This page provides a general, patient-friendly summary of prescribing considerations for enzalutamide. It is not a replacement for the official prescribing information approved for a specific country.
Active Ingredient
Generic name: Enzalutamide
Enzalutamide is an androgen receptor signaling inhibitor used as endocrine therapy in specific prostate cancer treatment settings.
The reference product Xtandi is available in 40 mg and 80 mg film-coated tablets in the current European product information.
Therapeutic Use
Depending on applicable regulatory approval, enzalutamide may be used in men with prostate cancer in several treatment settings, including:
- Metastatic hormone-sensitive prostate cancer, together with androgen deprivation therapy
- Metastatic castration-resistant prostate cancer in specified treatment circumstances
- High-risk non-metastatic castration-resistant prostate cancer
- Certain men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer who are not suitable for salvage radiotherapy
The exact approved indications, combinations, eligibility requirements, and treatment sequence depend on the applicable regulatory authority and product labeling.
Recommended Administration
Current European product information for Xtandi describes a recommended dose of 160 mg enzalutamide once daily, administered as four 40 mg tablets or two 80 mg tablets.
This information should not be used by a patient to determine a personal dose.
Treatment should be initiated and supervised by a physician experienced in the treatment of prostate cancer.
Androgen Deprivation Therapy
For patients with castration-resistant prostate cancer or metastatic hormone-sensitive prostate cancer who have not undergone surgical castration, medical castration using an LHRH analogue should generally continue according to the applicable prescribing information.
The patient’s oncologist determines the complete treatment regimen.
Dose Modification
Treatment may need to be interrupted or the dose reduced if clinically significant adverse reactions occur.
Dose modification should be performed only according to the treating physician’s instructions and the applicable product label.
Patients should never independently alter the number of tablets they take.
Contraindications and Important Precautions
The official product information should be reviewed before treatment.
Important precautions include:
Seizure Risk
Enzalutamide may increase the risk of seizures. Patients with a history of seizures or other factors that may predispose them to seizures should discuss these factors with their physician before treatment.
Patients who experience a seizure while taking enzalutamide require prompt medical evaluation.
Cardiovascular Disease
Ischemic heart disease has been reported in patients receiving enzalutamide. Patients with cardiovascular risk factors or existing cardiovascular disease should discuss these issues with their healthcare provider.
Falls and Fractures
Falls and fractures may occur during treatment. Individual risk can be influenced by age, bone health, other illnesses, and other medicines.
Hypertension
Blood pressure may increase during enzalutamide treatment. Blood pressure monitoring may therefore form part of routine follow-up.
Hypersensitivity
Enzalutamide can cause hypersensitivity reactions. Symptoms such as swelling of the face, lips, tongue, or throat or difficulty breathing require immediate medical attention.
Drug Interactions
Enzalutamide can affect the activity of drug-metabolizing enzymes and transport systems. Consequently, it may change exposure to certain other medicines.
Before prescribing enzalutamide, the healthcare professional should review:
- Prescription medicines
- Over-the-counter medicines
- Anticoagulants
- Antiepileptic medicines
- Heart medicines
- Medicines for infections
- Herbal products
- Vitamins and supplements
Patients should not assume that a non-prescription product is automatically safe to combine with enzalutamide.
Pregnancy and Reproductive Risk
Enzalutamide is intended for use in men with prostate cancer. Because medicines affecting androgen signaling can present reproductive risks, patients should follow the contraception and reproductive precautions contained in the official product information applicable to their treatment.
Women who are pregnant or may become pregnant should not handle or use enzalutamide unless specifically instructed under appropriate medical and product-handling guidance.
Monitoring
Monitoring during treatment may include clinical assessment of:
- Prostate cancer status
- Symptoms and treatment response
- Blood pressure
- Cardiovascular health
- Neurological symptoms
- Falls or fractures
- Adverse reactions
- Other medicines and possible interactions
The exact monitoring schedule is individualized.
Important Reminder
This page is a general educational summary. The official prescribing information supplied with the specific product and approved in the relevant jurisdiction takes precedence.
Enzalutamide treatment should be prescribed and monitored by a healthcare professional experienced in prostate cancer management.