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

Note: We can assist only if the medicine is unavailable in your country.”

Alunbrig (Brigatinib)

General Description:

Alunbrig (brigatinib) is an oral treatment for adults with advanced non-small cell lung cancer (NSCLC) that is ALK-positive. It targets the ALK protein, which plays a role in cancer cell growth and spread. The medication is usually taken once daily, beginning with a lower dose that may be increased based on how well it is tolerated.

GettingAlunbrig (brigatinib)in India

Alunbrig (brigatinib)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 accessAlunbrig (brigatinib)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 Alunbrig (brigatinib),MitoGENE is here to support your journey to access this treatment.

Disease Indications: Lung Cancer

Manufacturer: ARIAD Pharmaceuticals, Inc

Usage: Oral

Medicine Approved by:

  • European Medical Agency (EMA)
  • Food and Drug Administration (FDA)
  • Pharmaceuticals and Medical Devices Agency (PMDA)

Available Dosage Form& Package

  • 30 Tablets of 30 mg
  • 30 Tablets of 90 mg
  • 30 Tablets of 180 mg

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 Alunbrig (brigatinib) used for?

Alunbrig (brigatinib) is prescribed to treat adults with ALK-positive metastatic non-small cell lung cancer (NSCLC) who can’t tolerate crizotinib or whose cancer has progressed during or after treatment with it. Crizotinib is a commonly used first-line ALK inhibitor approved by both the FDA (USA) and EMA (Europe).

How does Alunbrig work?

The ALK gene helps regulate the growth of nerve cells. When mutated, it can lead to uncontrolled cell growth and cancer. ALK mutations are found in 3–7% of NSCLC cases.

Crizotinib often works well initially, but most patients eventually develop resistance, partly due to secondary ALK mutations. Around 40% of patients also develop brain or spinal cord metastases as the first site of disease progression.

Alunbrig is a next-generation ALK inhibitor designed to overcome resistance to crizotinib. It works by blocking the abnormal ALK protein, helping to slow or stop the growth of ALK-positive cancer cells.

Is Alunbrig approved?

Yes, Alunbrig has been approved for ALK-positive metastatic NSCLC patients who progressed on or can’t tolerate crizotinib by the following regulatory bodies:

  • FDA (USA) – April 28, 2017
  • EMA (Europe) – November 22, 2018
  • PMDA (Japan) – January 22, 2021

How do I take Alunbrig?

The recommended dosing schedule is:

  • 90 mg once daily for the first 7 days
  • If tolerated, increase to 180 mg once daily thereafter

Treatment continues until the disease worsens or side effects become unacceptable. Dose adjustments may be necessary—refer to the prescribing info for full details.

Always follow your doctor’s guidance for dosing.

What are the side effects of Alunbrig?

Common side effects include:

  • Nausea
  • Diarrhea
  • Fatigue
  • Cough
  • Headache

Serious side effects may include:

  • Interstitial lung disease (ILD)/pneumonitis
  • High blood pressure
  • Slow heart rate
  • Vision issues
  • Increased pancreatic enzymes
  • High blood sugar

Use in special populations

Alunbrig may harm an unborn baby. Avoid pregnancy and breastfeeding during treatment.

For full details on side effects and dosage, refer to the official prescribing information or speak with your healthcare provider.

References

1. Summary of Product Characteristics [FDA]: Alunbrig (brigatinib) [PDF]
ARIAD Pharmaceuticals Inc., fda.gov, Apr 2017.

2. FDA News Release: FDA approves new oral therapy to treat ALK-positive lung cancer
fda.gov, December 2015.

3. EMA. Human Medicines: Xalkori (crizotinib)
ema.europa.eu, cited June 2017

4. Gene Cards. ALK Gene (Protein Coding)
genecards.org

5. ALK inhibitors in non–small cell lung cancer: crizotinib and beyond
Clin Adv Hematol Oncol. Awad M.M. and Shaw A.T., July 2014

6. Alectinib in crizotinib-refractory ALK-rearranged non–small-cell lung cancer: a phase II global study
J Clin Oncol. March 2016

7. Drugs.com. FDA Approves Alunbrig
cited June 2017

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

If Alunbrig (Brigatinib) 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:

    Upload Prescription

    Upload Patient Consent Form

    Patient Consent Form
    Download

    Please download and complete this form, including your signature, and attach it to the request form or email it to info@mitogene.org along with the patient details.