60 mg, 150 mg, and 420 mg powder for concentrate for solution for infusion
What Zercepac is and what it is used for
Zercepac contains the active ingredient 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 quantities on the surface of certain cancer cells ( HER2 -positive cancer) and then stimulates cell growth. When Zercepac binds to HER2, the growth of the cancer cells is stopped and this leads to their death.
Your doctor may prescribe Zercepac for the treatment of breast cancer and gastric cancer when:
- You have early breast cancer with high levels of protein et HER2.
- You have metastatic breast cancer (breast cancer that has spread beyond the original tumor) with high levels of HER2. Zercepac can be prescribed in combination with the chemotherapy agents 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 an effect. It is also used in combination with medicines called aromatase inhibitors to treat patients with high levels of HER2 and hormone receptor-positive metastatic (spread) breast cancer (cancer that is sensitive to the presence of female sex hormones).
- You have metastatic gastric cancer with high levels of HER2 when it is used in combination with capecitabine or 5‑fluorouracil and cisplatin.
What you need to know before you receive Zercepac
Do not use Zercepac if:
- you are allergic to trastuzumab, murine (mouse) protein, or any of the other ingredients of this medicine (listed in section 6).
- you have severe breathing problems at rest due to your cancer or if you need oxygen therapy.
Warnings and precautions
Your doctor will closely monitor your treatment.
Control of the heart
Treatment with Zercepac alone or with a taxane may affect the heart, especially if you have previously been treated with anthracycline (taxanes and anthracyclines are two other types of medicine used to treat cancer). 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 Zercepac. If you develop signs of heart failure (insufficient pumping of blood from the heart), your heart function may be checked more frequently (every six to eight weeks). You may then receive treatment for heart failure or you may need to stop treatment with Zercepac.
Talk to your doctor, pharmacist, or nurse before receiving Zercepac if:
- you have had heart failure, coronary artery disease, valvular heart disease (heart murmur ), 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 (medicines used to treat cancer). These medicines (or other anthracyclines ) can damage the heart muscle and increase the risk of heart problems with Zercepac.
- you suffer from shortness of breath, especially if you are also being treated with taxidermy. Zercepac can cause breathing difficulties, especially when it is given for the first time. This can be more serious if you are already short of breath. Patients with severe breathing difficulties have very rarely died in connection with Zercepac treatment.
- you have previously received any other cancer treatment.
If you receive Zercepac together with other medicines 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
Other medicines and Zercepac
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 Zercepac to be removed from the body. You should therefore tell the doctor, pharmacist, or nurse that you have been treated with Zercepac if you start any new medication within 7 months of finishing treatment.
- 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 using this medicine.
- You should use effective contraception during treatment with Zercepac and for at least 7 months after treatment ends.
- Your doctor will advise you about the pros and cons of taking Zercepac during pregnancy. In rare cases, pregnant women treated with Zercepac have seen a reduction in the amount of (amniotic) fluid that surrounds the growing fetus in the womb. This condition can be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in fetal death.
Do not breastfeed your child during treatment with Zercepac and within 7 months after the last dose of Zercepac because Zercepac can pass to your child through breast milk.
Driving ability and use of machinery
Zercepac can affect your ability to drive or use machines. If you experience symptoms such as dizziness, sleepiness, chills, or fever during treatment, you should not drive or operate machinery until these symptoms have disappeared.
Zercepac contains less than 1 mmol sodium per dose, i.e. is almost sodium-free.
How to get Zercepac
Before starting treatment, your doctor will determine whether your tumor is HER2-positive. Only patients with HER2 -positive cancer (high amounts of HER2 ) will be treated with Zercepac. Zercepac should only be given by a doctor or nurse. Your doctor will prescribe the right dose and treatment regimen for you. The Zercepac dose depends on your body weight.
Zercepac intravenous formulation is given as an intravenous infusion (“drip”) directly into a blood vessel by healthcare professionals. The first dose is given over 90 minutes and you will be observed by healthcare professionals while you receive it in case you experience any side effects. If the first dose is well tolerated, the subsequent dose can be given within 30 minutes (see section 2 under “Warnings and precautions”). The number of infusions 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 vial labeling to ensure that the drug being prepared and administered is Zercepac (trastuzumab) and not trastuzumab emtansine.
In early breast cancer, metastatic breast cancer, and metastatic stomach cancer, Zercepac is given every three weeks. Zercepac can also be given once a week for metastatic breast cancer.
If you stop using Zercepac
Do not stop using this medicine without talking to your doctor first. All doses should be taken at the correct time each week or every three weeks (depending on your dosing interval). This helps the medicine work as well as possible.
It can take up to 7 months for Zercepac to disappear from the body. Therefore, your doctor may decide to continue to monitor your heart function even after treatment has ended.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, Zercepac can cause side effects, although not everybody gets them. Some of these side effects can be serious and may require hospitalization.
Serious side effects are
During an infusion with Zercepac, chills, fever and other flu-like symptoms may occur. These side effects are very common (may affect more than 1 in 10 users). 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, fluttering or irregular heartbeat), swelling of the face and lips, skin rash and weakness. Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
These effects mainly occur in connection with the first intravenous infusion (the “drip”) and during the first hours after the start of the infusion. They are usually temporary. You will be monitored by healthcare professionals during the infusion and for at least six hours after the start of the first infusion and one and two hours after the start of the other infusions. If you develop symptoms, the healthcare professional will slow down or stop the infusion and they may give you treatment to counteract the side effects. After the improvement of the symptoms, the infusion can be continued.
Sometimes symptoms may occur later than six hours after the infusion is started. If this happens to you, contact your doctor immediately. Sometimes the symptoms may improve and later worsen.
Other serious side effects can occur at any time during treatment with Zercepac and are not associated with the actual infusion of Zercepac. 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 ended and can be serious. They include weakening of the heart muscle which can eventually lead to heart failure, inflammation (swelling, redness, heat, and pain) around the heart, and changes in heart rhythm. This can lead to symptoms such as shortness of breath (including shortness of breath at night), cough, fluid retention (swelling) in the legs or arms, and palpitations (fluttering or irregular heartbeats) (see section 2 “Monitoring the heart”).
Your doctor will regularly check your heart during and after treatment, but you should tell your doctor immediately if you experience any of the above symptoms.
- Tumor lysis syndrome (a 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, tiredness, and confusion), heart problems (palpitations with a faster or slower heartbeat), seizures, vomiting or diarrhea, and tingling in the mouth, hands, or feet.
If you experience any of the above symptoms after stopping treatment with Zercepac, consult your doctor and tell the doctor that you have previously been treated with Zercepac.
Other side effects ar
Very common side effects of Zercepac: may affect more than 1 in 10 users
- infection _
- heartburn ( dyspepsia )
- chest pain
- abdominal pain
- joint pain
- low levels of red blood cells and white blood cells (which help fight infection ) sometimes with fever
- muscle pain
- conjunctivitis (inflammation of the conjunctiva of the eye)
- watery eyes
- runny nose
- hair loss
- hot flashes
- nail changes
- weight loss
- loss of appetite
- insomnia _ _
- taste changes
- decreased number of platelets
- numbness or tingling in the fingers and toes
- 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: may affect up to 1 in 10 users
- allergic reactions
- throat infection
- infection in the bladder and on the skin
- inflammation of the chest
- inflammation of the liver
- kidney damage
- increased muscle tone or tension (hypertonus)
- pain in arms and/or legs
- itchy rash
- sleepiness ( somnolence )
- dry mouth and skin
- dry eyes
- feeling weak and not feeling well
- lung infection
- lung impact
- back pain
- neck pain
- bone pain
- leg cramps
Uncommon side effects: may affect up to 1 in 100 users
- bumpy skin rash
- inflammation or scarring of the lungs
Rare side effects: may occur in up to 1 in 1,000 users
- anaphylactic reactions
Has been reported (occurring in an unknown number of users):
- abnormal or impaired blood clotting
- high potassium levels
- swelling or bleeding behind the eyes
- abnormal heart rhythm
- respiratory distress
- breathing problems
- acute accumulation of fluid in the lungs
- acute narrowed airways
- abnormally low oxygen content in the blood
- difficulty breathing when lying flat
- liver damage
- swelling of the face, lips, and throat
- kidney failure
- abnormally little amniotic fluid around the fetus in the womb
- underdeveloped lungs of the fetus in the womb
- abnormal development of the kidneys of the fetus in the womb
Some of the side effects you experience may be due to your underlying disease cancer. If you are treated with Zercepac together with chemotherapy, some of the side effects may also be due to the chemotherapy.
If you get side effects, talk to your doctor, pharmacist, or nurse.
How to store Zercepac
Zercepac should be stored by healthcare professionals in 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 the vial label (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 prepared solution must not be frozen.
- Infusion solutions should be used immediately after dilution. If not used immediately, the applied storage time and storage conditions before use are the responsibility of the user.
- Do not use Zercepac if you see particles or discoloration before administration.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is trastuzumab. Each vial contains either:
- 60 mg of trastuzumab to be dissolved in 3.0 ml of sterile water for injections or
- 150 mg of trastuzumab to be dissolved in 7.2 ml of sterile water for injections or
- 420 mg of trastuzumab to be dissolved in 20.0 ml of sterile water for injections.
- The prepared solution contains approximately 21 mg/ml of trastuzumab.
- Other ingredients are L‑histidine hydrochloride monohydrate, L‑histidine, α,α‑trehalose dihydrate, and polysorbate 20.
Appearance and package sizes of the medicine
Zercepac is a powder for concentrate for intravenous infusion, a solution supplied in a glass vial with a rubber stopper and containing 60 mg, 150 mg, or 420 mg of trastuzumab. The powder is freeze-dried and white to slightly yellow. Each carton contains 1 vial of powder.
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