PHESGO SC pertuzumab (rch) 600 mg and trastuzumab (rch) 600mg in 10mL solution for injection, vials

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Pertuzumab, Quantity: 600 mg; Trastuzumab, Quantity: 600 mg; water for injections, Quantity: 10 mL

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: polysorbate 20; sucrose; histidine; trehalose dihydrate; vorhyaluronidase alfa; histidine hydrochloride monohydrate; methionine

Administration route:

Subcutaneous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Early Breast Cancer (EBC),Phesgo is indicated in combination with chemotherapy for the:,? neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer,? adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence,Select patients for therapy based on a validated test.,Metastatic Breast Cancer (MBC),Phesgo is indicated in combination with docetaxel for patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Select patients for therapy based on a validated test.

Product summary:

Visual Identification: colourless to slightly brownish solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-07-06