Zercepac

Do not take it if

From the package leaflet in EMA’s product information, p. 50.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 Zercepac. Zercepac 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 Zercepac depends on your body weight.
• Zercepac intravenous formulation 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 “Warnings and precautions”). 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 Zercepac (trastuzumab) and not another trastuzumab-containing product (e.g. trastuzumab emtansine or trastuzumab deruxtecan).
• For early breast cancer, metastatic breast cancer and metastatic gastric cancer, Zercepac is given every 3 weeks. Zercepac may 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 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 Zercepac 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.

From the package leaflet in EMA’s product information, p. 52–53.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 51.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 51–52.

Other medicines

From the package leaflet in EMA’s product information, p. 51.

Driving and using machines

• Zercepac 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.
• Sodium Zercepac contains less than 1 mmol of sodium per dose, i.e. it is essentially sodium-free.
• Polysorbate 20 Zercepac contains 0.24 mg of polysorbate 20 in each 60 mg vial, which is equivalent to 0.08 mg/mL (after reconstitution with 3.0 mL sterile water for injection).
• Zercepac contains 0.6 mg of polysorbate 20 in each 150 mg vial, which is equivalent to 0.083 mg/mL (after reconstitution with 7.2 mL sterile water for injection).
• Zercepac contains 1.7 mg of polysorbate 20 in each 420 mg vial, which is equivalent to 0.085 mg/mL (after reconstitution with 20.0 mL sterile water for injection).
• Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

From the package leaflet in EMA’s product information, p. 52.

Side effects

• Like all medicines, Zercepac can cause side effects, although not everybody gets them. Some of these side effects may be serious and may lead to hospitalisation.
• Serious side effects During a Zercepac 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 serious side effects can occur at any time during treatment with Zercepac, not just related to an infusion. Tell a doctor or nurse straight away, if you notice any of the following side effects:
• 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 (swollen, red, hot, and in pain) of the lining around the heart and heart rhythm disturbances. This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart fluttering or irregular heart beat) (see section 2. Heart checks).
• 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.
• Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterized by high blood levels of potassium and phosphate, and low blood levels of calcium). Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart or a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet.
• If you experience any of the above symptoms when your treatment with Zercepac has finished, you should see your doctor and tell them that you have previously been treated with Zercepac.
• Other side effects Very common side effects: may affect more than 1 in 10 people
• infections
• diarrhoea
• constipation
• heartburn (dyspepsia)
• fatigue
• skin rashes
• chest pain
• abdominal pain
• joint pain
• low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
• muscle pain
• conjunctivitis
• watery eyes
• nose bleeds
• runny nose
• hair loss
• tremor
• hot flush
• dizziness
• nail disorders
• weight loss
• loss of appetite
• inability to sleep (insomnia)
• altered taste
• low platelet count
• bruising
• numbness or tingling of the fingers and toes, which occasionally may extend to the rest of the limb
• redness, swelling or sores in your mouth and/or throat
• pain, swelling, redness or tingling of hands and/or feet
• breathlessness
• headache
• cough
• vomiting
• nausea Common side effects: may affect up to 1 in 10 people
• allergic reactions
• throat infections
• bladder and skin infections
• inflammation of the breast
• inflammation of the liver
• kidney disorders
• increased muscle tone or tension (hypertonia)
• pain in the arms and/or legs
• itchy rash
• sleepiness (somnolence)
• haemorrhoids
• itchiness
• dry mouth and skin
• dry eyes
• sweating
• feeling weak and unwell
• anxiety
• depression
• asthma
• infection of lungs
• lung disorders
• back pain
• neck pain
• bone pain
• acne
• leg cramps Uncommon side effects: may affect up to 1 in 100 people:
• deafness
• bumpy rash
• wheezing
• inflammation or scarring of the lungs Rare side effects: may affect up to 1 in 1000 people
• jaundice
• anaphylactic reactions Side effects of unknown frequency: frequency cannot be estimated from the available data
• abnormal or impaired blood clotting
• high potassium levels
• swelling or bleeding at the back of the eyes
• shock
• abnormal heart rhythm
• respiratory distress
• respiratory failure
• acute accumulation of fluid in the lungs
• acute narrowing of the airways
• abnormally low oxygen levels in the blood
• difficulty in breathing when lying flat
• liver damage
• swelling of the face, lips and throat
• kidney failure
• abnormally low levels of fluid around baby in womb
• failure of the lungs of the baby to develop in the womb
• abnormal development of the kidneys of the baby in the womb Some of the side-effects you experience may be due to your underlying cancer. If you receive Zercepac 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.
• Reporting of side effects 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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 53–56.

How to store it

• Zercepac will be stored by the health 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 expiry date refers to the last day of that month.
• The unopened vial should be stored in a refrigerator (2°C-8°C).
• Do not freeze the reconstituted solution.
• Infusion solutions should be used immediately after dilution. If not used immediately, in- use storage times and conditions prior to use are the responsibility of the user.
• Do not use Zercepac 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.

From the package leaflet in EMA’s product information, p. 56.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

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