Herceptin contraindications and warnings


Following is information on contraindications to the use of trastuzumab in general, pregnancy & amp; Breastfeeding and children. Please note that the contraindications may vary depending on the dosage form of a drug (eg tablet, syringe, ointment).

When should trastuzumab not be used?

Trastuzumab must not be used if there is a hypersensitivity to the active substance or protein of the mouse, since trastuzumab is obtained by genetic engineering with the aid of mouse cells.

There is an increased risk of a fatal reaction to the infusion of patients with respiratory distress syndrome (Ruhedyspnoe) due to complications of advanced cancer and comorbidities. Therefore, these patients should not be treated with trastuzumab.

Only under special medical supervision and with caution may trastuzumab be given to

  • Pneumonia, especially in patients who are being treated concomitantly with cancer drugs such as paclitaxel or docetaxel.
  • previous treatment with the cytostatics anthracycline and cyclophosphamide because of the risk of heart damage. Here, the physician must carefully weigh the benefits and risks of trastuzumab use. If possible, anthracycline therapy should be avoided for up to 24 weeks after discontinuation of trastuzumab. If anthracycline or chemically related drugs are used, the physician must carefully monitor the heart function of the patient.
  • History of cardiac muscle weakness, cardiac arrhythmia, angina pectoris in need of treatment, valvular heart disease, myocardial infarction in the heart, and poor hypertension due to the lack of meaningful studies with such patients.

What should you watch out for during pregnancy and lactation?

In animal studies, the drug was found not to be harmful to the mother and offspring. However, it is not known if trastuzumab causes fetal harm when administered to pregnant women or if it may affect fertility. Therefore, the administration of trastuzumab should be avoided during pregnancy, unless the doctor considers the benefit to the mother greater the potential risk to the unborn child. After the market introduction of the drug, cases of amniotic fluid deficiency due to trastuzumab have been observed in pregnant women.

It is not known if trastuzumab in humans crosses into the milk. However, natural human immunoglobulin is released into the milk. Since the potential risk to the baby is unknown, women should not breastfeed during therapy with trastuzumab and for six months after the last dose.

What should be considered in children?

Trastuzumab efficacy and tolerability studies have not been undertaken with children under the age of 18 years. The use of the active ingredient in this age group is therefore prohibited.

Warnings and Precautions

  • Use of the drug is only permitted if breast cancer has been shown to be HER2.
  • Therapy with the drug should only be started by a doctor who has experience in the use of anticancer poisons.
  • The drug should only be given as an infusion into the vein. Use as injection or high-dose single bolus in the vein is prohibited.
  • If respiratory or cardiac symptoms occur after infusion, seek medical advice immediately.
  • If cardiac risk factors have emerged during the initial examination, cardiac function should be monitored regularly during treatment.
  • If cardiac output drops significantly during drug therapy, treatment should be stopped.
  • Infusion of the drug may cause respiratory distress or heart problems that make driving a car and operating machinery dangerous.

Sometimes medications release allergic reactions.
If you notice signs of allergic reaction, tell your doctor or pharmacist immediately.