Herceptin
Generic Name
Trastuzumab
Manufacturer
Genentech (a member of Roche Group)
Country
Switzerland / USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| herceptin 440 mg injection | ৳ 112,634.00 | N/A |
Description
Overview of the medicine
Trastuzumab (Herceptin) is a recombinant DNA-derived humanized monoclonal antibody that selectively targets the human epidermal growth factor receptor 2 (HER2) protein. It is used to treat HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
Uses & Indications
Dosage
Adults
Breast Cancer (3-week regimen): Initial loading dose of 8 mg/kg over 90 minutes, followed by 6 mg/kg every 3 weeks. Breast Cancer (weekly regimen): Initial loading dose of 4 mg/kg over 90 minutes, followed by 2 mg/kg weekly. Gastric Cancer: Initial loading dose of 8 mg/kg over 90 minutes, followed by 6 mg/kg every 3 weeks.
Elderly
No specific dose adjustment required based on age.
Renal_impairment
No specific dose adjustment required based on renal impairment.
How to Take
Administered as an intravenous infusion by a healthcare professional. Must not be administered as an intravenous push or bolus. Infusion rate should be carefully monitored.
Mechanism of Action
Trastuzumab binds to the extracellular domain of the HER2 receptor, inhibiting the proliferation of HER2-overexpressing tumor cells. It mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and inhibits HER2 cleavage and signaling pathways.
Pharmacokinetics
Onset
Not acutely applicable; therapeutic effects are observed over weeks/months of treatment.
Excretion
Primarily through catabolism (protein degradation). Minimal renal or hepatic excretion.
Half life
Approximately 28 days for a single dose; 5.8 days to 28 days with multiple doses, varies with HER2 shedding.
Absorption
Administered intravenously, hence 100% bioavailability. Peak serum concentrations are reached after infusion.
Metabolism
Catabolized like endogenous immunoglobulins; not metabolized by cytochrome P450 enzymes.
Side Effects
Contraindications
- Known hypersensitivity to Trastuzumab or any component of the formulation.
- Severe uncontrolled heart failure (NYHA Class III/IV) or symptomatic heart failure.
Drug Interactions
Taxanes
May increase risk of neutropenia and diarrhea, particularly when combined with paclitaxel. Closely monitor patients.
Anthracyclines
Increased risk of cardiotoxicity when used concurrently or sequentially with anthracyclines.
Storage
Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Reconstituted solution must be used immediately or stored appropriately.
Overdose
No specific antidote. Treatment is supportive and symptomatic. Monitor for signs of cardiac dysfunction and infusion reactions. Manage symptoms as appropriate.
Pregnancy & Lactation
Pregnancy Category D: Trastuzumab can cause fetal harm. Avoid use during pregnancy. Lactation: Not recommended during breastfeeding due to potential harm to the breastfed infant.
Side Effects
Contraindications
- Known hypersensitivity to Trastuzumab or any component of the formulation.
- Severe uncontrolled heart failure (NYHA Class III/IV) or symptomatic heart failure.
Drug Interactions
Taxanes
May increase risk of neutropenia and diarrhea, particularly when combined with paclitaxel. Closely monitor patients.
Anthracyclines
Increased risk of cardiotoxicity when used concurrently or sequentially with anthracyclines.
Storage
Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Reconstituted solution must be used immediately or stored appropriately.
Overdose
No specific antidote. Treatment is supportive and symptomatic. Monitor for signs of cardiac dysfunction and infusion reactions. Manage symptoms as appropriate.
Pregnancy & Lactation
Pregnancy Category D: Trastuzumab can cause fetal harm. Avoid use during pregnancy. Lactation: Not recommended during breastfeeding due to potential harm to the breastfed infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 36 months for unopened vials. Reconstituted solution is stable for 24 hours at 2-8°C when diluted in 0.9% sodium chloride.
Availability
Hospitals, Specialized Oncology Pharmacies
Approval Status
FDA Approved
Patent Status
Patent expired (generics available in many regions)
WHO Essential Medicine
YesClinical Trials
Numerous pivotal trials (e.g., HERA, NSABP B-31, NCCTG N9831 for breast cancer, ToGA for gastric cancer) have demonstrated the efficacy and safety of Trastuzumab. Ongoing research continues to explore new applications and combinations.
Lab Monitoring
- Cardiac function monitoring (LVEF) before treatment and at regular intervals during and after treatment.
- Complete Blood Count (CBC) with differential.
- Liver and kidney function tests.
Doctor Notes
- Confirm HER2 status with an FDA-approved test before initiating Trastuzumab.
- Baseline and ongoing LVEF monitoring is mandatory due to the risk of cardiotoxicity.
- Patients with pre-existing cardiac dysfunction or prior anthracycline exposure require careful risk-benefit assessment.
- Manage infusion reactions symptomatically; consider pre-medication for subsequent infusions if severe.
Patient Guidelines
- Patients must undergo HER2 testing prior to treatment initiation.
- Report any signs of heart problems (e.g., shortness of breath, swelling, rapid heartbeat) immediately.
- Report any signs of infusion reactions (e.g., fever, chills, rash, difficulty breathing) immediately.
- Understand the importance of regular cardiac monitoring during treatment.
Missed Dose Advice
If a dose is missed by one week or less, administer the usual maintenance dose as soon as possible. If more than a week has passed, consider re-starting the loading dose and continuing the maintenance schedule.
Driving Precautions
May cause fatigue, dizziness, or visual disturbances. Advise caution when driving or operating machinery, especially during or shortly after infusion. Avoid these activities if you feel unwell.
Lifestyle Advice
- Maintain a healthy diet and hydration.
- Avoid strenuous physical activities if experiencing fatigue or shortness of breath.
- Follow all recommended follow-up appointments and laboratory tests.
- Discuss any new or worsening symptoms with your doctor immediately.
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