APADX Apalutamide Tablets 60mg

【English Name】Apalutamide Tablets

【Other Names】Apalutamide / Erleada / Ansenke

【Specification】60mg × 120 tablets/box

【Manufacturer】Bigbear Pharmaceutical Laos

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-targeted 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 Adjustments】

For Grade 3 toxicity or intolerable adverse reactions:

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 Considerations】

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.