Indications:
Indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis.
Features and clinical data:
Apalutamide is the world's first drug for the treatment of non-metastatic castration-resistant prostate cancer and has been granted priority review by the U.S. FDA. Apalutamide is a second-generation androgen receptor (AR) antagonist.
Phase III data from a global multicenter, double-blind, randomized, placebo-controlled SPARTAN clinical trial showed that the median metastasis-free survival of patients in the apalutamide treatment group reached 40.51 months, which was more than two years longer than that in the control group (24.31 months), and the risk of distant metastasis or death was reduced by 72%. Compared with the control group, the apalutamide treatment group reduced the risk of PSA progression by 94%.
Dosage and Administration:
The recommended dose is 240 mg (4 tablets) once daily, taken orally. It can be taken alone or with food. The tablet should be swallowed whole with water. If you miss a dose, take the dose as soon as possible on the same day and take the dose as scheduled the next day. Do not take extra doses to make up for a missed dose.
Dose adjustment: If the patient experiences ≥ Grade 3 toxicity or intolerable adverse reactions, dosing should be suspended until the symptoms improve to ≤ Grade 1 or the original level. If necessary, resume the same dose or reduce the dose.
Adverse reactions:
The most common side effects and adverse reactions are: fatigue, arthralgia, rash, decreased appetite, peripheral edema, falls, fractures, weight loss, hypertension, hot flashes, diarrhea, and vomiting.
