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Trastuzumab Emtansine: Brands, Price & Uses in Bangladesh
Established (FDA-Approved) Indications HER2-positive metastatic breast cancer: Trastuzumab Emtansine is indicated, as a single agent and more.
About Trastuzumab Emtansine
Indications of Trastuzumab Emtansine
Established (FDA-Approved) Indications
- HER2-positive metastatic breast cancer: Trastuzumab Emtansine is indicated, as a single agent, for the treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, either separately or in combination. Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant therapy.
- Adjuvant treatment of HER2-positive early breast cancer: Trastuzumab Emtansine is indicated as a single agent for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based treatment.
Patient Selection Requirement
HER2 tumor status must be confirmed using an FDA-approved test before starting Trastuzumab Emtansine, as Trastuzumab Emtansine is effective only in HER2-positive disease.
Not Indicated / Off-Label Use
Trastuzumab Emtansine is not indicated for HER2-negative breast cancer or for use in place of trastuzumab in HER2-positive early-stage disease where trastuzumab alone or with chemotherapy is standard of care. Trastuzumab Emtansine is not interchangeable with trastuzumab. Use of Trastuzumab Emtansine outside these approved settings (e.g. other HER2-positive tumor types) is considered off-label and should only be undertaken under specialist oncology guidance.
Dosage & Administration of Trastuzumab Emtansine
Recommended Dose
| Indication | Dose of Trastuzumab Emtansine | Schedule |
|---|---|---|
| Metastatic HER2-positive breast cancer | 3.6 mg/kg body weight, IV infusion | Once every 3 weeks (21-day cycle), until disease progression or unacceptable toxicity |
| Adjuvant early breast cancer (residual disease) | 3.6 mg/kg body weight, IV infusion | Once every 3 weeks (21-day cycle), for a total of 14 cycles |
Administration
Trastuzumab Emtansine must be reconstituted and further diluted by a healthcare professional before use (see Reconstitution). The first infusion of Trastuzumab Emtansine should be administered over 90 minutes with close observation for infusion-related symptoms (fever, chills, dyspnea, hypotension) during and for at least 90 minutes after the start of infusion. If the first infusion of Trastuzumab Emtansine is well tolerated, subsequent infusions may be administered over 30 minutes, with observation during and for 30 minutes after infusion. Trastuzumab Emtansine must not be administered as an intravenous push or bolus.
Pre-Treatment Monitoring
Before each dose of Trastuzumab Emtansine, liver function tests (AST, ALT, bilirubin) and platelet counts should be assessed; left ventricular ejection fraction (LVEF) should be assessed at baseline and periodically during treatment with Trastuzumab Emtansine. Dose reductions, dose delays, or discontinuation of Trastuzumab Emtansine may be required based on hepatic, cardiac, pulmonary, or hematologic findings.
Missed Dose
If a planned dose of Trastuzumab Emtansine is delayed or missed, it should be administered as soon as possible; the dosing schedule should not be adjusted to make up for a missed dose, and the interval between doses of Trastuzumab Emtansine should not be shortened.
Side Effects of Trastuzumab Emtansine
Very Common / Common
- Fatigue, nausea, musculoskeletal pain, headache
- Constipation, diarrhea, abdominal pain
- Thrombocytopenia (low platelet count) and anemia
- Elevated liver enzymes (AST, ALT)
- Peripheral neuropathy (numbness/tingling in hands and feet)
- Epistaxis (nosebleeds)
- Infusion-related reactions (fever, chills, flushing)
- Dry mouth, decreased appetite
Serious Side Effects
- Hepatotoxicity, including nodular regenerative hyperplasia and, rarely, liver failure (see Precautions and Warnings)
- Cardiotoxicity with decreased left ventricular ejection fraction (see Precautions and Warnings)
- Interstitial lung disease/pneumonitis, including cases progressing to acute respiratory distress syndrome
- Severe thrombocytopenia with risk of bleeding
- Severe infusion reactions and hypersensitivity, including anaphylaxis
Patients experiencing severe or persistent side effects while receiving Trastuzumab Emtansine should contact their treating physician promptly.
Contraindications of Trastuzumab Emtansine
Trastuzumab Emtansine is contraindicated in patients with known serious hypersensitivity reactions to Trastuzumab Emtansine or to any of its excipients, or to trastuzumab.
Trastuzumab Emtansine is contraindicated during pregnancy because of the boxed warning for embryo-fetal toxicity; Trastuzumab Emtansine can cause fetal harm when administered to a pregnant woman (see Pregnancy and Lactation).
Frequently Asked Questions about Trastuzumab Emtansine
What is Trastuzumab Emtansine used for?
Trastuzumab Emtansine is used to treat HER2-positive metastatic breast cancer in patients previously treated with trastuzumab and a taxane, and as adjuvant treatment for HER2-positive early breast cancer with residual disease after neoadjuvant treatment. Trastuzumab Emtansine is not used for HER2-negative breast cancer.
How is Trastuzumab Emtansine given?
Trastuzumab Emtansine is given only as an intravenous infusion in a hospital or oncology clinic, at a dose of 3.6 mg/kg once every 3 weeks. The first infusion of Trastuzumab Emtansine is given slowly over 90 minutes; later infusions of Trastuzumab Emtansine may be given over 30 minutes if the first was well tolerated. Trastuzumab Emtansine cannot be taken as a tablet or injected at home.
What are the most serious risks of Trastuzumab Emtansine?
Trastuzumab Emtansine carries boxed warnings for liver damage (including rare liver failure), heart problems (reduced heart pumping function), and harm to an unborn baby if used during pregnancy. Regular blood tests and heart function tests are required while receiving Trastuzumab Emtansine to monitor for these risks.
Can Trastuzumab Emtansine be used during pregnancy or breastfeeding?
No. Trastuzumab Emtansine is contraindicated during pregnancy because it can cause serious harm to the fetus. Women who can become pregnant should use effective contraception during treatment with Trastuzumab Emtansine and for at least 7 months after the last dose. Breastfeeding is not recommended during treatment with Trastuzumab Emtansine and for at least 7 months afterward; a physician should be consulted for individual guidance.
Is Trastuzumab Emtansine the same as trastuzumab (Herceptin)?
No. Trastuzumab Emtansine is a different, more complex medicine than trastuzumab alone — Trastuzumab Emtansine links trastuzumab to a cytotoxic (cell-killing) chemotherapy component called DM1. Trastuzumab Emtansine must never be substituted for or with trastuzumab; a physician determines which of these medicines is appropriate.
What should be monitored while receiving Trastuzumab Emtansine?
While receiving Trastuzumab Emtansine, patients are monitored with liver function blood tests before every dose, periodic heart function (LVEF) tests, platelet counts, and observation for infusion reactions, breathing problems, and numbness or tingling in the hands or feet. Any new or worsening symptoms during treatment with Trastuzumab Emtansine should be reported to the treating physician immediately.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.