Enzalutamide Soft Capsules Application Scope

Enzalutamide (XTANDI®) is indicated for adult men with prostate cancer in the following settings:

Metastatic castration-resistant prostate cancer (mCRPC)
Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)
High-risk non-metastatic hormone-sensitive prostate cancer (nmHSPC), as monotherapy or combined with androgen deprivation therapy

Enzalutamide Soft Capsules Characteristics

Ingredients: Enzalutamide – a nonsteroidal androgen receptor inhibitor.
Properties: Oral antiandrogen that blocks androgen receptor signaling to inhibit prostate cancer growth.
Packaging Specification:
White to off-white oblong soft gelatin capsules, imprinted with “ENZ.” Available in bottles of 120 capsules or blister packs (112 capsules; 28 per wallet).
Storage: Store at 20–25 °C (68–77 °F), in a dry, well-ventilated place. Keep container tightly closed.
Expiry Date: As indicated on the packaging.
Executive Standard: Complies with FDA, EMA pharmacopeial and regulatory standards.
Approval Number: FDA-approved under NDA 203415 in August 2012 for mCRPC. Expanded approvals include nmCRPC (2018), mCSPC and nmHSPC (2019).
Date of Revision: Refer to latest label.
Manufacturer: Astellas Pharma (in partnership with Pfizer in certain regions).

Dosage and Administration:
- Recommended Dose: 160 mg orally once daily (e.g., four 40 mg soft capsules or two 80 mg tablets). Dose reduction (e.g., to 120/80 mg) may be considered for adverse effects.
- Administration: Take orally, with or without food.
- Missed Dose: If missed, take as soon as remembered unless the next scheduled dose is near. Do not double dose.
Adverse Reactions:
- Common Adverse Reactions: Fatigue, hot flushes, hypertension, falls, musculoskeletal pain.
- Serious Adverse Reactions: Seizure (~0.4% incidence); neurological events (rare). If seizure occurs, discontinue enzalutamide.
Contraindications: During pregnancy – risk of fetal harm.
Precautions:
- Monitor for seizures; avoid use in patients with predisposing factors.
- Caution when prescribing with medications that lower seizure threshold.

Potent inducer of CYP3A4 and moderate inducer of CYP2C9 and CYP2C19. May reduce plasma levels of concomitant drugs metabolized by these enzymes (e.g. anticoagulants, some endocrine therapies).

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.