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TRASTUZUMAB DERUXTECAN

TRASTUZUMAB DERUXTECAN

Background and Date of approval TRASTUZUMAB DERUXTECAN

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.

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.

How is TRASTUZUMAB DERUXTECAN administered?

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.

Side Effects of TRASTUZUMAB DERUXTECAN

Common side effects of Trastuzumab deruxtecan include:

  • Cough
  • Trouble breathing or shortness of breath
  • Fever
  • New or worsening breathing symptoms (e.g., chest tightness, wheezing)
  • Low white blood cell count (neutropenia)

Serious side effects of Trastuzumab deruxtecan are:

  • Severe lung problems (which may be life-threatening or lead to death)
  • Heart problems affecting the heart's ability to pump blood
  • Signs of infection or fever and chills
  • Irregular heartbeat
  • Sudden weight gain
  • Swelling of the ankles or legs

Warnings

  • Trastuzumab deruxtecan has severe and life-threatening threatening lung issues. It is important for patients to be closely monitored for symptoms like cough, difficulty breathing, or fever during treatment.
  • Trastuzumab deruxtecan can also lead to decreased white blood cells (neutropenia), which can increase the risk of serious infections. Routine blood check-ups are important to monitor neutropenia during treatment. Any signs of infection, fever, or chills should be reported immediately.
  • Trastuzumab deruxtecan also has a risk of heart problems that can affect the heart's ability to pump blood effectively. Patients should be observed for symptoms like shortness of breath, irregular heartbeat, sudden weight gain, or swelling of the legs, and these symptoms should be addressed promptly.

Precautions

  • Infections: Assess patients for infection risks before starting Trastuzumab deruxtecan and regularly monitor for signs of infection throughout treatment.
  • Lung Function: Regularly assess lung function and monitor for any breathing issues during treatment.
  • Heart Function: Check heart function before and during treatment with Trastuzumab deruxtecan.
  • Pregnancy and Contraception: Confirm pregnancy status before beginning treatment. Advise patients to use effective contraception during and after treatment to avoid potential harm to a developing fetus.

Word of Advice

If you are taking trastuzumab deruxtecan, it is crucial to regularly monitor your lung and liver functions with your doctor due to potential side effects. Both women and men should use effective contraception during treatment. Women should continue using birth control for at least seven months after the final dose of trastuzumab deruxtecan, while men should do so for four months after completing treatment to avoid risks to their partners who may become pregnant. It's essential to consult with your doctor about the best contraceptive methods and inform them before you decide to stop using contraception. 

Additionally, male patients should be aware that trastuzumab deruxtecan may impact fertility, so it is advisable to avoid fathering a child for four months after treatment and discuss sperm preservation options with your doctor before starting the medication.

Frequently Asked Questions

Q1.

Can I continue my regular activities while undergoing treatment with Trastuzumab deruxtecan?


 

Most patients can maintain their normal activities while on Trastuzumab deruxtecan. However, you should monitor how you feel closely. Side effects like fatigue, nausea, or other symptoms might necessitate adjustments to your daily routine. Always consult your healthcare provider for personalised advice based on your situation.

Q2.

Will trastuzumab deruxtecan affect my fertility?

Trastuzumab deruxtecan may have an impact on fertility. If you are planning to have children in the future, it's crucial to discuss this with your healthcare provider before starting treatment. They may suggest fertility preservation options and provide guidance tailored to your personal and family plans.

Q3.

Are there any foods to avoid while undergoing treatment with Trastuzumab deruxtecan?

While on Trastuzumab deruxtecan, managing nausea and vomiting is important, and your oncology care team can provide medications to help with these symptoms. Additionally, making changes to your diet can be beneficial. It's advisable to avoid foods that could aggravate these symptoms, such as heavy, greasy, or fatty foods and spicy or acidic items like lemons, tomatoes, and oranges.

Q4.

How long does adjuvant therapy with Trastuzumab deruxtecan typically last for HER2-positive early breast cancer?

Based on the findings from four major studies, the standard treatment for patients with HER2-positive early breast cancer involves taking adjuvant Trastuzumab deruxtecan for one year alongside chemotherapy. This approach has become the established method of care following these significant trials.

Q5.

What is the success rate of Trastuzumab deruxtecan in treating breast cancer?

The success of Trastuzumab deruxtecan in treating breast cancer is significant. Clinical studies have shown that the five-year invasive breast cancer-free survival rate is 97.4% among patients treated with trastuzumab.

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

Disclaimer

The drug information on this page is not a substitute for medical advice, it is meant for educational purposes only. For further details consult your doctor about your medical condition to know if you are eligible to receive this treatment.

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