Apalunix Apalutamide 60mg composition

Product Name: Apalutamide

Product Specification: 60 mg × 120 tablets/box

Manufacturer: Beacon Pharmaceuticals

Apalutamide is a second-generation, highly selective androgen receptor antagonist; its affinity for the androgen receptor is more than five times that of first-generation androgen receptor antagonists. A Phase III study involving 1,207 patients with non-metastatic castration-resistant prostate cancer demonstrated that apalutamide significantly prolonged metastasis-free survival compared to placebo (40.5 vs. 16.2 months). On February 14, 2018, apalutamide received FDA approval for the treatment of non-metastatic (cancer cells have not spread) castration-resistant (disease progresses despite hormone therapy) prostate cancer.

[Indications]

Apalutamide tablets are indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

[Dosage and Administration]

240 mg (4 tablets) once daily.

[Precautions]

Warnings and Precautions

● 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-targeting agents according to established guidelines.

● Seizures occurred in 0.2% of patients receiving ERLEADA. Permanently discontinue ERLEADA in patients who experience a seizure during treatment.

[Adverse Reactions]

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

[Drug Interactions]

Concomitant use with drugs that are sensitive substrates of CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may result in a loss of activity of these drugs. 【Dose Modification】

For Grade 3 toxicity or intolerable adverse effects:

Hold the dose until symptoms improve to ≤Grade 1 or baseline; then, if necessary, resume treatment at the same dose or a reduced dose (180 mg or 120 mg).

【Dosing Precautions】

Patients receiving anti-androgen therapy (e.g., apalutamide) should also receive a concomitant gonadotropin-releasing hormone (GnRH) analog (e.g., leuprolide, triptorelin, goserelin, histrelin) or undergo bilateral orchiectomy.

【Use in Special Populations】

Females and males of reproductive potential: Men with female partners of reproductive potential are advised to use effective contraception.

【Storage and Handling】

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) [see USP Controlled Room Temperature].

Store in the original packaging; do not discard the desiccant. Protect from light and moisture.

Specifications

Product Name: Apalunix (Apalutamide) 60 mg × 120 tablets (also known as Erleada / ARN-509)

Common Name: Apalutamide

Active Ingredient: Apalutamide

Dosage Form: Tablet

Specification: 60 mg × 120 tablets

Manufacturer: Beximco Pharmaceuticals

Indication: Apalutamide tablets are indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Dosage and Administration: 240 mg (4 tablets) once daily.