Apalunix

Brand: 孟加拉碧康

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Apalutamide (Apalutamide) instructions

Common name: Apalutamide
Trade name: Erleada
Full names: Apalutamide film tablets, Onco, apalutamide, apalutamide, Apalutamide, Erleada

Indications:
It is suitable for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC), metastatic castration-sensitive prostate cancer (mCSPC), metastatic hormone-sensitive prostate cancer (mHSPC) and castration-sensitive prostate cancer (CSPC) with high risk of metastasis.

Dosage:
The recommended daily oral dose is 240 mg (four 60 mg tablets).

Used orally.
Tablets should be swallowed whole and may be taken with or without food.

Adverse reactions:
The most common adverse reactions (≥10%) are fatigue, hypertension, rash, diarrhea, nausea, weight loss, joint pain, falls, hot flashes, decreased appetite, fractures, and peripheral edema.

Contraindications:
Hypersensitivity to the active substance or any of the listed excipients.

Pregnancy.

Notes:
Falls and fractures occurred in 16% and 12% of patients receiving ERLEADA, respectively. Evaluate patients for fracture and fall risk and treat patients with bone-targeted agents according to established guidelines.
Elepsy occurs in 0.2% of patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who develop epilepsy during treatment

Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in original packaging and do not discard desiccant. Protected from light and moisture.

Mechanism of action:
Apalutamide is an orally administered selective androgen receptor (AR) inhibitor that binds directly to the ligand-binding domain of AR. Apalutamide prevents AR nuclear translocation, inhibits DNA binding, blocks AR-mediated transcription, and lacks androgen receptor agonist activity. Apalutamide treatment reduced tumor cell proliferation and increased apoptosis, resulting in potent antitumor activity. One major metabolite, N-desmethylapalutamide, exhibits one-third the in vitro activity of apalutamide. In a mouse xenograft model of prostate cancer, administration of apalutamide caused reduced tumor cell proliferation and increased apoptosis, resulting in a reduction in tumor volume.

Safety and Efficacy:
The safety and efficacy of Erleada were based on a randomized clinical trial of 1,207 patients with non-metastatic, castration-resistant prostate cancer. Patients in the trial received Erleada or a placebo. All patients also received hormone therapy, either with gonadotropin-releasing hormone (GnRH) analogues or surgery to lower the amount of testosterone in the body (surgical castration). The median metastasis-free survival for patients taking Erleada was 40.5 months, compared with 16.2 months for those taking placebo.