Product Introduction:
Eleftha contains Trastuzumab, a recombinant humanized monoclonal antibody that selectively binds to the extracellular domain of the human epidermal growth factor receptor 2 (HER2). It is used in targeted cancer therapies, especially where HER2 overexpression is confirmed.
Uses:
Eleftha is used in the treatment of:
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HER2-positive metastatic breast cancer
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Early-stage HER2-positive breast cancer (as adjuvant therapy)
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HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma
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In combination with paclitaxel or other chemotherapies
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Maintenance therapy in HER2-positive cancers
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Neoadjuvant therapy (before surgery) for HER2-positive breast cancer
Storage Instructions:
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Store vials at 2°C to 8°C (refrigerated conditions)
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Do not freeze
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Reconstituted solution should be used immediately or stored as per guidelines
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Protect from light and keep in original carton until use
How It Works (Mechanism of Action):
Trastuzumab binds to the HER2 receptor, a transmembrane tyrosine kinase receptor overexpressed in certain tumors. This binding:
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Inhibits downstream cell signaling pathways that lead to proliferation
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Promotes antibody-dependent cellular cytotoxicity (ADCC)
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Induces cell cycle arrest and apoptosis
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Enhances immune response against tumor cells
Side Effects:
Common side effects:
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Fever, chills
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Nausea, vomiting
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Diarrhea
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Fatigue
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Rash
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Headache
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Low white blood cell count (neutropenia)
Severe side effects:
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Cardiotoxicity (e.g., heart failure, decreased LVEF)
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Infusion-related reactions (dyspnea, hypotension, anaphylaxis)
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Pulmonary toxicity (interstitial pneumonitis)
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Hepatotoxicity
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Severe allergic or hypersensitivity reactions
Dosage (Typical Recommended Dose):
For breast cancer (standard dosing):
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Loading dose: 4 mg/kg IV over 90 minutes
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Maintenance dose: 2 mg/kg IV weekly or 6 mg/kg IV every 3 weeks
For gastric cancer:
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Loading dose: 8 mg/kg IV
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Maintenance dose: 6 mg/kg IV every 3 weeks
Dosing must be individualized based on body weight and patient response.
Method of Administration:
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Administered as intravenous infusion after proper reconstitution and dilution
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First infusion: over 90 minutes under close monitoring
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Subsequent doses: over 30 minutes if well tolerated
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Should not be administered as IV push or bolus
Precautions:
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Cardiac monitoring (LVEF) before and during treatment
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Avoid in patients with severe heart disease or active infections
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Use effective contraception during and for 7 months after treatment
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Not recommended during pregnancy or breastfeeding
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Discontinue permanently if severe cardiotoxicity or hypersensitivity occurs
Drug Interactions:
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Increased cardiotoxicity risk with anthracyclines (e.g., doxorubicin)
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Caution with cyclophosphamide and other cytotoxic agents
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Limited formal drug interaction studies; monitor when used with other chemo agents
Allergies:
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Contraindicated in patients with known hypersensitivity to trastuzumab or other murine proteins
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Signs of allergy: rash, shortness of breath, facial swelling, hypotension
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Pre-medication may be considered to reduce infusion-related reactions
Overdose Information:
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Limited information on overdose; possible severe cardiac and respiratory complications
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Management is supportive, including hospitalization and cardiac monitoring
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Emergency medical care is essential in suspected overdose
Missed Dose Instructions:
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Missed dose should be administered as soon as possible
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Resume subsequent doses as per schedule or as directed by the oncologist
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Do not double dose or self-administer without medical guidance
Additional Notes:
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HER2 testing is mandatory before starting trastuzumab therapy
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Patients should be educated about symptoms of heart failure and respiratory distress
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Infusion must be conducted in a medical facility equipped to manage severe reactions
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Long-term use may require ongoing cardiac evaluations
