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HERCEPTIN
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 Herceptin
 Package:
VIALS (+20 ml. solvent): 1 x 440 mg.

Dosage:
MBC weekly schedule: The following loading and subsequent doses are recommended for monotherapy use and in combination with paclitaxel, docetaxel or an aromatase inhibitor.
Loading dose: The recommended initial loading dose is 4 mg/kg body weight administered as a 90-minute I.V. infusion.
Subsequent doses: The recommended weekly dose is 2 mg/kg body weight, beginning one week after the loading dose. If the initial loading dose was well tolerated, the dose can be administered as a 30-minute infusion. Emergency equipment must be available.
Administration in combination with an aromatase inhibitor: In the pivotal trial Herceptin and anastrozole were administered from day 1. There were no restrictions on the relative timing of Herceptin and anastrozole at administration. See prescribing information for full details.
Do not administer as an I.V. push or bolus. Should be administered until progression of disease. Patients with early breast cancer should be treated for 1 year or until disease or until disease recurrence. See prescribing information for full details.
EBC 3-weekly schedule: Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the initial dose was well tolerated, the subsequent doses can be administered as 30 minute infusions.
EBC weekly schedule: Initial loading dose of 4 mg/kg followed by 2 mg/kg every week for one year.
MGC 3 weekly schedule: Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the initial loading dose is well tolerated, the subsequent doses can be administered as a 30-minute infusion.

Prescribing Restrictions:    

Indications:
Metastatic Breast Cancer (MBC) For the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2; As a single agent, for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease. In combination with paclitaxel or 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 metastatic breast cancer.
Early Breast Cancer (EBC) Herceptin is indicated to treat patients with HER2 positive early breast cancer following surgery and chemotherapy neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. Should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Metastatic Gastric Cancer (MGC) In combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of 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. Should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.


Contra-Indications:
Patients with known hypersensitivity to trastuzumab, murine proteins, or to any other component of the product. Patients with severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.

Special Precautions:
See prescribing information for full details.

Side Effects:
The most common adverse reactions are infusion-related symptoms, such as fever and chills, usually following the first infusion. See prescribing information for full details.

Drug Interactions:
No interaction studies have been performed. A risk for interactions with concomitant medication cannot be excluded.