Zuhera Dosage/Direction for Use

Before starting Zuhera treatment, HER2 testing is mandatory.
Administer Zuhera as intravenous infusion.
Zuhera is not to be administered as an intravenous push or bolus.
Do not mix with other drugs.
Patients with MBC and MGC should be treated until disease progression.
Only a physician experienced in the administration of cytotoxic chemotherapy treatment should initiate treatment. Only a healthcare professional should administer Zuhera and it should be administered by a healthcare professional prepared to manage anaphylaxis and an emergency kit should be available to manage any unexpected complications.
Loading dose should be administered as a 90-minute intravenous infusion. If the initial loading dose is well tolerated, subsequent doses can be administered as a 30-minute infusion. Observe patients for at least six hours after the start of the first infusion and for two hours after the start of subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see Adverse Reactions). If a patient displays infusion-associated symptoms, the infusion may be interrupted to help control the symptoms; and may be resumed once the symptoms have abated.
Metastatic Breast Cancer (MBC): 3-weekly dosing: An initial loading dose of 8 mg/kg is recommended; a maintenance dose of 6 mg/kg at 3-weekly intervals is recommended, beginning 3 weeks after the loading dose.
The loading dose should be administered as an intravenous infusion over approximately 90 minutes. The subsequent doses can be administered as a 30-minute infusion, if the initial loading dose was well tolerated.
Weekly dosing: An initial loading dose of 4 mg/kg is recommended; a maintenance dose of 2 mg/kg at weekly intervals is recommended, beginning one week after the loading dose.
The loading dose should be administered as an intravenous infusion over approximately 90 minutes. The subsequent doses can be administered as a 30-minute infusion, if the initial loading dose was well tolerated.
Trastuzumab is indicated as monotherapy in patients who have already had two or more chemotherapy regimens for metastatic disease. Prior chemotherapy must have been an anthracycline and a taxane (at least), unless patients are unsuitable for these treatments. Hormonal therapy must also have been tried, and have failed, in hormone receptor-positive patients (unless patients are unsuitable for hormonal therapy).
Trastuzumab is indicated in combination with paclitaxel in patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; in combination with docetaxel in patients who have not received chemotherapy for their metastatic disease; and in combination with an aromatase inhibitor in postmenopausal patients with hormone-receptor positive MBC, who have not previously been treated with Trastuzumab.
Administration in combination with paclitaxel or docetaxel: In clinical trials, paclitaxel or docetaxel was administered the day following the first dose of Trastuzumab. If the dose was well tolerated, paclitaxel/docetaxel was administered immediately after the subsequent doses of Trastuzumab.
Administration in combination with an aromatase inhibitor: In a clinical trial, Trastuzumab and anastrozole were administered from day 1; without restrictions on the relative timing of administration of Trastuzumab and anastrozole.
Early Breast Cancer (EBC): Weekly dosing: Initial loading dose of 4 mg/kg followed by 2 mg/kg every week concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.
Three-weekly dosing: An initial loading dose of 8 mg/kg is recommended; a maintenance dose of 6 mg/kg at 3-weekly intervals is recommended, beginning 3 weeks after the loading dose.
Trastuzumab is indicated after surgery, neoadjuvant or adjuvant chemotherapy, and (if applicable) radiotherapy. Trastuzumab should be used after adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
Trastuzumab should be used in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
Trastuzumab should be used in combination with neoadjuvant chemotherapy followed by adjuvant Trastuzumab therapy, for locally advanced disease (including inflammatory disease) or tumours of diameter >2 cm.
Metastatic Gastric Cancer (MGC): Three-weekly dosing: An initial loading dose of 8 mg/kg is recommended; a maintenance dose of 6 mg/kg at 3-weekly intervals is recommended, beginning 3 weeks after the loading dose.
Duration of Treatment: Patients with metastatic breast cancer or metastatic gastric cancer should be treated with Trastuzumab until disease progression. Patients with early breast cancer should be treated with Trastuzumab for 1 year or until disease recurrence, whichever occurs first; it is not recommended to extend treatment in early breast cancer beyond one year.
Dose Reduction: During periods of reversible chemotherapy-induced myelosuppression, Trastuzumab may be continued; but observe the patient carefully for complications of neutropenia. Chemotherapy doses should be reduced or maintained as per the instructions for the specific regimen.
If LVEF drops 10 ejection fraction (EF) points from baseline and to below 50%, treatment should be stopped and a repeat LVEF assessment should be performed within approximately 3 weeks. Discontinuation of Trastuzumab should be strongly considered if LVEF does not improve, or declines further, or symptomatic cardiac heart failure (CHF) develops; unless the benefits outweigh the risks for the individual patient. All such patients should be referred for assessment by a cardiologist and followed up.
Missed Doses: For a dose missed by 1 week, administer the usual maintenance dose of Trastuzumab (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg), as soon as possible, without waiting till the next planned cycle. Subsequent maintenance doses should then be given according to the previous schedule.
For a dose missed by >1 week, administer a re-loading dose of Trastuzumab (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) over approximately 90 minutes; subsequent maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should then be given (weekly regimen: every week; three-weekly regimen: every 3 weeks) from that point.
Interchangeability and Automatic Substitution: Zuhera has been developed as a Biosimilar Product to Herceptin and is similar in quality, safety and efficacy to Herceptin. Zuhera is approved for all indications of Herceptin. Zuhera is not automatically substitutable or interchangeable with the reference product.