Osicent Osimertinib 80mg Tablets

Osicent Osimertinib 80mg Tablets

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Osicent 80mg - Introduction

Osicent 80mg Tablets is the first-line treatment for patients with a type of Non-small Cell Lung Cancer (NSCLC) that has specific changes in a gene called Epidermal Growth Factor Receptor (EGFR). These changes are called exon 19 deletions or exon 21 L858R mutations, found using an FDA-approved test. It is also used to treat patients with lung cancer that have an EGFR T790M mutation, especially if their cancer got worse after using other treatments targeting EGFR. 

Osicent 80mg tablet is manufactured by Incepta Pharmaceuticals. It contains Osimertinib, which works by inhibiting a protein called EGFR that helps cancer cells grow. It sticks to certain mutated forms of this protein much more strongly than the normal version, which helps it stop the growth of cancer cells. It has been shown to have the best results against lung cancer cells with these mutations in both lab studies and animal models.

Indications

Osimertinib is a medicine used to treat a type of lung cancer (NSCLC) that has a specific mutation called EGFR T790M. It’s meant for patients whose cancer has spread (metastatic) and has gotten worse after using other EGFR-targeting treatments. The mutation must be confirmed with an FDA-approved test.

Uses of Osicent Osimertinib Tablets 

Osicent (osimertinib) 80 mg tablets are primarily used to treat certain types of non-small cell lung cancer (NSCLC). Specifically, they are prescribed for:

  • First-Line Treatment: For patients with advanced or metastatic NSCLC that has specific mutations in the EGFR gene (like exon 19 deletions or exon 21 L858R mutations). These mutations are detected through an FDA-approved test.
  • Treatment After Progression: For patients with metastatic NSCLC that has an EGFR T790M mutation, particularly if the cancer has worsened after treatment with other EGFR-targeting therapies.

Pharmacology 

Osimertinib is a drug that blocks a protein called EGFR, which helps certain cancer cells grow. It works by sticking tightly to specific mutated forms of EGFR, like T790M, L858R, and exon 19 deletions, much more strongly than it does to the normal form of the protein. Studies in lab-grown cells and animals have shown that Osimertinib can stop the growth of lung cancer cells with these mutations.

When taken by mouth, Osimertinib is processed by the body, and two related substances (AZ7550 and AZ5104) are also found in the blood. AZ7550 works similarly to Osimertinib, while AZ5104 is even stronger against some EGFR mutations and the normal form of EGFR. Osimertinib also blocks other proteins, such as HER2, HER3, HER4, ACK1, and BLK, which are important for cell growth.

After taking Osimertinib, the amount in the blood increases steadily with higher doses. When taken daily, the drug builds up in the body, reaching a stable level after about 15 days. At this point, the highest concentration in the blood is about 1.6 times greater than the lowest concentration.

  • Absorption: After taking Osimertinib, it reaches its highest level in the blood in about 6 hours.
    • Distribution: The drug spreads well throughout the body, with 95% of it binding to proteins in the blood. 
    • Elimination: It stays in the body for about 48 hours before being cleared. 
    • Excretion: Osimertinib is primarily eliminated in the feces (68%) and a smaller amount through urine (14%). Only about 2% leaves the body unchanged.

    Osicent Dosage and administration 

    • Take one 80 mg osimertinib tablet once a day until the disease gets worse or side effects become too severe.
    • You can take the tablet with or without food.
    • If you miss a dose, skip it and take the next dose at the regular time.
    • To take the tablet with water: Put the tablet in 60 ml (2 ounces) of non-carbonated water. Stir until the tablet breaks into small pieces (it won’t fully dissolve). Drink the mixture right away. Rinse the container with 120 to 240 ml (4 to 8 ounces) of water and drink it immediately
    • Do not crush, heat, or use ultrasound to prepare the tablet.
    • If you need to take it through a nasogastric tube: Disperse the tablet in 15 ml of non-carbonated water. Use another 15 ml of water to transfer any leftover pieces to the syringe. Administer the 30 ml liquid through the tube with additional water flushes (about 30 ml).

    Drug Interaction

    • Strong CYP3A Inhibitors: Avoid taking Osimertinib with strong CYP3A inhibitors, like certain antibiotics (e.g., telithromycin), antifungals (e.g., itraconazole), and antivirals (e.g., ritonavir), as these can increase the levels of osimertinib in the blood. If these drugs must be used together, the patient should be closely monitored for side effects.
    • Strong CYP3A Inducers: Avoid taking Osimertinib with strong CYP3A inducers, like phenytoin, rifampicin, carbamazepine, or St. John’s Wort, as these can lower the levels of Osimertinib in the blood.

    Side Effects of Osient Osimertinib 80mg 

    Most common side effects include:
    • Diarrhea
    • Rash
    • Dry Skin
    • Nail toxicity
    • Stomatitis
    • Fatigue 
    • Decreased appetite.

    Osicent Osimertinib - Precautions and warnings 

    • Osicent Osimertinib 80mg can harm an unborn baby if taken during pregnancy. 
    • ILD or pneumonitis happened in 3.9% of patients taking osimertinib; 0.4% of these cases were fatal. If a patient is diagnosed with ILD or pneumonitis, osimertinib should be permanently stopped.
    • Osimertinib can cause QTc interval prolongation, which affects heart rhythm. Patients with a history of this issue, or those on medications that affect the QTc interval, should have regular ECGs and electrolyte checks. If QTc prolongation occurs, the dose should be reduced, or the medication should be stopped permanently.

    Osicent 80mg vs Tagrix 80mg

    Feature
    Osicent
    Tagrix
    Active Ingredient
    Osimertinib
    Osimertinib
    Brand Name
    Osicent
    Tagrix
    Manufacturer
    Incepta Pharmaceuticals Ltd.
    Beacon Pharmaceuticals Ltd.
    Drug Class
    EGFR Tyrosine Kinase Inhibitor
    EGFR Tyrosine Kinase Inhibitor
    Indication
    Non-small cell lung cancer (NSCLC) with specific EGFR mutations
    Non-small cell lung cancer (NSCLC) with specific EGFR mutations
    Cost
    Generally more affordable, depending on the market
    Typically similar in cost to Osicent, but varies by region
    Unique Features
    Produced by Incepta, a well-known pharmaceutical company in Bangladesh
    Produced by Beacon, another leading pharmaceutical company in Bangladesh
    Common Drug Interactions
    Interacts with CYP3A4 inhibitors, antacids, and proton pump inhibitors
    Interacts with CYP3A4 inhibitors, antacids, and proton pump inhibitors
    FDA ApprovedOsimertinib is FDA approved drugOsimertinib is FDA approved drug

    Storage Conditions

    Keep below 30°C and protect from moisture and light.

    FAQs

    Osimertinib 80 mg is used to treat non-small cell lung cancer (NSCLC) with specific EGFR mutations.

    Common side effects of Osimertinib 80 mg include diarrhea, rash, dry skin, nail toxicity, and fatigue.

    Tagrisso targets non-small cell lung cancer (NSCLC) with specific EGFR mutations.

    Yes, Tagrisso has been shown to be effective in treating stage 4 non-small cell lung cancer with specific EGFR mutations, prolonging survival and delaying disease progression.

    Tagrisso works by inhibiting the activity of mutated EGFR, which is responsible for the growth of certain types of non-small cell lung cancer. By blocking this pathway, the drug prevents cancer cells from growing and spreading.

    The duration of Tagrisso treatment depends on how well the medication is working and how well it is tolerated. Some patients take it for several months or years as long as it remains effective.

    No, Tagrisso is neither chemotherapy nor immunotherapy. It is a targeted therapy specifically designed to inhibit mutated EGFR in certain types of lung cancer.

    Tagrisso can remain effective for several months or even years, depending on the patient’s response and the progression of their cancer.

    Tagrisso is not a cure for lung cancer, but it can significantly extend survival and delay disease progression in patients with advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations.

    Alternatives to Osimertinib include other EGFR inhibitors such as Erlotinib (Tarceva), Gefitinib (Iressa), and Afatinib (Gilotrif).

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    Osicent Osimertinib 80mg Tablets
    $120
    Osicent Osimertinib 80mg Tablets