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Herceptin (trastuzumab) - patient safety update

Herceptin, for Breast cancer (female), Stomach cancer and Gastric cancer from Roche Products Limited

Roche, the manufacturers of cancer treatment trastuzumab, brand name Herceptin, have added a new side effect for the medicine.

Tumour lysis syndrome (TLS) has been added as an adverse event of unknown frequency.

TLS is a condition that occurs when a large number of cancer cells die within a short period, releasing their contents in to the blood.

Diagnosis of TLS is achieved with blood tests and, possibly, and ECG.

Symptoms of TLS include:
  • abdominal pain and distension
  • urinary symptoms
    - dysuria (painful or difficult urination)
    - oliguria (small urine output)
    - haematuria (blood in the urine)
  • pain in the upper back, abdomen or side of the body
  • hypocalcaemia - symptoms of anorexia, vomiting, cramps, seizures, spasms, altered mental status, and tetany
  • hyperkalaemia -symptoms of weakness and paralysis
Patients taking Herceptin who experience any of these symptoms should consult their doctor.

You can follow developments with Herceptin by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About Herceptin (source EMA)
Herceptin is used to treat the following types of cancer:
  • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. It can also be used earlier in treatment, in combination with chemotherapy. For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herceptin is used before surgery in combination with chemotherapy and then again after surgery on its own;
  • metastatic breast cancer (cancer that has spread to other parts of the body). It is used on its own in patients in whom previous treatments have failed. It is also used in combination with other anticancer medicines: with paclitaxel or docetaxel, or with an aromatase inhibitor;
When used as an infusion into a vein, Herceptin can also be used for:
  • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or 5‑fluorouracil (other anticancer medicines).
Herceptin can only be used when the cancer has been shown to ‘overexpress HER2’: this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.

The active substance in Herceptin, trastuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found on certain cells in the body. Trastuzumab has been designed to attach to HER2, which is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow.

Herceptin was first made available in the EU in 2000. It is manufactured by Roche.

European Medicines Agency website page for Herceptin
Merck Manual
Accessed 09/08/19
Links available in External Resources

EMA information on Herceptin

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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