New Delhi, India – 110 016

Enhertu (Trastuzumab Deruxtecan) Injection

Generic brands for Trastuzumab Deruxtecan Injection Available in India

Brand Name Enhertu
Generic Name Trastuzumab Deruxtecan
Strength 100mg
Manufacturer Astrazeneca Pharma India

Description

Description

This page contains brief details about the drug trastuzumab deruxtecan, it’s indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Date of Approval

Trastuzumab deruxetecan was first approved by the United States Food and Drug Administration (FDA) on December 20, 2019.

In a 2021 study, researchers assessed the safety and activity of trastuzumab deruxtecan (T-DXd) in patients with various HER2-expressing or HER2-mutant solid tumours. They reported a confirmed objective response rate (ORR) of 28.3% and a median progression-free survival (PFS) of 7.2 months.

The study highlighted promising activity in HER2-mutant non-small cell lung cancer (NSCLC) and other solid tumours.

Mechanism of Action of Trastuzumab Deruxtecan

Trastuzumab deruxetecan is an antibody-drug conjugate that targets HER2. It uses a humanised anti-HER2 IgG1 antibody. Trastuzumab deruxetecan includes a small molecule called DXd, which inhibits topoisomerase I and is linked to the antibody by a cleavable connector.

Once it binds to HER2 on cancer cells, Trastuzumab deruxetecan is taken into the cell. Inside the cell, the linker is broken down by lysosomal enzymes, releasing DXd. This molecule then causes DNA damage and triggers cell death.

Uses of Trastuzumab Deruxtecan

Trastuzumab deruxetecan is used in the treatment of the following:

HER2-positive metastatic breast cancer: Treat adult patients with inoperable or metastatic HER2-positive breast cancer who have already received a prior anti-HER2-based treatment.

HER2-low metastatic breast cancer: Treat adult patients with inoperable or metastatic HER2-low breast cancer who have undergone prior chemotherapy in the metastatic setting or experienced cancer recurrence during or within six months of completing adjuvant chemotherapy.

Locally advanced or metastatic gastric cancer: Treat adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have already received a prior trastuzumab-based treatment.

Trastuzumab Deruxtecan Dosage available

Trastuzumab deruxtecan is available as an injection and administered intravenously (into a vein) by the healthcare provider on scheduled appointments. Your healthcare provider will decide the suitable dosage for your condition according to your age and physical circumstances.

 

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News/Updates

References

1. Daiichi Sankyo UK Ltd, Electronic Medical Compendium (EMC),[Revised on July 2023][Accessed on Jan 2024] https://www.medicines.org.uk/emc/files/pil.12135.pdf

2. Daiichi Sankyo, Inc, Food and Drug Safety Administration (FDA), [Revised on Jan 2021] [Accessed on Jan 2024] https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761139s011lbl.pdf

3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s021lbl.pdf

Frequently Asked Questions

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Medicines once shipped will not be taken back. We will assist you with the Export Invoice and tracking details of your order. International orders might be subject to import taxes/duties. For information, please contact your local customs authority. Any such taxes are the responsibility of the parcel recipient and are not paid by us.

There are some medicines which have been approved recently in USA or Europe but not yet approved in India or any other countries are not permitted to be imported or marketed commercially. However, they may be required for the treatment of patients to save their lives who have exhausted all other available treatment options in their country. Named – Patient Program is to facilitate import of such medicines for personal use. There is a provision under the Indian Drugs and Cosmetics Rules, 1945, that permits the patient to import these medicine in small quantity. Similar regulatory provision also exist in other countries. We assist patient in preparing legal documents for import and connecting them with authorized suppliers in USA and Europe to secure genuine products.

A generic drug is a drug defined as “a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, quality and performance characteristics, and intended use”. There are Indian companies which manufacture and market these generic medicines after getting approval from Regulatory Authority of the country. These generic medicines contain the same active ingredients as the original formulation and are identical or within an acceptable bioequivalent range to the Innovator drug counterpart with respect to pharmacokinetic and pharmaco-dynamic properties. By extension, therefore, generics are considered identical in dose, strength, route of administration, safety, efficacy, and intended use. They are labeled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug. When generic products become available, the market competition often leads to substantially lower prices and thereby make is affordable for large number of needy patients.

It usually takes 8-9 working days after dispatch to reach medicine at outside India locations. Additional delays may occur due to heavy load on postal services and customs.

We advise to transfer money only through Interbank Transfer Modalities;

  • Online Net-banking for within India transfer.
  • International Wire Transfer (SWIFT) from outside India.
  • Cash on Delivery within India.

Cash on Delivery (COD) option is only available if the medicine is purchased and delivered in India. Preferred locations within India for COD facilities are within Municipal limits of New Delhi & NCR, Mumbai, Bangalore, Kolkata, Chennai & Hyderabad

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