HERCEPTIN

What it is

Herceptin SC is a solution for injection containing trastuzumab . Each vial contains 600 mg of trastuzumab in 5 mL . Herceptin SC solution is administered via subcutaneous injection only .

Approved indications

— HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy . — HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin . — Metastatic breast cancer with tumours that overexpress HER2 as monotherapy for patients who have received one or more chemotherapy regimens for their metastatic disease . — Metastatic breast cancer with tumours that overexpress HER2 in combination with taxanes for patients who have not received chemotherapy for their metastatic disease . — Metastatic breast cancer in combination with an aromatase inhibitor for post-menopausal patients with hormone-receptor positive disease .

Dosing overview

The recommended fixed dose of Herceptin SC is 600 mg, administered every three weeks, irrespective of patient body weight . Patients with early or locally advanced breast cancer should be treated for 1 year or until disease recurrence or unmanageable toxicity, whichever occurs first . Patients with metastatic breast cancer should be treated until progression of disease or unmanageable toxicity . The dose should be administered over 2–5 minutes .

Key safety warnings

Patients treated with Herceptin are at increased risk of developing congestive heart failure (NYHA Class II–IV) or asymptomatic cardiac dysfunction. These events have been observed in patients receiving Herceptin therapy alone or in combination with a taxane following anthracycline-containing chemotherapy. This may be moderate to severe and has been associated with death . Candidates for treatment with Herceptin, especially those with prior anthracycline and cyclophosphamide exposure, should undergo baseline cardiac assessment including history and physical examination, ECG and echocardiogram or MUGA scan . Severe hypersensitivity reactions have been infrequently reported in patients treated with Herceptin IV formulation. Signs and symptoms included anaphylaxis, urticaria, bronchospasm, angioedema, and/or hypotension. In some cases, the reactions have been fatal . Patients should be observed closely for hypersensitivity reactions. In the event of a hypersensitivity reaction, appropriate medical therapy should be administered, which may include adrenaline, corticosteroids, antihistamines, bronchodilators and oxygen . Severe pulmonary events leading to death have been reported with the use of Herceptin in the post-marketing setting. These events may occur as part of an administration-related reaction or with a delayed onset. In addition, cases of interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema, pulmonary hypertension, pulmonary fibrosis and respiratory insufficiency have been reported .

Contraindications

Herceptin is contraindicated in patients with known hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins or to any of its excipients . In the treatment of early or locally advanced breast cancer, Herceptin is contraindicated in patients with a left ventricular ejection fraction of less than 45% and those with symptomatic heart failure .

PBS listing

Herceptin SC (solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL) is listed on the PBS with streamlined restriction. There are 6 PBS items listed, with an ex-manufacturer price of A$1470.22 .

Regulatory history

Herceptin SC (trastuzumab 600 mg/5 mL solution for injection) was first registered on the ARTG on 19 March 2015 . The TGA approved the registration of Herceptin SC on 13 March 2015 for the treatment of HER2-positive early, locally advanced, and metastatic breast cancer, based on a review of its quality, safety, and efficacy . The TGA's evaluation found that the quality, nonclinical, and clinical data supported the new subcutaneous formulation of Herceptin, with efficacy and safety comparable to the intravenous formulation and an overall favourable benefit-risk balance .