OGIVRI

What it is

OGIVRI is trastuzumab (rch) powder for injection. OGIVRI is a biosimilar medicine to Herceptin. OGIVRI is available in 150 mg single-dose vials and 440 mg Pharmacy Bulk Pack vials.

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 OGIVRI. — Metastatic breast cancer with HER2-overexpressing tumours as monotherapy for those who have received one or more chemotherapy regimens, in combination with taxanes for those who have not received prior chemotherapy, or in combination with an aromatase inhibitor for post-menopausal patients with hormone-receptor positive metastatic breast cancer. — HER2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction in combination with cisplatin and either capecitabine or 5-FU for those who have not received prior anti-cancer treatment for their metastatic disease.

Dosing overview

For early breast cancer, the recommended initial loading dose is 8 mg/kg body weight (three-weekly schedule) or 4 mg/kg body weight (weekly schedule), followed by maintenance doses of 6 mg/kg (three-weekly) or 2 mg/kg (weekly) at the respective intervals. For locally advanced breast cancer, the three-weekly schedule uses an initial loading dose of 8 mg/kg body weight followed by a maintenance dose of 6 mg/kg body weight at three-weekly intervals. For metastatic breast cancer, the three-weekly schedule uses 8 mg/kg loading dose and 6 mg/kg maintenance, whilst the weekly schedule uses 4 mg/kg loading and 2 mg/kg maintenance. For advanced gastric cancer, the three-weekly schedule uses an initial loading dose of 8 mg/kg body weight followed by a maintenance dose of 6 mg/kg body weight at three-weekly intervals.

Key safety warnings

Patients treated with OGIVRI are at increased risk of developing congestive heart failure (NYHA class II–IV) or asymptomatic cardiac dysfunction, which has been observed in patients receiving OGIVRI therapy alone or in combination with a taxane following anthracycline-containing chemotherapy. This may be moderate to severe and has been associated with death. All candidates for treatment with OGIVRI, especially those with prior anthracycline and cyclophosphamide monohydrate exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram, echocardiogram, and/or multigated acquisition scan or magnetic resonance imaging. Severe hypersensitivity reactions have been infrequently reported in patients treated with OGIVRI. Signs and symptoms include anaphylaxis, urticaria, bronchospasm, angioedema, and/or hypotension. In some cases, the reactions have been fatal. Infusion-related reactions are known to occur with the administration of OGIVRI, including dyspnoea, hypotension, wheezing, hypertension, bronchospasm, tachycardia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria, angioedema and supraventricular tachyarrhythmia. Severe pulmonary events have been reported with the use of OGIVRI in the post-marketing setting. These events have occasionally been fatal. Cases of interstitial lung disease including pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary oedema, pulmonary hypertension, pulmonary fibrosis and respiratory insufficiency have been reported. Patients with hereditary fructose intolerance must not be given OGIVRI.

Contraindications

OGIVRI is contraindicated in patients with known hypersensitivity to the active substance (trastuzumab), murine proteins or to any of its excipients. In the treatment of early or locally advanced breast cancer, OGIVRI is contraindicated in patients with a left ventricular ejection fraction of less than 45% and those with symptomatic heart failure.

PBS listing

OGIVRI 150 mg powder for intravenous infusion is listed on the PBS as 16 items with streamlined authority required restriction at an ex-manufacturer price of A$105.18.

Regulatory history

OGIVRI trastuzumab (rch) was registered on the ARTG on 11 December 2018, with two strength variants: 150 mg powder for injection vial and 440 mg powder for injection vial with bacteriostatic water for injection.