سعر هيرسبتين 600مجم/5مل فيال محلول للحقن تحت الجلد 2024

Herceptin (trastuzumab, F. Hoffmann-La Roche) 600 mg/5 ml ready-to-use solution for subcutaneous injection (fixed dose): a HER2-targeted humanised monoclonal antibody used for HER2-positive breast cancer.

• HER2-positive metastatic breast cancer: monotherapy after at least two chemotherapy regimens; with paclitaxel or docetaxel; or with an aromatase inhibitor in postmenopausal hormone-receptor-positive disease.Population: AdultsEuropean Medicines Agency (EMA) - EPAR product information
• HER2-positive early breast cancer: after surgery, chemotherapy and radiotherapy; with paclitaxel or docetaxel after doxorubicin/cyclophosphamide; with docetaxel and carboplatin; or with neoadjuvant chemotherapy followed by adjuvant Herceptin.Population: AdultsEuropean Medicines Agency (EMA) - EPAR product information

• Most serious and/or common adverse reactions: cardiac dysfunction, administration-related reactions, haematotoxicity (particularly neutropenia), infections and pulmonary adverse reactions.International label, same product · European Medicines Agency (EMA) - EPAR product information

• Hypersensitivity to trastuzumab, murine proteins, hyaluronidase or any of the excipients.International label, same product · European Medicines Agency (EMA) - EPAR product information
• Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.International label, same product · European Medicines Agency (EMA) - EPAR product information
• None (US HERCEPTIN HYLECTA Prescribing Information lists no contraindications).International label, equivalent formulation · DailyMed (US National Library of Medicine)

• Cardiac dysfunction: increased risk of congestive heart failure (NYHA II-IV) or asymptomatic cardiac dysfunction, especially after anthracycline-containing chemotherapy; do not give concurrently with anthracyclines in the metastatic or adjuvant setting, and avoid anthracyclines for up to 7 months after stopping trastuzumab if possible.International label, same product · European Medicines Agency (EMA) - EPAR product information
• Administration-related reactions and hypersensitivity, including anaphylaxis, bronchospasm and angioedema, have been reported, rarely fatal; delayed onset is possible.International label, same product · European Medicines Agency (EMA) - EPAR product information
• Severe pulmonary events (interstitial lung disease, pneumonitis, ARDS, pulmonary oedema) have been reported, occasionally fatal; caution especially with concomitant taxanes.International label, same product · European Medicines Agency (EMA) - EPAR product information

• Anthracyclines (doxorubicin, epirubicin)Increased risk of cardiac dysfunction; trastuzumab may persist in the circulation for up to 7 months, so anthracycline-based therapy should be avoided for up to 7 months after stopping trastuzumab if possible, with careful cardiac monitoring if used.European Medicines Agency (EMA) - EPAR product information

• Avoid during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus. Post-marketing cases of foetal renal growth/function impairment with oligohydramnios, some with fatal pulmonary hypoplasia, have been reported. Women of childbearing potential should use effective contraception during treatment and for 7 months afterwards.International label, same product · European Medicines Agency (EMA) - EPAR product information
• Women should not breast-feed during treatment and for 7 months after the last dose (human IgG is secreted in milk; potential harm to the infant unknown).International label, same product · European Medicines Agency (EMA) - EPAR product information

• Trastuzumab: Binds the extracellular domain of the HER2 receptor, inhibiting proliferation of HER2-overexpressing tumour cells and mediating antibody-dependent cellular cytotoxicity.