Direct healthcare professional communication on the importance of adhering to cardiac monitoring guidance during trastuzumab (Herceptin) therapy to reduce the frequency and severity of left ventricular dysfunction and congestive heart failure
24.03.2017
Roche d.o.o., as a representative of Roche Registration Ltd, the marketing authorisation holder for Herceptin in the Republic of Croatia, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the importance of adhering to cardiac monitoring in line with the information contained in the Herceptin (trastuzumab) SmPC.
Summary
The adherence to trastuzumab cardiac monitoring information and treatment algorithm, as stated in the Herceptin (trastuzumab) SmPC, is important in order to ensure appropriate management of left ventricular dysfunction and congestive heart failure (CHF).
Physicians prescribing this medicine as well as physicians performing cardiac monitoring are reminded of the following:
- Cardiac assessments, as performed at baseline, should be repeated every 3 months during trastuzumab treatment.
- The stopping rules for trastuzumab should be adhered to, including cases when LVEF percentage drops ≥ 10 percent points from baseline and to below 50 %. Trastuzumab treatment should then be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
- Trastuzumab and anthracyclines should not be given concurrently in combination in the metastatic breast cancer (MBC) setting and in the adjuvant breast cancer treatment setting.
- Monitoring should be continued every 6 months following discontinuation of trastuzumab treatment until 24 months from the last administration of trastuzumab. In patients who receive anthracycline-containing chemotherapy, further monitoring is recommended, and should occur yearly up to 5 years from the last administration of trastuzumab, or longer if a continuous decrease of LVEF is observed.
- If symptomatic cardiac failure develops during trastuzumab therapy, it should be treated with standard medicinal products for CHF. Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment.
- LVEF measurement continues to be the required method to monitor cardiac function. Biomarkers may be a supportive tool for patients specifically at risk to experience CHF but cannot replace LVEF assessment by echocardiogram or radionuclide ventriculography (MUGA).
- Prescribing physicians should highlight to other physicians responsible for the follow-up of a trastuzumab treatment patient that it is important to continue regular cardiac monitoring as per the Herceptin SmPC.
Further information
Although there are no new cardiac safety risk signals with trastuzumab therapy, results from surveys have shown that adherence to cardiac monitoring could be improved to reduce the frequency and severity of left ventricular dysfunction and CHF in patients treated with trastuzumab therapy.
The direct healthcare professional communication is accompanied by an excerpt from relevant sections of the Herceptin SmPC.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
