Xbira 250 mg (Abiraterone)
Xbira 250 mg (Abiraterone) 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 approximately 200%. AUC24 dextrorphan, an active metabolite of dextromethorphan, increased by approximately 33%.
It is advisable to prescribe medication 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 narrow therapeutic index, metabolized via CYP2D6, should be considered. metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone, and tramadol.
Based on in vitro data, abiraterone is a substrate of the CYP3A4 isoenzyme. Caution should be exercised 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 together with food significantly increases the absorption of abiraterone acetate. The effectiveness and safety of abiraterone medicine, taken with food, is not established. Xbira should not be taken with food.
Increased blood pressure, hypokalemia and fluid retention due to excess mineralocorticoids
should be given with caution in patients with a history of cardiovascular disease. Safety of the medicine in 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 eliminated.
In patients receiving 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 decrease in the frequency and severity of these adverse events.
Caution should be exercised 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 least once a month.
In clinical studies, a marked 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 before starting Xbira, every 2 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 immediately 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 is carefully monitored.
Xbira 250 mg can 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 impossible.
Women of childbearing age
Is not suitable for use in women. It is assumed that taking CYP17 inhibitors by pregnant women will change the concentration of hormones, which can affect the development of the fetus. To prevent accidental exposure, pregnant or pregnant women should not work with the medicine without gloves.
Contraception in men and women
It is not known whether abiraterone or its metabolites are present in the sperm. It is necessary to use a condom if a sexual intercourse with a pregnant woman is planned. If the sexual act is planned with a woman of childbearing age, it is necessary to use a condom along with other effective methods of contraception.
Ability to conceive
Studies of the toxicity of abiraterone acetate for the reproductive system have not been conducted; there is no evidence of the effect of the medicine on fertility.
Pregnancy and lactatemia
Does not apply to women. There are no data on the use of Abiraterone in pregnant women. The medicine is contraindicated in pregnant women and able to become pregnant women. It is not known whether abiraterone acetate or its metabolites in milk is excreted.
The cancellation of SCS and relief of stressful situations
With the withdrawal of prednisone or prednisolone, caution should be exercised and signs of insufficiency of adrenal cortex function should be monitored. If the use of Abiraterone continues after the cancellation of the SCS, then the symptoms of excess mineralocorticoids should be monitored. In patients receiving prednisone or prednisolone, in case of stressful situations, an increased dose of GCS may be required before, during and after a stressful situation.
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 into account when treating patients receiving a diet with a controlled sodium content.
Influence 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.
Xbira 250 mg is an antitumor agent whose active substance is abiraterone. Additional components are also added to abiraterone: lactose monohydrate, MCC, carboxymethylcellulose, sodium dodecyl sulfate, pyrogenic silicon dioxide. XBIRA is a remedy for the treatment of prostate cancer. Apply once a day, without chewing and washing with a lot of water. To date, XBIRA is considered to be the most effective medicine for the treatment of prostate cancer, abiraterone limits the action of all the sources that produce hormones – androgens and are responsible for the functioning of the reproductive system of men. This is important, as hormones contribute to the emergence and increase of tumors in cancer. XBIRA is a medicine that slows down the CYP17 component necessary for the androgen biosynthesis process. Due to this, the work of all male hormones is suppressed. XBIRA reduces the process of accumulation of testosterone and other hormones to a minimum. Contraindications for use are inflammation and serious liver disease; it is prohibited for admission to underage children and people who are allergic to any of the constituents of the medicine.