HERZUMA

What it is

HERZUMA is a trastuzumab (recombinant) powder for injection available in 150 mg and 440 mg vials for intravenous infusion.

Approved indications

— Metastatic (Stage IV) HER2 positive breast cancer. — Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastroesophageal junction. — Early HER2 positive breast cancer.

Key safety warnings

Cases of interstitial lung disease and pneumonitis have been reported with anti-HER2 therapies including trastuzumab derivatives. Patients should be advised to immediately report cough, dyspnoea, fever, and any new or worsening respiratory symptoms. Patients should be monitored for signs and symptoms of interstitial lung disease or pneumonitis, and evidence of these conditions should be promptly investigated. Patients with suspected interstitial lung disease or pneumonitis should be evaluated by radiographic imaging and consultation with a pulmonologist should be considered. Patients with a history of interstitial lung disease or pneumonitis may be at increased risk and should be monitored carefully. Cases of neutropenia, including febrile neutropenia, have been reported with anti-HER2 therapies. Complete blood counts should be monitored prior to initiation of treatment and prior to each dose, and as clinically indicated. Based on the severity of neutropenia, treatment may require dose interruption or reduction. Left ventricular ejection fraction decrease has been observed with anti-HER2 therapies. Left ventricular ejection fraction should be assessed prior to initiation of treatment and at regular intervals during treatment as clinically indicated. Treatment should be permanently discontinued if left ventricular ejection fraction falls below 40% or if there is an absolute decrease from baseline of greater than 20%. Treatment should be permanently discontinued in patients with symptomatic congestive heart failure. Trastuzumab can cause fetal harm when administered to a pregnant patient. In post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Patient pregnancy status should be verified prior to initiation of treatment. Patients should be informed of the potential risk to a fetus. Patients who could become pregnant should use effective contraception during treatment and for at least 7 months following the last dose.

Contraindications

No contraindications are listed.

PBS listing

HERZUMA is listed on the PBS for breast cancer and gastric cancer indications under Section 100 (Efficient Funding Chemotherapy Program) with Authority Required streamlined restriction as a biosimilar brand.

Regulatory history

HERZUMA trastuzumab 150 mg powder for injection was first registered on the ARTG on 17 July 2018. HERZUMA trastuzumab 440 mg powder for injection with diluent was first registered on the ARTG on 20 April 2020. The PBAC recommended PBS listing in July 2019 for breast cancer and gastric cancer indications under streamlined Authority Required classification as a biosimilar brand. The PBAC made a further recommendation in November 2021 to include early HER2 positive breast cancer as an approved indication.