40mg Bdenza Enzalutamide Prostate Cancer Drugs 112 Capsules

Drug Name】
Generic name: enzalutamide soft capsules

Product name: XTANDI

English name: Enzalutamide Soft Capsules

Chinese Pinyin: Enzhalu’an Ruanjiaonang

【Indications】
This product is suitable for

Adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) who are at high risk of metastasis;

Treatment of adult patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or minimally symptomatic after failure of male hormone deprivation therapy (ADT) and who are not receiving chemotherapy.

【Dosage】
Medication should be used under the guidance of a specialist with experience in treating prostate cancer.

Dosage

The recommended dose is 160 mg of enzalutamide (four 40 mg softgels) taken orally once daily.

Non-surgical castration patients should continue medical castration with luteinizing hormone-releasing hormone (LHRH) analogues during treatment.

If the patient fails to take the medication on time, the prescribed dose should be taken as soon as possible. If you miss a full day of medication, you should continue taking your usual daily dose the next day.

If patients experience grade ≥3 toxicity or intolerable adverse reactions, the drug should be discontinued for 1 week or until symptoms subside to grade ≤2, and then restarted at the same dose or at a reduced dose (120 or 80 mg) if necessary.

Concomitant use with strong CYP2C8 inhibitors

Coadministration with strong CYP2C8 inhibitors should be avoided whenever possible.

If a patient must take a strong CYP2C8 inhibitor concomitantly, the enzalutamide dose should be reduced to 80 mg once daily. After discontinuing coadministration of a strong CYP2C8 inhibitor, the enzalutamide dose should be restored to the pre-coadministration dose level.

liver damage

No dose adjustment is required in patients with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C, respectively).

renal impairment

No dose adjustment is required in patients with mild or moderate renal impairment. Patients with severe renal impairment or end-stage renal disease should use this product with caution (see [Precautions]).

children and teenagers

Enzalutamide is indicated for the treatment of castration-resistant prostate cancer in adult men, but there is no experience with its use in children or adolescents.

elderly

No dose adjustment is required in elderly patients.

Dosing method

This product is for oral use. Do not chew, dissolve or open softgels. Take the entire capsule with water, with or without food.

【Adverse reactions】
The most common adverse drug reactions (≥10%) in randomized placebo-controlled clinical trials and more common in the enzalutamide group (≥2% higher than the placebo group) were asthenia/fatigue, decreased appetite, Hot flashes, joint pain, dizziness/nausea, high blood pressure, headache, and weight loss.

【Storage】
Store below 25℃.