XBIRA
Drug profile of Xbira
xbira 250mg tablet are containing an active component known as Abiraterone acetate which exhibits anti-tumor activity against prostate cancer.xbira 250mg Cipla is a derivative of androstene, which involves in the prohibition process of steroid 17 alpha hydroxylase and containing anti-neoplastic activity.
Abiraterone acetate xbira 250mg tablet 250mg is an oral tablet which is an active acetate ester form of steroidal compound known as Abiraterone with anti-androgenic activity.
Abiraterone acetate 250mg is involved by interfering with testosterone activity by inhibiting the synthesis.
PRODUCT DETAILS :
Brand name: XbiraActive substance: Abiraterone acetate
Strength: 250mg
Mfg: Cipla
Pack: 120 tablets in a container
Classified as: Anti-neoplastic agent
Price : xbira 250mg price in India
Metastatic castration resistance prostate cancer
Metastatic high risk castration sensitive prostate cancer
Involved in the treatment of metastatic castration resistance prostate cancer patients who are not responding prior chemotherapy regimen called docetaxel in concomitant with prednisolone.
For the treatment of metastatic CRPC in grown-up men who are asymptomatic or somewhat symptomatic after disappointment of androgen deprivation treatment in whom chemotherapy isn't clinically shown, with prednisone or prednisolone
Abiraterone, an active form which expels its action on androgen biosynthesis by inhibiting an enzyme called 17 alpha hydroxylase/C17, 20-lyase (CYP17).
This xbira 250mg enzyme is essential for androgen biosynthesis which is expressed in testicular, adrenal & prostatic cancer cells.
A CYP17 enzyme activates two consecutive reactions;
Transformation of pregnenolone & progesterone to their 17 alpha hydroxy derivatives with the help of 17 alpha hydroxylase.
Production of dehydroepiandrosterone & androstenedione, relatively by CYP17, 20 lyase activity.
DHEA & androstenedione are androgens which as messenger of testosterone.
Abiraterone (xbira 250mg )involved in inhibiting this CYP17 which may also leads to cause elevation of mineralocorticoid formation by adrenals.
xbira 250mg tablet Androgen deprivation treatment such as gonadotrophin releasing hormone agonist or orchiectomy may decrease the androgen production in the testes not in adrenals or tumor.
xbira 250mg is used to reduce testosterone level and will affect the growth of tumor cells.
The systemic exposure of xbira 250mg tablet elevates while administered with meals.
Food should not be taken for at least 2 hours earlier the dose of Xbira or at least one hour after the dose of xbira 250mg .
Volume of distribution of Abiraterone is 19669 ± 13358L
Two major circulating metabolite of Abiraterone is;
Abiraterone sulphate
N-oxide Abiraterone sulphate
88% of metabolite is excreted through feces; 5% in urine.
The component present in feces is an unchanged form of Abiraterone.
When to take the Xbira
xbira 250mg tablet should be administered on an empty stomach and food not taken for at least 2 hour before the dose or 1 hour after the dose.
Dosage regimens of xbira 250mg
In advanced CRPC:
The prescribed dose of xbira 250mg tablet is 1000mg should be administered as a once daily with 5mg of prednisolone should be given two times a day
In advanced high risk CSPC:
The prescribed dose of xbira 250mg is 1000mg should be administered as a once daily with 5mg of prednisolone should be given two times a day
In moderate hepatic damage patients, the dose of xbira 250mg tablet should be reduced to 250mg as a single dose.
In moderate liver damaged patients, AST & ALT level should be monitored frequently.
In severe liver damaged patients, xbira 250mg should not be recommended.
Therapy should be resumed at reduced dose of 750mg as a single dose.
If liver toxicities reappear with the dose of 750mg, should be retreated with 500mg single dose followed with LFT.
Discontinue the xbira 250mg tablet therapy permanently, if patients may have current elevation of AST & ALT.
Concurrent use of Xbira with CYP3A4 inducers:
In case concurrent use of xbira 250mg tablet with CYP3A4 inducers, the frequency of Xbira tablets should be increased to two times a day, it may only occur in co administration time.
If co administration discontinues, then frequency changes to once daily.
Joint pain, swelling or discomfort
Hot flush
Hypertension
Diarrhea
Vomiting
Cough
Hypertension
Dyspnea
Urinary tract infection
Contusion
Lab abnormalities:
Anemia
Increasing alkaline phosphatase
Hypertriglyceridaemia
Lymphopenia
Hypercholestremia
Hyperglycemia
Increased AST, AST
Hypophosphatemia
Hypokalemia
Post marketing reports:
Non infectious pneumonitis
Myopathy, involving rhabdomyolysis
Fulminant hepatitis, acute hepatic failure leads to death
To avoid this condition, increases the dose of xbira 250mg tablet for reducing the problems.
xbira 250mg is an inhibitor of CYP2D6 & CYP2C8, when administering 30mg of dextromethorphan with Xbira 100mg & 5mg of prednisolone causes increasing the AUC & Cmax of dextromethorphan (CYP2D6 substrate).
Avoid the co administration of CYP2D6 substrate with xbira 250mg tablet.
In combination of Xbira with pioglitazone, causes increasing the systemic exposure of pioglitazone.
Risk factors like, increased blood pressure, water retention, hypokalemia
Food should not be taken at least 2 hours before or 1 hour after the dose of Xbira
Hypersensitivity reactions may occur due to patients is contraindicating to the component present in the xbira 250mg tablet.
xbira 250mg inhibits CYP17, causes increasing the mineralocorticoid levels leads to hypokalemia, hypertension & retention of fluids.
Concurrent use of xbira 250mg tablet with corticosteroid leads to diminish adrenocorticotrophic hormone which concludes as reduction in extent & harshness of these adverse effects.
Control the blood pressure and correct the level of potassium and fluids if required.
Adrenocortical insufficiency:
Adrenocortical deficiency occurs during the therapy of xbira 250mg with prednisolone.
In this condition, treatment should be interrupt or discontinue.
Monitor the signs & symptoms occurred due to this condition.
Elevation of dose of corticosteroids occurs in both before and during the treatment.
Increasing AST, bilirubin, ALT may leads to this condition.
Patients may undergo Hepatic function test frequently before or during the treatment.
xbira 250mg tablet should not be used in pregnancy condition
Breast feeding should not be allowed.
The potency of xbira 250mg has not been evaluated in pediatric patients.
No drug safety evaluated in geriatric patients above 65 years of age.
Keep the container free from moisture, heat & light
Consult with medical oncologist and follow the instructions
Follow the regular dosing schedule
Provide supportive measures
Monitor the patients for arrhythmia, cardiac failure & determines liver function to reduce the liver injuries.
PHONE NO : +91-9940472902
WEBSITE URL : https://pillsbag.com/products/xbira
KEYWORDS : xbira,xbira 250mg,xbira 250mg tablet,xbira 250mg price in India
Prescribing information of Xbira
The most important indication of xbira 250mg tablet is;Metastatic castration resistance prostate cancer
Metastatic high risk castration sensitive prostate cancer
Involved in the treatment of metastatic castration resistance prostate cancer patients who are not responding prior chemotherapy regimen called docetaxel in concomitant with prednisolone.
For the treatment of metastatic CRPC in grown-up men who are asymptomatic or somewhat symptomatic after disappointment of androgen deprivation treatment in whom chemotherapy isn't clinically shown, with prednisone or prednisolone
Mechanism of Xbira 250mg Cipla :
xbira 250mg tablet consisting of Abiraterone acetate is a prodrug form which get altered into Abiraterone inside the body after oral administration.Abiraterone, an active form which expels its action on androgen biosynthesis by inhibiting an enzyme called 17 alpha hydroxylase/C17, 20-lyase (CYP17).
This xbira 250mg enzyme is essential for androgen biosynthesis which is expressed in testicular, adrenal & prostatic cancer cells.
A CYP17 enzyme activates two consecutive reactions;
Transformation of pregnenolone & progesterone to their 17 alpha hydroxy derivatives with the help of 17 alpha hydroxylase.
Production of dehydroepiandrosterone & androstenedione, relatively by CYP17, 20 lyase activity.
DHEA & androstenedione are androgens which as messenger of testosterone.
Abiraterone (xbira 250mg )involved in inhibiting this CYP17 which may also leads to cause elevation of mineralocorticoid formation by adrenals.
xbira 250mg tablet Androgen deprivation treatment such as gonadotrophin releasing hormone agonist or orchiectomy may decrease the androgen production in the testes not in adrenals or tumor.
xbira 250mg is used to reduce testosterone level and will affect the growth of tumor cells.
Absorption
Maximum plasma concentration of xbira 250mg is reaches within 2 hours after drug intake.The systemic exposure of xbira 250mg tablet elevates while administered with meals.
Food should not be taken for at least 2 hours earlier the dose of Xbira or at least one hour after the dose of xbira 250mg .
Distribution
xbira 250mg tablet is largely bound to human plasma protein with >99%.Volume of distribution of Abiraterone is 19669 ± 13358L
Metabolism
Abiraterone acetate is undergone hydrolysis and leads to change into Abiraterone which is an active form.Two major circulating metabolite of Abiraterone is;
Abiraterone sulphate
N-oxide Abiraterone sulphate
Excretion
The terminal mean half life of Xbira is 12 ± 5 hours.88% of metabolite is excreted through feces; 5% in urine.
The component present in feces is an unchanged form of Abiraterone.
When to take the Xbira
xbira 250mg tablet should be administered on an empty stomach and food not taken for at least 2 hour before the dose or 1 hour after the dose.
Dosage regimens of xbira 250mg
In advanced CRPC:
The prescribed dose of xbira 250mg tablet is 1000mg should be administered as a once daily with 5mg of prednisolone should be given two times a day
In advanced high risk CSPC:
The prescribed dose of xbira 250mg is 1000mg should be administered as a once daily with 5mg of prednisolone should be given two times a day
Dose alteration:
In liver impairment patients:In moderate hepatic damage patients, the dose of xbira 250mg tablet should be reduced to 250mg as a single dose.
In moderate liver damaged patients, AST & ALT level should be monitored frequently.
In severe liver damaged patients, xbira 250mg should not be recommended.
Hepatotoxicity:
Patient suffered with liver toxicity, during the treatment xbira 250mg tablet should be postponed and provide supportive measures.Therapy should be resumed at reduced dose of 750mg as a single dose.
If liver toxicities reappear with the dose of 750mg, should be retreated with 500mg single dose followed with LFT.
Discontinue the xbira 250mg tablet therapy permanently, if patients may have current elevation of AST & ALT.
Concurrent use of Xbira with CYP3A4 inducers:
In case concurrent use of xbira 250mg tablet with CYP3A4 inducers, the frequency of Xbira tablets should be increased to two times a day, it may only occur in co administration time.
If co administration discontinues, then frequency changes to once daily.
Xbira caused side effects
FatigueJoint pain, swelling or discomfort
Hot flush
Hypertension
Diarrhea
Vomiting
Cough
Hypertension
Dyspnea
Urinary tract infection
Contusion
Lab abnormalities:
Anemia
Increasing alkaline phosphatase
Hypertriglyceridaemia
Lymphopenia
Hypercholestremia
Hyperglycemia
Increased AST, AST
Hypophosphatemia
Hypokalemia
Post marketing reports:
Non infectious pneumonitis
Myopathy, involving rhabdomyolysis
Fulminant hepatitis, acute hepatic failure leads to death
Drug- drug interaction
The concomitant use of xbira 250mg with CYP3A4 inducers like rifampin, causes decreasing the exposure of Abiraterone.To avoid this condition, increases the dose of xbira 250mg tablet for reducing the problems.
xbira 250mg is an inhibitor of CYP2D6 & CYP2C8, when administering 30mg of dextromethorphan with Xbira 100mg & 5mg of prednisolone causes increasing the AUC & Cmax of dextromethorphan (CYP2D6 substrate).
Avoid the co administration of CYP2D6 substrate with xbira 250mg tablet.
In combination of Xbira with pioglitazone, causes increasing the systemic exposure of pioglitazone.
Food drug interaction
Consuming food with xbira 250mg , leads to elevate the level of xbira 250mg tablet in the body.Risk factors like, increased blood pressure, water retention, hypokalemia
Food should not be taken at least 2 hours before or 1 hour after the dose of Xbira
Possible contraindications
xbira 250mg is contraindicated to pregnant & lactating womenHypersensitivity reactions may occur due to patients is contraindicating to the component present in the xbira 250mg tablet.
Safety measures
Hypertension, hypokalemia & fluid retention:xbira 250mg inhibits CYP17, causes increasing the mineralocorticoid levels leads to hypokalemia, hypertension & retention of fluids.
Concurrent use of xbira 250mg tablet with corticosteroid leads to diminish adrenocorticotrophic hormone which concludes as reduction in extent & harshness of these adverse effects.
Control the blood pressure and correct the level of potassium and fluids if required.
Adrenocortical insufficiency:
Adrenocortical deficiency occurs during the therapy of xbira 250mg with prednisolone.
In this condition, treatment should be interrupt or discontinue.
Monitor the signs & symptoms occurred due to this condition.
Elevation of dose of corticosteroids occurs in both before and during the treatment.
Hepatic toxicities:
In post marketing studies, due to xbira 250mg tablet therapy hepatic toxicity may occur due to acute hepatic injury leads to death.Increasing AST, bilirubin, ALT may leads to this condition.
Patients may undergo Hepatic function test frequently before or during the treatment.
Pregnancy and lactation
Pregnancy category: Xxbira 250mg tablet should not be used in pregnancy condition
Breast feeding should not be allowed.
The potency of xbira 250mg has not been evaluated in pediatric patients.
No drug safety evaluated in geriatric patients above 65 years of age.
Storage and handling
xbira 250mg tablet container should be stored at 20oC to 25oCKeep the container free from moisture, heat & light
Missed dose
Missed dose of xbira 250mg tablet should be avoided.Consult with medical oncologist and follow the instructions
Follow the regular dosing schedule
Over dosage
The over dose of xbira 250mg has no specific antidote.
Provide supportive measures
Monitor the patients for arrhythmia, cardiac failure & determines liver function to reduce the liver injuries.
CONTACT US
EMAIL ID : millionhealthpharmaceuticals@gmail.comPHONE NO : +91-9940472902
WEBSITE URL : https://pillsbag.com/products/xbira
KEYWORDS : xbira,xbira 250mg,xbira 250mg tablet,xbira 250mg price in India
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