Xbira Tablets

Description

Product Description

Xbira 250 mg (Abiraterone)

Xbira 250 mg (Abiraterone) helps in Treatment of hormone-safe prostate growth in patients with infection movement during or after chemotherapy including docetaxel (in a mix with prednisone or prednisolone).

Interaction of Abiraterone

In a study evaluating the effect of abiraterone acetate taken together with prednisone, on a single dose of dextromethorphan (substrate CYP2D6), the dextromethorphan AUC increased by 200%. AUC₂₄ dextrorphan, an active metabolite of dextromethorphan, increased by 33%.

It is advisable to prescribe medicine carefully to patients receiving medicines that are metabolized through the CYP2D6 system, especially for medicines with a narrow therapeutic index. In such cases, the possibility of reducing the dose of medicines with a low therapeutic index, metabolized via CYP2D6, should be considered. metoprolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone, and tramadol.

Based on in vitro data, abiraterone is a substract of the CYP3A4 isoenzyme. Caution should be taken with the simultaneous administration with strong inhibitors of the isoenzyme CYP3A4 (ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) and inductors (phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital).

Special instructions for the use of  Xbira

Taking Xbira 250 mg taken together with food significantly increases the absorption of abiraterone acetate. The effectiveness and safety of abiraterone medicine is not established when taken with food. Xbira should be taken without food (i.e empty stomach)

Increased blood pressure, hypokalemia and fluid retention due to excess mineralocorticoids should be taken with caution by patients with a history of cardiovascular disease. Safety of the medicine for patients with a fraction of left ventricular ejection <50% or heart failure III-IV functional class according to the NYHA classification is not established. Before starting the Xbira medicine, hypokalemia and arterial hypertension should be terminated.

In patients having abiraterone, an increase in blood pressure, hypokalemia and fluid retention due to an increase in the concentration of mineralocorticoids in the blood due to inhibition of CYP17 may occur. The introduction of SCS concomitantly with medicine weakens the stimulating effect of ACTH, which leads to a reduction in the frequency and severity of these adverse events.

Caution should be taken in the treatment of patients whose condition may worsen with increased blood pressure or the development of hypokalemia, for example, patients with heart failure, recent myocardial infarction, or ventricular arrhythmia. AD, potassium concentration in the blood plasma and the degree of fluid retention should be monitored at regular intervals

Hepatotoxicity

In clinical studies, we have noticed increase in the activity of liver enzymes, requiring the elimination or correction of the dose of the medicine. The activity of serum transaminases and bilirubin should be measured prior to starting Xbira, every 1 weeks in the first 3 months of treatment, and then monthly. With the development of clinical symptoms and signs suggesting a violation of liver function, it should instantly measure the activity of serum transaminases, in particular ALT. If the activity of ALT is 5 times higher than IGN or bilirubin concentration is 3 times higher than ULN, Xbira should be stopped immediately and the liver function should be carefully monitored.

Xbira 250 mg should be used again only after the return of liver function to the baseline values and only when treated with lower doses.

If patients in any period of therapy develop a severe form of hepatotoxicity (ALT activity exceeds VGN 20 times), Abiraterone should be withdrawn, re-administration of the medicine in such patients is not adisable.

Women of childbearing age

Should not be prescribed to women. It is assumed that taking CYP17 inhibitors by pregnant women will change the concentration of hormones, which can affect the development of the baby. To prevent accidental exposure, pregnant women should not work with the medicine without gloves.

Information on some excipients included with the preparation

This medication contains 1 mol (27.2 mg) of sodium in each dose (4 tablets), which should be taken considered when treating patients receiving a diet with a controlled sodium content.

Effect on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. Xbira medicine (Abiraterone) has no effect or has a negligible effect on the ability to drive and move vehicles.