Beacon、Janssen、PHARMA 2 VIENTIANE、Everest Apalutamide PROSTAXEN 60mg*30 tablets Prostate cancerfor stage 1 2 3 cancer

[Drug Name]
Generic Name:Apalutamide Tablets. inherit;">Generic Name:Apalutamide Tablets

Product Name:ONC®ERLEADA®

English name: Apalutamide Tablets

Chinese Pinyin: Apata'an Pian

[Indications]
This product is indicated for the treatment of high risk non-metastatic prostate cancer (NM-CRI). inherit;">
This product is indicated for the treatment of adult patients with high risk of metastatic non-metastatic cachectic resistant prostate cancer (NM-CRPC).

[Dosage]
Recommended Dosage

The recommended dose of this product is 240 mg (four 60 mg tablets) taken orally once daily. The tablets must be swallowed whole. The tablets may be taken alone or with food.

Patients should also be treated with synchronized deprivation therapy, i.e., concomitant treatment with gonadotropin-releasing hormone analogues (GnRHa) or have undergone bilateral orchiectomy.

If you miss a dose, take it as soon as possible on the same day and continue to take it the next day. Do not take an extra dose to make up for a missed dose.

Dosage adjustment

If a patient develops grade ≥3 toxicity or intolerable adverse reactions, withhold administration until symptoms improve to grade ≤1 or original grade, and resume the same dose or reduce the dose (180 mg or 120 mg) if necessary.

Medications for Special Populations

kid

The safety and efficacy of this product in pediatric patients have not been established.

autumn of one's years

No dosage adjustment is required for elderly patients (see instruction manual [Geriatric Use]).

renal insufficiency

No dose adjustment is necessary in patients with mild to moderate renal impairment. Since this product has not been studied in patients with severe renal insufficiency, it should be used with caution in this patient population (see labeling [pharmacokinetics]). If a patient is receiving treatment, the patient should be continuously monitored for adverse reactions as listed in [Adverse Reactions] and the dose should be reduced according to the dosage.

liver damage

No dose adjustment is necessary for patients with mild or moderate hepatic impairment at baseline (Child-Pugh Class A and B, respectively). This product is not recommended for use in patients with severe hepatic impairment because no data are available for this patient population and because it is primarily eliminated by the liver (see labeling [pharmacokinetics]).

[Adverse reactions]
11% of patients discontinued apalutamide due to adverse reactions, the most common of which was rash (3%). inherit;">Apalutamide was discontinued in 11% of patients due to adverse reactions, most commonly rash (3%). Adverse reactions resulted in discontinuation or dose reduction of apalutamide in 33% of patients;the most common (>1%) were rash, diarrhea The most common (>1%) are skin rash, diarrhea, fatigue, nausea, vomiting, high blood pressure, and hematuria. Serious adverse reactions occurred in 25% of patients treated with apalutamide compared with 23% of patients treated with placebo. The most common serious adverse reactions in the apalutamide group (>2%) were fractures (3%) and urinary retention (4%) in the placebo group.

[Storage]
Store at no more than 30℃. inherit;">Store at no more than 30℃. Store in the original packaging, do not discard the desiccant, protect from light and moisture.