阿帕鲁胺Erleada(apalutamide Tablets)

Aparu amine Erleada(apalutamide Tablets) is suitable for the treatment of patients with non-metastatic castration-resistant prostate cancer.

[Specification]
This product is a tablet, and each tablet contains 60mg of active ingredients.

[Method of administration]
240mg(4 tablets) once a day.

【 Precautions 】
Warnings and precautions
● 16% and 12% of patients who received ERLEADA had falls and fractures respectively. Evaluate that patient’s risk of fracture and fall, and treat patients with bone-targeted drug according to established guidelines.
● Epilepsy occurs in 0.2% of patients receiving ERLEADA. Patients with epilepsy during treatment permanently terminate ERLEADA.

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

drug interaction
● Simultaneous use with sensitive substrates whose drugs are CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may lead to the inactivation of these drugs.

Use in special people.
● Women and men with reproductive potential: It is recommended that men with female partners with reproductive potential use effective contraception.

How to supply/store and dispose
ERLEADA(apalutamide) 60mg film-coated tablets are slightly yellow to grayish green oval tablets with “AR 60” recessed on one side. ERLEADA 60mg tablets are available in 120 tablet bottles. Each bottle contains silica gel desiccant.
NDC No.5967600
Storage and disposal
Store at 20°C to 25 C (68 F to 77°F); Go out to 15°C to 30 C (59 F to 86°F) [see USP Controlled Room Temperature].
Store in the original packaging. Don’t abandon desiccant. Protect from light and moisture.