Tagrix 80 mg (Osimertinib)

Tagrix (Osimertinib) 80 mg is a targeted therapy used in the treatment of non-small cell lung cancer (NSCLC) that tests positive for specific epidermal growth factor receptor (EGFR) mutations. It is especially effective in cases where the cancer has developed resistance to other EGFR inhibitors due to a T790M mutation. As an oral medication, Tagrix offers a convenient and effective treatment option for patients with advanced NSCLC.

How It Works

Mechanism of Action

Osimertinib, the active ingredient in Tagrix, is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI). It specifically targets and inhibits EGFR mutations, including T790M, L858R, and exon 19 deletions, which are commonly associated with NSCLC. Here’s how it works:

1. EGFR Inhibition:
   • EGFR is a protein that, when mutated, can lead to uncontrolled cell growth and cancer. Osimertinib binds irreversibly to the mutated EGFR tyrosine kinase domain, blocking the signaling pathways that promote cancer cell proliferation.
2. Targeting T790M Mutation:
   • Many NSCLC patients develop resistance to first- and second-generation EGFR inhibitors due to the emergence of the T790M mutation. Osimertinib is specifically designed to overcome this resistance by selectively targeting the T790M mutant cells while sparing wild-type EGFR, thus reducing toxicity to normal cells.
3. Cell Death and Tumor Regression:
   • By inhibiting the aberrant EGFR signaling, Osimertinib induces apoptosis (programmed cell death) in cancer cells, leading to tumor shrinkage and improved patient outcomes.
4. Blood-Brain Barrier Penetration:
   • Osimertinib has the ability to cross the blood-brain barrier, making it effective in treating brain metastases in NSCLC patients, a common complication in advanced stages of the disease.

Side Effects

While Tagrix (Osimertinib) is generally well-tolerated, it can cause side effects, some of which can be serious. Below is a list of common and severe side effects associated with the medication:

Common Side Effects

• Diarrhea:
  • Diarrhea is one of the most common side effects and may require anti-diarrheal medications to manage.
• Rash:
  • A skin rash, often resembling acne, is a frequent side effect. It can vary from mild to moderate and may require topical treatments.
• Nail Changes:
  • Patients may experience changes in their nails, including brittleness or discoloration.
• Dry Skin:
  • Dryness of the skin is common and may require moisturizing lotions or creams.
• Fatigue:
  • Many patients report feeling tired or fatigued, which can impact daily activities.
• Stomatitis:
  • Inflammation of the mouth lining, leading to soreness and discomfort.

Serious Side Effects

• Interstitial Lung Disease (ILD):
  • ILD is a rare but potentially life-threatening side effect that can cause difficulty breathing, cough, and fever. Immediate medical attention is required if symptoms of ILD develop.
• Cardiac Toxicity:
  • Tagrix can cause QT prolongation, a condition that affects the heart’s rhythm. Regular monitoring of heart function is recommended during treatment.
• Hepatotoxicity:
  • Liver function tests should be monitored regularly, as Osimertinib can cause elevated liver enzymes, indicating potential liver damage.
• Keratitis:
  • Inflammation of the cornea (keratitis) can occur, leading to eye pain, blurred vision, and sensitivity to light.

Indications

Tagrix (Osimertinib) 80 mg is primarily indicated for the treatment of:

• First-Line Treatment of NSCLC:
  • Tagrix is approved as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific EGFR mutations, including exon 19 deletions and exon 21 L858R mutations.
• T790M-Positive NSCLC:
  • It is also indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR TKI therapy.
• Brain Metastases:
  • Due to its ability to cross the blood-brain barrier, Tagrix is effective in treating NSCLC patients with brain metastases, providing a significant survival benefit.

Contraindications

Tagrix (Osimertinib) should not be used in certain populations or under specific conditions due to potential risks. Key contraindications include:

• Hypersensitivity:
  • Contraindicated in patients with known hypersensitivity to Osimertinib or any of the excipients in Tagrix.
• Severe Interstitial Lung Disease:
  • Patients with a history of severe or life-threatening ILD should avoid Tagrix, as the drug can exacerbate lung conditions.
• Pregnancy:
  • Tagrix can cause fetal harm and should not be used during pregnancy. Women of childbearing potential should use effective contraception during treatment and for a period after the last dose.
• Lactation:
  • Breastfeeding is not recommended during treatment with Tagrix due to the potential for serious adverse reactions in the infant.

Pricing Information

The price of Tagrix (Osimertinib) varies widely depending on the country, healthcare system, and availability. Below is a table summarizing the approximate costs in various countries:

Country	Price (per 80 mg tablet)	Reference
United States	$500 – $600	GoodRx
United Kingdom	£400 – £450	NHS
Canada	CAD $700 – $800	Canada Drugs
Australia	AUD $900 – $1000	PBS
Germany	€450 – €500	Apotheken Umschau

Top 5 Global Brands

The global pharmaceutical industry includes several leading companies known for their innovation and leadership in oncology and targeted therapies, particularly in the development and distribution of EGFR inhibitors like Osimertinib. The top global brands include:

1. AstraZeneca:
   • AstraZeneca, the developer of Tagrisso (the brand name for Osimertinib), is a global leader in oncology, particularly in lung cancer treatment. Tagrisso is one of their flagship products in this area.
2. Pfizer:
   • Pfizer is a major player in the oncology field, offering a wide range of targeted therapies and immunotherapies, including those targeting EGFR mutations.
3. Roche:
   • Roche is renowned for its work in personalized cancer treatment and diagnostics, with a strong focus on targeted therapies for various cancers, including lung cancer.
4. Novartis:
   • Novartis is a key player in cancer treatment, offering innovative therapies across multiple oncology indications, including targeted EGFR inhibitors.
5. Boehringer Ingelheim:
   • Boehringer Ingelheim is known for its oncology research, particularly in the development of lung cancer therapies, and continues to be a significant contributor to advances in cancer treatment.