Xbira

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BRAND :  XBIRA PRICE :  575$ STRENGTH : 250MG ACTIVE :  XBIRA-ABIRATERONE-ACETATE-250MG COMPANY NAME :  CIPLA TABLETS :  120 TABLETS read more

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Drug profile of Xbira

Xbira 250mg tablets 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 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.

Brand name: Xbira

Active substance: Abiraterone acetate

Strength: 250mg

Mfg: Cipla

Pack: 120 tablets in a container

Classified as: Anti-neoplastic agent

 

Prescribing information of Xbira

The most important indication of Xbira 250mg tablets 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 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 enzyme is essential for androgen biosynthesis which is expressed in testicular, adrenal & prostatic cancer cells.

A CYP17 enzyme activates two consecutive reactions;

  1. Transformation of pregnenolone & progesterone to their 17 alpha hydroxy derivatives with the help of 17 alpha hydroxylase.
  2. Production of dehydroepiandrosterone & androstenedione, relatively by CYP17, 20 lyase activity.

DHEA & androstenedione are androgens which as messenger of testosterone.

Abiraterone involved in inhibiting this CYP17 which may also leads to cause elevation of mineralocorticoid formation by adrenals.

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 is used to reduce testosterone level and will affect the growth of tumor cells.

Absorption

Maximum plasma concentration of Xbira is reaches within 2 hours after drug intake.

The systemic exposure of Xbira 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.

Distribution

Xbira  250mg 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 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

In advanced CRPC:

The prescribed dose of Xbira 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 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 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 should not be recommended.

Hepatotoxicity:

Patient suffered with liver toxicity, during the treatment Xbira 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 therapy permanently, if patients may have current elevation of AST & ALT.

Concurrent use of Xbira with CYP3A4 inducers:

In case concurrent use of Xbira 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

Fatigue

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

Drug- drug interaction

The concomitant use of Xbira with CYP3A4 inducers like rifampin, causes decreasing the exposure of Abiraterone.

To avoid this condition, increases the dose of Xbira for reducing the problems.

Xbira 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.

In combination of Xbira with pioglitazone, causes increasing the systemic exposure of pioglitazone.

Food drug interaction

Consuming food with Xbira, leads to elevate the level of Xbira 250mg  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 is contraindicated to pregnant & lactating women

Hypersensitivity reactions may occur due to patients is contraindicating to the component present in the Xbira tablets.

Safety measures

Hypertension, hypokalemia & fluid retention:

Xbira inhibits CYP17, causes increasing the mineralocorticoid levels leads to hypokalemia, hypertension & retention of fluids.

Concurrent use of Xbira 250mg 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 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 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: X

Xbira should not be used in pregnancy condition

Breast feeding should not be allowed.

The potency of Xbira tablets has not been evaluated in pediatric patients.

No drug safety evaluated in geriatric patients above 65 years of age.

Storage and handling

Xbira tablet container should be stored at 20oC to 25oC

Keep the container free from moisture, heat & light

Missed dose

Missed dose of Xbira 250mg tablets 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.

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