Apalutamide is suitable for specific types of prostate cancer patients and should be used in combination with GnRH analogs or for patients who have undergone bilateral orchidectomy.

1. Drug name

Common name: Apalutamide

Product Name: ERLEADA.

2. Indications

Used for the treatment of non metastatic castration resistant prostate cancer (NM-CRPC) patients.

3. Specifications and characteristics

Specification: 60mg/tablet.

Appearance: Tablets.

4. Main components

The active ingredient is Apalutamide, with the chemical name 4- [7- (6-cyano-5-trifluoromethylpyridin-3-yl) -8-oxo-6-thio-5,7-diazaspiro [3.4] oct-5-yl] -2-fluoro-N-methylbenzamide.

5. Usage and dosage

Recommended dosage: Take 240mg orally once daily (4 60mg tablets), whole tablet, before or after meals.

Combination therapy: Simultaneously receiving gonadotropin-releasing hormone (GnRH) analogs or bilateral orchidectomy.

Dose adjustment: If there is ≥ grade 3 toxicity or intolerable side effects, the medication should be suspended until the symptoms improve to ≤ grade 1 or the original grade, and the original dose can be restored or reduced (180mg or 120mg).

6. Medication precautions

Omission: If missed, please make up for it as soon as possible on the same day, and continue according to the original plan the next day. No additional make-up is allowed.

Vomiting: If vomiting occurs after taking the medication, there is no need to take it again. Follow the original plan for the next dose..

Before and after meals: There are no dietary restrictions, but high-fat meals may delay absorption by about 2 hours.

7. Medication for special populations

Pregnancy: Prohibited, may cause harm to the fetus.

Breastfeeding period: No data available, not recommended for use.

Elderly: Patients over 65 years old need to be monitored for adverse reactions (such as fracture and fall risk).

Liver and kidney function: Mild to moderate injury does not require dose adjustment, severe data is insufficient.

8. Adverse reactions

Common reactions (≥ 10%): fatigue (39%), hypertension (25%), rash (24%), diarrhea (20%), joint pain (16%), fractures (12%), etc.

Serious risks: falls (16% vs 9%), epilepsy (0.2%), cardiovascular events (such as myocardial infarction).

9. Contraindications

Pregnancy (can cause harm to the fetus).

Prohibited for individuals allergic to ingredients.

10. Drug interactions

CYP3A4/2C19 inducers, such as rifampicin, may reduce exposure to apatamide.

CYP3A4 inhibitors, such as ketoconazole, may increase the concentration of apatamide.

P-gp/BCRP substrates, such as rosuvastatin, may reduce their efficacy.

11. Storage method

The original packaging should be protected from light and moisture, with a temperature range of 20-25 ℃ (allowing fluctuations of 15-30 ℃).

Do not discard desiccants and avoid contact with children.

Apalutamideinformation