Abiralieva 250 — Abiraterone Acetate 250 mg (120 Tablets)

Abiralieva is available in tablet form, with each tablet containing the optimal dosage of the active substance:

• Active Compound: Abiraterone Acetate — 250 mg per tablet.
• Excipients: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium (ensuring proper substance release), magnesium stearate, and sodium lauryl sulfate.
• Appearance: The tablets have a stable structure and specific marking confirming the product's authenticity.

Pharmacodynamics: Abiraterone acetate is converted in the body into abiraterone, which irreversibly blocks the CYP17 enzyme. This leads to a sharp decrease in serum testosterone levels to undetectable values. Without androgen support, tumor growth slows down or stops altogether.

Pharmacokinetics: Maximum plasma concentration is reached within 2 hours after administration. It is crucial to note that taking the drug with food drastically increases its absorption (up to 10 times), which may lead to toxicity; therefore, it must be taken strictly on an empty stomach.

Abiralieva 250 mg is used in combination therapy with steroid medications (usually prednisolone) for:

• 🔹 Metastatic Castration-Resistant Prostate Cancer (mCRPC): In patients with disease progression during or after chemotherapy.
• 🔹 Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): As first-line therapy to prevent the rapid spread of metastases.

Adhering to the administration rules is key to the safety and effectiveness of the treatment:

• Standard Regimen: The recommended dose is 1000 mg (exactly 4 tablets of 250 mg each) once daily.
• Administration Schedule: Tablets must be taken strictly on an empty stomach — at least 1 hour before a meal or 2 hours after.
• Crucial Condition: The drug is always taken in combination with low doses of prednisolone (to prevent fluid retention and hypertension).
• Method: Tablets should not be chewed or broken; they must be swallowed whole with water.

Main limitations for prescribing the medication:

• ⛔ Severe Hepatic Impairment: The drug is metabolized in the liver, so serious functional disorders are a contraindication.
• ⛔ Gender and Age: Not intended for women or children. Strictly prohibited during pregnancy.
• ⛔ Cardiac Pathologies: Use with caution in cases of severe heart failure or uncontrolled hypertension.
• ⛔ Hypersensitivity: Allergic reactions to abiraterone or excipients.

Abiraterone affects the performance of other medications:

• ❌ CYP2D6 Substrates: May increase the concentration of drugs such as dextromethorphan or metoprolol.
• ❌ CYP3A4 Inducers: For example, rifampicin may decrease the effectiveness of Abiralieva.
• ⚠️ Attention: Inform your doctor if you are taking medications for arrhythmia or strong painkillers.

Special precautions when handling the medication:

• For Patients: Abiraterone may be present in semen. The use of a condom is mandatory if the partner is pregnant or may become pregnant.
• For Others: Pregnant women are prohibited from touching damaged or broken tablets without protective gloves, as the drug is absorbed through the skin.

When used in combination with prednisolone, side effects are usually manageable:

• 🟢 Very Common: Swelling of the extremities, low blood potassium levels, increased blood pressure.
• 🟡 General: Diarrhea, urinary tract infections, hot flashes.
• 🟡 Laboratory: Increased levels of liver enzymes (ALT/AST).
• ⚠️ Important: Regular monitoring of blood pressure and blood tests is mandatory throughout the treatment period.

Specific symptoms of acute overdose have not been described, but the risks increase:

• Risks: Increased toxic effects on the liver and the cardiovascular system.
• Aid: No specific antidote exists. Gastric lavage and supportive therapy in a hospital setting are recommended.
• Monitoring: Mandatory dynamic monitoring of liver functions.

Conditions to ensure the stability of the drug:

• 🌡️ Temperature: Store at temperatures between 15°C and 30°C in a dry place.
• 📦 Packaging: Tablets must be kept in a tightly closed original bottle or blister.
• 👶 Safety: Keep in a place inaccessible to children.
• ⏳ Quantity: Each pack contains 120 tablets (or another quantity as per the photo marking — 20 Tablets), designed for a specific stage of the course.