kadcyla trastuzumab emtansine for injection 100mg per vial per box

Description

Indication & Scope

Trastuzumab emtansine (T-DM1) Injection (Kadcyla®) is an antibody-drug conjugate. The anti-HER2 antibody trastuzumab binds selectively to HER2 on tumor cells and delivers DM1 (microtubule inhibitor) into tumor cells to induce cell apoptosis. It also retains anti-HER2 antibody-mediated anti-tumour activity.

Mechanism
HER2-targeted antibody-drug conjugate (ADC)
Drug class
Prescription Antibody-Drug Conjugate / Targeted Antineoplastic Agent
Clinical use
HER2-positive early breast cancer, HER2-positive metastatic breast cancer

Specification

Generic Name	Trastuzumab Emtansine Injection
Brand Name	Kadcyla®
Ingredient	Trastuzumab Emtansine
Dosage Form	Injection
Package	100mg/vial/box
Conditions Treated	Adjuvant therapy for HER2-positive early breast cancer with residual invasive lesions after neoadjuvant taxane plus trastuzumab treatment; Monotherapy for HER2-positive metastatic breast cancer previously treated with trastuzumab and taxane
Taboos	Hypersensitivity to trastuzumab emtansine or any excipients
Place of origin	Kaiseraugst, Switzerland
Priscription Type	Prescription Drug
Storage Conditions	Store at 2°C – 8°C, protect from light. Do not freeze; avoid vigorous shaking.
Manufacturer	F.Hoffmann-La Roche Ltd.
Registration Authority	National Medical Products Administration (NMPA)
Approval number	SJ20200003
Approval Date	November 07, 2024
Shelf Life	36 months

How to use ?

Recommended Dose: 3.6 mg/kg administered intravenously every 3 weeks (21-day cycle).Early breast cancer: Maximum 14 cycles. Metastatic breast cancer: Continue until disease progression or intolerable toxicity. Dose adjustment: Dose interruption, reduction or permanent discontinuation according to thrombocytopenia, hepatic toxicity, cardiac dysfunction and infusion-related reactions.

Time: First infusion: 90-minute intravenous infusion. If well tolerated, subsequent infusions can be administered over 30 minutes.

Interaction: Do not mix with other drugs in the same infusion set. No formal drug-drug interaction studies available.

Side effects: Thrombocytopenia, hepatic dysfunction, left ventricular ejection fraction decline, infusion-related reactions, fatigue, nausea, musculoskeletal pain, peripheral neuropathy, rash.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is the difference between trastuzumab and trastuzumab emtansine?

Ado-trastuzumab emtansine contains a monoclonal antibody called trastuzumab that binds to a protein called HER2, which is found on some breast cancer cells.

What is trastuzumab emtansine?

Trastuzumab emtansine is a combination of the drug trastuzumab (also known as Herceptin) and a chemotherapy drug called emtansine.

Do you lose your hair with trastuzumab?

Some targeted (biological) therapies may cause hair loss or hair thinning.

Does trastuzumab cause heart problems?

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms.