eyes
- hair loss
- hot flashes
- nail changes
- weight loss
- loss of appetite
- insomnia (insomnia)
- taste changes
- decreased platelet count
- numbness or tingling in the fingers and toes, which can sometimes spread to the rest of the arm or leg
- redness , swelling or sores in the mouth and / or throat
- pain, swelling, redness or tingling in the hands and / or feet
- shortness of breath
Common side effects of Ontruzant (may affect up to 1 in 10 people)
|allergic reaction throat infection infection you in the bladder and on the skin inflammation of the chest inflammation of the liver renal impact increased muscle tone or tension (hypertension)pain in arms and/or legs itchy skin rashdrowsiness ( somnolence )hemorrhoidsitchingleg cramps||dry mouth and skin dry eyessweatingfeeling of weakness and not feeling wellconcernDepressionasthmalung infection lung impact back pain neck painskeletal penance|
Uncommon side effects of Ontruzant (may affect up to 1 in 100 people):
- lumpy rash
- hissing / wheezing breathing
- inflammation or scarring of the lungs
Rare side effects of Ontruzant (may affect up to 1 in 1,000 people):
- jaundice (yellowish discoloration of the skin or eyes)
- anaphylactic reactions
Other side effects reported with Ontruzant (frequency can not be calculated from the available data):
- abnormal or impaired blood coagulation
- high potassium levels
- swelling or bleeding behind the eyes
- abnormal heart rhythm
- respiratory distress
- breathing problems
- acute accumulation of fluid in the lungs
- acutely narrower airways
- abnormally low oxygen content in the blood
- difficulty breathing when lying upright
- liver damage
- swelling of the face, lips and neck
- kidney failure
- abnormally little amniotic fluid around the fetus in the womb
- underdeveloped lungs of the fetus in utero
- abnormal development of the kidneys of the fetus in the womb
Some of the side effects you are experiencing may be due to your underlying cancer. If you are being treated with Ontruzant with cytotoxic drugs, some of the side effects may also be due to the cytotoxic drugs.
If you get any side effects, talk to your doctor, pharmacist, or nurse.
How to store Ontruzant
Ontruzant should be stored by healthcare professionals at the hospital or clinic.
- 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 expiration date is the last day of the specified month.
- The unopened vial should be stored in a refrigerator (2 ° C-8 ° C).
- The reconstituted solution must not be frozen.
- Infusion solutions should be used immediately after reconstitution . If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C to 8 ° C.
- Do not use Ontruzant if you notice particles or discoloration before 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.
Contents of the package and other information
- The active substance is trastuzumab. Each vial contains either:
- 150 mg trastuzumab to be dissolved in 7.2 ml of water for injection , or
- 420 mg trastuzumab to be dissolved in 20 ml water for injection .
- The reconstituted solution contains approximately 21 mg / ml trastuzumab.
- The other ingredients are L ‑ histidine hydrochloride monohydrate, L ‑ histidine, α, α-trehalose dihydrate, polysorbate 20.
What the medicine looks like and contents of the pack
Ontruzant is a powder for concentrate for intravenous infusion, a solution provided in a glass vial with a rubber stopper containing either 150 mg or 420 mg of trastuzumab. The powder is freeze-dried and white to slightly yellow. Each carton contains 1 vial of powder.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Samsung Bioepis NL BV
Olof Palmestraat 10
2616 LR Delft
FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1
Samsung Bioepis NL BV
Olof Palmestraat 10
2616 LR Delft
Contact the representative of the marketing authorization holder to find out more about this medicine:
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