Apalutamide (Erleada) is an innovative androgen receptor inhibitor primarily used for the treatment of specific types of prostate cancer. As a second-generation non-steroidal anti-androgen drug, it effectively inhibits tumor growth by directly blocking the androgen receptor signaling pathway.

Indications for Apalutamide (Erleada)

Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Apalutamide is indicated for adult patients with prostate cancer that has metastasized and remains sensitive to treatments that lower testosterone levels.

In clinical practice, it must be used in combination with gonadotropin-releasing hormone (GnRH) analogs, or administered to patients who have undergone bilateral orchiectomy.

Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)

Indicated for patients with prostate cancer that has not developed distant metastasis but has become resistant to conventional castration therapy.

In such patients, apalutamide can effectively delay the progression of the disease to the metastatic stage.

Specifications and Properties of Apalutamide (Erleada)

240mg Tablet

Appearance Characteristics: Bluish-gray to gray, oval-shaped film-coated tablet.

Marking System: Engraved with "E240" on one side using a dedicated embossing technique.

60mg Tablet

Appearance Characteristics: Light yellowish-green to grayish-green, rectangular film-coated tablet.

Marking System: Engraved with the "AR60" logo on one side.

Formulation Composition

Contains colloidal anhydrous silica, croscarmellose sodium, hypromellose acetate succinate, silicified microcrystalline cellulose, and magnesium stearate.

The film coating layer contains specific colorants and film-forming materials.

Storage Conditions for Apalutamide (Erleada)

Storage Temperature

Temperature Requirement: Store at 20°C to 25°C (68°F to 77°F); short-term storage within the range of 15°C to 30°C (59°F to 86°F) is permitted.

Special Storage Precautions

Light Protection Requirement: Must be stored in the original packaging to protect from light exposure.

Moisture Protection Measures: The original bottle contains a silica gel desiccant, which must not be discarded during use.

Child Protection: All packages are equipped with child-resistant closure devices.

Post-Use Management

Shelf Life After Opening: Once opened, the product should be used up within the specified time limit.

Abnormal Situation Handling: If the tablets show abnormalities such as discoloration or cracking, use must be stopped immediately.