304 North Cardinal St.
Dorchester Center, MA 02124
Generic Name: Osimertinib
Medicine Name: Tagrix 80
Manufacturer: Beacon Pharmaceuticals Limited
Tablet: 10’s Strip / 30’s Pot
Originator: Tagrisso by AstraZeneca
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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)
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.
Here is a more detailed explanation of Tagrix’s mechanism of action:
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
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
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
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:
How to disperse Tagrix-80mg-Osimertinib tablets:
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)
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)
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.
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.
Osimertinib is usually taken as a pill that is taken by mouth. The dosage and schedule for taking osimertinib will depend on the specific condition being treated, the patient’s age and overall health, and other factors. It is important to take osimertinib exactly as directed by a healthcare provider. The medication should be taken with water and may be taken with or without food. If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule should be resumed. It is important not to take a double dose of osimertinib to make up for a missed dose.
If you have any questions or concerns about taking osimertinib, it is important to discuss them with a healthcare provider. They can provide more specific information about how to take the medication and address any concerns you may have.
How effective is Tagrix-80mg-Osimertinib?
It is difficult to determine how effective osimertinib (trade name Tagrisso) will be for a particular patient, as the effectiveness of the medication can vary depending on several factors, including the type and stage of the cancer being treated, the patient’s overall health, and other factors. In clinical trials, osimertinib is effective at slowing or stopping the growth of non-small cell lung cancer (NSCLC) in some people. However, it is not a cure for NSCLC, and the benefits of treatment may vary from person to person.
If you are considering taking osimertinib for the treatment of NSCLC, it is important to discuss the potential risks and benefits of the medication with a healthcare provider. They can help you understand the expected effectiveness of the medication and whether it is appropriate for you based on your specific situation.
Here are some frequently asked questions about osimertinib (trade name Tagrisso):
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.