This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

Tukysa (tucatinib)

General Description:

Tukysa (tucatinib) is a targeted therapy approved for use in combination with trastuzumab and capecitabine to treat adult patients with advanced, unresectable, or metastatic HER2-positive breast cancer.It has received regulatory approval from both the U.S. FDA and the European Medicines Agency (EMA) and is available in multiple pack sizes.

Getting Tukysa (tucatinib) in India

Tukysa (tucatinib)  has been approved in countries like the U.S. and Europe but is not yet available for commercial sale in India. However, it is accessible through the Named Patient Program (NPP) for eligible patients.

MitoGENE helps Indian patients access Tukysa (tucatinib) legally and safely under their doctor’s supervision. We handle the documentation, regulatory approvals, and logistics to ensure compliance with Indian regulations.

If you or your loved one may benefit from Tukysa (tucatinib), MitoGENE is here to support your journey to access this treatment.

Disease Indications:Breast Cancer

Manufacturer:Seattle Genetics

Usage:Oral

Medicine Approved by:

  • Food and Drug Administration (FDA)
  • European Medical Agency (EMA)
  •  Health Canada
  •  Therapeutic Goods Administration (TGA)
  •  Swissmedic (CH)

Available Dosage Form& Package

  • 88 tablets of 50 mg (EU)
  • 84 tablets of 150 mg (EU)

Shipping:Room Temperature Shipping. This medication is shipped using standard delivery methods, ensuring it remains within a controlled room temperature range of 15°C to 25°C throughout transit.

What is Tukysa (tucatinib) used for?

Tukysa (tucatinib) is a prescription medicine used to treat HER2-positive breast cancer that is either locally advanced (has spread to nearby tissue) or metastatic (has spread to other parts of the body, including the brain).

It is taken in combination with trastuzumab and capecitabine, and is generally prescribed to patients who have previously undergone one or more HER2-targeted therapies.


What side effects may occur with Tukysa (tucatinib)?

According to the official prescribing information, common side effects (affecting more than 1 in 5 patients) may include:

  • Diarrhea
  • Palmar-plantar erythrodysesthesia (hand-foot syndrome)
  • Nausea and vomiting
  • Fatigue
  • Liver toxicity (hepatotoxicity)
  • Stomatitis (mouth inflammation)
  • Loss of appetite
  • Abdominal pain
  • Headache
  • Anemia (low red blood cell count)
  • Skin rash

This list is not exhaustive. Please consult your treating physician and refer to the full prescribing information at the bottom of the page for detailed safety guidance.


References

1. Full prescribing information [FDA]: Tukysa (tucatinib)[PDF]
Seattle Genetics, April 17, 2020

2. Breast Cancer HER2 Status
American Cancer Society, last checked on August 18, 2020

3. FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer
FDA press release, April 17, 2020

4. Seattle Genetics Announces the Approval of TUKYSA™ (tucatinib) in Switzerland for the Treatment of Patients with Metastatic HER2-Positive Breast Cancer
Seattle Genetics press release, May 12, 2020

5. New drug approvals
Health Science Authority Singapore, last checked on Sep 2, 2020

6. Tukysa (tucatinib) product monograph [PDF]
Health Canada, last checked on Sep 2, 2020

7. Seattle Genetics Announces TUKYSA® (tucatinib) Approved Within Months for All Countries Participating in FDA’s Project Orbis Initiative
Seattle Genetics press release, Aug 12, 2020

8. EU approves Tukysa combo for advanced HER2-positive breast cancer
Press release, Feb 2021

How to Access Tukysa (tucatinib) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)?

If Tukysa (tucatinib) is not yet approved or commercially available in India, MitoGENE can assist you in accessing it legally through the Named Patient Program (NPP). Here’s how the process works: