Apalutamide (Erleada) is a new-generation androgen receptor inhibitor that has been approved for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). By blocking the nuclear translocation of androgen receptors and their binding to DNA, this drug effectively inhibits tumor progression.

Precautions for Administration of Apalutamide (Erleada)

Confirmation of Indications

Indicated for metastatic castration-sensitive prostate cancer (in combination with GnRH analogs or after bilateral orchiectomy).

Indicated for non-metastatic castration-resistant prostate cancer (requires confirmation that the prostate-specific antigen doubling time (PSADT) is ≤ 10 months).

Assessment of Underlying Diseases

Cardiovascular system: A detailed record of medical history related to hypertension, diabetes mellitus, and dyslipidemia is required.

Nervous system: Screen for a history of epilepsy, brain injury, stroke, or brain tumors.

Skeletal system: Assess for osteoporosis and a history of previous fractures.

Standard Administration Regimen

Recommended dose: 240 mg orally once daily (either one 240 mg tablet or four 60 mg tablets can be used, depending on the available specifications).

Administration requirements: Swallow the tablets whole; do not chew or crush them. They can be taken with or without food.

Dosage Adjustment Guidelines

Suspension of medication is required when grade 3 or above adverse reactions occur.

Permanent discontinuation of medication is necessary in cases of severe interstitial lung disease (ILD)/pneumonia or confirmed severe cutaneous adverse reactions (SCARs).

After other adverse reactions improve to grade ≤ 1, treatment can be resumed at the original dose or reduced to 180 mg/120 mg.

Cardiovascular and Cerebrovascular Events (Incidence: 3.7%-4.4%)

Key monitoring points: Regularly assess blood pressure, electrocardiogram (ECG), and neurological symptoms.

Interventions: Optimize the management of cardiovascular risk factors; permanent discontinuation of medication should be considered for grade 3-4 events.

Other Important Reactions

Seizures: Incidence rate is 0.4%; permanent discontinuation of medication is required after the first seizure occurs.

ILD/Pneumonia: Incidence rate is 0.8%; immediate discontinuation of medication and evaluation are necessary.

Medication Monitoring of Apalutamide (Erleada)

Laboratory Monitoring Matrix

Hematological monitoring: Perform a complete blood count at baseline and during each treatment cycle.

Biochemical indicators: Monitor liver function, renal function, electrolytes, blood lipids, and thyroid function (thyroid-stimulating hormone (TSH) testing every 4 months).

Clinical Manifestation Tracking

Quality of life: Regularly assess the degree of fatigue (incidence rate: 39%) and joint pain (incidence rate: 17%).

Symptom burden: Record the progression of rash and changes in body weight (16% of patients experience weight loss).

Neurological function: Monitor changes in consciousness and prodromal symptoms of seizures.

Elderly Patients (Accounting for 40% of Patients Aged ≥ 75 Years)

Enhanced fall risk assessment: The incidence of falls is twice as high as that in younger patients.

Attention to drug interactions: Elderly patients often use multiple cardiovascular drugs concurrently.

Men of Reproductive Age

Contraceptive requirements: Effective contraceptive measures must be used during treatment and for 3 months after the last dose.

Impact on fertility: This drug may impair fertility; it is recommended to undergo fertility counseling before starting treatment.