Active Ingredient: Enzalutamide
Enzalutamide is indicated for:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 160 milligrams enzalutamide, once daily.
The recommended dose is 160 mg enzalutamide as a single oral daily dose.
Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients with CRPC or mHSPC who are not surgically castrated.
Patients with high-risk BCR nmHSPC may be treated with enzalutamide with or without a LHRH analogue. For patients who receive enzalutamide with or without a LHRH analogue, treatment can be suspended if PSA is undetectable (<0.2 ng/mL) after 36 weeks of therapy. Treatment should be reinitiated when PSA has increased to ≥2.0 ng/mL for patients who had prior radical prostatectomy or ≥5.0 ng/mL for patients who had prior primary radiation therapy. If PSA is detectable (≥0.2 ng/mL) after 36 weeks of therapy, treatment should continue (see section 5.1).
If a patient misses taking enzalutamide at the usual time, the prescribed dose should be taken as close as possible to the usual time. If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at the same or a reduced dose (120 mg or 80 mg) if warranted.
It can be taken with or without food.
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