NANOGEN | Lyophilized Powder For Intravenous Infusion FACEPTOR (Trastuzumab)

Faceptor 150 mg: Each single-dose vial of lyophilized powder for intravenous infusion contains:

Active ingredients: Trastuzumab………150mg

Excipients: Histidine hydrochloride monohydrate, Histidine, Trehalose dihydrate, Polysorbate 20

Faceptor 440 mg: Each multiple-dose vial of lyophilized powder for intravenous infusion contains:

Active ingredients:  Trastuzumab………440mg

Excipients: Histidine hydrochloride monohydrate, Histidine, Trehalose dihydrate, Polysorbate 20

Each vial of bacteriostatic water for injection contains:

Excipients: 1.1% benzyl alcohol as a preservative, Water for Injection

Vial of lyophilized powder for intravenous infusion: white to pale yellow lyophilized powder in colorless glass vial, capped with rubber stopper, seal with aluminum flip-off seal, plastic cap. After reconstitution, the solution is clear, colorless to pale yellow, free of visible particulates. The reconstituted Faceptor solution contains 21 mg/mL of trastuzumab.

pH: 5.4 – 6.6

Osmolality: 45 – 75 mOsm/kg

Vial of bacteriostatic water for injection: clear, colorless solution in colorless vial, capped with rubber stopper, seal with aluminum flip-off seal, plastic cap, free of visible particulates.

pH: 4.5 – 7.0

Breast cancer

Metastatic breast cancer

Faceptor is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):

• As monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
• In combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
• In combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
• In combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.

Early breast cancer

Faceptor is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC):

• Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
• Following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
• In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
• In combination with neoadjuvant chemotherapy followed by adjuvant Faceptor therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.

Faceptor should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic gastric cancer

Faceptor in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Faceptor should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

HER2 testing is mandatory prior to initiation of therapy.

Faceptor treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy and should be administered by a healthcare professional only.

Administration route: intravenous infusion.

DO NOT ADMINISTER AS AN IV PUSH OR BOLUS.

Metastatic breast cancer

Three-weekly schedule

The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.

Weekly schedule

The recommended initial loading dose of Faceptor is 4 mg/kg body weight. The recommended weekly maintenance dose of Faceptor is 2 mg/kg body weight, beginning one week after the loading dose.

Administration in combination with paclitaxel or docetaxel

In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the Summary of Product Characteristics (SmPC) for paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.

Administration in combination with an aromatase inhibitor

In the pivotal trial (BO16216), trastuzumab and anastrozole were administered from day 1. There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the SmPC for anastrozole or other aromatase inhibitors).

Early breast cancer

Three-weekly and weekly schedule

As a three-weekly regimen the recommended initial loading dose of Faceptor is 8 mg/kg body weight. The recommended maintenance dose of Faceptor at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.

As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.

Metastatic gastric cancer

Three-weekly schedule

The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.

Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients.

Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.

FACEPTOR 150 mg: Box of 1 vial of lyophilized powder for concentrate for solution for infusion.

FACEPTOR 440 mg: Box of 1 vial of lyophilized powder for concentrate for solution for infusion and 1 vial of Bacteriostatic Water for Injection 20mL.

Store in the refrigerator at 2^oC - 8^oC. Do not freeze. Protect from light.

For storage conditions after reconstitution of the medicinal product, see section shelf life.

Unopened vial of lyophilized powder : 48 months from manufacturing date.

Unopened vial of bacteriostatic water for injection : 48 months from manufacturing date.

Aseptic reconstitution and dilution should not be frozen.