Metastatic hormone-sensitive prostate cancer (mHSPC)

Active Ingredient: Apalutamide

Indication for Apalutamide

Population group: men, only adults (18 years old or older)

Apalutamide is indicated in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

For this indication, competent medicine agencies globally authorize below treatments:

240 mg once daily

Route of admnistration

Oral

Defined daily dose

240 - 240 mg

Dosage regimen

From 240 To 240 mg once every day

Detailed description

The recommended dose is 240 mg as an oral single daily dose.

Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated.

If a dose is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. Extra tablets should not be taken to make up the missed dose.

If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted.

Dosage considerations

It can be taken with or without food.

Active ingredient

Apalutamide

Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide treatment decreases tumor cell proliferation and increases apoptosis leading to potent antitumor activity.

Read more about Apalutamide

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