Description
Product Features:
Product Name | : Erdafixen |
Generic Name | : Erdafitinib |
Manufacturer | : Everest Pharma Ltd |
Indication | : Anti Cancer |
Formulation | : Tablet |
Strength | : 4 mg |
Quantity | : 28 Tablets |
Storage | : Room temperature |
Registrations | : Export Only |
What is Erdafixen 4 mg?
Erdafixen 4 mg includes inhibitor of fibroblast growth factor receptor (FGFR), Erdafitinib. A class of proteins engaged in cell development, division, and survival are called FGFRs. When mutations or fusions arise in the genes that produce these receptors, they can become overactive and cause uncontrollably rapid cell growth and cancer formation. By specifically binding to and blocking FGFR1, FGFR2, FGFR3, and FGFR4, erdafitinib blocks the signaling pathways promoting tumor growth.
Erdafixen 4 mg is a perfect illustration of precision medicine in oncology since it is especially intended for people whose malignancies show FGFR genetic changes.
Approved Indications
Erdafixen 4 mg is mainly approved for the treatment of locally advanced or metastatic urothelial carcinoma (UC) in patients with genetic alterations of FGFR2 or FGFR3. This approval, granted by organizations like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), followed compelling clinical trial results showing its effectiveness in this patient population.
Patients must be tested for the presence of FGFR alterations before the initiation of treatment with Erdafixen 4 mg. That guarantees that the therapy is targeted in those that stand the most gain, where potential side effects are minimized.
How Does Erdafixen 4 mg Work?
Erdafixen 4 mg exerts its anti-cancer effects by:
- Inhibiting FGFR Signaling: The drug binds to the ATP-binding pocket of the FGFRs thereby impeding their activation as well as downstream signaling.
- Disrupting Cancer Cell Growth: Erdafixen 4 mg works by preventing FGFR pathways and inhibits the growth of tumor cells and induces apoptosis.
- Targeting Specific Mutations: Unlike conventional chemotherapy that impacts both normal and malignant cells, Erdafixen 4 mg focuses solely on cells harboring FGFR alterations, minimizing harm to surrounding healthy tissues.
Clinical Efficacy
Erdafixen 4 mg received its approval based on data from the Phase 2 BLC2001 clinical trial in patients with FGFR-altered urothelial carcinoma who either progressed on prior chemotherapy or were not eligible for chemotherapy. Key findings included:
- An objective response rate (ORR) of 40 percent — 40 percent of patients seeing their tumor shrink.
- Pulling out a median duration of response of 5.6 months. Meaning many of the benefits were sustained.
- Better quality of life for those patients who had few other treatment options.
Erdafixen 4 mg has the potential to deliver clinically relevant benefits for patients with advanced or metastatic disease, as demonstrated by these results.
Dosage and Administration
- The initial dose of Erdafitinib is 8 mg (two 4 mg tablets) orally once daily.
- The dose can be increased to 9 mg daily after two weeks, depending on the patient’s response, and serum phosphate levels.
- The tablets can be taken with or without food and should be swallowed whole.)
- If a dose is missed, take as soon as possible on the same day, do not double dose.
→ Regular screening for phosphate levels, liver function and ophthalmic examination is crucial for patient safety and impacts on management.
Side Effects and Safety Considerations
While Erdafixen 4 mg is generally well-tolerated, it is associated with a range of potential side effects. The most common include:
- Hyperphosphatemia (elevated phosphate levels)
- Fatigue
- Nausea and vomiting
- Diarrhea
- Dry mouth
- Decreased appetite
- Vision changes
More serious but less common side effects may include ocular disorders, hand-foot syndrome, and elevated liver enzymes.
Precautions and Warnings
- Eye Health Monitoring: There have been reported cases of vision-threatening ocular conditions with use of erdafitinib, such as retinal detachment. Notify them of any changes in vision immediately.
- Phosphate Level Regular Monitoring: Because the drug impacts phosphate metabolism, routine blood tests must be taken to evaluate the patient’s phosphate levels.
- Use in Pregnancy: Erdafitinib may cause fetal harm and is not recommended for use during pregnancy.
- Drug Interactions: Patients need to also disclose to their doctor any other medications that they are taking to minimize potentially harmful interactions.
Advantages of Erdafixen 4 mg
- Precision Medicine: Erdafixen 4 mg targets specific genetic alterations, offering a personalized approach to cancer treatment.
- Oral route: Take it as an oral medication, which has better patient compliance and quality of life than intravenous therapeutics.
- Hope for Resistant Cancers: In cases of FGFR-altered urothelial carcinoma for which previous treatments have been exhausted, Erdafixen 4 mg is a new pathway.
Challenges and Future Directions
Though promising, Erdafixen 4 mg presents difficulties. Over time, resistance to FGFR inhibitors can develop, therefore restricting the long-term efficacy of the medicine. Combining therapy with additional targeted drugs or immunotherapies is one of the actively studied ways to overcome resistance.
Furthermore under investigation are the possibilities of Erdafixen 4 mg in various FGFR-driven tumors including lung cancer, breast cancer, and cholangiocarcinoma (bile duct cancer). These initiatives could increase the potential therapeutic uses for Erdafixen 4 mg.
Conclusion
In the field of targeted cancer treatment, Erdafixen 4 mg (Erdafitinib) marks a notable progress. For those with few therapy choices, it gives hope by tackling the particular genetic causes of some tumors. Erdafixen 4 mg has the ability to change the life of innumerable patients all around as study keeps finding fresh uses and improves its application.
For those with FGFR-altered tumors, Erdafixen 4 mg is more than simply a pharmaceutical; it’s evidence of the force of precision medicine and the unrelenting search for improved cancer treatments.
Disclaimer: This information is provided solely for educational reasons and should not be considered medical advice. Always consult with your doctor or healthcare professional before taking any drug.
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