Tagrix-80mg-Osimertinib

 

Tagrix-80mg-Oimertinib | Package Insert

Description

Tagrix-80mg-Osimertinib is a prescription medication used to treat adults with non-small cell lung cancer (NSCLC) that has abnormal epidermal growth factor receptor (EGFR) gene(s). EGFR is a protein that aids cell growth and division, but overactivity can cause cancer cells to grow and spread uncontrollably.

Tagrix is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against CNS metastases. It is used alone in patients whose cancer cells have specific mutations in a gene for EGFR. It is used to prevent lung cancer from returning after surgery, as a first treatment for metastatic lung cancer, or when previous treatment with an EGFR tyrosine kinase inhibitor (TKI) failed. (1)

Indications

Tagrix-80mg-Osimertinib is a kinase inhibitor used to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed on or after EGFR TKI therapy. It is approved under accelerated approval based on tumor response rate and duration of response, with continued approval contingent on verification and clinical benefit description in confirmatory trials.

• Adjuvant therapy is recommended for non-small cell lung cancer (NSCLC) patients who have undergone tumor resection, and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations.
• For adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, first-line treatment is recommended.
• In patients with metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy, treatment is recommended. (2)

Mechanism of Action

• Tagrix-80mg-Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It works by irreversibly binding to and inhibiting the EGFR protein. EGFR is a protein that helps cells grow and divide. When EGFR is overactive, it can cause cancer cells to grow and spread uncontrollably.
• Tagrix is specifically designed to target certain mutant forms of EGFR, including the T790M mutation. The T790M mutation is a common resistance mutation that develops in patients with NSCLC treated with first- or second-generation EGFR TKIs.
• By blocking the activity of EGFR, Tagrix can help slow or stop the growth and spread of cancer cells, even in patients who have developed resistance to other EGFR TKIs.
• Tagrix is a very effective treatment for NSCLC with certain EGFR mutations. It has been shown to improve survival and shrink tumors in many patients.

Here is a more detailed explanation of Tagrix’s mechanism of action:

• Tagrix binds to the EGFR protein at the ATP binding site. This prevents the EGFR protein from binding to ATP, the energy source it needs to function.
• Tagrix also forms a covalent bond with the EGFR protein, which makes the inhibition irreversible.
• This prevents the EGFR protein from signaling to cancer cells to grow and divide.
• Tagrix is a very selective TKI, meaning it is more likely to bind to mutant forms of EGFR than to wild-type EGFR. This helps to minimize the risk of side effects. (3)

 

Dosage and Administration for Tagrix-80mg-Osimertinib

Adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations

• The recommended dosage of Tagrix 80 mg, taken orally once a day.
• Continue treatment with Tagrix until disease recurrence, unacceptable toxicity, or for up to 3 years.

First-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations

• The recommended dosage of Tagrix is 80 mg, taken orally once a day.
• Continue treatment with Tagrix until disease progression or unacceptable toxicity.

Metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy

• The recommended dosage of Tagrix is 80 mg, taken orally once a day.
• Continue treatment with Tagrix until disease progression or unacceptable toxicity.

Tagrix can be taken with or without food. If a dose of Tagrix is missed, do not make up the missed dose and take the next dose as scheduled.

How to takeTagrix-80mg-Osimertinib tablets:

• Swallow the tablets whole with water.
• Do not crush, chew, or break the tablets.
• If you have difficulty swallowing the tablets, you can disperse them in non-carbonated water and drink the suspension immediately.

How to disperse Tagrix-80mg-Osimertinib  tablets:

1. Place one tablet in a glass with 60 mL (2 ounces) of non-carbonated water.
2. Stir until the tablet is dispersed into small pieces.
3. Drink the suspension immediately.
4. Rinse the glass with 120 mL to 240 mL (4 to 8 ounces) of water and drink immediately. (4)

Side Effects

This medication may cause diarrhea, nausea, mouth sores, dry skin, tiredness, back pain, headaches, or a loss of appetite. If these effects persist or worsen, inform your doctor or pharmacist immediately. The medication is prescribed because the benefits outweigh the risk of side effects. If you experience a slow heartbeat, severe dizziness, fainting, heart failure symptoms, lung disease symptoms, or blood clots, seek medical help. This medication may also lower your ability to fight infections, increasing the risk of serious infections or worsening existing ones. A severe allergic reaction is rare, but if you notice symptoms like a rash, itching, swelling, severe dizziness, or trouble breathing, seek medical help. If you notice other side effects, contact your doctor or pharmacist. (5)

Interactions of Tagrix-80mg-Osimertinib

Tagrix can interact with a number of other medications, including:

It is important to be aware of certain medications that can either increase or decrease the effectiveness of Tagrix. Medications that induce CYP3A4 can cause Tagrix to be metabolized more quickly, leading to lower levels in the bloodstream and making it less effective. Examples of such medications include carbamazepine, phenobarbital, and rifampin. Conversely, medications that inhibit CYP3A4 can slow down the metabolism of Tagrix, leading to higher levels in the bloodstream and increasing the risk of side effects. Examples of such medications include clarithromycin, itraconazole, and ketoconazole.

Furthermore, Tagrix can prolong the QT interval, which measures the time it takes for the heart to beat. Taking other medications that have the same effect can increase the risk of a serious heart rhythm problem called torsades de pointes. Some examples of these medications include amiodarone, methadone, and moxifloxacin.

Finally, Tagrix can interact with other cancer medications, such as cisplatin and docetaxel. These interactions can increase the risk of side effects or make either medication less effective. It is important to inform your healthcare provider of any other medications you are taking to ensure their safety and effectiveness in treating your condition. (6)

 

Life Expectancy & Success Rate of Tagrix-80mg-Osimertinib

Tagrix-80mg-Osimertinib is a treatment that significantly improves life expectancy in patients with non-small cell lung cancer (NSCLC) with certain EGFR mutations. In the ADAURA clinical trial, patients with early-stage EGFR-mutated NSCLC had an estimated 88% five-year survival rate, while patients with advanced EGFR T790M mutation-positive NSCLC had a median overall survival of 38.6 months, compared to 31.8 months for patients treated with erlotinib or gefitinib.

Clinical Trials of Tagrix-80mg-Osimertinib

The US FDA, EU, and Japanese MHLW approved Tagrisso based on results from two studies called AURA extension and AURA2. AstraZeneca and Roche developed the cobas EGFR Mutation Test v2, which helps identify EGFR mutations in non-small cell lung cancer patients. Two AURA phase II clinical trials were conducted on 411 EGFRm T790M NSCLC patients who showed progression on or after EGFR TKI therapy. The trials showed an overall objective response rate (ORR) of 59%, with individual severe grade 3+ adverse events being rare. The most common adverse events observed were diarrhea, rash, dry skin, and nail toxicity.

 

Here are some frequently asked questions about osimertinib (trade name Tagrisso):

1. What is osimertinib used for? Tagrix-80-Osimertinib is a medication that is used to treat non-small cell lung cancer (NSCLC). It is a type of targeted therapy called an epidermal growth factor receptor (EGFR) inhibitor, which means it works by blocking the action of the EGFR protein.
2. How is osimertinib taken? Osimertinib is usually taken as a pill that is taken by mouth. The medication should be taken with water and may be taken with or without food.
3. What are the potential side effects of osimertinib? Common side effects of osimertinib include diarrhea, rash, and nausea. Other potential side effects may include fatigue, stomach pain, and constipation.
4. Who should not take osimertinib? Osimertinib is not suitable for everyone, and certain individuals should not take the medication. It is important to discuss your medical history and current medications with a healthcare provider before starting osimertinib to determine if it is appropriate for you.
5. Is osimertinib a cure for NSCLC? Osimertinib is not a cure for non-small cell lung cancer (NSCLC). It is a treatment that can help to slow or stop the growth of cancer cells in some people with NSCLC. The benefits of treatment may vary from person to person.

If you have any additional questions about osimertinib, it is important to discuss them with a healthcare provider. They can provide more specific information about the medication and its use.