Description
Description: Xbira, manufactured by Cipla Ltd., is a pharmaceutical formulation comprising 250 mg tablets of the active ingredient Abiraterone. Xbira is a potent medication indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men. As an oral therapy, Xbira offers convenience and efficacy in managing advanced prostate cancer, providing patients with a valuable option to help slow disease progression and improve quality of life.
Active Substance: The active substance in Xbira is Abiraterone, a selective inhibitor of the enzyme CYP17A1, which plays a crucial role in androgen biosynthesis. By inhibiting CYP17A1, Abiraterone blocks the production of androgens (male hormones), including testosterone and dihydrotestosterone (DHT), which fuel the growth and progression of prostate cancer cells, particularly in the castration-resistant setting.
Indications: Xbira is indicated for the treatment of:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC): Xbira is used in combination with prednisone or prednisolone as a second-line or subsequent-line therapy for adult men with mCRPC who have progressed on or are intolerant to prior androgen deprivation therapy (ADT) and docetaxel-based chemotherapy.
Mechanism of Action: Abiraterone exerts its anticancer effects by:
- Inhibiting Androgen Biosynthesis: Abiraterone selectively inhibits the enzyme CYP17A1, which is involved in the production of androgens in the adrenal glands, testes, and prostate cancer cells, leading to a significant reduction in circulating testosterone and intratumoral DHT levels.
- Suppressing Prostate Cancer Growth: By depriving prostate cancer cells of androgen signaling, Abiraterone inhibits cell proliferation, induces apoptosis (programmed cell death), and slows tumor growth and progression in patients with mCRPC.
Benefits:
- Extended Survival: Clinical studies have demonstrated that treatment with Xbira in combination with prednisone or prednisolone prolongs overall survival and progression-free survival in patients with mCRPC, offering hope for improved clinical outcomes and quality of life.
- Oral Administration: Xbira is available in convenient oral tablet form, allowing for easy administration at home or under medical supervision, thereby enhancing patient convenience and treatment adherence.
- Well-Tolerated Profile: Xbira has a manageable side effect profile, with most adverse effects being mild to moderate in severity and manageable with supportive care and dose adjustments.
How to Use: Xbira tablets should be taken orally once daily, preferably on an empty stomach, at least one hour before or two hours after meals, with water. The tablets should be swallowed whole and should not be crushed, chewed, or divided. It is essential to follow the prescribing healthcare provider’s instructions regarding dosage and duration of treatment.
Dosage: The recommended dosage of Xbira varies depending on the specific indication and individual patient factors. The standard dosage regimen for Xbira in combination with prednisone or prednisolone is one 250 mg tablet taken orally once daily. Dosage adjustments may be necessary based on factors such as liver function, adverse effects, and treatment response.
Efficacy: Clinical trials and real-world evidence have demonstrated the efficacy of Xbira in prolonging overall survival and progression-free survival in patients with mCRPC who have progressed on or are intolerant to prior ADT and docetaxel-based chemotherapy. Its targeted mechanism of action and broad spectrum of activity make it a valuable option for patients with this challenging malignancy.
Storage: Xbira tablets should be stored according to the manufacturer’s instructions, typically at controlled room temperature, away from moisture, heat, and direct sunlight. The medication should be kept in its original packaging and protected from freezing or extreme temperatures. Unused tablets should be disposed of properly according to local regulations.
Side Effects: Common side effects of Xbira may include fatigue, hypertension (high blood pressure), fluid retention, hypokalemia (low potassium levels), and elevated liver enzymes. Less common but more severe side effects may include adrenal insufficiency, hepatotoxicity, and cardiovascular events. Patients should be monitored regularly for adverse effects, and any concerning symptoms should be reported to the healthcare provider promptly.
Precautions: Certain precautions should be observed when using Xbira:
- Hepatic Function: Xbira may cause hepatotoxicity, so liver function tests should be performed regularly during treatment, and dosage adjustments may be necessary in patients with impaired liver function.
- Adrenal Function: Xbira may suppress adrenal function and exacerbate adrenal insufficiency, particularly in patients receiving concomitant corticosteroid therapy. Adrenal function should be monitored regularly, and corticosteroid doses may need to be adjusted accordingly.
- Pregnancy and Lactation: Xbira may cause fetal harm if used during pregnancy, so it should be avoided in pregnant women or women planning to become pregnant. Breastfeeding should be discontinued during Xbira therapy.
In summary, Xbira by Cipla Ltd. offers a targeted and effective treatment option for patients with metastatic castration-resistant prostate cancer (mCRPC). With its well-established efficacy, convenient oral administration, and manageable side effect profile, Xbira provides hope for patients battling this challenging malignancy and may help improve survival outcomes and quality of life.
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