Product Description

Yanlieshu (Bicalutamide Capsules)

[Name of drug]

Generic name: Bicalutamide Capsules

Trade name: Yanlieshu

English name: Bicalutamide Capsules

[Ingredient] Bicalutamide   Chemical name: Bicalutamide   Molecular formula: C18H14N2O4F4S  Molecular weight: 430.37

[Indications] Yanlieshu (Bicalutamide Capsules) is indicated for use in combination with a luteinizing hormone-releasing hormone (LHRH) analog or orchectomy for the treatment of advanced prostatic carcinoma.

[Dosage and Administration] Take orally. (1) Adults: male adults including the elderly: 1 capsule (50 mg), QD. Treatment with this product should be started at the same time as treatment with an LHRD analog or orchectomy. (2) Children: This product is contraindicated in children. (3) Renal impairment: Dosage adjustment is not necessary in patients with renal impairment. (4) Hepatic impairment: Dosage adjustment is not necessary in patients with mild hepatic impairment. Drug accumulation may occur in patients with moderate to severe hepatic impairment (see Precautions).

[Pharmacology & Toxicology] Yanlieshu is a non-steroidal androgen receptor inhibitor without other endocrinological action. It binds to androgen receptors without activating gene expression, thereby inhibiting stimulation of androgens and leading to reduction of prostatic tumors. Antiandrogen withdrawal syndrome may occur in a subset of patients when Yanlieshu is clinically discontinued. Yanlieshu is a racemic mixture and its antiandrogen action is manifested only by the (R)-enantiomer.

[Pharmacokinetics] Yanlieshu is well-absorbed following oral administration. Co-administration of Yanlieshu with food has no clinically significant effect on its bioavailability.

[Adverse Reactions] Yanlieshu may lead to flushes, itching, breast tenderness and gynecomastia, which may remit following orchectomy. Yanlieshu may also lead to diarrhea, nausea, vomiting, debility, dry skin and rare transient liver function changes (elevated transaminase levels, jaundice).

[Contraindications]

1. Yanlieshu is contraindicated in women and children.

2. Yanlieshu cannot be used in patients who are allergic to it.

3. Yanlieshu cannot be used together with terfenadine, astemizol or cisapride.

[Strength] 50mg*30 capsules/pack

[Storage] Preserved less than 30℃.

[Expiry date] 24 months

[Approval Number] Approved by H20060983

[Corporate Name] Shanxi Zhendong Pharmaceutical Co. Ltd.